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HEALTHCARE CONFERENCE: DAY 2

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August 2016 / 2

Healthcare Conference: Day 2

JP Morgan Healthcare Conference: Day 2

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SUMMARY The 34th annual JP Morgan Healthcare Conference is being held in San Francisco, CA from January 11-14, 2016. A list of events and catalysts that were announced or updated at the conference today is included in this report. Additionally, below are some key points from today’s company presentations.

ABOUT THE AUTHORS BioMedTracker is an independent research service that offers proprietary clinical assessments and patient-based revenue forecasts of developmental drugs within a comprehensive and intuitive drug information database. Clients from the pharmaceutical, biotech, and investment industries rely on BioMedTracker for its insight on the likelihood of approval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape of every important disease and indication. Over the last several years, BioMedTracker has become the leader in providing objective information alongside evidence based clinical assessments and investment research on pipeline drugs worldwide. For more information on getting direct access to BioMedTracker, please email [email protected]. MedDeviceTracker is an all new medtech intelligence platform that provides clients with real-time data and analysis on medical devices and diagnostics. From the people behind BioMedTracker, comes an event-driven research service for the medical device and diagnostic marketplace. For access to MedDeviceTracker please contact your sales representative or email [email protected].

DISCLAIMER Copyright © 2016 Sagient Research This report is published by Sagient Research (the Publisher). This report contains information from reputable sources and although reasonable efforts have been made to publish accurate information, you assume sole responsibility for the selection, suitability and use of this report and acknowledge that the Publisher makes no warranties (either express or implied) as to, nor accepts liability for, the accuracy or fitness for a particular purpose of the information or advice contained herein. The Publisher wishes to make it clear that any views or opinions expressed in this report by individual authors or contributors are their personal views and opinions and do not necessarily reflect the views/opinions of the Publisher.


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KEY POINTS – DAY 2 The second day of JPM saw several large companies providing fairly general overviews.

Bristol-Myers Squibb (BMY) focused on the continued expansion of its immune-oncology franchise led by guidance for the continued development of Opdivo across tumor types, including a foray into DLBCL. Sanofi (SNY) suggested a transformative year 2016 as the company works to maintain its diabetes franchise and gain a small foothold in oncology, likely through acquisitions. Finally, GlaxoSmithKline (GSK) disclosed plans to submit regulatory filings for Benlysta SC for lupus in 2016.

Astellas (4503:JP) presented new data from its Japanese lung cancer study of ASP8273, its entrant into the next generation of EGFR inhibitors. ASP8273 trails Tagrisso (AZN), which has already been FDA approved, and rociletinib (CLVS), for which an NDA has already been filed.

CureVac provided guidance for its prostate cancer drug, CV9104. The company

announced that top-line data would likely be available in 2016.

Immunogen (IMGN) suggested that its highly-anticipated data for mirvetuximab in ovarian cancer would likely be presented at the 2016 ASCO. The company also said IMGN779 from its new class of DNA alkylating agents would enter Phase I clinical study for AML in 1H2016.

Acadia (ACAD) expects to report first results from its Phase II study of Nuplazid in Alzheimer's disease during the second half of 2016.

For their cardiovascular franchise, Amgen (AMGN) reiterated important catalysts for Repatha in the second half of 2016, which should demonstrate that its LDL-c lowering does improve atherosclerosis and CV events: top-line data from both the cardiovascular outcomes study and the IVUS coronary imaging study. Officials view the latter as a complementary differentiating factor. AMGN's presentation had Rx data showing Repatha and competitor Praluent are currently running neck and neck, but with only about 400 total Rxs per week each. AMGN officials hope payor utilization management criteria will change with positive results from the outcomes study. REGN/SNY are expecting interim analyses in Praluent's cardiovascular outcomes study in 2016, with a futility analysis at 50% of events and, in H2, a futility/overwhelming efficacy analysis at 75% of events. If those are negative, the final results are expected in H2 2017, per SNY's presentation at the conference (REGN's presentation will come tomorrow, but they already released the slides). In heart failure, AMGN officials were excited about the prospects for omecamtiv, but still need to go through several hurdles for a decision on Phase III.


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Amicus (FOLD) had new, patient-level data on migalastat's impact on diarrhea in Fabry disease, showing more clearly the larger separation at higher levels of baseline symptoms, though the number of placebo patients in the higher baseline group was small. The company expects to submit answers to the day-150 EMA questions shortly, with a CHMP opinion continued to be expected early 2016. They still need to meet with the FDA later this quarter to determine on a regulatory pathway (due to mixed data). For their epidermolysis bullosa drug, Zorblisa, acquired with Scioderm, the company noted the Phase III was powered for a difference on target wound healing of ~17%. They just barely saw that degree of difference in the small Phase IIb in the ITT population (19%), but there was a substantially larger difference in the evaluable population (41%). They are also selecting patients with larger and more chronic wounds to improve the chances for a positive study. The Phase III trial is approximately half enrolled, and officials extended the estimate for top-line data to H2 2016.

On the diabetes front, Lilly (LLY) expects positive cardiovascular outcomes data from SGLT2 inhibitor Jardiance to be added to its label in the US and EU in 2016. Data for the Phase IIIb MARLINA study of DPP4 inhibitor Tradjenta in patients with albuminuria is also expected, but will likely just be released as the data is presented at a medical meeting. Sanofi announced plans to start Phase III trials in Q4 for a couple diabetes drugs they licensed in November of last year, SGLT2 inhibitor sotagliflozin (which also has SGLT1 properties) and GLP1 agonist efpeglenatide. However, these compounds are late to the game and it is unclear if they are differentiated enough to have much impact.


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CONTENTS Alexion Pharmaceuticals, Inc. (ALXN) ........................................................................................ 6

Kanuma for Lysosomal Acid Lipase Deficiency ........................................................................ 6

Alkermes plc (ALKS) ..................................................................................................................... 6

ALKS 3831 for Schizophrenia .................................................................................................... 6

Amicus Therapeutics, Inc. (FOLD) ................................................................................................ 7

Zorblisa for Epidermolysis Bullosa ........................................................................................... 7

Zorblisa for Epidermolysis Bullosa ........................................................................................... 9

Astellas Pharma, Inc. .................................................................................................................... 9

Gilteritinib for Acute Myelogenous Leukemia (AML) ............................................................. 9

ASP8273 for Non-Small Cell Lung Cancer (NSCLC) ................................................................. 10

Chimerix, Inc. (CMRX) ................................................................................................................ 11

CMX8521 for Norovirus .......................................................................................................... 11

Brincidofovir (IV) for Cytomegalovirus (CMV) Infection (Antiviral) ..................................... 12

Eli Lilly & Company (LLY) ........................................................................................................... 13

LY3012207 for Sarcoma .......................................................................................................... 13

Endologix, Inc. (ELGX) ................................................................................................................ 13

Nellix Endovascular Aneurysm Sealing System for Aortic Aneurysm ................................... 13

Glenmark Pharmaceuticals Limited ........................................................................................... 14

GBR 830 for Atopic Dermatitis (Eczema) ............................................................................... 14

GBR 1302 for Cancer ............................................................................................................... 14

Halozyme Therapeutics, Inc. (HALO) ........................................................................................ 15

PEGPH20 for Pancreatic Cancer ............................................................................................. 15



ImmunoGen, Inc. (IMGN) ........................................................................................................... 18

Mirvetuximab soravtansine for Ovarian Cancer ................................................................... 18

Liquida Technologies .................................................................................................................. 19

ENV905 for Ocular Inflammation (Ophthalmology) .............................................................. 19

ENV1105 for Diabetic Macular Edema (Ophthalmology)...................................................... 20


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ENV1305 for Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology) ........ 21

Merrimack Pharmaceuticals, Inc. (MACK) ................................................................................. 21

Onivyde for Pancreatic Cancer ............................................................................................... 21

Opko Health (OPK) ..................................................................................................................... 22

MOD-6030 for Obesity ........................................................................................................... 22

MOD-6030 for Diabetes Mellitus, Type II .............................................................................. 22

CTAP201 for Hyperparathyroidism (Secondary) ................................................................... 23

Roche Holding AG (RHHBF) ....................................................................................................... 23

PEGPH20 Companion Diagnostic for Pancreatic Cancer ....................................................... 23

Atezolizumab for Bladder Cancer .......................................................................................... 24

Atezolizumab for Non-Small Cell Lung Cancer (NSCLC)......................................................... 24

Sangamo Biosciences, Inc. (SGMO) ........................................................................................... 25

SB-LSD4 for Fabry's Disease ................................................................................................... 25

SB-318 for Mucopolysaccharidosis I (MPS I; Hurler Syndrome) ........................................... 26

True North Therapeutics, Inc. ..................................................................................................... 26

TNT009 for Complement Deficiencies / Abnormalities ........................................................ 26

List of New BioMedTracker Catalysts…………………………………………………………………………………….28 List of Updated BioMedTracker Catalyts………………………………………………..……………………………..32 List of MedDeviceTracker Catalysts……………………………………………………………………………………….40


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ALEXION PHARMACEUTICALS, INC. (ALXN) Kanuma for Lysosomal Acid Lipase Deficiency

Event Date: 01/12/2016

Event Type: Progress Update - Product Launch (U.S.) (Clinical Analysis)

Trial Name: N/A

Market Group: Metabolic

Lead Company: Alexion Pharmaceuticals, Inc. (ALXN)

Partner Companies: N/A

Phase: Approved

Change to Likelihood of Approval: 0%

Likelihood of Approval: 100% (Same As Avg.)

Average Approval: 100%

Analysis: Alexion announced that Kanuma has been launched in the U.S.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (ALXN, Slide 20)

ALKERMES PLC (ALKS) ALKS 3831 for Schizophrenia


Event Type: Regulatory - Meeting with FDA (Clinical Analysis)

Trial Name: N/A

Market Group: Psychiatry

Lead Company: Alkermes plc (ALKS)


Phase: II


Likelihood of Approval: 17% (5% Above Avg.)


Analysis: Alkermes announced that they completed an End-of-Phase II meeting with the FDA to discuss ALKS 3831 for the treatment of schizophrenia.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (ALKS, Slide 36)


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AMICUS THERAPEUTICS, INC. (FOLD) Zorblisa for Epidermolysis Bullosa


Event Type: Trial Data - Updated Results (Clinical Analysis)

Trial Name: Phase IIb - SD-003


Lead Company: Amicus Therapeutics, Inc. (FOLD)


Phase: III




Placebo Treatment Treatment Placebo Treatment Treatment Treatment Description Placebo

Evaluable SD-101 3% Evaluable Patients

SD-101 6% Evaluable Patients

Placebo ITT

Patients

SD-101 3% ITT Patients

SD-101 6% ITT

Patients Number of Evaluable Patients

17 16 12 N/A N/A N/A

Target Wound Healing at Month 1 (Endpoint=Primary)

41.000 % 38.000 % 67.000 % 41.000 % 38.000 % 53.000 %

Target Wound Healing at Month 2

41.000 % 44.000 % 82.000 % (P= 0.0400)

41.000 % 44.000 % 60.000 %

Median Time to Wound Closure (Endpoint=Secondary)

91.000 Days

86.000 Days

30.000 Days

N/A N/A N/A

Analysis: Amicus presented results for the Phase IIb study of SD-101 for epidermolysis bullosa (EB). Previous data from this study were last seen in September 2014. Context

42/44 patients have entered the optional extension study (SD-004) SD-101 6% concentration selected for Phase III study based on Phase IIb dose

response Wound closure at Month 2 (versus Month 1) is optimal time to measure

primary endpoint. Endpoint is accepted by FDA and EU regulators Defined approval pathway with Phase III (Study 005) study design based on


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EMA and FDA feedback Top-line data for Study 005 expected 2H 2016 Rolling NDA initiated 4Q15

Design 48 EB patients (age ≥ 6 months)* - 1:1:1 Randomization - Daily Topical Application *Initial Disease Severity: Mean target lesion size (cm2) 14.0 (range 5-39); mean lesionalBSA: 19.4% (range 0.4-48%); mean wound age (days): 182 (range 21-1,639) EB Subtypes enrolled: Simplex (n=11), Recessive Dystrophic (n=29), and Junctional (n=8) Endpoints Primary Efficacy Endpoint - Target Wound Healing at Month 1 - Baseline wound: Chronic (≥ 21 days),size 5-50 cm2 Results

Placebo response minimized by analyzing subgroup of patients with wounds ≥ 10 cm2

o Complete target wound closure SD-101 6% - 50% (n= 4) vs. Placebo - 12.5% (n=8) at Month 2

Phase IIb results used to calculate appropriate sample size in Phase III study o p ≤ 0.05 if treatment difference ~17% or greater

Wound closure at Month 2 (versus Month 1) is optimal time to measure primary endpoint

Most Common Adverse Events Treatment-emergent adverse events (TEAE) generally similar across treatment groups. No deaths and no severe TEAEs. No serious adverse events reported in SD-101 6% group. Comment The ITT analysis for the high dose only showed a modest improvement in patients with complete target wound closure at 2 months (19% difference), but the evaluable patient analysis had a much larger difference (41%). The company noted at the JPM conference that the Phase III study is powered for a 17% difference, and also is including baseline entry criteria that will hopefully improve the chances for success (more chronic and larger wounds).


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We should note, though, that the Phase IIb study was relatively small (only 45 patients) and there was no evidence of a dose response. Time to wound closure was more consistent between the ITT and evaluable populations, but again, there was no dose response. As a result, we are limiting our increase in likelihood of approval to 2%.

Source: Sagient Analysis J.P. Morgan Healthcare Conference 01/12/2016 (FOLD) Dermatology Summit 01/10/2016 (Company Presentation)

Zorblisa for Epidermolysis Bullosa


Event Type: Regulatory - Rolling NDA/BLA Initiated (Clinical Analysis)

Trial Name: N/A


Lead Company: Amicus Therapeutics, Inc. (FOLD)


Phase: III




Analysis: Amicus reported that the Company's rolling NDA for Zorblisa for the treatment of epidermolysis bullosa was initiated in the fourth quarter of 2015.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (FOLD, Slide 13)

ASTELLAS PHARMA, INC.

Gilteritinib for Acute Myelogenous Leukemia (AML)



Trial Name: Phase I/II - CHRYSALIS

Market Group: Oncology


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Lead Company: Astellas Pharma, Inc. (4503:JP)


Phase: III




Analysis: Astellas reported new data for Gilteritinib (ASP2215) from the Phase I/II trial in FLT3+ AML patients at the 34th annual JP Morgan Healthcare conference. Results from this study were last seen in December 2015. Design Patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) were studied in an open-label safety, tolerability, and PK trial. Response rate, overall survival, event free survival, and leukemia free survival were also evaluated. Results Across all FLT3+ subjects treated with ASP2215 great or equal to 80mg, the median duration of response was 111 days (8-383 range). Duration of response was calculated from the first observed response of PR or better. Median time to best response was 32 days (26-364 range). Time to best response was only evaluated for subjects who achieved best response of PR or better. Median overall survival was 218 days (12-430 range).

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Astellas, Slide 8)

ASP8273 for Non-Small Cell Lung Cancer (NSCLC)



Trial Name: Phase I/II - EGFRmut (Japan)


Lead Company: Astellas Pharma, Inc. (4503:JP)


Phase: II



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Treatment Treatment Description ASP8273 300 mg Number of Patients N/A Number of Evaluable Patients 70 Overall Response Rate (ORR) 64.000 %

Analysis: Astellas reported new data for ASP8273 from the Phase I/II trial in T790M+ NSCLC patients in Japan at the 34th annual JP Morgan Healthcare conference. Results from this study were last seen in February 2015. Design Patients with non-small cell lung cancer (NSCLC) with EGFR activating mutations previously treated with EGFR-TKIs were studied in an open-label, dose escalation safety, tolerability, MTD, and RP2D trial. Results Subjects with evaluable data (n=70) treated with 300mg ASP8273 showed at least stable disease in target lesions. Preliminary ORR was 64% (n=45/70), including both confirmed and unconfirmed responses.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Astellas, Slide 9)

CHIMERIX, INC. (CMRX) CMX8521 for Norovirus


Event Type: Progress Update (Clinical Analysis)

Trial Name: N/A

Market Group: Infectious disease

Lead Company: Chimerix, Inc. (CMRX)


Phase: Preclinical

Change to Likelihood of Approval: N/A


Average Approval: N/A


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Analysis: Chimerix announced an update to its Norovirus development program at the JPM Conference. CMX8521 is a nucleoside with in vitro activity against mouse and human norovirus. A 7-day non-GLP toxicology/toxicokinetic study has been completed in-life with no clinical or gross post-mortem signs of toxicity. Clinical pathology and TK results are pending. There has been no off-target pharmacology observed in vitro when screened against a panel of 87 receptors, transporters and enzymes associated with adverse pharmacology.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (CMRX, Slide 28)

Brincidofovir (IV) for Cytomegalovirus (CMV) Infection (Antiviral)



Trial Name: N/A

Market Group: Infectious disease

Lead Company: Chimerix, Inc. (CMRX)


Phase: Preclinical




Analysis: Chimerix announced that the Company is developing an intravenous formulation of brincidofovir. A 28-day IND-enabling preclinical study is currently ongoing. Chimerix anticipates a FTIH study for brincidofovir (IV) will begin in the second half of 2016.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (CMRX, Slide 14)


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ELI LILLY & COMPANY (LLY) LY3012207 for Sarcoma



Trial Name: N/A


Lead Company: Eli Lilly & Company (LLY)

Partner Companies: Bristol-Myers Squibb (BMY)

Phase: NDA/BLA




Analysis: Eli Lilly announced that the Company has begun U.S. rolling regulatory submission for olaratumab for the treatment of soft tissue sarcoma in late 2015.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (LLY, Slide 11)

ENDOLOGIX, INC. (ELGX)

Nellix Endovascular Aneurysm Sealing System for Aortic Aneurysm


Event Type: Regulatory - PMA Modular Filing (Clinical Analysis)

Trial Name: N/A

Market Group: Cardiovascular

Lead Company: Endologix, Inc. (ELGX)


Phase: PMA




Analysis: Endologix announced that it has completed the submission of PMA modules 1 and 3. The company is currently working toward modular 2, which is expected in February,


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and modular 4, which is expected in the March or April time frame.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (ELGX; Slide 9)

GLENMARK PHARMACEUTICALS LIMITED GBR 830 for Atopic Dermatitis (Eczema)


Event Type: Trial Announcement - Initiation (Clinical Analysis)

Trial Name: Phase II

Market Group: Allergy

Lead Company: Glenmark Pharmaceuticals Limited (GNP:IN)


Phase: II




Analysis: Glenmark reported that a Phase IIa trial of GBR 830 has been initiated in the US with atopic dermatitis as the primary indication.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Glenmark, Slide 10)

GBR 1302 for Cancer


Event Type: Trial Announcement - Initiation (Clinical Analysis)

Trial Name: N/A


Lead Company: Glenmark Pharmaceuticals Limited (GNP:IN)


Phase: I





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Analysis: Glenmark reported that it has initiated a Phase I trial of GBR-1302 in Germany. GBR-1302 is listed in the pipeline with HER2-positive cancers are the primary indications.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Glenmark, Slide 10)

HALOZYME THERAPEUTICS, INC. (HALO)

PEGPH20 for Pancreatic Cancer


Event Type: Trial Announcement - Patient Enrollment Completed (Clinical Analysis)

Trial Name: Phase II - HALO-202 (w/Abraxane + Gemcitabine)


Lead Company: Halozyme Therapeutics, Inc. (HALO)

Partner Companies: Nektar (NKTR)

Phase: II

Change to Likelihood of Approval:

0%



Analysis: Halozyme Therapeutics provided key program updates and its Annual financial guidance at the 34th annual JP Morgan Healthcare Conference. Halozyme announced that they achieved target enrollment in Stage 2 of Halozyme Study 202 of investigational new drug PEGPH20 in metastatic pancreatic ductal adenocarcinoma patients. Halozyme has enrolled approximately 120 patients through the end of 2015. The company remains blinded to the efficacy results and projects presentation of mature progression-free survival data in the event driven study in the fourth quarter of 2016. 45 total sites (US only) enrolled 146 patients in Stage 1, which was shown in the interim data that has been released. 114 patients was the target enrollment for Stage 2.

Source: Press Release 01/11/2016 J.P. Morgan Healthcare Conference 01/12/2016 (HALO, Slide 9)


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Trial Name: Phase II - HALO-202 (w/Abraxane + Gemcitabine)




Phase: II




Analysis: Halozyme Therapeutics reported a continued reduction in the rate of thromboembolic (TE) events in the PEGPH20 treatment arm in Stage 2 of Study 202. Results from this study were last seen in May 2015. Design Study 202 (Halo 109-202) is a Phase II multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreatic cancer. Endpoints The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and ABRAXANE alone. A second primary endpoint will assess the TE event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival. Results With patient data through December 15, 2015, Halozyme reported a TE event rate in the PEGPH20 arm of 12 percent (9 out of 73 patients) compared to the previously reported 42 percent (31 out of 74 patients) in Stage 1 of the study. Halozyme amended the study protocol in 2014, including the addition of prophylactic administration of low molecular weight heparin (enoxaparin) in both treatment arms based on a reported potential imbalance of TE events in the study.


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The TE event rate in both stages and arms of the study are: Enoxaparin Prophylaxis

Dose PEGPH20 +

ABRAXANE + Gemcitabine

ABRAXANE + Gemcitabine

Stage 1 (through Dec. 5, 2014)

N/A 42% (n=74) 25% (n=61)


40 mg/day; or 40 mg/day increased to 1

mg/kg/day

28% (n=18) 29% (n=7)


Started on 1 mg/kg/day 7% (n=55) 4% (n=27)


TOTAL – Stage 2 12% (n=73) 9% (n=34)




Event Type: Trial Announcement (Clinical Analysis)

Trial Name: Phase III - HALO-301




Phase: II




Analysis: Halozyme Therapeutics announced that they remain on schedule to initiate a Phase III HALO-301 study at the end of March 2016 for PEGPH20 in Stage IV metastatic pancreatic ductal adenocarcinoma high-HA patients. Phase III Study The company provided an update on the Phase III trial design, selecting approximately 200 sites in 20 countries concentrated in North America, Europe, South America and Asia Pacific. The protocol and statistical design have been reviewed by the majority of participating countries, including the U.S. and multiple E.U. member states through the voluntary harmonization procedure (VHP). Target enrollment is 420 patients.


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The trial will be a randomized 2:1 double blind, placebo-controlled, global study. The trial is powered for two primary endpoints, progression-free survival (PFS) and overall survival. Statistical powering to support PFS is based on achieving a hazard ratio of 0.59.


IMMUNOGEN, INC. (IMGN) Mirvetuximab soravtansine for Ovarian Cancer



Trial Name: Phase I - FOLR1-Positive


Lead Company: ImmunoGen, Inc. (IMGN)


Phase: I




Treatment Treatment Treatment Treatment Description Mirvetuximab

Soravtansine All Patients

Mirvetuximab Soravtansine

High and Medium FRa Expression

Mirvetuximab Soravtansine Patients on

Treatment >6 Months Number of Patients 20 16 7 Confirmed Objective Response

7 Patients 7 Patients 6 Patients

Analysis: ImmunoGen reported updated results on their Phase I trial of Mirvetuximab Soravtansine for ovarian cancer at the 34th annual J.P. Morgan Healthcare Conference on January 12, 2016. Results were previously seen in November 2015. Context ImmunoGen reported that clinical data from the 40-patient cohort from the Phase I


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Mirvetuximab Soravtansince trial for ovarian cancer will be presented at a medical meeting in the second quarter of 2016. These findings informed inclusion criteria for FORWARD I. Results The results show that most patients had tumor shrinkage. Of all the patients, 35% (7/20) had a confirmed objective response and 6 of 7 patients had a confirmed reponse on treatment 6 months or longer. Objective reponse rates for all patients with high or medium FRa expression was 44% (7/16). Most Common Adverse Events The most common (>25% patients) side effects were diarrhea, blurred vision, vomiting, fatigue, nausea, and headaches. The majority of these effects were grade 1 or 2 and were seen to be manageable or reversible.

Source: Press Release 01/10/2016 J.P. Morgan Healthcare Conference 01/12/2016 (IMGN, Slides 7-9)

LIQUIDA TECHNOLOGIES ENV905 for Ocular Inflammation (Ophthalmology)


Event Type: Trial Data - Preclinical Results (Clinical Analysis)

Trial Name: Preclinical Studies

Market Group: Ophthalmology

Lead Company: Liquidia Technologies


Phase: Preclinical




Analysis: Envisia announced preclinical results of ENV905 for the treatment of post-operative inflammation.


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Context The Company plans to file an IND for ENV905 in the second half of 2016. Design ENV905 was tested in a rabbit model of inflammation, compared to daily topical QID Durezol and placebo. Results ENV905 is efficacious for more than 3 weeks in a rabbit model of inflammation. Single dose of ENV905 is equivalent or superior to daily topical QID Durezol in vivo.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Envisia, Slide 16)

ENV1105 for Diabetic Macular Edema (Ophthalmology)


Event Type: Trial Data - Preclinical Results (Clinical Analysis)

Trial Name: Preclinical Studies




Phase: Preclinical




Analysis: Envisia presented preclinical data for ENV1105 for the treatment of diabetic macular edema. Design ENV1105 was studied in a rabbit model versus Ozurdex. Results ENV1105 showed 6 to 12 months of duration in the study. PRINT dexamethasone formulation achieves therapeutic concentrations in the rabbit vitreous/retina for more than 3 months, compare with roughly 1 month for Ozurdex.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Envisia, Slide 19)


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ENV1305 for Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology)



Trial Name: N/A




Phase: Preclinical




Analysis: Envisia lists ENV1305 in preclinical development for the treatment of wet age-related macular degeneration (AMD). The Company anticipates elevating ENV1305 into preclinical development in 2016.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Envisia, Slides 6 and 23)

MERRIMACK PHARMACEUTICALS, INC. (MACK) Onivyde for Pancreatic Cancer


Event Type: Progress Update - Product Launch (U.S.) (Clinical Analysis)

Trial Name: N/A


Lead Company: Merrimack Pharmaceuticals, Inc. (MACK)

Partner Companies: PharmaEngine Baxalta (BXLT)

Phase: Approved




Analysis: Merrimack announced that Onivyde for pancreatic cancer was launched in the United States on October 26, 2015.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (MACK)


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OPKO HEALTH (OPK) MOD-6030 for Obesity


Event Type: Progress Update - Suspension (Clinical Analysis)

Trial Name: N/A


Lead Company: Opko Health (OPK)


Phase: Suspended




Analysis: Opko is moving forward with MOD-6031 and expects initiate a Phase I study in 1Q 2016. As such, we are suspending MOD-6030.

Source: Sagient Analysis J.P. Morgan Healthcare Conference 01/12/2016 (OPK, Slide 22)

MOD-6030 for Diabetes Mellitus, Type II


Event Type: Progress Update - Suspension (Clinical Analysis)

Trial Name: N/A

Market Group: Endocrine



Phase: Suspended




Analysis: Opko is moving forward with MOD-6031 and expects initiate a Phase I study in 1Q 2016. As such, we are suspending MOD-6030.

Source: Sagient Analysis J.P. Morgan Healthcare Conference 01/12/2016 (OPK, Slide 22)


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CTAP201 for Hyperparathyroidism (Secondary)



Trial Name: N/A

Market Group: Endocrine



Phase: II




Analysis: Opko continues to list CTAP201 in Phase II development for mild-to-moderate secondary hyperparathyroidism (SHPT) in CKD stage 5 patients.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (OPK, Slide 10)

ROCHE HOLDING AG (RHHBF) PEGPH20 Companion Diagnostic for Pancreatic Cancer



Trial Name: N/A


Lead Company: Roche Holding AG (RHHBF)

Partner Companies: Halozyme (HALO)

Phase: Preclinical




Analysis: Halozyme announced they are advancing development of the companion diagnostic test to prospectively identify patients with high levels of hyaluronan, or HA and expect a U.S. IDE submission in February 2016.


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Halozyme has partnered with Ventana to develop the companion diagnostic and announced the methodology and scoring algorithm have been finalized. Based on the cutpoint for the Ventana diagnostic, Halozyme now expects approximately 35 to 40 percent of metastatic pancreatic cancer patients to have high-HA tumors, similar to the previously reported interim results from Stage 1 of its Phase 2 study using the Halozyme prototype assay. Analysis of biopsy samples from patients in Stage 1 of Study 202 with the new diagnostic show a PFS benefit in the PEGPH20 arm with a hazard ratio of 0.48.

Source: Press Release 01/11/2016 J.P. Morgan Healthcare Conference 01/12/2016 (HALO, Slide 15-16)

Atezolizumab for Bladder Cancer



Trial Name: N/A



Partner Companies: Chugai (4519:JP)

Phase: NDA/BLA




Analysis: Roche announced that it has initiated a rolling NDA for the approval of Atezolizumab for the treatment of bladder cancer in the US. Roche is seeking for approval based on the Phase III IMvigor210 study of Atezolizumab monotherapy in patients who are treatment-naive and ineligible for platinum-containing therapy.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Roche, Slide 21)

Atezolizumab for Non-Small Cell Lung Cancer (NSCLC)



Trial Name: N/A



August 2016 / 26



25



Partner Companies: Chugai (4519:JP)

Phase: NDA/BLA




Analysis: Roche announced that it has initiated a rolling NDA for the approval of Atezolizumab for the treatment of NSCLC in the US. Roche is seeking for approval based on the Phase III FIR, BIRCH and POPLAR studies of Atezolizumab monotherapy.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (Roche, Slide 21)

SANGAMO BIOSCIENCES, INC. (SGMO)

SB-LSD4 for Fabry's Disease



Trial Name: N/A


Lead Company: Sangamo Biosciences, Inc. (SGMO)


Phase: Preclinical




Analysis: Sangamo currently lists SB-LSD4 for the treatment of Fabry disease in preclinical development in its pipeline. Sangamo plans to file an IND for SB-LSD4 in the second half of 2016.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (SGMO, Slide 18)


August 2016 / 27



26


SB-318 for Mucopolysaccharidosis I (MPS I; Hurler Syndrome)


Event Type: Regulatory - IND Filing (Clinical Analysis)

Trial Name: N/A


Lead Company: Sangamo Biosciences, Inc. (SGMO)


Phase: IND




Analysis: Sangamo filed an IND application for SB-318 for the treatment of Hurler Syndrome (MPS I) at the end of 2015.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (SGMO, Slide 18)

TRUE NORTH THERAPEUTICS, INC. TNT009 for Complement Deficiencies / Abnormalities



Trial Name: Phase Ia/Ib - TNT009-01

Market Group: Autoimmune/ immunology

Lead Company: True North Therapeutics, Inc.


Phase: I




Analysis: True North Therapeutics announced more results at the 34th annual JP Morgan Healthcare Conference from their Phase Ia/Ib study of TNT009. Initial results were released earlier in January 2016.


August 2016 / 28



27


Context Top-line Phase Ib data are expected in mid-2016. Design The Phase Ia trial in NHVs is completed. The single ascending dose (0.3, 1, 3, 10, 30, 60, and 100 mg/kg IV) and multiple ascending dose (30 and 60 mg/kg IV weekly for four weeks) portions have been completed for NHVs. Results POM demonstrated via blood-based PD assay. Additional results can be seen in the presentation slides. Most Common Adverse Events No relevant AEs reported to date.

Source: J.P. Morgan Healthcare Conference 01/12/2016 (True North, Slides 7-10)


August 2016 / 29


Expected Date Range Company Symbol Drug Indication Phase Expected Catalyst Catalyst Title Analysis Link

Now-06/30/2016Acadia Pharmaceuticals, Inc.

ACAD Nuplazid Alzheimer's Disease (AD) IITrial Announcement - Initiation

Phase II Agitation - Study to Start

Acadia announced that the Company plans on initiating a Phase II Alzheimer's Disease agitation study for Nuplazid in the first half of 2016.

118210

07/01/2016-12/31/2016Acadia Pharmaceuticals, Inc.

ACAD Nuplazid Alzheimer's Disease (AD) IITrial Data - Top-Line Results

Phase II 019 Study - Topline Results

Acadia Pharmaceuticals expects to report results from its Phase II study of Nuplazid in Alzheimer's Disease in the second half of 2016.

118211

Now-12/31/2016Actelion Pharmaceuticals Ltd.

ALIOF Lucerastat Fabry's Disease ITrial Data - Top-Line Results

Phase Ib - Top-Line ResultsActelion expects to have Phase Ib results for Lucerastat for the treatment of Fabry disease in 2016.

118166


ALIOF OpsumitPulmonary Arterial Hypertension (PAH)

ApprovedTrial Data - Top-Line Results

Phase II MERIT - Top-Line Results

Actelion expects to have results from its Phase II MERIT study of Opsumit in 2016.

118164


ALIOF PivlazHemorrhagic stroke / Intracerebral Hemorrhage (ICH)

IITrial Data - Top-Line Results

Phase II REVERSE - Top-Line Results

Actelion expects to have Phase II results for Clazosentan in 2016.

118165


ALIOF Ponesimod Multiple Sclerosis (MS) IIIProgress Update - Development Review

Development UpdateActelion plans to provide an update on its Phase III multiple sclerosis program of Ponesimod in 2016.

118167

01/12/2016-12/31/2016 Adaptimmune Ltd. ADAP NY-ESO-1(C259)Non-Small Cell Lung Cancer (NSCLC)

I/IITrial Announcement - Initiation

Trial to Start

GlaxoSmithKline announced that they expect to initiate a clinical study of NY-ESO-1 for the treatment of non-small cell lung cancer (NSCLC) in 2016 or 2017. We await an update through 2016.

118240

01/12/2016-12/31/2016 Adaptimmune Ltd. ADAP NY-ESO-1(C259) Sarcoma I/IITrial Announcement - Initiation

POC Study to Start

GlaxoSmithKline announced that they expect to initiate a clinical proof of concept (POC) study of NY-ESO-1 for the treatment of sarcoma in 2016 or 2017. We await an update through 2016.

118237

Now-12/31/2016Alder Biopharmaceuticals, Inc.

ALDR ALD1613 Cushing's Syndrome Preclinical Regulatory - IND Filing IND FilingAlder expects to submit an IND filing for ALD1613 for the treatment of Cushing's syndrome in 2016.

118203

04/01/2016-09/30/2016Alder Biopharmaceuticals, Inc.

ALDR ALD403 Migraine and Other Headaches IIITrial Data - Updated Results

Phase IIb Chronic Migraines - Updated Results

Alder expects 24-week data for the Phase IIb study of ALD403 for chronic migraine in mid-2016.

118192

01/12/2016-12/31/2016Alder Biopharmaceuticals, Inc.

ALDR Clazakizumab Psoriatic Arthritis (PA) IIb Partnership - New Partnership - NewAlder seeks to identify a strategic partner for its clazakizumab program. We await and update through the end of 2016.

118202

01/01/2017-12/31/2017Alexion Pharmaceuticals, Inc.

ALXN ALXN1210Paroxysmal Nocturnal Hemoglobinuria (PNH)

IIRegulatory - NDA/BLA Filing

NDA FilingAlexion is targeting approval for ALXN1210 for the treatment of PNH in 2018. As such we expect a NDA filing in 2017.

118191

Now-12/31/2016Alexion Pharmaceuticals, Inc.

ALXN ALXN1540 Crigler-Najjar syndrome PreclinicalTrial Announcement - Initiation

Clinical Trials to Start

ALXN 1540 one of the mRNA rare disease programs from the Company’s collaboration with Moderna is expected to enter the clinic in 2016 in patients with Crigler-Najjar Syndrome (CN-1).

118208

01/12/2016-12/31/2016 Alkermes plc ALKS ALKS 7119 Alzheimer's Disease (AD) PreclinicalTrial Data - Top-Line Results

Phase I - Top-Line Results

Alkermes expects to initiate a Phase I study of ALKS 7119 with an initial focus on agitation in Alzheimer's disease (AD) in the first quarter of 2016. Data from this trial is expected in 2016.

118256

01/12/2016-12/31/2016 Alkermes plc ALKS RDB 1450 Cancer INDTrial Data - Top-Line Results

Phase I - Top-Line ResultsAlkermes announced that they plan to advance RDB 1450 for the treatment of cancer into clinical trials and have early data in 2016.

118252

09/01/2016-12/31/2016 Amgen, Inc. AMGN Kyprolis Multiple Myeloma (MM) ApprovedTrial Data - Updated Results

Phase III ENDEAVOR - Updated Results

Amgen expects results for the Kyprolis ENDEAVOR study in later 2016.

118169

01/12/2016-04/30/2016 Amicus Therapeutics, Inc. FOLD Zorblisa Epidermolysis Bullosa IIITrial Data - Updated Results

Phase IIb SD-003 - Updated Results

Amicus expects to publish results from the Phase IIb study of Zorblisa for EB at dermatology conferences in the coming months. We expect an update through early 2016.

118255

01/12/2016-12/31/2016 ARMO Biosciences AM0010 Solid Tumors ITrial Announcement - Initiation

Phase II/II - Study to StartARMO plans to initiate registration enabling Phase II/III studies for AM0010 in multiple solid tumors in 2016.

118258

12/03/2016-12/06/2016 bluebird bio BLUE LentiGlobin Anemia I/II Trial Data - Other Clinical Results at ASH

bluebird bio announced that it plans to give a data update for LentiGlobin for beta-thalassemia and sickle cell disease at the 2016 American Society of Hematology Annual Meeting which will take place from December 3-6 2016.

118266

01/12/2016-12/31/2016 bluebird bio BLUE LentiGlobin Anemia I/IIRegulatory - MAA Submission (Europe)

MAA Submission

bluebird bio announced that they plan to pursue conditional approval in Europe on the basis of data from the ongoing Northstar (HGB-204) and HGB-205 studies as part of the adapative licensing pilot. We await an update in the time frame above.

118268

12/03/2016-12/06/2016 bluebird bio BLUE LentiGlobin Sickle Cell Anemia I Trial Data - Other Clinical Results at ASH

bluebird bio announced that it plans to give a data update for LentiGlobin for beta-thalassemia and sickle cell disease at the 2016 American Society of Hematology Annual Meeting which will take place from December 3-6 2016.

118265

01/12/2016-12/31/2016Boehringer Ingelheim GmbH

Tradjenta Diabetes Mellitus, Type II ApprovedTrial Data - Top-Line Results

Phase IIIb MARLINA - Topline Results

Eli Lilly expects an external data readout for the Phase IIIb MARLINA study of Linagliptin for the treatment of type 2 diabetes in 2016.

118275

01/12/2016-12/31/2016Bristol-Myers Squibb Company

BMY Opdivo Bladder Cancer IITrial Data - Top-Line Results

Phase II - CheckMate-275 - Top-Line Results

Bristol-Myers Squibb anticipates that registrational data from the Phase II CheckMate-275 study of Opdivo for second line bladder cancer will be available in 2016.

118179


BMY OpdivoBrain Cancer (malignant glioma; AA and GBM)

IIITrial Data - Top-Line Results

Phase III - CheckMate-143 - Top-Line Results

Bristol-Myers Squibb anticipates that registrational data from the Phase II CheckMate-143 study of Opdivo for recurrent glioblastoma will be available in 2016.

118181

BioMedTracker JPM New Catalysts - Day 2


August 2016 / 30





BMY Opdivo Head and Neck Cancer IIITrial Data - Top-Line Results


Bristol-Myers Squibb anticipates that registrational data from the Phase II CheckMate-141 study of Opdivo in second line head and neck cancer will be available in 2016.

118176


BMY Opdivo Hodgkin's Lymphoma IITrial Data - Top-Line Results


Bristol-Myers Squibb anticipates that registrational data from the Phase II CheckMate-205 study of Opdivo for second line Hodgkin lymphoma will be available in 2016.

118175


BMY OpdivoNon-Hodgkin's Lymphoma (NHL)



Bristol-Myers Squibb anticipates that registrational data from the Phase II CheckMate-139 study of Opdivo for relapsed/refractory diffuse large B-cell lymphoma will be available in 2016.

118177


BMY OpdivoNon-Small Cell Lung Cancer (NSCLC)



Bristol-Myers Squibb anticipates that registrational data from the Phase II CheckMate-026 study of Opdivo in first-line PD-L1 expressers with NSCLC will be available in 2016.

118182

01/12/2016-09/30/2016 Chimerix, Inc. CMRX Brincidofovir Antiviral - Other Treatments IIIRegulatory - Meeting with FDA

Meeting with FDA

Chimerix announced that the company will review data from the AdVise study with Regulatory agencies to determine a path for approval. The Company aims to determine its development plan by the summer of 2016. As such we await a meeting with the FDA in the time frame above.

118171

01/12/2016-12/31/2016 Chimerix, Inc. CMRX BrincidofovirCytomegalovirus (CMV) Infection (Antiviral)

IIIRegulatory - Meeting with FDA

Meeting with FDA

Chimerix plans to meet with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2016 to define regulatory paths for CMV prevention and/or treatment with brincidofovir.

118172

01/12/2016-12/31/2016 Chimerix, Inc. CMRX BrincidofovirCytomegalovirus (CMV) Infection (Antiviral)

IIIRegulatory - Meeting with European Medicines Agency

Meeting with EMA

Chimerix plans to meet with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2016 to define regulatory paths for CMV prevention and/or treatment with brincidofovir.

118173

07/01/2016-12/31/2016 Chimerix, Inc. CMRX Brincidofovir (IV)Cytomegalovirus (CMV) Infection (Antiviral)

PreclinicalTrial Announcement - Initiation

FTIH Study to Start

Chimerix announced that the Company is developing an intravenous formulation of brincidofovir. A 28-day IND-enabling preclinical study is currently ongoing. Chimerix anticipates a FTIH study for brincidofovir (IV) will begin in the second half of 2016.

118254

01/12/2016-12/31/2016 Eli Lilly & Company LLY Abemaciclib Breast Cancer IIITrial Data - Top-Line Results

Phase II - Topline ResultsEli Lilly expects data readout for a Phase II study of Abemaciclib as a single agent for the treatment of breast cancer in 2016.

118270

01/12/2016-12/31/2016 Eli Lilly & Company LLY Baricitinib Rheumatoid Arthritis (RA) IIITrial Data - Top-Line Results

Phase III RA BEYOND - Topline Results

Eli Lilly expects an external data readout for the Phase III RA-BEYOND (long-term extension) study of baricitinib for the treatment of rheumatoid arthritis.

118271

01/12/2016-12/31/2016 Eli Lilly & Company LLY Baricitinib Rheumatoid Arthritis (RA) IIIRegulatory - J-NDA Filing (Japan)

Japanese NDA Filing Eli Lilly announced plans for a Japanese regulatory filing for Baricitinib for the treatment of rheumatoid arthritis in 2016.

118277

Now-12/31/2016 Eli Lilly & Company LLY Ixekizumab Ankylosing Spondylitis SuspendedTrial Announcement - Initiation

Phase III - Trial to StartEli Lilly announced the potential initiation of a Phase III study of Ixekizumab for the treatment of axial spondyloarthritis in 2016.

118269

01/12/2016-12/31/2016 Eli Lilly & Company LLY Ixekizumab Psoriasis BLATrial Data - Top-Line Results

Phase III IXORA S - Topline Results

Eli Lilly expects an internal data readout for the Company's Phase III IXORA-S study of Ixekizumab for the treatment of psoriasis in 2016.

118274

01/12/2016-12/31/2016 Eli Lilly & Company LLY Ixekizumab Psoriatic Arthritis (PA) IIITrial Data - Top-Line Results

Phase III SPIRIT P2 - Topline Results

Eli Lilly expects an internal data read out for its Phase III SPIRIT P2 study of Ixekizumab for the treatment of psoriatic arthritis in 2016.

118273

Now-06/30/2016 Eli Lilly & Company LLY LY3012207 Sarcoma IIIRegulatory - Rolling NDA/BLA Completion

Rolling NDA Completed

Eli Lilly announced that the Company has begun a U.S. rolling regulatory submission for olaratumab for the treatment of soft tissue sarcoma in late 2015. We await on the completion of the rolling NDA submission through the first half of 2016.

118262

01/01/2017-04/30/2017 Envisia Therapeutics ENV1105Diabetic Macular Edema (Ophthalmology)


Phase II - Trial to StartEnvisia expects to initiate a Phase II study of ENV1105 for the treatment of diabetic macular edema in early 2017.

118197



Phase III - Trial to StartEnvisia expects to initiate a Phase III study of ENV1105 for the treatment of diabetic macular edema at the end of 2017.

118198


PreclinicalTrial Data - Top-Line Results

Phase II - Top-Line ResultsEnvisia expects Phase II results of ENV1105 for the treatment of diabetic macular edema in 2017.

118205

01/12/2016-12/31/2016 Envisia Therapeutics ENV1305Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology)


Preclinical Study - Trials to Start

Envisia anticipates elevating ENV1305 for the treatment of wet age-related macular degeneration (AMD) into preclinical development in 2016.

118222

09/01/2016-09/30/2017 Envisia Therapeutics ENV515Glaucoma / Ocular Hypertension (Ophthalmology)

IITrial Announcement - Initiation

Phase IIb/III - Trial to StartEnvisia announced that they expect to initiate a Phase IIb/III study of ENV515 for the treatment of glaucoma in late 2016 through approximately the third quarter of 2017.

118201

09/01/2017-12/31/2017 Envisia Therapeutics ENV515Glaucoma / Ocular Hypertension (Ophthalmology)


Phase III - Trial to StartEnvisia announced that they expect to initiate a Phase III study of ENV515 for the treatment of glaucoma at the end of 2017.

118199

07/01/2016-12/31/2016 Envisia Therapeutics ENV905Ocular Inflammation (Ophthalmology)

Preclinical Regulatory - IND Filing IND FilingEnvisia announced that they plan to file an IND for ENV905 for the treatment of post-operative inflammation in the second half of 2016.

118168



Phase II - Trial to StartEnvisia expects to initiate a Phase II study of ENV905 in patients with post-cataract inflammation in late 2016 through approximately mid-year 2017.

118195



Phase III - Trial to StartEnvisia expects to initiate a Phase III study of ENV905 in patients with post-cataract inflammation at the end of 2017.

118196


August 2016 / 31





PreclinicalTrial Data - Top-Line Results

Phase II - Top-Line ResultsEnvisia expects Phase II results of ENV905 for the treatment of post-operative inflammation in 2017.

118206

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK Benlysta SCSystemic Lupus Erythematosus (SLE)

IIIRegulatory - NDA/BLA Filing

BLA FilingGlaxoSmithKline announced that they plan to submit regulatory filings for Benlysta SC for the treatment of systemic lupus erythematosus (SLE) in 2016.

118223

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK Benlysta SCSystemic Lupus Erythematosus (SLE)

IIIRegulatory - MAA Submission (Europe)

MAA FilingGlaxoSmithKline announced that they plan to submit regulatory filings for Benlysta SC for the treatment of systemic lupus erythematosus (SLE) in 2016.

118224

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK GSK-1265744 LAP HIV / AIDS IIbTrial Announcement - Initiation

Phase III PrEP - Studies to StartGlaxoSmithKline announced that they expect to start Phase III studies of cabotegravir for the treatment of pre-exposure prophylaxis (PrEP) in 2016.

118228

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK GSK1278863 Anemia IITrial Announcement - Initiation

Phase III - Trial to StartGlaxoSmithKline announced that they plan to start a Phase III study of daprodustat for the treatment of anemia in 2016.

118226

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK GSK-2816126 Cancer ITrial Data - Top-Line Results

Phase I - Recommended Phase II Dose (RP2D)

GlaxoSmithKline announced that they expect to have the recommended Phase II dose of GSK-2816126 in 2016. As such we expect results from the Phase I study of GSK-2816126 within that same time frame.

118267

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK GSK-2879552 Small Cell Lung Cancer (SCLC) ITrial Data - Top-Line Results

Phase I - Recommended Phase II Dose (RP2D)

GlaxoSmithKline announced that they expect to have the recommended Phase II dose of GSK-2879552 in 2016. As such we expect results from the Phase I study of GSK-2879552 within that same time frame.

118242

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK GSK525762 Solid Tumors ITrial Announcement - Initiation

Combination Study to StartGlaxoSmithKline announced that they plan to start a combination study with GSK525762 in 2016.

118243

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK GSK525762 Solid Tumors ITrial Data - Top-Line Results

Single Agent Efficacy DataGlaxoSmithKline announced that they plan to release single agent efficacy data of GSK525762 across indications in 2016.

118244

01/12/2016-12/31/2016 GlaxoSmithKline plc GSK Nucala Asthma ApprovedProgress Update - Product Launch (Europe)

Product Launch (Europe)GlaxoSmithKline announced that they expect to launch Nucala for the treatment of asthma in Europe in 2016.

118229

01/12/2016-09/30/2016Glenmark Pharmaceuticals Limited

GNP:IN GBR 1342 Cancer Preclinical Regulatory - IND Filing IND FilingGlenmark reported that it plans to file an Investigational New Drug (IND) application to initiate a Phase I study of GBR 1342 in the US in the next 9 months.

118260

10/01/2016-12/31/2016Halozyme Therapeutics, Inc.

HALO PEGPH20 Pancreatic Cancer IITrial Data - Top-Line Results

Phase II 202 Stage 2 - Top-Line Results

Halozyme Therapeutics provided key program updates and its Annual financial guidance at the 34th annual JP Morgan Healthcare Conference. Halozyme announced that they achieved target enrollment in Stage 2 of Halozyme Study 202 of investigational new drug PEGPH20 in metastatic pancreatic ductal adenocarcinoma patients. Halozyme has enrolled approximately 120 patients through the end of 2015. The company remains blinded to the efficacy results and projects presentation of mature progression-free survival data in the event driven study in the fourth quarter of 2016.

118272

01/01/2017-12/31/2017 Intersect ENT XENTRESOLVE Bioabsorbable Drug-eluting Implant

Allergy IIITrial Data - Top-Line Results

Phase III RESOLVE II - Top-Line Results

Intersect expects results from the RESOLVE II study in 2017. 118239

01/12/2016-12/31/2016Merrimack Pharmaceuticals, Inc.

MACK Onivyde Breast Cancer - Imaging ITrial Data - Top-Line Results

Phase I - Top-Line ResultsMerrimack expects to report results from the Phase I study of Onivyde for imaging of breast cancer in 2016.

118253

Now-03/31/2016 Opko Health OPK Factor VIIa-CTPHemophilia A and B - General Clotting Products


Phase IIa to StartOpko expects to commence a Phase IIa study of its long-acting Factor VIIa-CTP for hemophilia A and B during the first quarter of 2016.

118264

07/01/2016-09/30/2016 Opko Health OPK RayaldeeHyperparathyroidism (Secondary)

NDAProgress Update - Product Launch

US Product LaunchOpko expects to launch Rayaldee in the early part of the second half of 2016. We await an update in the third quarter.

118263

01/01/2018-06/30/2018 Otonomy, Inc. OTIC OTO-104 Meniere's Disease IIIRegulatory - NDA/BLA Filing

NDA FilingOtonomy expects Phase III results for OTO-104 in the second half of 2017 and if positive an NDA submission in the first half of 2018.

118257

07/01/2016-12/31/2016Regeneron Pharmaceuticals, Inc.

REGN PraluentDyslipidemia / Hypercholesterolemia

ApprovedTrial Data - Updated Results

Phase III ODYSSEY Outcomes - Second Interim Results

Sanofi announced that a second interim analysis of Praluent from the Phase III ODYSSEY OUTCOMES study will be released in the second half of 2016. This analysis will include futility and efficacy when ~75% of events have occurred.

118190



Approved Trial Data - Final ResultsPhase III ODYSSEY Outcomes - Final Results

Sanofi announced that a final data set of Praluent from the Phase III ODYSSEY OUTCOMES study is expected in the second half of 2017.

118185

01/12/2016-06/30/2016 Roche Holding AG RHHBF Atezolizumab Bladder Cancer NDARegulatory - Rolling NDA/BLA Completion

Rolling NDA Completion

Roche announced that it has initiated a rolling NDA for the approval of Atezolizumab for the treatment of bladder cancer in the US. We await on the completion of the rolling NDA submission through the first half of 2016.

118193

01/12/2016-06/30/2016 Roche Holding AG RHHBF AtezolizumabNon-Small Cell Lung Cancer (NSCLC)

NDARegulatory - Rolling NDA/BLA Completion

Rolling NDA Completion

Roche announced that it has initiated a rolling NDA for the approval of Atezolizumab for the treatment of NSCLC in the US. We await on the completion of the rolling NDA submission through the first half of 2016.

118174

Now-12/31/2016 Sangamo Biosciences, Inc. SGMO SB-318Mucopolysaccharidosis I (MPS I; Hurler Syndrome)


Phase I/II SB-318-1502 to StartSangamo plans to initiate the Phase I/II SB-318-1502 clinical trial of SB-318 for the treatment of Hurler syndrome in 2016.

118232

07/01/2016-12/31/2016 Sangamo Biosciences, Inc. SGMO SB-728-T HIV / AIDS IITrial Data - Updated Results

Phase I/II 1101 - Updated Results

Sangamo expects to have data from an additional 5 subjects in Cohort 3 from its Phase II SB-728-1101 study in the second half of 2016.

118230

10/01/2016-12/31/2016 Sangamo Biosciences, Inc. SGMO SB-FIX Hemophilia B INDTrial Data - Top-Line Results

Phase I/II - Top-Line ResultsSangamo expects to have initial data from its Phase I studies of SB-FIX by the end of 2016.

118227


August 2016 / 32




07/01/2016-12/31/2016 Sangamo Biosciences, Inc. SGMO SB-LSD4 Fabry's Disease Preclinical Regulatory - IND Filing IND FilingSangamo plans to file an IND for SB-LSD4 in the second half of 2016.

118225

04/01/2016-06/30/2016 Sanofi SNY GZ402666 Pompe Disease II/IIITrial Announcement - Initiation

Phase III - Trial to StartSanofi announced that they expect to initiate a Phase III trial of NeoGAA for the treatment of Pompe disease in the second quarter of 2016.

118186

10/01/2016-12/31/2016 Sanofi SNY Isatuximab Multiple Myeloma (MM) I/IITrial Announcement - Initiation

Phase III - Trial to StartSanofi announced that they expect to initiate a Phase III study of isatuximab for the treatment of multiple myeloma (MM) in the fourth quarter of 2016.

118189

04/01/2016-06/30/2016Shire Pharmaceuticals Group PLC

SHPG Firazyr Hereditary Angioedema (HAE) ApprovedTrial Data - Top-Line Results

Phase III Japan - Top-Line Results

Shire reports that Phase III top-line data from their Japan study of Hereditary Angioedema is expected to be available in the second quarter of 2016.

118280


SHPG Lifitegrast Dry Eye (Ophthalmology) IIIProgress Update - Product Launch (U.S.)

U.S. Product LaunchShire expects a U.S. product launch of Lifitegrast in Dry Eye in the third quarter of 2016.

118276

Now-03/31/2016Shire Pharmaceuticals Group PLC

SHPG SHP-465Attention Deficit Hyperactivity Disorder (ADHD)


Phase III Study 305 - Top-Line Results

Shire reports that top-line results for the Phase III pediatric trial of SHP-465 for ADHD is expected in the first quarter of 2016.

118279

Now-03/31/2016Shire Pharmaceuticals Group PLC

SHPG SHP607Other Retinopathy (Ophthalmology)

IITrial Announcement - Patient Enrollment Completed

Phase II ROP - Patient Enrollment Completion

Shire expects the SHP607 Phase II Retinopathy of Prematurity trial to be fully enrolled in the first quarter of 2016.

118278

01/12/2016-06/30/2016Takeda Pharmaceutical Company Ltd

4502:JP Ninlaro Multiple Myeloma (MM) ApprovedRegulatory - Filing for Approval (Emerging Markets)

Filing for Approval (Emerging Markets)

Takeda announced that they anticipate filing for approval for Ninlaro in emerging markets in the near future. We await an update in the time frame above.

118209


4502:JP TAK-003Dengue Fever - Vaccines and Treatments


Phase III - Study to StartTakeda announced that they anticipate initiating a Phase III trial of their dengue vaccine in 2016.

118207

01/01/2017-12/31/2017True North Therapeutics, Inc.

TNT009Complement Deficiencies / Abnormalities

ITrial Announcement - Initiation

CAD Registration Trial to StartTrue North Therapeutics anticipates opening a cold agglutinin disease registration trial in 2017 for TNT009.

118241

01/01/2017-12/31/2018Ultragenyx Pharmaceutical Inc.

RARE KRN23X-Linked Hypophosphatemia (XLH)


Phase III Pediatric - Top-Line Results

Ultragenyx expects to have Phase III data from its pediatric study of KRN23 in patients with XLH in 2017 or after. We await an update in the time frame above.

118214




Phase III CL303 - Top-Line Results

Ultragenyx expects to have Phase III data from its adult study of KRN23 in patients with XLH in 2017 or after. We await an update in the time frame above.

118215


RARE Triheptanoin Metabolic - General IITrial Data - Top-Line Results

Phase II CL201 - Top-Line Results

Ultragenyx expects to have data from its Phase II study of Triheptanoin in patients with Glucose Transporter Type 1 Deficiency Syndrome in the second half of 2016.

118221


August 2016 / 33


Expected Date Range Company Symbol Drug Indication Phase Expected Catalyst Catalyst Title Analysis Updated Analysis Link

01/12/2016-06/30/2016Actelion Pharmaceuticals Ltd.

ALIOF OpsumitPulmonary Arterial Hypertension (PAH)


Phase II - MELODY-1 - Top-Line Results

Actelion announced that the results from the Phase II study in combined pre- and post-capillary pulmonary hypertension due to left ventricular dysfunction (CpcPH-LVD) with macitentan are expected before the end of the year.

Date Range Delayed (12/03/2015) - We await an update. Date Range Delayed (01/12/2016) - Actelion announced that it has the results from its Phase II MELODY study of Opsumit and is currently reviewing for Phase III evaluation. We await an update on the release of the data in the first half of 2016.Catalyst Occurred (01/12/2016) - Actelion announced that at the end of 2015 the initial results of the Phase II MELODY study with macitentan became available.

113346


ALXN KanumaLysosomal Acid Lipase Deficiency

ApprovedProgress Update - Product Launch (U.S.)

US Product Launch

Alexion announced that the company plans on launching Kanuma for lysosomal acid lipase deficiency in the US in the second half of 2015. Because the PDUFA date is expected on September 8 2015 we now expect to see the product launch through the last 4 months of the year.

Date Range Delayed (09/04/2015) - Alexion Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of the Company's Biologics License Application (BLA) for Kanuma (sebelipase alfa) for the treatment of lysosomal acid lipase deficiency (LAL-D). The previously disclosed September 8 2015 PDUFA date has been extended by the standard extension period of three months. As such we now await a product launch update in the time frame above. Date Range Refined (12/08/2015) - Alexion Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Kanuma (sebelipase alfa) for the treatment of patients of all ages with a diagnosis of lysosomal acid lipase deficiency (LAL-D). Alexion is preparing to serve patients in the U.S. with Kanuma and expects that Kanuma will become available commercially during the first week of January 2016. The Company’s expanded access program will remain open to enable patients with LAL-D in the U.S. to access Kanuma until commercial product is available.Catalyst Occurred (01/12/2016) - Alexion announced that Kanuma has been launched in the U.S.

113946


ALXN SBC-103Mucopolysaccharidosis IIIB (MPS IIIB; Sanfilippo B Syndrome)

I/IITrial Data - Top-Line Results

Phase I/II Top-Line Data

Synageva BioPharma announced that the investigational new drug (IND) application to the U.S. Food & Drug Administration (FDA) to evaluate SBC-103 as a treatment for mucopolysaccharidosis IIIB (MPS IIIB also known as Sanfilippo B syndrome) is active. The company plans to start enrolling patients with MPS IIIB in a Phase I/II study investigating intravenous administration of SBC-103 shortly and to report preliminary data from this study in 2015.

Date Range Refined (01/12/2015) - Synageva expects preliminary data from the Phase I/II study of SBC-2014 in the second half of 2015.Date Range Refined (11/05/2015) - Alexion expects preliminary data from the Phase I/II trial of SBC-103 for patients with mucopolysaccharidosis IIIB in the fourth quarter of 2015. Date Range Delayed (12/11/2015) - Alexion expects to have 6-month data from its Phase I/II study of SBC-103 for the treatment of MPS IIIB in the first quarter of 2016.Catalyst Occurred (01/12/2016) - Alexion announced preliminary data from the Phase I/II study of SBC-103 for patients with mucopolysaccharidosis IIIB.

105402

07/01/2016-12/31/2016Alexion Pharmaceuticals, Inc.

ALXN SolirisDelayed Graft Function (DGF)

II/IIITrial Data - Top-Line Results

Phase II/II PROTECT - Top-Line Results

Alexion expects preliminary data from the Phase II/II study of eculizumab for delayed graft function in 2016.

Date Range Refined (01/12/2016) - Alexion announced that enrollment has been completed in the registrational study of eculizumab for DGF and the Company expects preliminary data to be available in the second half of 2016.

116366

07/01/2016-09/30/2016 Alkermes plc ALKS ALKS 5461Major Depressive Disorder (MDD)


Phase III FORWARD-5 - Top-Line Results

Alkermes reported that data from the Phase III FORWARD-5 efficacy study of ALKS 5461 for major depressive disorder are expected in 2016.

Date Range Refined (03/02/2015) - Alkermes reported that top-line results from the Phase III FORWARD-5 efficacy study of ALKS 5461 for major depressive disorder are expected in the first quarter of 2016.Date Range Delayed (12/16/2015) - Alkermes announced that the three core efficacy studies for ALKS 5461 remain on track to read out in 2016 with data from the third study anticipated in mid-2016. Date Range Refined (01/12/2016) - Alkermes announced that they anticipate data from the Phase III FORWARD-5 study of ALKS 5461 for the treatment of major depressive disorder (MDD) in the third quarter of 2016.

102406

Now-01/31/2016 Alkermes plc ALKS ALKS 7119 Alzheimer's Disease (AD) Preclinical Regulatory - IND Filing IND Submission

Alkermes announced a new drug candidate ALKS 7119 for the treatment of agitation in patients with alzheimer’s disease major depressive disorder (MDD) and other central nervous system (CNS) indications. Alkermes intends to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the second quarter 2015.

Date Range Delayed (06/19/2015) - We await an update on the IND filing for ALKS 7119 through the first half of the third quarter of 2015.Date Range Delayed (08/03/2015) - As Alkermes expects to initiate the first clinical study of ALKS 7119 in early Q1 2016 we look for a potential IND filing towards the end of the year.Date Range Delayed (12/15/2015) - We await an update through January 2016. New Information (01/12/2016) - Alkermes expects to initiate a Phase I study of ALKS 7119 with an initial focus on agitation in Alzheimer's disease (AD) in the first quarter of 2016. As such we continue to await an IND filing through January 2016.

109063

01/12/2016-03/31/2016 Alkermes plc ALKS ALKS 7119 Alzheimer's Disease (AD) PreclinicalTrial Announcement - Initiation

Phase I - Trial to Start

Alkermes announced a new drug candidate ALKS 7119 for the treatment of agitation in patients with alzheimer’s disease major depressive disorder (MDD) and other central nervous system (CNS) indications. Alkermes has successfully completed preclinical development and expects to initiate the first clinical study of ALKS 7119 in the third quarter of 2015.

Date Range Delayed (08/03/2015) - Alkermes expects to initiate the first clinical study of ALKS 7119 in early Q1 2016.Date Range Refined (01/12/2016) - Alkermes expects to initiate a Phase I study of ALKS 7119 with an initial focus on agitation in Alzheimer's disease (AD) in the first quarter of 2016.

109065

07/01/2016-09/30/2016Alnylam Pharmaceuticals, Inc.

ALNY FitusiranHemophilia A and B - General Clotting Products


Phase III Trials to StartAlnylam Pharmaceuticals announced plans to proceed to pivotal Phase III studies of ALN-AT3 in mid-2016.

Date Range Delayed (01/11/2016) - Alnylam plans to start two Phase III trials of fitusiran in severe hemophilia A and B patients with and without inhibitors in mid- and late 2016 respectively.Date Range Refined (01/12/2016) - Sanofi announced that they expect to initiate a Phase III study of fitusiran for the treatment of hemophilia in the third quarter of 2016.

112851

07/01/2016-12/31/2016 Amgen, Inc. AMGN AMG 334Migraine and Other Headaches


Phase IIb Prophylaxis Top-Line Data

Amgen reported that the Phase IIb migraine prophylaxis study is expected to report top-line data in 2015.

Date Range Delayed (08/03/2015) - Amgen reported that the Phase IIb migraine prophylaxis study is expected to report top-line data in 2016.Date Range Refined (01/12/2016) - Amgen reported that Phase IIb data for AMG334 for migraine prophylaxis are expected in the second half of 2016.

99866

01/01/2029-12/31/2029 Amgen, Inc. AMGN Enbrel Ankylosing Spondylitis Approved Patent - Expiration Patent ExpirationThe patent for Enbrel is expected to expire on October 23 2012.

Date Range Delayed (10/23/2012) - Amgen today announced the issuance of U.S. Patent No. 8063182 related to Enbrel (etanercept). This patent is owned by Hoffman-La Roche (Roche) and exclusively licensed to Amgen. Immunex Corporation (acquired by Amgen in 2002) originally licensed this patent application from Roche in 1999 and in 2004 Amgen paid Roche a one-time payment and obtained an exclusive fully paid-up license to the application which issued today as the '182 patent. The patent describes and claims the fusion protein that is etanercept and by statute the '182 patent has a term of 17 years from today. Date Range Delayed (01/12/2016) - Amgen maintains exclusivity for Enbrel through 2029.

8004

BioMedTracker JPM Updated Catalysts - Day 2


August 2016 / 34




01/01/2029-12/31/2029 Amgen, Inc. AMGN EnbrelJuvenile Rheumatoid Arthritis

Approved Patent - Expiration Patent ExpirationThe patent for Enbrel is expected to expire on October 23 2012.


8006

01/01/2029-12/31/2029 Amgen, Inc. AMGN Enbrel Psoriasis Approved Patent - Expiration Patent ExpirationThe patent for Enbrel is expected to expire on October 23 2012.


8003

01/01/2029-12/31/2029 Amgen, Inc. AMGN Enbrel Psoriatic Arthritis (PA) Approved Patent - Expiration Patent ExpirationThe patent for Enbrel is expected to expire on October 23 2012.


8005

01/01/2029-12/31/2029 Amgen, Inc. AMGN Enbrel Rheumatoid Arthritis (RA) Approved Patent - Expiration Patent ExpirationThe patent for Enbrel is expected to expire on October 23 2012.


8002

07/01/2016-12/31/2016 Amgen, Inc. AMGN RepathaDyslipidemia / Hypercholesterolemia


Phase III GLAGOV - Top-Line Results

Amgen expects data from the GLAGOV study in 2016.Date Range Refined (01/12/2016) - Amgen expects data from its Phase III coronary imaging study for Repatha in the second half of 2016.

104955

Now-03/31/2016 Amgen, Inc. AMGN Romosozumab Osteoporosis / Osteopenia IIITrial Data - Top-Line Results

Phase III FRAME (PMO) - Top Line Data

Results from a Phase III study of AMG 785 in postmenopausal osteoporosis are expected towards the end of 2015.

New Information (01/14/2014) - UCB expects Phase III romosozumab PMO data in 2015. We continue to expect data towards the end of the year as previously guided.Date Range Delayed (01/30/2014) - Amgen reported that the Phase III data of romosozumab for the treatment of postmenopausal osteoporosis is expected to be released in the first half of 2016.Date Range Delayed (07/30/2014) - UCB expects Phase III romosozumab PMO data in the second half of 2016.Date Range Expedited (10/27/2014) - UCB expects Phase III romosozumab PMO data in the first half of 2016.Date Range Expedited (01/12/2016) - Amgen expects data from its ~7200 patient PMO study of romosozumab in the first quarter of 2016.

62074

Now-04/30/2016 Amicus Therapeutics, Inc. FOLD Zorblisa Epidermolysis Bullosa IIIRegulatory - Rolling NDA/BLA Initiation

Rolling NDA Initiation

Scioderm believes its partnership options are open based on its potential to file SD-101 in 2014 in the U.S. We expect an update on a potential filing in the second half of 2014 following the completion of the Phase IIb/III trial.

Date Range Delayed (12/17/2014) - Scioderm has not provided an update on the potential filing for Zorblisa in the US. We await an update through the first half of 2015.Date Range Delayed (12/18/2014) - Scioderm intends to initiate trial of Zorblisa (SD-101) for the treatment of Epidermolysis Bullosa (EB) in the first quarter of 2015 and expects to have top-line results in the second half of 2015. Based on this information we expect to see a potential filing in late 2015/early 2016.Date Range Refined (07/14/2015) - Scioderm announced that it has agreed with the U.S. Food and Drug Administration (FDA) to submit a rolling New Drug Application (NDA) submission for Zorblisa for the treatment of blisters and lesions in patients with Epidermolysis Bullosa (EB). Based on discussion with and agreement by the Agency Scioderm plans to submit the nonclinical components of the NDA in the third quarter of 2015 followed by submission of the chemistry manufacturing and control (CMC) components by early fourth quarter of this year. Date Range Delayed (08/31/2015) - Amicus reports that that FDA has agreed to a rolling NDA submission for Zorblisa for epidermolysis bullosa beginning in 4Q15.Date Range Delayed (12/18/2015) - We await an update through early 2016.Catalyst Occurred (01/12/2016) - Amicus reported that the Company's rolling NDA for Zorblisa for the treatment of epidermolysis bullosa was initiated in the fourth quarter of 2015.

97321

Now-04/30/2016 Baxalta Incorporated BXLT Adynovate Hemophilia A ApprovedRegulatory - sNDA/sBLA Filing

sBLA Filing

Baxalta announced initial results from a Phase III clinical trial of ADYNOVATE for the treatment for hemophilia A in previously-treated patients (PTPs) with severe hemophilia A younger than 12 years of age. With the study results the company plans to file for marketing authorization in Europe and aims to file for a pediatric indication in the U.S. in early 2016.

New Information (01/12/2016) - Nektar reports that they intend to file a European BLA submission for Adynovate in hemophilia A in the second half of 2016. We continue to expect a pediatric application in the U.S. in early 2016.

117448


August 2016 / 35




07/01/2016-12/31/2016 Baxalta Incorporated BXLT Adynovate Hemophilia A ApprovedRegulatory - MAA Submission (Europe)

MAA Filing Regulatory filings for BAX 855 are planned for 2014.

Date Range Refined (11/13/2013) - Based on the results of the Phase II/III PROLONG-ATE study Baxter expects to complete the trial and file for regulatory approval late in 2014. We expect a EU filing to occur in a similar timeframe.Date Range Delayed (01/13/2014) - Baxter expects to file for European approval for BAX 855 in 2016.Date Range Refined (08/21/2014) - Baxter is initiating a Phase III study of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study. According to the National Institute of Health (NIH) clinical trial registry the primary completion of the study is expected in April 2016. We expect an update on the MAA filing for BAX 855 from the time of the expected primary completion in April 2016 to the end of 2016.New Information (02/11/2015) - Baxter expects to file for marketing authorization with the European Medicines Agency in 2016 upon completion of their pediatric study. Date Range Expedited (12/07/2015) - Baxalta expects to file for marketing authorization for ADYNOVATE to treat hemophilia A in Europe in early 2016.Date Range Delayed (01/12/2016) - �Nektar reports that they intend to file a European BLA submission for Adynovate in hemophilia A in the second half of 2016.

84237

01/01/2017-04/30/2017 Bayer AG BAYRY Amikacin InhaleHospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial)


Phase III INHALE 1 - Top-Line Data

Nektar expects to release Phase III INHALE 1 top-line results during mid-2015.

Date Range Delayed (08/09/2014) - Nektar reported that Amakacin Inhale is being evaluated in gram-negative pneumonias and ventilated patients and Bayer expects Phase III data in early 2016. Date Range Delayed (05/08/2015) - Nektar Therapeutics announced that the Phase III trials of Amikacin for the treatment of hospital acquired pneumonia is expected to be completed in the first part of 2016. As such we expect an update a top-line data update in the time frame above. Date Range Delayed (01/12/2016) - Nektar reported that they intend to release top-line results from the Phase III INHALE program of Amikacin Inhale for Gram-Negative Pneumonia in early 2017.

97082



Phase III INHALE 2 - Top-Line Data

Nektar expects to release Phase III INHALE 2 top-line results during mid-2015.

Date Range Delayed (08/09/2014) - Nektar reported that Amakacin Inhale is being evaluated in gram-negative pneumonias and ventilated patients and Bayer expects Phase III data in early 2016. Date Range Delayed (05/08/2015) - Nektar Therapeutics announced that the Phase III trials of Amikacin for the treatment of hospital acquired pneumonia is expected to be completed in the first part of 2016. As such we expect an update a top-line data update in the time frame above.Date Range Delayed (01/12/2016) - Nektar reported that they intend to release top-line results from the Phase III INHALE program of Amikacin Inhale for Gram-Negative Pneumonia in early 2017.

97083



MAA FilingNektar announced that they have planned filings with the FDA and EMA for Amikacin Inhale in Q4 2015.

Date Range Delayed (10/07/2014) - Nektar reported that Amakacin Inhale is being evaluated in gram-negative pneumonias and ventilated patients and Bayer expects Phase III data in early 2016. As such we expect regulatory filings in mid- to late-2016. Date Range Delayed (01/12/2016) - Nektar reported that they intend to release top-line results from the Phase III INHALE program of Amikacin Inhale for Gram-Negative Pneumonia in early 2017. As such we expect regulatory filings in mid- to late-2017.

97086



NDA FilingNektar announced that they have planned filings with the FDA and EMA for Amikacin Inhale in Q4 2015.

Date Range Delayed (10/07/2014) - Nektar reported that Amakacin Inhale is being evaluated in gram-negative pneumonias and ventilated patients and Bayer expects Phase III data in early 2016. As such we expect regulatory filings in mid- to late-2016. Date Range Delayed (01/12/2016) - �Nektar reported that they intend to release top-line results from the Phase III INHALE program of Amikacin Inhale for Gram-Negative Pneumonia in early 2017. As such we expect regulatory filings in mid- to late-2017.

97085

Now-06/30/2016 Bayer AG BAYRY Ciprofloxacin DPI Bronchiectasis IIITrial Data - Top-Line Results

Phase III RESPIRE 1 Top-Line Data

Nektar expects to have Phase III RESPIRE 1 top-line data in Q3 2015.

Date Range Delayed (08/09/2014) - Nektar reported that Cipro DPI is being evaluated in non-cystic-fibrosis bronchiectasis and Bayer expects Phase III results in the latter part of 2015. Date Range Delayed (11/18/2014) - Nektar expects potential Phase III data readouts for Ciprofloxacin DPI in non-cystic fibrosis bronchiectasis throughout 2016. Date Range Refined (01/13/2015) - Nektar expects potential Phase III data readouts for Ciprofloxacin DPI in non-cystic fibrosis bronchiectasis in mid-2016.Date Range Expedited (01/12/2016) - Nektar reported that they intend to release Phase III RESPIRE 1 top-line data of Cirpofloxacin DPI for Non-Cystic Fibrosis Bronchiectasis in the first half of 2016.

97087

07/01/2016-12/31/2016 Bayer AG BAYRY Ciprofloxacin DPI Bronchiectasis IIITrial Data - Top-Line Results

Phase III RESPIRE 2 Top-Line Data�

Nektar expects to have Phase III RESPIRE 2 top-line data in Q3 2015.

Date Range Delayed (08/09/2014) - Nektar reported that Cipro DPI is being evaluated in non-cystic-fibrosis bronchiectasis and Bayer expects Phase III results in the latter part of 2015. Date Range Delayed (11/18/2014) - Nektar expects potential Phase III data readouts for Ciprofloxacin DPI in non-cystic fibrosis bronchiectasis throughout 2016. Date Range Refined (01/13/2015) - Nektar expects potential Phase III data readouts for Ciprofloxacin DPI in non-cystic fibrosis bronchiectasis in mid-2016.Date Range Delayed (01/12/2016) - Nektar reported that they intend to release Phase III RESPIRE 2 top-line data of Cirpofloxacin DPI for Non-Cystic Fibrosis Bronchiectasis in the second half of 2016.

97089


August 2016 / 36




07/01/2016-12/31/2016 Biogen, Inc. BIIB ZFP - Beta-Thalassemia Sickle Cell Anemia Preclinical Regulatory - IND Filing IND Filing

Biogen Idec and Sangamo BioSciences announced an exclusive worldwide collaboration and license agreement focused on the development of therapeutics for hemoglobinopathies inherited conditions that result from the abnormal structure or underproduction of hemoglobin. Sangamo is responsible for all research and development activities through the first clinical proof of concept trial in beta-thalassemia and both companies will perform activities to enable submission of an Investigational New Drug (IND) application for SCD. We await an update on an IND filing for SCD through 2014.

Date Range Delayed (01/16/2014) - Sangamo plans to file an IND for the Biogen Idec-partnered ZFP beta-thalassemia drug for the treatment of sickle cell anemia in 2015. New Information (01/12/2015) - Sangamo announced that they expect the initiation in the first half of 2015 of a Phase I clinical trial of its zinc finger nuclease (ZFN)-modified hematopoietic stem cell approach for the potential cure of beta-thalassemia. The Company also expects that an investigational new drug (IND) application for this approach in sickle cell disease will be filed by the end of the year. Both programs are partnered with Biogen Idec. Date Range Delayed (08/05/2015) - Sangamo announced that they expect to file a new Investigational New Drug (IND) application for its zinc finger nuclease (ZFN)-mediated genome editing programs targeting beta-thalassemia and sickle cell disease (SCD) in 2016. Date Range Delayed (11/03/2015) - Biogen is now expecting to file an IND in 2017 for its sickle cell product being developed in collaboration with Sangamo.Date Range Expedited (01/12/2016) - Sangamo plans to file an IND for its partnered Sickle cell disease program with Biogen in the second half of 2016.

96735

04/15/2016-04/21/2016 bluebird bio BLUE Lenti-DAdrenomyeloneuropathy (Adrenoleukodystrophy)

II/IIITrial Data - Top-Line Results

Phase II/III Starbeam - Top-Line Results at AAN

bluebird bio expects to present data from its Phase II/III Starbeam study of childhood cerebral adrenoleukodystrophy (CCALD) program during 2016.

Date Range Refined (12/02/2015) - bluebird bio plans to present data from the Starbeam study of LentiD in CCALD in the first half of 2016.Date Range Refined (01/12/2016) - bluebird bio announced that they plan to present data from the Starbeam study of LentiD in CCALD at the American Academy of Neurology Annual meeting that takes place from April 15-21 2016.

106377

07/01/2016-12/31/2016 bluebird bio BLUE LentiGlobin Anemia I/IITrial Announcement - Initiation

HGB-207 Trial (Adolescents) to Start

bluebird bio announced that it has reached general agreement with the U.S. Food and Drug Administration (FDA) on the design of its planned clinical trials HGB-207 and HGB-208. We await an update on the initiation of these trials through mid-2015.

New Information (06/10/2015) - bluebird announced the completion of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee’s (RAC) public review of the HGB-208 pediatric study protocol for bluebird bio’s LentiGlobin BB305 product candidate in beta-thalassemia major. The RAC recommendation was to delay initiation of the study in the United States for one to two years. This recommendation has no effect on the HGB-207 protocol plan. We continue to await an update through mid-2015.Date Range Delayed (09/30/2015) - We await an update through the rest of 2015.Date Range Delayed (12/02/2015) - bluebird bio currently plan to initiate two new clinical trials of LentiGlobin called HGB-207 for adult and adolescent patients with beta-thalassemia major and HGB-208 for pediatric patients with beta-thalassemia major. We await an update through the first half of 2016.Date Range Delayed (01/12/2016) - bluebird bio announced that it plans to initiate the HB-207 study of LentiGlobin in the second half of 2016.

111829

09/01/2016-12/31/2016 Chimerix, Inc. CMRX Brincidofovir Antiviral - Other Treatments IIIRegulatory - NDA/BLA Filing

NDA FilingChimerix plans to submit the NDA for Brincidofovir using both the SUPRESS and AdVise data in early 2016.

Date Range Delayed (01/12/2016) - Chimerix announced that the company will review data from the AdVise study with Regulatory agencies to determine a path for approval. The Company aims to determine its development plan by the summer of 2016. As such we await a NDA filing in late 2016.

106365

02/08/2016-02/10/2016 Chimerix, Inc. CMRX Brincidofovir Smallpox I Trial Data - OtherFinal Preclinical Results at ASM

Chimerix expects that final results from its pivotal study of an animal model for smallpox including data on the incidence and severity of clinical and laboratory events in each cohort are expected by the fourth quarter of 2015 and will be submitted to an upcoming medical conference and to the FDA for discussion of next steps.

Date Range Delayed (12/16/2015) - Chimerix announced that the Company expects to review data from the animal rule study of brincidofovir for the treatment of smallpox with the FDA in the first half of 2016.Date Range Refined (01/12/2016) - Chimerix will announce full data from the Animal Rule Study at the upcoming ASM Biodefense and Emerging Diseases Research Meeting in February 2016.

113408

Now-04/30/2016 Eli Lilly & Company LLY Baricitinib Rheumatoid Arthritis (RA) IIIRegulatory - NDA/BLA Filing

NDA FilingEli Lilly plans to file for approval of Baricitinib for rheumatoid arthritis in 2015.

Date Range Refined (09/17/2015) - Incyte expects a submission of the NDA filing for baricitinib by Lilly in late 2015 or early 2016. Date Range Refined (01/12/2016) - Eli Lilly expects to file regulatory submissions for Baricitinib for the treatment of rheumatoid arthritis in early 2016.

106223

Now-04/30/2016 Eli Lilly & Company LLY Baricitinib Rheumatoid Arthritis (RA) IIIRegulatory - MAA Submission (Europe)

MAA SubmissionEli Lilly plans to file for approval of Baricitinib for rheumatoid arthritis in 2015.

Date Range Delayed (09/17/2015) - Incyte expects a submission of the NDA filing for baricitinib by Lilly in late 2015 or early 2016. We expect an EU filing in a similar time frame.Date Range Refined (01/12/2016) - Eli Lilly expects to file regulatory submissions for Baricitinib for the treatment of rheumatoid arthritis in early 2016.

106224

Now-12/31/2016 Eli Lilly & Company LLY LY3012207 Sarcoma IIIRegulatory - MAA Submission (Europe)

MAA Filing

Based on the ongoing discussions with the FDA Eli Lilly intends to submit U.S. and European regulatory applications for Olaratumab in soft tissue sarcoma using the Phase II data. The Company aims to complete the U.S. submission before the end of 2015. We look for an update on the European filing through the first half of 2016.

Date Range Delayed (01/12/2016) - Eli Lilly announced plans for a European regulatory submission for Olaratumab for the treatment of soft-tissue sarcoma in 2016.

113546

Now-01/31/2016 Eli Lilly & Company LLY LY3012207 Sarcoma IIIRegulatory - NDA/BLA Filing

NDA Filing

Based on the ongoing discussions with the FDA Eli Lilly intends to submit U.S. and European regulatory applications for Olaratumab in soft tissue sarcoma using the Phase II data. The Company aims to complete the U.S. submission before the end of 2015.

Date Range Delayed (12/18/2015) - We await an update.Catalyst Occurred (01/12/2016) - Eli Lilly announced that the Company has begun regulatory submission for olaratumab for the treatment of soft tissue sarcoma in late 2015.

113547

Now-03/31/2016 Gilead Sciences, Inc. GILDTenofovir alafenamide fumarate

Hepatitis B (HBV) Treatment (Antiviral)

NDARegulatory - NDA/BLA Filing

NDA FilingGilead expects to submit an NDA for TAF in HBV in Q1 2016.

Catalyst Occurred (01/12/2016) - Gilead announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25 mg an investigational once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.

113739


August 2016 / 37




02/01/2016-03/31/2016 GlaxoSmithKline plc GSK Galafold Fabry's Disease IIIRegulatory - CHMP (European Panel) Results

CHMP Opinion

Amicus has submitted a marketing authorization application (MAA) to request full approval of Galafold (migalastat HCl) for Fabry patients who have amenable genetic mutations. Galafold is the first investigational Fabry drug to be granted Accelerated Assessment in the EU. Under Accelerated Assessment the Committee for Medicinal Products for Human Use (CHMP) may shorten the MAA review period from 210 days under standard review to 150 days under Accelerated Assessment. Based on an internal analysis of the centralized European approval procedure we estimate the European marketing authorization for this drug for this indication will be granted in approximately 9-15 months. As the approval decision is normally issued 67 days from adoption of a positive Committee for Medicinal Products for Human Use (CHMP) opinion we then estimate the CHMP opinion to occur between January 2016 and July 2016.

New Information (06/25/2015) - Amicus Therapeutics announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) and the Centralized Procedure has begun for the oral small molecule pharmacological chaperone Galafold (migalastat HCl) for Fabry patients who have amenable genetic mutations. As previously announced Galafold is the first investigational Fabry drug to be granted Accelerated Assessment in the EU. Date Range Expedited (01/12/2016) - Amicus expects a CHMP opinion on Galafold for Fabry's disease in early 2016 likely during the February or March meeting.

112326

Now-03/31/2016 GlaxoSmithKline plc GSK Galafold Fabry's Disease IIIRegulatory - NDA/BLA Filing

NDA Filing

Amicus expects to present results for Amigal studies for the treatment of Fabry's disease to the FDA in the fourth quarter of 2014. As submission pre-submissions and meetings occur in the second half of 2014 Amicus expects a potential submission to the FDA in early 2015.

New Information (01/13/2015) - Amicus reported that FDA regulatory interaction for the Amigal studies for the treatment of Fabry's disease is expected in the first quarter of 2015. We await an update on the timing of a NDA filing following the meeting with the FDA.Date Range Delayed (03/19/2015) - Amicus Therapeutics announced that it has met with regulatory authorities in the U.S. to discuss the approval pathways for migalastat HCl as a precision medicine monotherapy for Fabry patients who have amenable genetic mutations. Subsequently Amicus plans to schedule a pre-NDA meeting and to submit an accelerated approval NDA under Subpart H in the second half of 2015.Date Range Refined (09/15/2015) - Amicus Therapeutics announced that a Pre-NDA meeting was held with the U.S. Food and Drug Administration (FDA) to discuss migalastat for the treatment of Fabry disease. Amicus remains on track to submit an NDA in the fourth quarter of 2015 under Accelerated Approval.Date Range Delayed (10/02/2015) - Amicus Therapeutics announced additional regulatory guidance from the U.S. Food and Drug Administration (FDA) on the oral small molecule pharmacological chaperone migalastat for the treatment of Fabry disease. In conjunction with the Agency Amicus is further evaluating several U.S. pathways including potentially generating additional data on migalastat's effect on gastrointestinal symptoms in Fabry disease to support submission requesting full approval as well as a Subpart H strategy. In addition the Agency has requested further integration of existing clinical data across studies which will

102944

Now-03/31/2016Glenmark Pharmaceuticals Limited

GNP:IN GBR 1302 Cancer ITrial Announcement - Initiation

Phase I - Trial to Start

Glenmark Pharmaceuticals announced the completion of Phase I supporting studies and the submission of a clinical trial application to the Paul-Ehrlich Institute in Germany with a novel clinical development candidate GBR 1302. GBR 1302 is a HER2xCD3 bi-specific antibody based on Glenmark's proprietary BEAT platform. Glenmark expects to obtain approval for the initiation of clinical studies with GBR1302 during this financial year.

Date Range Delayed (12/23/2015) - We await an update. Catalyst Occurred (01/12/2016) - Glenmark reported that it has initiated a Phase I trial of GBR-1302 in Germany. GBR-1302 is listed in the pipeline with HER2-positive cancers are the primary indications.

115151


GNP:IN GBR 830 Atopic Dermatitis (Eczema) II Regulatory - IND Filing IND FilingGlenmark intends to open an US IND for clinical studies of GBR 830 in Q2 FY 2015 – 16. We await an update in the time frame above.

Date Range Delayed (10/28/2015) - We await an update.Catalyst Occurred (01/12/2016) - Glenmark reported that a Phase IIa trial of GBR 830 has been initiated in the US with atopic dermatitis as the primary indication.

114730


GNP:IN GBR 830 Atopic Dermatitis (Eczema) IITrial Announcement - Initiation

Phase II - Trial to Start

Glenmark has now completed clinical Phase I studies for GBR 830 in the Netherlands. GBR 830 was well tolerated and its safety and pharmacokinetics profile in healthy volunteers fully support the transition into clinical Phase II studies. Preparations for initiating Phase II studies in both atopic dermatitis and celiac disease in the US and Europe are in order. Glenmark expects dosing to commence in the next few months.

Date Range Delayed (12/28/2015) - We await an update. Catalyst Occurred (01/12/2016) - Glenmark reported that a Phase IIa trial of GBR 830 has been initiated in the US with atopic dermatitis as the primary indication.

114731


HALO PEGPH20 Breast Cancer PreclinicalTrial Announcement - Initiation

Phase Ib/II Study to Start

Eisai and Halozyme Therapeutics announced that they have signed a clinical collaboration agreement to evaluate Eisai's agent eribulin mesylate (brand name: Halaven eribulin) in combination with Halozyme's investigational drug PEGPH20 (PEGylated recombinant human hyaluronidase) in first line HER2-negative metastatic breast cancer. The companies will jointly share the costs of a Phase Ib/II clinical trial to assess whether or not eribulin in combination with PEGPH20 can improve overall response rate (ORR) -- the proportion of women that have a predefined reduction in tumor burden -- as compared with eribulin alone as a therapy in women with advanced breast cancer. We await an update on the trial initiation by the end of 2015.

Date Range Delayed (08/10/2015) - Halozyme announced that they expect to initiate the Phase Ib/II clinical trial using PEGPH20 in combination with HALAVEN (eribulin) in first line HER2-negative metastatic breast cancer patients with high-HA in early 2016. Date Range Delayed (01/12/2016) - Halozyme announced that they expect to initiate the Phase Ib/II clinical trial using PEGPH20 in combination with HALAVEN (eribulin) in first line HER2-negative metastatic breast cancer patients with high-HA by the end of the second quarter of 2016.

113729


HALO PEGPH20Non-Small Cell Lung Cancer (NSCLC)

I/IITrial Announcement - Other

Phase Ib/II PRIMAL - Patient Enrollment Completed (Phase Ib Portion)

Halozyme plans to complete patient enrollment in the on-going global Phase Ib multi-center randomized clinical trial (PRIMAL) evaluating PEGPH20 as a second-line therapy for patients with locally advanced or metastatic NSCLC in the third quarter of 2015 pending the number of dose escalation cohorts of PEGPH20.

New Information (08/10/2015) - Halozyme announced that progress through the initial dose escalation cohorts is taking longer than anticipated likely due to the initial trial design which constrains the number of patients that could be screened and potentially enrolled at the same time. The design of the trial has recently been modified and five new sites have been initiated in order to address this problem. An update is expected in November 2015.Date Range Delayed (11/23/2015) - Halozyme is progressing into a second dosing cohort in the Halozyme Phase Ib/II PRIMAL study of PEGPH20 plus docetaxel in non-small cell lung cancer patients. Actions initiated during the quarter have resulted in an increase in the number of patients screened for the study. Once a maximum tolerated dose is determined the company plans to expand the study with additional sites outside the U.S. and screen patients prospectively for trial eligibility based on high levels of HA. We await an update through the first quarter of 2016.Date Range Delayed (01/12/2016) - Halozyme expects to advance to dose expansion phase in the Keytruda and PRIMAL studies pending the number of dose cohorts in the second half of 2016.

106286


HALO PEGPH20 Pancreatic Cancer IITrial Announcement - Initiation

Phase III to Start

Halozyme plans to initiate patient enrollment and dosing for a registration trial of PEGPH20 for pancreatic cancer in the fourth quarter of 2015 or the first quarter of 2016 pending regulatory feedback.

Date Range Refined (04/08/2015) - Based on FDA feedback Halozyme is targeting the end of first quarter 2016 to initiate the Phase III study of PEGPH20 in patients with metastatic pancreatic cancer.Date Range Refined (01/12/2016) - Halozyme reported that the Phase III trial for PEG-PH20 in pancreatic cancer is now expected to start in March 2016.

106281


August 2016 / 38




Now-01/31/2016Halozyme Therapeutics, Inc.

HALO PEGPH20 Pancreatic Cancer IITrial Announcement - Patient Enrollment Completed

Phase II HALO-202 - Enrollment Complete

Halozyme reported that they expect enrollment to complete in their Phase II HALO-202 study in the second half of 2014.

New Information (04/04/2014) - Halozyme announced that as a result of a recommendation received yesterday from an independent Data Monitoring Committee (DMC) it is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase II trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer. The DMC is assessing clinical data that indicates a possible difference in the thromboembolic event rate between the group of patients treated with PEGPH20 nab-paclitaxel and gemcitabine versus the group of patients treated with nab-paclitaxel and gemcitabine without PEGPH20. The Company is halting enrollment and dosing of PEGPH20 as precautionary actions while the DMC's full evaluation of the data is ongoing. We continue to await an update in the time frame above.New Information (05/19/2014) - Halozyme announced that they have provided the DMC with requested information and data and the DMC has informed that they support continued enrollment of patients and dosing of PEGPH20 in the Phase II trial. The Company is now providing information to the FDA so they can conduct their assessment of the request for the clinical hold to be lifted so that Halozyme may continue enrollment of patients and dosing of PEGPH20 in the Phase II trial. We continue to await an update in the time frame above.Date Range Delayed (06/04/2014) - Halozyme announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase II trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer

97365

04/01/2016-09/30/2016 ImmunoGen, Inc. IMGN Coltuximab RavtansineDiffuse Large B-Cell Lymphoma (DLBCL) - NHL


Combination Study to Start

ImmunoGen announced that for coltuximab ravtansine ImmunoGen is assessing alternative combination strategies and expects to initiate combination clinical testing in 2016.

Date Range Refined (01/12/2016) - ImmunoGen reports that they intend to provide disclosure regarding the combination regimen for their planned Phase II combination study in the first half of 2016 and initiate the Phase II combination study mid-year.

114433

Now-12/31/2016 ImmunoGen, Inc. IMGN IMGN529Diffuse Large B-Cell Lymphoma (DLBCL) - NHL


Phase II w/ Rituximab - Trial to Start

ImmunoGen announced that the Company is planning to initiate a clinical trial to assess the combination of IMGN529 with rituximab for the treatment of non-hodgkin lymphoma. We await an update in the time frame above.

Date Range Delayed (12/07/2015) - The Phase II combination study of IMGN529 with rituximab for patients with relapsed or refractory B-Cell lymphoma is not yet open for participant recruitment. We await an update.Date Range Delayed (01/12/2016) - ImmunoGen reports that the Phase II trial of IMGN529 in combination with rituximab for Diffuse Large B-Cell Lymphoma (DLBCL) is poised to start in 2016. We await an update on specific timing.

111969

Now-06/30/2016 ImmunoGen, Inc. IMGN IMGN779Acute Myelogenous Leukemia (AML)

INDTrial Announcement - Initiation

Clinical Trials to StartImmunoGen announced plans to start clinical testing for IMGN779 in early 2016.

Date Range Delayed (01/12/2016) - ImmunoGen expects to initiate the Phase I trial of IMGN779 for Acute Myelogenous Leukemia (AML) in the first half of 2016.

115084

04/01/2016-06/30/2016 ImmunoGen, Inc. IMGNMirvetuximab soravtansine

Ovarian Cancer I Trial Data - Final ResultsPhase I Expansion Cohort - Final Results

ImmunoGen announced that the enrollment of patients into the Phase I expansion cohort of IMGN853 is expected to complete by year end 2015 with presentation of the findings for the full 40-patient cohort anticipated in mid-2016.

Date Range Delayed (09/18/2015) - ImmunoGen announced plans to release full data for the 46-patient cohort in the second quarter of 2016. New Information (01/12/2016) - ImmunoGen reported that clinical data from the 40-patient cohort from the Phase I Mirvetuximab Soravtansine trial for ovarian cancer will be presented at a medical meeting in the second quarter of 2016.

114432

Now-12/31/2016 Impax Laboratories, Inc. IPXL Rytary Parkinson's Disease (PD) Approved Partnership - New New Partnership

Impax intends to initiate activities to find a partner or partners for markets outside the U.S. looking to grow their non-US neurology franchise. We look for a potential licensing deal for Rytary through 2013.

Date Range Delayed (12/12/2013) - We await an update on a partnership for Rytary throughout the first half of 2014. Date Range Delayed (01/14/2014) - Impax reported that they plan to seek potential partnerships for the commercialization of Rytary outside of the United States. As such we await an update through the end of 2014.Date Range Delayed (12/19/2014) - We continue to await an update on a potential licensing deal for Rytary.Date Range Delayed (12/22/2015) - We continue to await an update.New Information (01/12/2016) - Impax announced that ex-U.S. partnering activities for Numient for the treatment of Parkinson's disease (PD) are ongoing. We continue to await an update through 2016.

87108

07/01/2016-12/31/2016 Intersect ENT XENTRESOLVE Bioabsorbable Drug-eluting Implant

Allergy IIITrial Announcement - Patient Enrollment Completed

Phase III RESOLVE II - Patient Enrollment Completed

Intersect ENT announced it expects to complete patient enrollment for the RESOLVE II trial in 2016.

Date Range Delayed (01/12/2016) - Intersect expects to complete enrollment in the RESOLVE II study in H2.

106226

01/01/2017-06/30/2017Merrimack Pharmaceuticals, Inc.

MACK MM-302 Breast Cancer IITrial Data - Top-Line Results

Phase II HERMIONE - Top-Line Results

Merrimack anticipates results from HERMIONE the Phase II clinical study of MM-302 in patients with HER2-positive metastatic breast cancer designed to support a potential Accelerated Approval application to the FDA in 2017.

Date Range Refined (01/12/2016) - Merrimack anticipates results from HERMIONE the Phase II clinical study of MM-302 in patients with HER2-positive metastatic breast cancer designed to support a potential Accelerated Approval application to the FDA in the first half of 2017.

116932

07/01/2016-12/31/2016 Nektar Therapeutics NKTR NKTR-181 Chronic Pain IIITrial Data - Top-Line Results

Phase III - Top-Line Results

Nektar plans on releasing the first Phase III trial results in Q1 2016.

Date Range Delayed (01/12/2016) - Nektar reports that they intend to release top-line data from the Phase III SUMMIT-07 study of NKTR-181 for chronic lower back pain in the second half of 2016.

97097

07/01/2016-12/31/2016 Nektar Therapeutics NKTR NKTR-181 Chronic Pain IIITrial Announcement - Initiation

Phase III SUMMIT-12 - Trial to Start

Nektar plans to initiate a second Phase III trial in Q3 2015.

Date Range Expedited (11/18/2014) - Nektar expects to initiate the second Phase III study of NKTR-181 by the middle of 2015.New Information (02/25/2015) - Nektar Therapeutics announced that the SUMMIT Phase III (SUMMIT-12) program will also include a Phase III efficacy and safety trial in opiod-experienced patients with chronic lower back pain.Date Range Delayed (09/29/2015) - We await an update.Date Range Delayed (12/21/2015) - We await an update.Date Range Delayed (01/12/2016) - A second Phase III efficacy study is planned to initiate in the second half of 2016. The trial in opioid-experienced patients with chronic lower back pain (SUMMIT-12) will begin after the first efficacy study is completed.

97096

07/01/2016-12/31/2016 Opko Health OPK LagovaShort Stature / Growth Hormone Deficiency

IIITrial Announcement - Initiation

Pivotal Phase III Trial (Prepubertal GHD Children) to Start

Opko announced that a non-inferiority Phase III study of Lagova for the treatment of growth hormone deficiency is anticipated to start in 2015.

Date Range Delayed (10/07/2015) - OPKO announced that based on the recent Phase II clinical data the Company confirms its plan to initiate a global pivotal Phase III study in prepubertal GHD children in 2016 following supply of the product by Pfizer in a pen device evaluating a single dose of hGH-CTP versus daily injections of growth hormone. We await an update in the first half of 2016. Date Range Delayed (01/12/2016) - Opko expects to initiate the pediatric Phase III clinical trial of hGH-CTP during the second half of 2016.

101729


August 2016 / 39




07/01/2016-12/31/2016 Opko Health OPK LagovaShort Stature / Growth Hormone Deficiency


Phase III 005 - Top-Line Results

Opko stated that there is a milestone related an adult Phase III study of hGH-CTP for H2 2015. Given the expected completion date of the ongoing Phase III study we assume this to be referring to top-line results for the study.

Date Range Delayed (07/10/2015) - OPKO has completed enrollment in the single pivotal Phase III trial of its long acting human growth hormone (hGH-CTP) in growth hormone deficient (GHD) adults. The study is expected to end toward the second half of 2016. As such we now anticipate top-line results from this study in the first half of 2016. Date Range Delayed (01/12/2016) - Opko expects top-line data in adults Phase III of hGH-CTP in adults to be available in the second half of 2016.

90428




Phase III ODYSSEY Outcomes - Top-Line Results

Regeneron expects the Phase III ODYSSEY Outcomes study of alirocumab for dyslipidemia to read out in 2018.

Date Range Expedited (09/28/2015) - Results from the ODYSSEY OUTCOMES trial are anticipated in 2017.Date Range Expedited (01/12/2016) - Sanofi announced that an interim analysis of Praluent from the Phase III ODYSSEY OUTCOMES study will be analyzed when ~50% of events have occurred. The Company anticipates releasing a second interim analysis for futility and efficacy when ~75% of events have occurred in the second half of 2016. As such we anticipate top-line results through the third quarter of 2016.

103135

Now-12/31/2016 Roche Holding AG RHHBF Atezolizumab Bladder Cancer NDATrial Data - Top-Line Results

Phase III IMvigor211 - Top-Line Results

Roche plans on announcing topline results for the Phase III IMvigor211 study of atezolizumab for the treatmtent of bladder cancer in 2017.

Date Range Expedited (01/12/2016) - Roche expects to have data from its Phase III IMvigor 211 study of Atezolizumab for the treatment of bladder cancer in 2016.

115289

Now-04/30/2016 Roche Holding AG RHHBF Atezolizumab Bladder Cancer NDARegulatory - NDA/BLA Filing

NDA FilingRoche plans to file for regulatory approval of RG7446 for bladder cancer in 2016.

Date Range Refined (09/29/2015) - Roche plans to file for regulatory approval of atezolizumab for bladder cancer in early 2016. Catalyst Occurred (01/12/2016) - Roche announced that it has initiated a rolling NDA for the approval of Atezolizumab for the treatment of bladder cancer in the US.

102274

Now-04/30/2016 Roche Holding AG RHHBF AtezolizumabNon-Small Cell Lung Cancer (NSCLC)

NDARegulatory - NDA/BLA Filing

NDA Filing - 2nd/3rd LineRoche stated that they could potentially file for approval of their anti-PDL1 (RG7446) for NSCLC in 2016.

Date Range Refined (09/28/2015) - Roche expects a U.S. filing for atezolizumab for the treatment of NSCLC in early 2016. Catalyst Occurred (01/12/2016) - Roche announced that it has initiated a rolling NDA for the approval of Atezolizumab for the treatment of NSCLC in the US.

89467

Now-03/31/2016Sangamo Biosciences, Inc.

SGMO SB-318Mucopolysaccharidosis I (MPS I; Hurler Syndrome)

Preclinical Regulatory - IND Filing IND Filing

Sangamo announced that SB-LSD is in preclinical development and will be execute preclinical efficacy as well as in vivo proof of concept studies. The Company also has plans to scale up manufacturing to prepare for clinical development. In addition toxicology studies will be conducted in relevant animal models. Two INDs are planned for 2015.

New Information (01/12/2015) - Sangamo announced an update on the progress of Sangamo's proprietary programs in the lysosomal storage disorders (LSDs) that use its In Vivo Protein Replacement Platform (IVPRP) approach. The Company expects to file IND applications for its first two programs in Hunter's and Hurler's disease by the end of 2015. Date Range Delayed (12/30/2015) - We await an update.Catalyst Occurred (01/12/2016) - Sangamo filed an IND application for SB-318 for the treatment of Hurler Syndrome (MPS I) at the end of 2015.

84256

10/01/2016-12/31/2016 Sanofi SNY Efpeglenatide Diabetes Mellitus, Type II IITrial Announcement - Initiation

Phase III to StartHanmi expects to initiate a Phase III study for HM11260C (LAPS-CA-Exendin-4) during 2015.

Date Range Delayed (12/24/2015) - We await an update.Date Range Delayed (01/12/2016) - Sanofi announced that they expect to initiate a Phase III study of efpeglenatide for the treatment of diabetes in the fourth quarter of 2016.

106420

01/12/2016-03/31/2016 Sanofi SNY Olipudase Alfa Niemann-Pick Disease I/IITrial Announcement - Initiation

Phase II/III - Trial to Start

Genzyme announced plans to begin enrolling patients in a Phase II/III study of SAR402665 for the treatment of Niemann-Pick Type B in 2015. The trial is expected to initiate in February 2015.

Date Range Delayed (02/26/2015) - This study is not yet open for participant recruitment. We await an update.Date Range Delayed (03/30/2015) - This study is not yet open for participant recruitment. We continue to await an update.Date Range Delayed (04/28/2015) - �This study is not yet open for participant recruitment. We continue to await an update. Date Range Delayed (06/04/2015) - Genzyme announced that the Company is preparing to initiate enrollment for a Phase II/III adult study of olipudase alfa in the second half of 2015.Date Range Refined (08/03/2015) - The Phase II/III study of olipudase alfa in patients with acid sphingomyelinase deficiency is expected to start in August 2015.Date Range Delayed (08/31/2015) - The Phase II/III study of olipudase alfa in patients with acid sphingomyelinase deficiency is not yet open for participant recruitment. We await an update.Date Range Delayed (09/28/2015) - This study is not yet open for participant recruitment. We continue to await an update.Date Range Delayed (11/25/2015) - This study is not yet open for participant recruitment. We continue to await an update.Date Range Refined (01/12/2016) - Sanofi announced that they expect to initiate a pivotal Phase II/III study of olipudase alfa in Niemann Pick type B in the first quarter of 2016.

108684

10/01/2016-12/31/2016 Sanofi SNY Sotagliflozin Diabetes Mellitus, Type II IIITrial Announcement - Initiation

Phase III - Trial to StartLexicon announced that Phase III trials of sotagliflozin (LX4211) in type 2 diabetes are expected to initiate in 2016.

Date Range Refined (01/12/2016) - Sanofi announced that they expect to initiate a Phase III study of sotagliflozin for the treatment of diabetes in the fourth quarter of 2016.

116512


SHPG SHP-465Attention Deficit Hyperactivity Disorder (ADHD)


NDA Resubmission

Shire announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts - MAS) being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. The Company now expects to submit to the FDA by second quarter 2017 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults which typically entails a 6-month review.

Date Range Expedited (01/12/2016) - Shire reports that their FDA refiling of SHP-465 for ADHD is now expected in the fourth quarter of 2016.

110094


SHPG SHP607Other Retinopathy (Ophthalmology)


Phase II ROP - Top-Line Data

Shire reported that the Phase II data of HGT-ROP-001 for the treatment of retinopathy of prematurity is expected to be released in the second half of 2014.

Date Range Delayed (11/18/2013) - Shire reported that the Phase II headline data is expected to be released in the first half of 2015.Date Range Delayed (10/27/2014) - Shire reported that the Phase II headline data is expected to be released towards later 2015.Date Range Expedited (02/17/2015) - Shire reported that the Phase II headline data is expected to be released in the second half of 2015.Date Range Delayed (12/03/2015) - Shire reported that the Phase II headline data is expected to be released in mid-2016.Date Range Expedited (01/12/2016) - Shire reported that Phase II SHP607 top-line data for their Retinopathy of Prematurity trial is expected in the second quarter of 2016.

88403


August 2016 / 40





4502:JP Ninlaro Multiple Myeloma (MM) ApprovedRegulatory - J-NDA Filing (Japan)

J-NDA FilingTakeda is targeting regulatory filings in the US EU and Japan for MLN9708 in multiple myeloma during its fiscal year 2014 ending March 31 2015.

Date Range Delayed (11/21/2014) - Takeda anticipates filing MLN9708 (ixazomib) for approval during its 2015 financial year ending in March 31 2016.Date Range Refined (05/21/2015) - Takeda announced that the Company plans to submit Ixazomib for approval within the first half of fiscal 2015 ending March 31 2016 Date Range Delayed (09/22/2015) - We await an update.Date Range Delayed (12/08/2015) - We continue to await an update.Date Range Delayed (01/12/2016) - Takeda announced that they anticipate filing for approval in Japan for Ninlaro in FY2016.

76873

1/12/2016True North Therapeutics, Inc.

TNT009Complement Deficiencies / Abnormalities

ITrial Data - Updated Results

Phase Ia - Updated Data at J.P. Morgan

True North announced that they will present the results of the Phase Ia study validating TNT009’s proof-of-mechanism along with the overall development plan for TNT009 at the 34th Annual J.P. Morgan Healthcare Conference on Tuesday January 12 2016.

Catalyst Occurred (01/12/2016) - True North Therapeutics announced more results at the 34th annual JP Morgan Healthcare Conference from their Phase Ia/Ib study of TNT009.

117576

Now-06/30/2016Ultragenyx Pharmaceutical Inc.

RARE KRN23Bone Complications (including bone metastases)


Phase II TIO or ENS - Top-Line Results

Ultragenyx Pharmaceutical announced the initiation of a new development program for the human monoclonal anti-FGF23 antibody KRN23 (UX023) in tumor-induced osteomalacia (TIO). Ultragenyx intends to initiate a Phase II study of KRN23 in six adult TIO patients in the first half of 2015 and anticipates interim safety and efficacy data from the study by the end of 2015.

Date Range Delayed (04/07/2015) - Ultragenyx expects to have interim Phase II data of KRN23 targeting Tumor-Induced Osteomalacia (TIO) in late 2015 or early 2016.Date Range Delayed (01/12/2016) - Ultragenyx expects to have Phase II TIO interim data for KRN23 in the first half of 2016.

114825



IIITrial Announcement - Initiation

Phase III - Pediatric Trial to Start

Ultragenyx and Kyowa Hakko Kirin plan to proceed with a pediatric Phase III study in 2016. The exact design details are yet to be determined but will likely utilize RGI-C as the primary endpoint and would include a standard of care reference arm. This study is expected to be required for potential approval in the US and could also serve as a confirmatory study in the EU if a conditional marketing authorization were granted.

Date Range Refined (01/12/2016) - Ultragenyx expects to initiate its Phase III study of KRN23 in pediatric patients for XLH in mid-2016.

117069




MAA Filing

Feedback from the EMA indicates that conditional approval filing for KRN23 may be possible based on ongoing pediatric and adult studies. Ultragenyx stated that the decision to file based on 40-week rickets data from pediatric Phase II in Q4 2015 (original 36 patients) or in mid-2016 (expanded n=~50).

New Information (12/02/2015) - Ultragenyx Pharmaceutical and Kyowa Hakko Kirin announced interim data through 40 weeks from the first 36 patients in the ongoing pediatric Phase II study of KRN23 for the treatment of X-linked hypophosphatemia (XLH). Ultragenyx and Kyowa Hakko Kirin plan to file for a conditional marketing authorization in the EU on the basis of these data and on prior feedback from the EMA suggesting that the companies could do so if the data indicated a positive benefit-to-risk profile. We await an update in the time frame above. Date Range Delayed (01/12/2016) - Ultragenyx plans to file a conditional marketing authorization with the EMA. Pending future discussions the filing will occur in the second half of 2016.

114214


RARE TriheptanoinFatty Acid Oxidation Disorders (FAOD)

IITrial Data - Updated Results

Phase II LC FAOD - Updated Results (78 Weeks)

Ultragenyx announced that 78 week results for the Phase II study of UX007 in fatty acid oxidation disorders is expected in the second half of 2016.

Date Range Delayed (01/12/2016) - Ultragenyx expects to have the Phase II 78-week data for Triheptanoin in mid-2016.

115591


RARE TriheptanoinFatty Acid Oxidation Disorders (FAOD)


Phase III - Trial to Start

Ultragenyx announced that the Company intends to begin planning for a Phase III study of UX007 in LC-FAOD. An update on the design and timing of the Phase III study will be provided after discussions with regulatory authorities in the first half of 2016. As such we await a Phase III initiation update in the time frame above.

Date Range Refined (01/12/2016) - Ultragenyx expects to enroll the first patient in its Phase III study of UX007 in patients with FAOD in the second half of 2016.

115592


August 2016 / 41


Expected Start Date Company Symbol Device Indication Phase Expected Catalyst Analysis Updated Analysis Catalyst ID

Now-12/31/2016TriVascular Technologies, Inc.

TRIVOvation Abdominal Stent Graft System

Aortic Aneurysm ApprovedPMA Approval (Japan) - Ovation Prime

Endologix anticipates approval and launch of Ovation Prime in Japan in 2016. 118184

01/12/2016-03/31/2016 Intersect ENT XENT PROPEL Sinus Implant Allergy ApprovedRegulatory PMA Supplemental Approval - Frontal Indication

Intersect ENT announced at the J.P. Morgan Healthcare Conference that it anticipates to receive PMA Supplemental approval for Propel-mini's frontal indication.

Date Range Refined (09/30/2015) - Intersect ENT announced that the company has submitted a supplemental premarket approval (PMA-s) submission to the U.S. Food and Drug Administration (FDA) to seek approval to expand the indication of the PROPEL mini steroid releasing sinus implant to the treatment of patients undergoing frontal sinus surgery. Given the FDA's standard 180-day review period we await an update in the time frame above.Date Range Delayed (01/12/2016) - Intersect expects approval of the frontal sinus indication for PROPEL Mini this quarter.

106493

01/12/2016-06/30/2016Boston Scientific Corporation

BSXEluvia Drug-Eluting Vascular Stent System

Peripheral Arterial Disease (PAD)

IDE CE Mark ApprovalBoston Scientific announced that it expects the Eluvia Drug-Eluting Stent System to receive CE Mark approval in 2016.

New Information (05/01/2015) - Boston Scientific said that it anticipates receiving CE Mark approval for Eluvia in the first half of 2016.New Information (01/12/2016) - Boston Scientific announced that it expects to launch Eluvia in Europe in the first half of 2016. Given this estimate we expect CE Mark approval in the same time frame.

110863


BSXEluvia Drug-Eluting Vascular Stent System

Peripheral Arterial Disease (PAD)

IDE Product Launch (EU)

Boston Scientific said it anticipates launching Eluvia in Europe in 2016. Given the companies anticipation of CE Mark approval in the first half of 2016 we expect the launch of the product to occur in the second half of 2016.

Date Range Expedited (01/12/2016) - Boston Scientific announced that it expects to launch Eluvia in Europe in the first half of 2016.

110998

01/12/2016-06/30/2016 Endologix, Inc. ELGXAFX Endovascular AAA System

Aortic Aneurysm Approved CE Mark Approval - AFX2Endologix expects to receive CE Mark approval for AFX2 in the first half of 2016 and launch the product during Q3 2016.

118183

02/01/2016-02/29/2016 Endologix, Inc. ELGXNellix Endovascular Aneurysm Sealing System

Aortic Aneurysm PMA PMA Module 2 FilingEndologix announced that is expects to submit PMA modules 2 and 3 later in 2015.

Date Range Delayed (11/20/2015) - Endologix announced that it expects it will submit Modular 2 of its modular PMA in February 2016.New Information (01/12/2016) - Endologix announced that it has completed the submission of PMA modules 1 and 3. The company is currently working toward modular 2 which is expected in February and modular 4 (final module) which is expected in the March or April time frame.

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02/01/2016-02/29/2016 Roche Holding AG RHHBFPEGPH20 Companion Diagnostic

Pancreatic Cancer PreclinicalRegulatory - IDE Submission

Halozyme announced that they anticipate finalizing the specifications and submiting an investigational device exemption for the companion diagnostic. The companion diagnostic will support initiation of patient enrollment in the planned Phase III study, which is expected to begin by the end of the first quarter of 2016.

Date Range Refined (02/01/2016 - 02/29/2016) - Halozyme announced that a U.S. IDE submission is anticipated in February 2016 for the PEGPH20 companion diagnostic test.

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2/8/2016Boston Scientific Corporation

BSX WATCHMANStroke Prevention in Atrial Fibrillation (SPAF)

ApprovedUS Reimbursement - National Coverage Final Decision

Boston Scientific said that it will understand more about the national coverage decision as well as the new technology add-on payment in the back-half of 2015.

Date Range Delayed (10/13/2015) - The Watchman procedure was not granted a fiscal-year 2016 new-technology add-on payment by the Centers for Medicare and Medicaid Services (CMS) in its hospital inpatient rule put out in summer 2015 however Boston Scientific notes that CMS established new higher-paying categories (MD-DRGs) for percutaneous intracardiac procedures to include the left-atrial appendage closure device procedure. The Chief Medical Officer of Boston Scientific said CMS's decision to include Watchman in the MS-DRGs will mean hospitals will on average receive 19% more in Medicare reimbursements. Boston Scientific is now waiting on CMS to establish a national coverage policy for the Watchman procedure. The agency opened a national coverage analysis earlier this year in response to a request from the company. A proposal is expected in November and a final decision by next February.Date Range Refined (01/12/2016) - Boston Scientific said it expects to hear a decision on WATCHMAN reimbursement on February 8 2016.

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Aortic Aneurysm PMAPMA Module 4 (Final) Submission

Endologix announced it completed patient enrollment in the EVAS FORWARD IDE study in November. The patients in this study will be followed for one year after which the company will submit the final module of the PMA to the FDA. Based on this timeline the company remains on track for potential FDA approval of Nellix in late 2016. As such we look for a final PMA module submission sometime in the first half of 2016.

New Information (06/17/2015) - Endologix announced that based on current assumptions and timelines the Company anticipates submission of the premarket approval (PMA) application to the U.S. FDA in early 2016.Date Range Refined (11/20/2015) - Endologix announced that it expects to submit Modular 4 the final module for the Nellix PMA in March 2016.Date Range Delayed (01/12/2016) - Endologix announced that it has completed the submission of PMA modules 1 and 3. The company is currently working toward modular 2 which is expected in February and modular 4 (final module) which is expected in the March or April time frame.

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Aortic Aneurysm Approved US Product Launch - AFX 2Endologix Inc. announced it expects to launch the AFX2 delivery system for the bifurcated main body device by the end of 2015.

Date Range Delayed (10/12/2015) - Endologix announced that it has received U.S. Food and Drug Administration (FDA) approval for the AFX2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms (AAA). Endologix anticipates a commercial launch in the U.S. expected to begin in the first quarter of 2016.Date Range Delayed (01/12/2016) - Endologix said it plans to launch the AFX2 in the U.S. during Q2 2016.

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Aortic Aneurysm PMAEU Launch - Next Generation

Endologix announced it plans to launch an enhanced version of Nellix in Europe by the end of 2015.

Date Range Delayed (11/06/2015) - Endologix announced that the next generation of Nellix is scheduled for launch in Europe during the second quarter 2016.

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04/01/2016-06/30/2016 GenMark Diagnostics, Inc. GNMK ePlex Diagnostic Platforms Development U.S. FDA 510(k) SubmissionGenMark expects to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) for the ePlex system during the second half of 2015.

Date Range Delayed (04/16/2015) - GenMark Diagnsotics announced it now plans to submit its 510(k) application with the FDA in the first quarter of 2016.Date Range Delayed (01/12/2016) - GenMark said that it expects a 510(k) submission to the FDA for ePlex in the second quarter of 2016.

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04/01/2016-06/30/2016 Intersect ENT XENT Nova Sinus Implant Allergy IDEPhase IV PROGRESS - Patient Enrollment Completed

Intersect expects to complete enrollment in the NOVA study cohort of the PROGRESS study in Q2.

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Aortic Aneurysm PMAIDE EVAS FORWARD 1-Year Data at SVS

Endologix announced that it expects to present 1-year clinical results from the Nellix IDE study in June 2016.

Date Range Refined (01/12/2016) - Endologix announced that it plans to present 1-year follow-up from the Nellix IDE study at the Society for Vascular Surgery (SVS) meeting in June 2016.

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07/01/2016-09/30/2016 DexCom Inc. DXCMDexcom G4 Platinum Continuous Glucose Monitoring System

Diabetes Mellitus, Type II ApprovedPhase IV DIaMonD - Top-Line Results

DexCom expects results from the DIaMonD study early in the second half of 2016. We look for a potential data readout in Q3.

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Aortic Aneurysm Approved Product Launch (EU) - AFX2Endologix announced that In Europe AFX2 is expected to be introduced in the first quarter of 2016.

Date Range Delayed (01/12/2016) - Endologix said it expects to launch the AFX2 in Europe during Q3 2016.

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07/01/2016-09/30/2016 Intersect ENT XENT Nova Sinus Implant Allergy IDEPhase IV PROGRSS - Top-Line Results

Intersect expects data from the Nova study cohort of the PROGRESS study in Q3.

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07/01/2016-12/31/2016 Accelerate Diagnostics, Inc. AXDX ID/AST Blood Culture Assay Infectious Disease Approved in Europe Product Launch (US)Accelerate said it hopes to launch the ID/AST System in late 2016 assuming it receives FDA clearance earlier in 2016.

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MedDeviceTracker JPM Catalysts - Day 2


August 2016 / 42



BSX S-ICD SystemVentricular Tachycardia or Fibrillation

ApprovedEMBLEM MRI S-ICD Product Launch (EU)

Boston Scientific expects to launch the EMBLEM MRI S-ICD in Europe in 2016.

Date Range Delayed (01/12/2016) - Boston Scientific said it expects to launch the next-generation Emblem MRI-safe device in Europe in the second half of 2016.

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Aortic Aneurysm PMA PMA ApprovalEndologix announced that it expects to receive PMA approval in the U.S. in 2015.

Date Range Expedited (01/13/2011) - Endologix expects to launch the Nellix device in the United States in 2012 pending FDA approval.Date Range Delayed (08/18/2011) - Endologix Inc. announced it now expects FDA PMA approval in 2015.Date Range Delayed (10/26/2012) - Endologix Inc. now expects to be in position to receive FDA approval in 2016.Date Range Refined (11/04/2013) - Endologix Inc. now expects to achieve PMA approval in the U.S. in the second half of 2016.Date Range Delayed (08/05/2014) - Endologix Inc. announced it now expects PMA approval to occur in the U.S. by the end of 2016.New Information (11/19/2014) - Endologix announced that it anticipates FDA approval of the Nellix System in the U.S. before the end of 2016.New Information (04/29/2015) - Endologix announced that it is still on track for potential U.S. FDA approval in late 2016.New Information (06/17/2015) - Based on current assumptions and timelines the Company anticipates submission of the premarket approval (PMA) application to the U.S. FDA in early 2016 and is anticipating FDA approval of the Nellix System by the end of 2016.Date Range Delayed (01/12/2016) - Endologix announced that it expects to receive PMA approval for Nellix around the end of 2016 or early 2017.

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Aortic Aneurysm PMA U.S. Product LaunchEndologix announced it plans to launch Nellix in the United States in late 2016.

Date Range Delayed (01/12/2016) - Endologix announced that it expects to receive PMA approval for Nellix around the end of 2016 or early 2017. The company expects the launch to occur around the same time frame.

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09/28/2016-12/31/2016 GenMark Diagnostics, Inc. GNMK ePlex Diagnostic Platforms Development Product Launch - U.S.GenMark Diagnostics announced it plans to launch ePlex in the United States during the first half of 2016.

Date Range Delayed (01/12/2016) - GenMark said that it expects a 510(k) submission to the FDA for ePlex in the second quarter of 2016. Assuming an approval at the end of a standard 90-day 510(k) review by the FDA from the end of Q2 we expect an update on the launch in the time frame above.

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Aortic Aneurysm PMA Approval (Brazil)Endologix announced that it anticipates approval and launch of Nellix in Brazil in 2017.

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Aortic Aneurysm PMA PMA Approval (Japan)Endologix announced that it anticipates approval and launch of Nellix in Japan in 2017.

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01/01/2017-12/31/2017 Intersect ENT XENT Nova Sinus Implant Allergy IDEPMA Approval Decision - Frontal

Intersect expects to receive a supplemental premarket approval (PMA) from the U.S. Food and Drug Administrstion (FDA) for NOVA in 2017.

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Aortic Aneurysm PMANellix CHEVAS - CE Mark Approval

Endologix anticipates approval and launch of Nellix CHEVAS in Europe in 2018.

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01/01/2018-12/31/2018TriVascular Technologies, Inc.

TRIV Ovation Alto System Aortic Aneurysm Preclinical PMA Approval (US)Endologix anticipates US approval of Ovation Alto in 2018 or early 2019.

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01/01/2018-04/30/2019TriVascular Technologies, Inc.

TRIV Ovation Alto System Aortic Aneurysm Preclinical CE Mark ApprovalEndologix anticipates European approval of Ovation Alto in 2018.

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Aortic Aneurysm PMA Approval (China)Endologix announced that for the China market its current plans are to focus on commercializing Nellix in the 2018 time frame.

Date Range Delayed (01/12/2016) - Endologix expects approval and launch of Nellix in China in 2019.

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Aortic Aneurysm PMANellix CHIVAS - PMA Approval

Endologix anticipates approval and launch of Nellix CHIVAS in the US in 2020.

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