yale pharmaceutical pipeline product licensee indication … · 2019-12-16 · product indication...
TRANSCRIPT
Product Licensee Indication Preclinical Phase I Phase II Phase III NDA/BLA Market
Zerit® Bristol-Myers HIV / AIDS ggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Emtriva™ Gilead HIV / AIDS ggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Levovir Bukwang Hepatitis B ggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Intuniv Shire ADHD ggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Kyprolis Amgen Cancer ggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Lymerix™ (Withdrawn) Glaxo Lyme gggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Spravato Janssen Depression ggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
NTO-1152 Cloretazine Nanotherapeutics Cancer gggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
BHV-0223 BioHaven Refratory OCD ggggggggggggggggggggggggggggggggggggggggggg g
Elvucitabine™ Achillion HIV / AIDS ggggggggggggggggggggggggggggggggggggggggggg g
Triapine™ Nanotherapeutics Cancer ggggggggggggggggggggggggggggggggggggggggggg g
KD018 Not Partnered Chemotherapy/Diarrheaggggggggggggggggggggggggggggggggggggggggggg g
CERE-110 Sangamo Alzheimer's ggggggggggggggggggggggggggggggggggggggggggg g
Radezolid Melinta Antibacterial ggggggggggggggggggggggggggggggggggggggggggg g
OBP-601/Censavudine Oncolys HIV ggggggggggggggggggggggggggggggggggggggggggg g
AZD0530 AstraZeneca Alzheimer's ggggggggggggggggggggggggggggggggggggggggggg g
ICON-1 Iconic Therapeutics AMD ggggggggggggggggggggggggggggggggggggggggggg g
SPN817 Supernus CNS - Seizures ggggggggggggggggggggggggggggggggggggggggggg
CDX3379 Celldex Therapeutics Cancer ggggggggggggggggggggggggggggggggggggggggggg g
CDX1401 Celldex Therapeutics Oncology ggggggggggggggggggggggggggggggggggggggggggg g
CDX301 Celldex Therapeutics Various ggggggggggggggggggggggggggggggggggggggggggg g
PTX-100 Prescient Cancer ggggggggggggggggggggggggggggg g
NC318 NextCure Oncology ggggggggggg gggggggggg g
BIS-001ER Biscayne Pharma Undisclosed ggggggggggggggggggggggggggggg g
VSV Oncolytic Virus Vyriad MedImmune Cancer ggggggggggggggggggggggggggggg g
Anti-ICOS Bristol-Myers Oncology ggggggggggggggggggggggggggggg g
TRXE-002 Kazia Therapeutics Ovarian Cancer ggggggggggggggggggggggggggggggggggggggg
ARV-110 Arvinas Prostate Cancer gggggggggg gggggggggg
PBS Vax™ - VSV Vaccine Pfizer Profectus HSV gggggggggg g g
PBS Vax™ - VSV Vaccine Pfizer Profectus HBV gggggggggg g g
PBS Vax™ - VSV Vaccine Pfizer Profectus HCV gggggggggg g g
PBS Vax™ - VSV Vaccine Pfizer Profectus HPV gggggggggg g g
VesiculoVax™ Pfizer Profectus RSV gggggggggg g
VesiculoVax™ Pfizer Profectus Equine Encephalitis gggggggggg g
Gene Editing Platform Confidential Orphan Indication 1 gggggggggg g
Gene Editing Platform Confidential Orphan Indication 2 gggggggggg g
RX-04 Melinta Sanofi Antibacterial gggggggggg g
GFB-204 Not Partnered Cancer gggggggggg g
AXER-204 ReNetX Spinal Cord/Stroke gggggggggg g
Nanoparticle vaccine Allertein Peanut Allergy gggggggggg g
IMM-01 Immunova Cancer gggggggggg g
Troxatyl Beijing HebaBiz Cancer gggggggggg g
Chikungunya - VesiculoVax™ Pfizer Profectus Chikungunya gggggggggg g
Lassa - VesiculoVax™ Pfizer Profectus Lassa gggggggggg g
PAT-DX1 Patrys Cancers gggggggggg g
PAT-DX1-NP Patrys Cancers gggggggggg g
LN001 LIFNano Therapeutics Multiple Sclerosis ggggggggggg
CPE-54 IGF Oncology Ovarian Cancer gggggggggg g
ARV-471 Arvinas Breast Cancer gggggggggg g
NC410 NextCure Oncology gggggggggg g
INZ-701 Inozyme Calcification Disorders gggggggggg g
YALE PHARMACEUTICAL PIPELINE
Product Licensee Internal Development Clinical Testing
FISH Vysis/Abbott gggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
CNTNAP2 DNA Sequencing Athena Diagnosticsgggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Wackers-Liu CQ MedX gggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Diabetes Diagnostic RSR & Roche gggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
Downs Syndrome Quest gggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
OvaSure Ovarian Cancer Diagnostic LabCorp gggggggggggggggggggggggggggggggggggggggggggggggggg
Stabilimax NZ Applied Spinegggggggggggggggggggggggggggggggggggggggggggggggggg
Apoptosis Assay Precision Therapeuticsgggggggggggggggggggggggggggggggggggggggggggggggggg
Ovarian Cancer Diagnostic in China SurExam gggggggggggggggggggggggggggggggggggggggggggggggggg
Ovarian Cancer Diagnostic in Israel Not Partneredgggggggggggggggggggggggggggggggggggggggggggggggggg
Wand Micro-Access Safey Introducer Access Scientificgggggggggggggggggggggggggggggggggggggggggggggggggg
ClariVein Venous Ablation Device Vascular Insightsgggggggggggggggggggggggggggggggggggggggggggggggggg
PT-301 Oncology diagnostic/prognostic Precision Therapeuticsgggggggggggggggggggggggggggggggggggggggggggggggggg
Bone Disease/Fractures Unigene gggggggggggggggg
Ischemic Bowel Disease Inverness Medical Innovations gggggggggggggggg
ContraMed Device ContraMed gggggggggggggggg
Varicose Vein Dissector Vascular Insights gggggggggggggggg
Urine Preeclampsia Diagnostic Siemens Medical gggggggggggggggg
YALE DEVICE & DIAGNOSTIC PIPELINE
Marketed
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YALE DEVICE & DIAGNOSTIC PIPELINE
Zerit® (Bristol-Myers)Emtriva® (HIV/Gilead)
Levovir® (Bukwang/Eisai)Soliris™ (Alexion)
Intuniv (Shire)Kyprolis (Onyx)
Onrigin™ (Bejing Pason)NHP 001 (Confidential)
Elvucitabine™ (Achillion)Triapine™ (NanoTherapeutics)
KD018 (Kadmon)CERE-110 (Ceregene)CERE-120 (Ceregene)
NLX-P101 (Neurologix)AAV-hAADC2 (Genzyme)
BMS-986001 (Bristol Myers Squibb/Oncolys)Radezolid (RX-1741) (Rib-X)
Vax125(VaxInnate)Huperzine A (Insero)
VSV Vaccine (Profectus)M2e Influenza vaccine (VaxInnate)
NHP 229 (Confidential)Curcumin (Allertein)
GGTI 2418 (Not Partnered)hI-conI (Iconics)
RX-04 (Rib-X/Sanofi-Aventis)CERE-120 (Ceregene)
AAV/dXIAP (Neurologix)AAV-p11 (Neurologix)AAV/NPY (Neurologix)
GFB 204 (Not Partnered)Complement Factor H (Optherion)
Riboswitch Inhibitors (BioRelix/Merck)Swine F lu Vaccine (VaxInnate)
Bithionol (Not Partnered)NHP 554L (Confidential)
Nogo (Axerion)HYG-102 (Hygeia)
Oncolytic Virus (AzGardaBio)L-BHDU (Bukwang)Vaccines (Allertein)
Nanoparticle immunostimulatory agent…Prion Protein (Axerion/AstraZeneca)
The Yale Pharmaceutical Pipeline
Preclin ical Phase I Phase II Phase III NDA/BLA Market
Product Indication Preclinical Phase I Phase II Phase III NDA/BLA MarketZerit® (Bristol-Myers) HIV / AIDS 1 1 1 1 1 1Emtriva® (HIV/Gilead) HIV 1 1 1 1 1 1Levovir® (Bukwang/Eisai) Hepatitis B 1 1 1 1 1 1Soliris™ (Alexion) PNH, RA, Nephritis 1 1 1 1 1 1Intuniv (Shire) ADHD 1 1 1 1 1 1Kyprolis (Onyx) Onyx 1 1 1 1 1 1Onrigin™ (Bejing Pason) Vion 1 1 1 1 0 0NHP 001 (Confidential) Refratory OCD 1 1 1 0 0 0Elvucitabine™ (Achillion) HIV / AIDS; HBV 1 1 1 0 0 0Triapine™ (NanoTherapeutics) Cancer 1 1 1 0 0 0KD018 (Kadmon) Chemotherapy/Diarrhea 1 1 1 0 0 0CERE-110 (Ceregene) Parkinson's Disease 1 1 1 0 0 0CERE-120 (Ceregene) Parkinson's Disease 1 1 1 0 0 0NLX-P101 (Neurologix) Parkinson's Disease 1 1 1 0 0 0AAV-hAADC2 (Genzyme) Parkinson's Disease 1 1 1 0 0 0BMS-986001 (Bristol Myers Squibb/Oncolys) Anti-HIV 1 1 1 0 0 0Radezolid (RX-1741) (Rib-X) Antibiotic 1 1 1 0 0 0Vax125(VaxInnate) vaccine 1 1 1 0 0 0Huperzine A (Insero) Epilepsy 1 1 0 0 0 0VSV Vaccine (Profectus) HIV / AIDS 1 1 0 0 0 0M2e Influenza vaccine (VaxInnate) vaccine 1 1 0 0 0 0NHP 229 (Confidential) GERD 1 1 0 0 0 0Curcumin (Allertein) Cystic Fibrosis 1 1 0 0 0 0GGTI 2418 (Not Partnered) Cancer 1 1 0 0 0 0hI-conI (Iconics) Cancer 1 1 0 0 0 0RX-04 (Rib-X/Sanofi-Aventis) Antibiotic 1 0 0 0 0 0CERE-120 (Ceregene) Huntington's 1 0 0 0 0 0AAV/dXIAP (Neurologix) Huntington's 1 0 0 0 0 0AAV-p11 (Neurologix) Depression 1 0 0 0 0 0AAV/NPY (Neurologix) Epilepsy 1 0 0 0 0 0GFB 204 (Not Partnered) Cancer 1 0 0 0 0 0Complement Factor H (Optherion) Macular degeneration 1 0 0 0 0 0Riboswitch Inhibitors (BioRelix/Merck) Antibacterials 1 0 0 0 0 0Swine Flu Vaccine (VaxInnate) vaccine 1 0 0 0 0 0Bithionol (Not Partnered) Cancer 1 0 0 0 0 0NHP 554L (Confidential) Hepatopretection in HCV 1 0 0 0 0 0Nogo (Axerion) Spinal Cord/Stroke 1 0 0 0 0 0HYG-102 (Hygeia) Skin Fragility 1 0 0 0 0 0Oncolytic Virus (AzGardaBio) Glioma 1 0 0 0 0 0L-BHDU (Bukwang) Shingles 1 0 0 0 0 0Vaccines (Allertein) Peanut Allegry 1 0 0 0 0 0Nanoparticle immunostimulatory agent (Immunova)
Cancer 1 0 0 0 0 0Prion Protein (Axerion/AstraZeneca) Alzheimer's 1 0 0 0 0 0
Urine Preeclampsia Diagnostic (Siemens Medical)Varicose Vein Dissector (Vascular Insights)
ContraMed Device (ContraMed)Ischemic Bowel Disease (Inverness Medical Innovations)
Bone Disease/Fractures (Unigene)PT-301 Oncology diagnostic/prognostic (Precision Therapeutics, Inc.)
ClariVein Venous Ablation Device (Vascular Insights)Wand Micro-Access Safey Introducer (Access Scientific)
Ovarian Cancer Diagnostic in Israel (Not Partnered)Ovarian Cancer Diagnostic in China (SurExam)
Apoptosis Assay (Precision Therapeutics)Stabilimax NZ (Applied-Spine)
OvaSure Ovarian Cancer Diagnostic (LabCorp)Downs Syndrome (Quest)
Diabetes Diagnostic (RSR & Roche)Wackers-Liu CQ (MedX)
CNTNAP2 DNA Sequencing (Athena Diagnostics)FISH (Vysis/Abbott)
The Yale Device and Diagnostic Pipeline
Internal Development Clin ic al Tes ting Marketed
Product Internal DevelopmentClinical Testing MarketedUrine Preeclampsia Diagnostic (Siemens Medical) 1 0 0Varicose Vein Dissector (Vascular Insights) 1 0 0ContraMed Device (ContraMed) 1 0 0Ischemic Bowel Disease (Inverness Medical Innovations) 1 0 0Bone Disease/Fractures (Unigene) 1 0 0PT-301 Oncology diagnostic/prognostic (Precision Therapeutics, Inc.) 1 1 0ClariVein Venous Ablation Device (Vascular Insights) 1 1 0Wand Micro-Access Safey Introducer (Access Scientific) 1 1 0Ovarian Cancer Diagnostic in Israel (Not Partnered) 1 1 0Ovarian Cancer Diagnostic in China (SurExam) 1 1 0Apoptosis Assay (Precision Therapeutics) 1 1 0Stabilimax NZ (Applied-Spine) 1 1 0OvaSure Ovarian Cancer Diagnostic (LabCorp) 1 1 0Downs Syndrome (Quest) 1 1 1Diabetes Diagnostic (RSR & Roche) 1 1 1Wackers-Liu CQ (MedX) 1 1 1CNTNAP2 DNA Sequencing (Athena Diagnostics) 1 1 1FISH (Vysis/Abbott) 1 1 1
Yale Office of Cooperative ResearchPipeline Analysis
Based on information available as of February 20072008 2009 2010 2011 2012 2013 2014 2015
Expected Revenue (Disc) 1,882,500 4,855,000 8,156,152 13,935,500 19,849,167 19,837,000 20,354,667 9,842,250
Expected Revenue (Prob) 1,521,125 3,586,000 5,609,071 7,978,750 10,164,425 10,290,750 10,462,250 4,342,388
2008 2009 2010 2011 2012 2013 2014 2015
OCR #519 Projected Sales 8,600,000 33,700,000 60,000,000 70,000,000 72,000,000 72,000,000 70,000,000 70,000,000 1 Royalty Rate 5.0% 5.0% 5.0% 5.0% 5.0% 5.0% 5.0% 5.0%
Yale Royalty (no risk) 430,000 1,685,000 3,000,000 3,500,000 3,600,000 3,600,000 3,500,000 2,625,000 Cloretazine Probability to Market 60%Vion Yale Share (IIA) #### Phase III US patents expire July 2015
Rest of world 2016Expected Revenue (Disc) 430,000 1,685,000 3,000,000 3,500,000 3,600,000 3,600,000 3,500,000 2,625,000 Expected Revenue (Prob) 258,000 1,011,000 1,800,000 2,100,000 2,160,000 2,160,000 2,100,000 1,575,000
2008 2009 2010 2011 2012 2013 2014 2015OCR #337 Projected Sales 10,000,000 73,333,333 ######### 265,333,333 344,666,667 406,000,000 457,333,333 500,000,000
3 Royalty Rate 0.75% 0.75% 0.75% 1.50% 1.75% 2.00% 2.00% 2.25%Yale Royalty (no risk) 7,500 55,000 125,500 398,000 603,167 812,000 914,667 1,125,000
Soliris Probability to Market 75%Alexion Yale Share (IIA) 10% NDA/BLA No expiration prior to 2016All indications Split with Oklahoma ***License royalty terms subject to change
Expected Revenue (Disc) 7,500 55,000 125,500 398,000 603,167 812,000 914,667 1,125,000 Expected Revenue (Prob) 5,625 41,250 94,125 298,500 452,375 609,000 686,000 843,750
2008 2009 2010 2011 2012 2013 2014 2015OCR #388 Projected Sales - - - 18,600,000 66,700,000 124,000,000 175,500,000 175,500,000
5 Royalty Rate 4.0% 4.0% 4.0% 4.0% 4.0% 5.0% 5.0% 5.0%Yale Royalty (no risk) - - - 744,000 1,334,000 - - -
Triapine Probability to Market 30%Vion Yale Share (IIA) #### Phase II All patents expires May 2012
Expected Revenue (Disc) - - - 744,000 1,334,000 - - - Expected Revenue (Prob) - - - 223,200 400,200 - - -
2008 2009 2010 2011 2012 2013 2014 2015OCR #601 Projected Sales - - - - 5,000,000 20,000,000 20,000,000 20,000,000
6 Royalty Rate 2.0% 2.0% 2.0% 2.0% 2.0% 2.0% 2.0% 2.0%Yale Royalty (no risk) - - - - 50,000 200,000 200,000 126,000
AAV for CNS Probability to Market 20%Neurologix Yale Share (IIA) 50% Phase I US patents expire June 2015
Split with Rockefeller Rest of world expires June 2016 Expected Revenue (Disc) - - - - 50,000 200,000 200,000 126,000 Expected Revenue (Prob) - - - - 10,000 40,000 40,000 25,200
2008 2009 2010 2011 2012 2013 2014 2015OCR #552 Projected Sales 20,000,000 40,000,000 60,000,000 70,000,000 80,000,000 80,000,000 80,000,000 80,000,000
7 Royalty Rate 13.9% 13.9% 13.9% 13.9% 13.9% 13.9% 13.9% 13.9%Yale Royalty (no risk) 695,000 1,390,000 2,085,000 2,432,500 2,780,000 2,780,000 2,780,000 -
Clevudine Probability to Market ####Eisai-Asia Yale Share (IIA) 25% Market in Asia Patents expire January 2015
Split with UGARF and BuckwangExpected Revenue (Disc) 695,000 1,390,000 2,085,000 2,432,500 2,780,000 2,780,000 2,780,000 - Expected Revenue (Prob) 695,000 1,390,000 2,085,000 2,432,500 2,780,000 2,780,000 2,780,000 -
2008 2009 2010 2011 2012 2013 2014 2015OCR #552 Projected Sales - 20,000,000 40,000,000 60,000,000 70,000,000 80,000,000 80,000,000 80,000,000
8 Royalty Rate 12.0% 12.0% 12.0% 12.0% 12.0% 12.0% 12.0% 12.0%Yale Royalty (no risk) - 600,000 1,200,000 1,800,000 2,100,000 2,400,000 2,400,000 -
Clevudine Probability to Market 50%Pharmasset-exAsiaYale Share (IIA) 25% Phase IIb needed in US Patents expire January 2015
Split with UGARFExpected Revenue (Disc) - 600,000 1,200,000 1,800,000 2,100,000 2,400,000 2,400,000 - Expected Revenue (Prob) - 300,000 600,000 900,000 1,050,000 1,200,000 1,200,000 -
2008 2009 2010 2011 2012 2013 2014 2015OCR #971 1072 Projected Sales - - - - 15,000,000 30,000,000 30,000,000 30,000,000
9 Royalty Rate 2.0% 2.0% 2.0% 2.0% 2.0% 2.0% 2.0% 2.0%Yale Royalty (no risk) - - - - 90,000 180,000 180,000 180,000
PHY906 Probability to Market 20%Phytoceutica Yale Share (IIA) 30% Phase II Most Patents through 2020
Expected Revenue (Disc) - - - - 90,000 180,000 180,000 180,000 Expected Revenue (Prob) - - - - 18,000 36,000 36,000 36,000
2008 2009 2010 2011 2012 2013 2014 2015OCR #812 Projected Sales - - - 18,600,000 66,700,000 124,000,000 175,500,000 175,500,000
11 Royalty Rate 1.0% 1.0% 1.0% 1.0% 1.0% 1.0% 1.0% 1.0%Yale Royalty (no risk) - - - 186,000.0 667,000.0 1,240,000.0 1,755,000.0 1,755,000.0
XL784 Probability to Market 30%Exelixis Yale Share (IIA) #### Phase II US patents expire Aug 2016
Other universities have separate licenses Rest of world expires August 2017Expected Revenue (Disc) - - - 186,000 667,000 1,240,000 1,755,000 1,755,000 Expected Revenue (Prob) - - - 55,800 200,100 372,000 526,500 526,500
2008 2009 2010 2011 2012 2013 2014 2015OCR #474 Projected Sales 50,000,000 75,000,000 75,000,000 75,000,000 75,000,000 75,000,000 75,000,000 75,000,000
12 Royalty Rate 5.0% 5.0% 5.0% 5.0% 5.0% 5.0% 5.0% 5.0%Yale Royalty (no risk) 750,000 1,125,000 1,125,000 1,125,000 1,125,000 1,125,000 1,125,000 281,250
Connexyn Probability to Market 75%Shire Yale Share (IIA) 30% NDA filed US patents expire Sept 2015
Split with ArnstenExpected Revenue (Disc) 750,000 1,125,000 1,125,000 1,125,000 1,125,000 1,125,000 1,125,000 281,250 Expected Revenue (Prob) 562,500 843,750 843,750 843,750 843,750 843,750 843,750 210,938
2008 2009 2010 2011 2012 2013 2014 2015OCR #500, 510 Projected Sales - - 50,000,000 100,000,000 200,000,000 200,000,000 200,000,000 200,000,000
14 Royalty Rate 5.00% 5.00% 5.00% 5.00% 5.00% 5.00% 5.00% 5.00%Yale Royalty (no risk) - - 1,875,000 3,750,000 7,500,000 7,500,000 7,500,000 3,750,000
Elvucitabine Probability to Market 30%Achillion Yale Share (IIA) 75% Phase II All patents expire May 2014 (Cut 2014 by 50%)HIV ***Special Case: 75% of first $1.5M to Vion; From then on, 25% to Vion
Special Case 620,652 Expected Revenue (Disc) - - 620,652 3,750,000 7,500,000 7,500,000 7,500,000 3,750,000 Expected Revenue (Prob) - - 186,196 1,125,000 2,250,000 2,250,000 2,250,000 1,125,000
20162,181,000
1,169,175
201670,000,000
5.0%-
- -
2016528,666,667
2.25%1,189,500
1,189,500 892,125
2016175,500,000
5.0%-
- -
201620,000,000
2.0%24,000
24,000 4,800
201680,000,000
13.9%-
- -
201680,000,000
12.0%-
- -
201630,000,000
2.0%180,000
180,000 36,000
Yale Pharmaceutical PipelineAGENT LICENSEE INDICATION STAGE DEPARTMEN
TLEAD YALE INVENTOR
OCR #
1 Zerit® Bristol-Myers HIV / AIDS Market Pharmacology Prusoff 1332 Emtriva™ Gilead HIV / AIDS Market Pharmacology Cheng 3403 Levovir Bukwang/Eisai Hepatitis B Market Pharmacology Cheng 5524 Soliris™ Alexion PNH, RA, Nephritis Market Immunobiology Bothwell 4395 Connexyn Shire ADHD NDA/BLA Neurobiology Arnsten 4746 Cloretazine™ Vion Cancer Phase III Pharmacology Sartorelli 5197 Clevudine™/L-FMAU Pharmasset (Ex-Asia) Hepatitis B Phase III Pharmacology Cheng 5528 Elvucitabine™ Achillion HIV / AIDS Phase II Pharmacology Cheng 500 5109 Triapine™ Vion Cancer Phase II Pharmacology Sartorelli 388
10 PHY906 Phytoceutica Chemotherapy/Diarrhea Phase II Pharmacology Cheng 107211 XL 784 Exelixis Diabetic Neuropathy Phase II Genetics Artavanis-T. 81212 Comb therapy for depressionTargacept Depression Phase II13 Cloretazine™ in Elderly AMLVion Elderly AML Phase II Pharmacology Sartorelli 36814 AAV for CNS Neurologix Parkinson's Disease Phase II Neurosurgery During 60115 PR-171 Proteolix Cancer Phase II MCDB Crews 122616 Curcumin SEER Cystic Fibrosis Phase I Physiology Kaplan 92217 KS119W Vion Cancer Pre-clinical Pharmacology Cheng18 VSV Vaccine Profectus HIV / AIDS Phase I Pathology Rose 68319 Icon Iconics Cancer/MacularDegeneration Pre-clinical MB&B Garen 136820 BEHAB Confidential Glioma Pre-clinical Neurobiology Hockfield 561 121421 Nogo Biogen-Idec Spinal Cord Injury Pre-clinical Neurology Strittmatter 104222 Novel Azoles OneWorld Health Chagas Disease Pre-clinical Chemistry Hamilton 120123 E Protein Confidential West Nile virus vaccine Pre-clinical Internal Medicine Fikrig 109424 Chitinase Inhibitors MedImmune Asthma, Inflammation Pre-clinical Internal Medicine Elias 118125 Terphenyl Compounds Kemia Cancer Pre-clinical Chemistry Hamilton 118326 Genvascor Cardium Therapeutics Peripheral Arterial Occlusive Disease (PAOD)Pre-clinical Pharmacology Sessa 99227 GGTI Tigris Pre-clinical29 GFB Tigris Check with Lead Pre-clinical 54030 4E-d4T/OBP601 Oncolys Check with Lead Phase I Altieri 81131 Renalase REN Pharmaceuticals Pre-clinical Desir32 Lupus Drug Confidential Check with Lead Pre-clinical Neurobiology Arnsten33 RX-1741 Rib-X Phase II
CONFIDENTIAL LicenseeAGENT LICENSEE INDICATION STAGE DEPARTMENTPATENT EXPIRATIONLEAD YALE INVENTORComments1 Zerit® Bristol-MyersHIV / AIDS Market Pharmacology 2007 Prusoff
Zerit XR® Bristol-MyersHIV / AIDS Market Pharmacology Dec-07 PrusoffEmtriva™ Gilead Hepatitis B Phase III PharmacologyPending Cheng
3 Clevudine™/L-FMAUBukwang/EisaiHepatitis B Phase III Pharmacology 2017 Cheng4 Pexelizumab™Alexion Inflammation from Cardiopulmonary BypassPhase III Internal Medicine 2015 Smith5 SPD-503 Shire ADHD Phase III Neurobiology 2015 Arnsten 30% Rev to Yale6 Cloretazine™Vion Leukemia Phase III Pharmacology 2010 Sartorelli Trial underway7 Troxatyl® Shire/SGX Leukemia Phase II Pharmacology 2015 Cheng
Troxatyl® Shire/SGX Pancreatic CancerPhase II Pharmacology 2015 Cheng8 Elvucitabine™Achillion Hepatitis B Phase II Pharmacology 2019 Cheng
Elvucitabine™Achillion HIV / AIDS Phase II Pharmacology 2019 Cheng9 Triapine™ Vion Lung Cancer Phase II Pharmacology 2010 Sartorelli Trial underway
Triapine™ Vion Pancreatic CancerPhase II Pharmacology 2010 Sartorelli Trial underway10 PHY906 Phytoceutica Chemotherapy/DiarrheaPhase I/IIa PharmacologyPending Cheng
Triapine™ Vion Leukemia Phase I Pharmacology 2010 Sartorelli Trial underway11 TAPET® Vion Solid TumorsPhase I Multiple Pawelek Second Generation are in Preclinical
Cloretazine™Vion Solid TumorsPhase I Pharmacology 2010 Sartorelli Trial underway12 AAV for CNS Avigen,NeurologixParkinson's DiseasePhase I Neurosurgery 2018 During13 XL 784 Exelixis Diabetic NeuropathyPhase I Genetics 2016 Artavanis-T.
XL 784 Exelixis Cancer Phase I Genetics 2016 Artavanis-T.14 VSV Vaccine Wyeth HIV / AIDS Pre-clinical Pathology 2018 Rose15 Icon Iconics Cancer Pre-clinical MB&B Pending Garen16 IPDR Hana BiosciencesCancer Pre-clinical Pharmacology 2015 Cheng17 Genentech BEHAB (Confidential)Glioma Pre-clinical Neurobiology 2014 Hockfield18 Nogo biogen-idec Spinal Cord InjuryPre-clinical Neurology Pending Strittmatter Research19 Novel Azoles OneWorld HealthChagas DiseasePre-clinical Chemistry Pending Hamilton Research20 VaxInnate E Protein (Confidential)West Nile virus vaccinePre-clinical Internal MedicinePending Fikrig Research21 Chitinase InhibitorsMedImmune Asthma, InflammationPre-clinical Internal MedicinePending Elias Research22 Terphenyl CompoundsKemia Cancer Pre-clinical Chemistry Pending Hamilton23 Epoxomicin Pre-clinical MCDB Pending Crews
Removed
Glaxo Lyme Disease VaccineMarketTriapine™ Vion Prostate CancerPhase II Pharmacology Oct-10 Sartorelli Indication droppedTriapine™ Vion Head and Neck CancerPhase II Pharmacology Oct-10 Sartorelli Trial underwayTriapine™ Vion Breast CancerPhase II Pharmacology Oct-10 SartorelliBr-OddU Achillion Epstein-Barr VirusPre-clinical Pharmacology Jul-19 Cheng
written
Reference
Extended release; approved 12/02verified onlineGilead terminated license; AKA lfmau; Gilead says reached I/IIverified at company websitePIII completed April 2005press release 9/24verified at company websiteverified at company websiteverified at company websiteverified at company websiteverified at company websiteverified at company website
verified at company websiteverified at company websiteverified at company website;aka VNP40101Mletterverified at company websiteverified at company website
No longer at vion websiteNo longer at vion websiteNo longer at vion websiteverified at company website/LOddU?
2006 2007 2008 2009 2010
524 1,492 3,062 5,40910,000 109,000 315,322 639,745
Total tests 10,524 110,492 318,384 645,154
$140 $140 $133.00 $126.35
$1,473,360 $15,468,880 $42,345,072 $81,515,208
Royalty ########## $1,082,821.60 $2,964,155.04 $5,706,064.55worst $491,120 $5,156,293 $14,115,024 $27,171,736MRP $34,378.40 $360,940.53 $988,051.68 $1,902,021.52
Net revenue per test
Net revenue
Yale Test for Ovarian CancerAssumptions: Commercial launch on 1/1/2007
Assumes all testing performed using currently available ELISA kits - 7 biomarkers
High-risk testsGeneral population tests
Summary Sheet: Yale Pipeline
Licensee Triangle Shire Alexion Achillion SuperGen Triangle VionFile code C D F B G E HDrug Name Coviracil Troxatyl 5g1.1-SC 443HIV 5FP LFMAU TriapineAlternate Name bl4d4c clevudineOCR Numbers 340 604 589 1055/510 346 552 368Principal Investigator Cheng Bothwell Cheng Cheng Cheng SartorelliOther Notes Emory SpartaPriority Year 1991 1994 1994 1997 1991 1993 1991
StageTarget/Compound Phase III Phase III Phase III Phase I Phase II Phase II Phase IITypeDisease Class Anti-inf Anti-neo Other Anti-inf Anti-neo Anti-inf Anti-neoTimeSales Ramp-up (Years) 3 3 4 3 3 3Patent life (Remaining Yrs) 13 13 14 10 12 10RevenuePeak Sales 140 400 500 160 395 140 400License DetailsCash Upfront MISSINGMilestone @ IND filing/Phase I Start INFOMilestone @ Phase I EndMilestone @ Phase II StartMilestone @ Phase II End 2,000,000 100,000 Milestone @ Phase III Start 50,000 Milestone @ Phase III End 3,000,000 Milestone @ NDA filing 750,000 50,000 6,000,000 250,000 Milestone @ First Sale 600,000 50,000 1,500,000 100,000 500,000 Fixed Royalty Rate 2.5% 3.0% 2.0% 14.0% 5.0%Minimum Royalty
Variable Royalty #1 3.0%
Variable Royalty #2 3.5%Variable Royalty #3 4.0%Variable Royalty #4Variable Royalty #5
Custom Information Yale gets Royalty Min: Min $25k Sublic: 25% ofMinimum 25% Royalties to Yale8% of $50M royalty 12% to Achillionroyalty: $75k Min. Royalty: after 3 yrs-
*Note that all royalties and royalties $100M after FDA starting in $750k; after 4 yrs- $1M;milestones listed do not reflectpaid to over $100M approval 1996 after 5 yrs-$1.25M; afterany listed splits with other Emory 6 yrs-$1.5Minstitutions 50% of all money 10% Milestones to Yale
to Yale $5M sales milestone forevery $100M in sales up
through $600M; Max $30M
Annual Revenue to Yale(If All Programs are Successful)Licensee Triangle Shire Alexion Achillion SuperGen Triangle VionFile code C D F B G E HDrug Name Coviracil Troxatyl 5g1.1-SC 443HIV 5FP LFMAU TriapineAlternate Name bl4d4c clevudineOCR Numbers 340 604 589 1055/510 346 552 368Principal Investigator Cheng Bothwell Cheng ChengOther Notes Emory SpartaPriority Year 1994 1994 1997 1991 1994 1991
FY 2002 - - - - - 2003 - - - - - 2004 - - - - - 2005 - - - 500,000 - 2006 9,250,000 - - 562,500 - - 2007 1,693,061 - - 975,143 - 2008 4,919,495 2,369,810 1,678,443 3,013,191 -
2009 8,445,134 5,000,000 1,710,140 5,672,644 - 2010 10,438,185 5,000,000 2,935,740 6,393,389 250,000 2011 10,751,331 5,000,000 4,233,337 6,585,190 4,979,721 2012 11,073,871 5,000,000 4,983,242 6,782,746 - 2013 11,406,087 5,000,000 5,132,739 6,986,228 - 2014 11,748,270 5,000,000 5,286,721 - - 2015 - 5,000,000 5,445,323 - -
Annual Revenue to Licensee(If All Programs are Successful)Licensee Triangle Shire Alexion Achillion SuperGen Triangle VionFile code C D F B G E HDrug Name Coviracil Troxatyl 5g1.1-SC 443HIV 5FP LFMAU TriapineAlternate Name bl4d4c clevudineOCR Numbers 340 604 589 1055/510 346 552 368Principal Investigator Cheng Bothwell Cheng ChengOther Notes Emory SpartaPriority Year 1994 1994 1997 1991 1994 1991
FY 2002 - - - - - - 2003 - - - - - - 2004 - - - - - - 2005 - 93,792,401 - - - - 2006 - ####### - - - - 2007 79,603,486 ####### - - 27,861,220 - 2008 ####### ####### 24,597,477 - 86,091,171 - 2009 ####### ####### 76,006,205 - ####### - 2010 ####### ####### ####### - ####### - 2011 ####### ####### ####### 88,474,495 ####### 89,594,425 2012 ####### ####### ####### - ####### - 2013 ####### ####### ####### - ####### - 2014 ####### ####### ####### - - -
Adjust payment:If revenueunder $1.5M,75% to Achil.Once over, 25%to AchillionSublic: 25% of12% to Achillion
AchillionA443HBVbl4d4c1055/647Cheng
1997
Total- - - - - - - 500,000 - 9,812,500
1,333,544 4,001,748 1,452,789 13,433,728
2,493,954 23,321,872 3,596,281 28,613,595 4,233,337 35,782,916 4,360,337 32,200,196 4,491,147 33,016,201 4,625,881 26,660,872 4,764,658 15,209,981
AchillionA443HBVbl4d4c1055/647Cheng
1997
Total- - - - - - - 93,792,401 - 289,818,519
20,895,915 625,882,412 64,568,378 1,036,168,732
110,842,382 1,390,280,164 159,834,715 1,647,276,145 188,148,293 1,952,038,541 193,792,742 1,854,873,387 199,606,524 1,910,519,588 205,594,720 1,762,240,456