future pharmaceutical trends - patent & pipeline –
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Future Pharmaceutical Trends - Patent & Pipeline – . Chris Peterson, PharmD Aimee Tharaldson, PharmD. Objectives. Patent Expiration Overview: 2011-2013 Traditional Pipeline Highlights Specialty Pipeline Overview. Objectives. Patent Expiration Overview: 2011-2013 - PowerPoint PPT PresentationTRANSCRIPT
2011 Express Scripts, Inc.All Rights Reserved
Future Pharmaceutical Trends- Patent & Pipeline –
Chris Peterson, PharmDAimee Tharaldson, PharmD
2011 Express Scripts, Inc.All Rights Reserved
• Patent Expiration Overview: 2011-2013
• Traditional Pipeline Highlights• Specialty Pipeline Overview
Objectives
2
2011 Express Scripts, Inc.All Rights Reserved
• Patent Expiration Overview: 2011-2013
• Traditional Pipeline Highlights• Specialty Pipeline Overview
Objectives
3
2011 Express Scripts, Inc.All Rights Reserved
Patent Expiration Landscape
200120022003200420052006200720082009201020112012201320142015
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2011 Express Scripts, Inc.All Rights Reserved
Patent Expiration LandscapeNext 5 Years
2011 2012 2013 2014 2015$0
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2011 Express Scripts, Inc.All Rights Reserved
Patent Expiration LandscapeNext 5 Years
2011 2012 2013 2014 2015$0
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$25
$30
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LipitorZyprexaLevaquinConcerta
PlavixSeroquelSingulairDiovanActos
Lexapro
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CymbaltaOxyContinNiaspan
NexiumCelebrexActonel
AbilifyGleevec
Namenda
6
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2011
7
Drug Manufacturer
Patent Sales (US)
Taxotere Sanofi Mar 15 $1,200 Xalatan Pfizer Mar 22 $711 Concerta* J&J May 01 $1,437 Femara Novartis Jun 03 $682 Nasacort AQ* Sanofi Jun 15 $244 Levaquin J&J Jun 20 $1,523 Arixtra GSK Expired $340Uroxatral Sanofi Jul 18 $248 Combivir* ViiV 4Q2011 $328 Zyprexa Lilly Oct 23 $2,958 Solodyn (45, 90, 135)* Medicis Nov 01 $667 Lipitor* Pfizer Nov 30 $7,245
* Settlement Agreement
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2011
8
Drug Manufacturer
Patent Sales (US)
Taxotere Sanofi Mar 15 $1,200 Xalatan Pfizer Mar 22 $711 Concerta* J&J May 01 $1,437 Femara Novartis Jun 03 $682 Nasacort AQ* Sanofi Jun 15 $244 Levaquin J&J Jun 20 $1,523 Arixtra GSK Expired $340Uroxatral Sanofi Jul 18 $248 Combivir* ViiV 4Q2011 $328 Zyprexa Lilly Oct 23 $2,958 Solodyn (45, 90, 135)* Medicis Nov 01 $667 Lipitor* Pfizer Nov 30 $7,245
* Settlement Agreement
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2012
9
Drug Manufacturer
Patent Sales (US)
Avandia* GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 Plavix BMS May-17 $6,130 Clarinex* Merck Jul-01 $248 Tricor* Abbott Jul-01 $1,345 Singulair Merck Aug-03 $4,073 Actos* Takeda Aug-17 $3,535 Xopenex neb* Sunovion Aug-20 $545 Geodon Pfizer Sep-01 $1,281 Diovan Novartis Sep-21 $3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199
* Settlement Agreements
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2012
10
Drug Manufacturer
Patent Sales (US)
Avandia* GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 Plavix BMS May-17 $6,130 Clarinex* Merck Jul-01 $248 Tricor* Abbott Jul-01 $1,345 Singulair Merck Aug-03 $4,073 Actos* Takeda Aug-17 $3,535 Xopenex neb* Sunovion Aug-20 $545 Geodon Pfizer Sep-01 $1,281 Diovan Novartis Sep-21 $3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199
* Settlement Agreements
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2012
11
Drug Manufacturer
Patent Sales (US)
Avandia* GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 Plavix BMS May-17 $6,130 Clarinex* Merck Jul-01 $248 Tricor* Abbott Jul-01 $1,345 Singulair Merck Aug-03 $4,073 Actos* Takeda Aug-17 $3,535 Xopenex neb* Sunovion Aug-20 $545 Geodon Pfizer Sep-01 $1,281 Diovan Novartis Sep-21 $3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199
* Settlement Agreements
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2012
12
Drug Manufacturer
Patent Sales (US)
Avandia* GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 Plavix BMS May-17 $6,130 Clarinex* Merck Jul-01 $248 Tricor* Abbott Jul-01 $1,345 Singulair Merck Aug-03 $4,073 Actos* Takeda Aug-17 $3,535 Xopenex neb* Sunovion Aug-20 $545 Geodon Pfizer Sep-01 $1,281 Diovan Novartis Sep-21 $3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199
* Settlement Agreements
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2012
13
Drug Manufacturer
Patent Sales (US)
Avandia* GSK 1Q2012 $342 Lexapro* Forest Mar-14 $2,812 Seroquel AstraZeneca Mar-26 $5,172 Avapro BMS Mar-30 $486 Provigil* Cephalon Apr-01 $1,133 Plavix BMS May-17 $6,130 Clarinex* Merck Jul-01 $248 Tricor* Abbott Jul-01 $1,345 Singulair Merck Aug-03 $4,073 Actos* Takeda Aug-17 $3,535 Xopenex neb* Sunovion Aug-20 $545 Geodon Pfizer Sep-01 $1,281 Diovan Novartis Sep-21 $3,533 Detrol Pfizer Sep-25 $790 Atacand AstraZeneca Dec-04 $199
* Settlement Agreements
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2013
14
Drug Manufacturer
Patent Sales (US)
Propecia* Merck Jan-01 $154 Opana ER* Endo Jan-01 $369 Reclast Novartis Mar-02 $405 Zometa Novartis Mar-02 $768 Valcyte Genentech Mar-15 $289 OxyContin Purdue Apr-16 $3,085 Zomig AstraZeneca May-14 $200 AcipHex Eisai May-18 $1,055 Temodar Merck Aug-11 $389 Advicor* Abbott Sep-20 $111 Niaspan* Abbott Sep-20 $1,129 Cymbalta Lilly Dec-11 $3,153
* Settlement Agreement
2011 Express Scripts, Inc.All Rights Reserved
Patent Expirations: 2013Drug Manufacture
rPatent Sales
(US)Propecia* Merck Jan-01 $154 Opana ER* Endo Jan-01 $369 Reclast Novartis Mar-02 $405 Zometa Novartis Mar-02 $768 Valcyte Genentech Mar-15 $289 OxyContin Purdue Apr-16 $3,085 Zomig AstraZeneca May-14 $200 AcipHex Eisai May-18 $1,055 Temodar Merck Aug-11 $389 Advicor* Abbott Sep-20 $111 Niaspan* Abbott Sep-20 $1,129 Cymbalta Lilly Dec-11 $3,153
* Settlement Agreement
15
2011 Express Scripts, Inc.All Rights Reserved
• Patent Expiration Overview: 2011-2013
• Traditional Pipeline Highlights• Specialty Pipeline Overview
Objectives
16
2011 Express Scripts, Inc.All Rights Reserved
Cardiovascular PipelineXarelto (rivaroxaban – Bayer/J&J)
Indication: Stroke/systemic embolism in a-fib.Route: Oral (once daily)Comments: Approved July 1, 2011. Also under
FDA Review for a-fib indication (Nov. 5, 2011).
Eliquis (apixaban – BMS/Pfizer)Indication: Stroke/systemic embolism in a-fib.Route: Oral (twice daily)Comments: Submission of NDA by the end of
2011 with FDA approval in 2012. 17
2011 Express Scripts, Inc.All Rights Reserved
FDA Action Dates: Cardiovascular
Drug Manufacturer Use Action Date
Simvastatin/sitagliptin Merck DM/Lipids Oct 17Xarelto (rivaroxaban) Bayer/J&J A-Fib (new indication) Nov 5Azilsartan/chlorthalidone Takeda Hypertension Dec 23Eliquis (apixaban) BMS/Pfizer A-Fib 2012ethyl icosapentate (AMR101)
Amarin hypertriglyceridemia
2012
Kynamro (mipomersen) Genzyme/ISIS Hyperlipidemia 2012
18
2011 Express Scripts, Inc.All Rights Reserved
Diabetes Pipeline Dapagliflozin (AstraZeneca/BMS)
Indication: Type 2 diabetesRoute: Oral (two times daily)Comments: FDA Ad Board held on July 19. FDA
action date is October 28, 2011.
Bydureon (exenatide LAR – Amylin/Lilly)Indication: Type 2 diabetesRoute: subcutaneous injection (once weekly)Comments: “Complete response” received in
March 2011. FDA action date is January 28, 2012. 19
2011 Express Scripts, Inc.All Rights Reserved
Diabetes Pipeline Insulin Degludec (Novo-Nordisk)
Indication: DiabetesRoute: Subcutaneous injection (three times
weekly)Comments: Long-acting basil insulin.
Submission planned by the end of 2011.
20
2011 Express Scripts, Inc.All Rights Reserved
FDA Action Dates: Diabetes
Drug Manufacturer Use Action Date
Simvastatin/sitagliptin Merck T2DM/Lipids Oct 17Dapagliflozin BMS/AZ Diabetes Oct 28Janumet XR Merck Type 2 diabetes Nov 11
Alogliptin Takeda Type 2 diabetes Jan 26Alogliptin/pioglitazone Takeda Type 2 diabetes Jan 26Bydureon Lilly/Amylin Type 2 diabetes Jan 28Insulin decludec Novo Nordisk Diabetes 2012Pioglitazone/sitagliptin Merck Type 2 diabetes 2012
21
2011 Express Scripts, Inc.All Rights Reserved
Respiratory Pipeline Eklira (aclidinium – Forest)
Indication: COPDRoute: Inhalation (twice daily)Comments: FDA Action date is Apr 30, 2012.
Glycopyrronium (NVA237 – Novartis) Indication: COPDRoute: Inhalation (once daily)Comments: NDA submission planned by the
end of 2011.
22
2011 Express Scripts, Inc.All Rights Reserved
FDA Action Dates: Respiratory
Drug Manufacturer Use Action Date
Dymista Meda Allergic Rhinitis Feb 4Omnaris HFA Nasal Sunovion Allergic rhinitis Apr 06Eklira Forest COPD Apr 30QNaze Teva Allergic Rhinitis May 24glycopyrronium (NVA237)
Novartis COPD 2012
23
2011 Express Scripts, Inc.All Rights Reserved
CNS Pipeline Opana ER (oxymorphone e.r. –
Endo)Indication: Chronic painRoute: Oral (Twice daily)Comments: “Tamper resistant” formulation.
FDA Action date is Dec 13, 2011.
Remoxy (oxycodone e.r. – Pfizer) Indication: Chronic painRoute: Oral (Twice daily)Comments: “Tamper resistant” formulation.
Complete response issued in in June.24
2011 Express Scripts, Inc.All Rights Reserved
CNS Pipeline Levomilnacipran (Forest)
Indication: DepressionRoute: Oral (once daily)Comments: Isomer of milnacipran (Savella).
NDA by expected “early 2012”.
25
2011 Express Scripts, Inc.All Rights Reserved
CNS Pipeline Levadex (dihydroergotamine - MAP)
Indication: Acute migraineRoute: InhalationComments: Asthma-sized inhaler device. FDA
Action date is Mar 26, 2012.
26
2011 Express Scripts, Inc.All Rights Reserved
FDA Action Dates: CNSDrug Manufacturer Use Action DateOnfi Lundbeck Seizures 4th QuarterCPI-300 IntelGenx Depression Nov 13Opana E.R. (TR) Endo Pain Dec 13Fentanyl SL Spray Insys Pain Jan 4Adasuve Alexza Agitation Feb 4Levadex MAP Migraine Mar 26MoxDuo QRxPharma Pain May 11IPX066 Impax Parkinson’s
disease2012
Levomilnacipran Forest Depression 2012Telcagepant Merck Migraine 2012
27
2011 Express Scripts, Inc.All Rights Reserved
FDA Action Dates: OtherDrug Manufacture
r Use Action Date
Saflutan Merck Glaucoma 4Q2011Alendronate, effervescent
EffRx Osteoporosis Nov 11
Bio-T Gel Teva HRT Nov 14Plan B One Step (OTC) Teva Contraceptive Dec 7Anturol Antarex Overactive
Bladder Dec 8
Civanex Winston Osteoarthritis Dec 31Ivermectin Cream Topaz Head Lice Feb 7Prochieve Watson Preterm Birth Feb 26Avanafil Vivus Erectile
dysfunctionApr 30
Linaclotide Forest Chronic Constipation
Jun 9
28
2011 Express Scripts, Inc.All Rights Reserved
• Patent Expiration Overview: 2011-2013
• Traditional Pipeline Highlights• Specialty Pipeline Overview
Objectives
29
2011 Express Scripts, Inc.All Rights Reserved
FDA New Drug Approvals
2008 2009 2010 2011 (YTD)02468
1012141618
30
Traditional SpecialtySource: U.S. Food and Drug Administration
2011 Express Scripts, Inc.All Rights Reserved
Specialty Trend Continues to Dwarf Traditional
PMPY
2010 2011 2012 2013$0
$200
$400
$600
$800
$1,000
Annual Trend
31
2010 2011 2012 20130%
5%
10%
15%
20%
25%
30%
Source: Express Scripts’ Drug Trend Report data and Forecasting
Specialty Traditional
2011 Express Scripts, Inc.All Rights Reserved
Top Specialty Therapy Classes
#5 Growth De-ficiency
#4 Anticoagulants
#3 Cancer
#2 Multiple Sclerosis
#1 Inflammatory Conditions
$0 $10 $20 $30 $40
$6
$7Total PMPY = $130
PMPY
2010 PMPY
$22
$30
$37
Source: Express Scripts’ Drug Trend Report data
2011 Express Scripts, Inc.All Rights Reserved
Therapy Class Review• Inflammatory Conditions• Multiple Sclerosis• Cancer• Hepatitis C• Cystic Fibrosis• Other Drugs to Watch
33
2011 Express Scripts, Inc.All Rights Reserved
Inflammatory ConditionsPipeline Trends
• Oral biologics will compete with injectables
• More therapies for gout?• “Biobetters” on the horizon
34
2011 Express Scripts, Inc.All Rights Reserved
Inflammatory ConditionsPipeline
35
Drug (Manufacturer) Indication Route
Approval
Orencia* (BMS) RA (new SQ) SQ ApprovedHumira* (Abbott) Ulcerative
ColitisSQ Feb 2012
Apremilast (Celgene) Psoriasis, PA Oral 2012Tofacitinib (Pfizer) RA, Psoriasis Oral 2012Arcalyst* (Regeneron) Gout SQ 2012Ilaris* (Novartis) Gout SQ 2012Benlysta* (HGS / GSK) Lupus (new
SQ)SQ 2013
Fostamatinib (Rigel / AZ)
RA Oral 2013
INCB-28050 (Incyte / Lilly)
RA Oral 2013
RA = Rheumatoid Arthritis; PA = Psoriatic Arthritis*Already on the market for another indication or different route
2011 Express Scripts, Inc.All Rights Reserved
Oral BiologicsApremilast (Celgene)
Indication: Psoriasis, Psoriatic ArthritisRoute: Oral (twice daily)Comments: Inhibits inflammatory cytokines;
Approval in 2012 for psoriasis
Tofacitinib (Pfizer)Indication: Rheumatoid Arthritis, PsoriasisRoute: Oral (twice daily)Comments: Inhibits JAK; Approval in 2012 for
RA
36
RA = Rheumatoid ArthritisJAK = Janus Kinase
2011 Express Scripts, Inc.All Rights Reserved
GoutIlaris (canakinumab - Novartis)
Indication: Treatment and prevention of acute gout
Route: SQ InjectionComments: Negative Ad Board, CRL in August
Arcalyst (rilonacept - Regeneron)Indication: Treatment and prevention of acute
goutRoute: SQ InjectionComments: Approval in 2012?
- Both already on market for CAPS - 37
CRL = Complete Response Letter; CAPS = Cryopyrin-Associated Periodic Syndromes
2011 Express Scripts, Inc.All Rights Reserved
Multiple Sclerosis Pipeline Trends
• More oral disease-modifying drugs• May see combination use of MS
drugs• Expanded MS use for currently
marketed drugs
38
2011 Express Scripts, Inc.All Rights Reserved
Multiple Sclerosis Pipeline
39
Drug Manufacturer Route ApprovalBG-12 Biogen Idec Oral 2012Laquinimod Teva / Active
BiotechOral 2012
Lemtrada* Genzyme IV 2012Teriflunomide Sanofi Oral 2012Zenapax* Biogen Idec /
AbbottSQ 2012
Tovaxin Opexa SQ 2013Peg-Avonex Biogen Idec IM 2014*Already on the market for another indication
2011 Express Scripts, Inc.All Rights Reserved
Oral Disease-Modifying Drugs for MS
Dimethyl Fumarate (BG-12 – Biogen Idec)Indication: Relapsing Remitting Multiple
SclerosisRoute: Oral (two times daily)Comments: Approval in 2012; G.I./flushing
issues
Laquinimod (Teva / Active Biotech)Indication: Relapsing Remitting Multiple
SclerosisRoute: Oral (once daily)Comments: Approval in 2012; May liver
enzymes40
2011 Express Scripts, Inc.All Rights Reserved
Currently Marketed Drugs Expand into MS
Lemtrada (alemtuzumab - Genzyme)Indication: Relapsing Remitting Multiple
SclerosisRoute: IV Infusion (5 then 3 days per year)Comments: Approved for CLL; ITP and
infection risk
Zenapax (daclizumab – Biogen Idec/Abbott)Indication: Relapsing Remitting Multiple
SclerosisRoute: SQ Injection (once monthly)Comments: Approved for transplant; Infection
and liver toxicity risk41
CLL = Chronic Lymphocytic Leukemia; ITP = Immune Thrombocytopenic Purpura
2011 Express Scripts, Inc.All Rights Reserved
Cancer Pipeline Trends• Cancer treated as a chronic
condition– Oral drugs– Targeted therapies
• Niche or orphan cancer types • Pharmacogenomics plays a role
42
2011 Express Scripts, Inc.All Rights Reserved
2011 Cancer Drug Approvals
43
Drug (Manufacturer) Indication Route
Approval
Yervoy (Bristol Myers Squibb)
Malignant Melanoma
IV March 25th
Sylatron (Merck) Melanoma SQ March 29th
Caprelsa (AstraZeneca) Thyroid Cancer Oral April 6th
Zytiga (Centocor) Prostate Cancer Oral April 28th
Zelboraf (Genentech) Malignant Melanoma
Oral August 17th
Adcetris (Seattle Genetics)
HL and ALCL IV August 19th
Xalkori (Pfizer) Lung Cancer (NSCLC)
Oral August 26th
HL = Hodgkin’s Lymphoma; ALCL = Anaplastic Large Cell Lymphoma;NSCLC = Non-Small Cell Lung Cancer
2011 Express Scripts, Inc.All Rights Reserved
PharmacogenomicsZalboraf (vemurafenib – Genentech)
Indication: Malignant MelanomaRoute: Oral (twice daily)Comments: For patients with BRAF mutation;
Approved Aug. 17th
Xalkori (crizotinib - Pfizer)Indication: Non-Small Cell Lung CancerRoute: Oral (twice daily)Comments: For patients with ALK mutation;
Approved Aug. 26th
44
2011 Express Scripts, Inc.All Rights Reserved
Cancer Pipeline- 2011 –
Erwinaze (crisantaspase – EUSA)Indication: Acute Lymphoblastic LeukemiaRoute: IM (every other day)Comments: Cell growth inhibitor; Approval in
2011
Ruxolitinib (Incyte)Indication: MyelofibrosisRoute: Oral (twice daily)Comments: JAK inhibitor; FDA action: Dec 3rd
45
JAK = Janus Kinase
2011 Express Scripts, Inc.All Rights Reserved
Cancer Pipeline- 2012 -
Drug Use Route
Axitinib (Pfizer)
Kidney Cancer
Oral
Biovax ID (Biovest)
Lymphoma (NHL)
SQ
Bositinib (Pfizer)
Leukemia (CML)
Oral
Brivanib (Bristol-Myers)
Liver Cancer
Oral
Cabozantinib (Exelixis)
Thyroid Cancer
Oral
Carfilzomib (Onyx)
Multiple Myeloma
IV
Herceptin (Genentech)
Breast Cancer (SQ)
SQ
Lucanix (NovaRx)
Lung Cancer (NSCLC)
Inj.
Drug Use Route
NeuVax Vaccine (Apthera)
Breast Cancer
Inj.
Omapro (Cephalon)
Leukemia (CML)
SQ
Perifosine (Keryx)
Multiple Myeloma
Oral
Regorafenib (Bayer)
Kidney Cancer
Oral
Ridaforolimus (Merck)
Bone Sarcomas
Oral
Talacteroferrin alfa (Agennix)
Lung Cancer (NSCLC)
Oral
Tivozanib (Aveo)
Kidney Cancer
Oral
Vismodegib (Genentech)
Basal Cell Carcinoma
Oral46
NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer
2011 Express Scripts, Inc.All Rights Reserved
Cancer Pipeline- 2012 -
Drug Use Route
Axitinib (Pfizer)
Kidney Cancer
Oral
Biovax ID (Biovest)
Lymphoma (NHL)
SQ
Bositinib (Pfizer)
Leukemia (CML)
Oral
Brivanib (Bristol-Myers)
Liver Cancer
Oral
Cabozantinib (Exelixis)
Thyroid Cancer
Oral
Carfilzomib (Onyx)
Multiple Myeloma
IV
Herceptin (Genentech)
Breast Cancer (SQ)
SQ
Lucanix (NovaRx)
Lung Cancer (NSCLC)
Inj.
Drug Use Route
NeuVax Vaccine (Apthera)
Breast Cancer
Inj.
Omapro (Cephalon)
Leukemia (CML)
SQ
Perifosine (Keryx)
Multiple Myeloma
Oral
Regorafenib (Bayer)
Kidney Cancer
Oral
Ridaforolimus (Merck)
Bone Sarcomas
Oral
Talacteroferrin alfa (Agennix)
Lung Cancer (NSCLC)
Oral
Tivozanib (Aveo)
Kidney Cancer
Oral
Vismodegib (Genentech)
Basal Cell Carcinoma
Oral47
NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer
2011 Express Scripts, Inc.All Rights Reserved
Cancer Pipeline- 2012 -
Drug Use Route
Axitinib (Pfizer)
Kidney Cancer
Oral
Biovax ID (Biovest)
Lymphoma (NHL)
SQ
Bositinib (Pfizer)
Leukemia (CML)
Oral
Brivanib (Bristol-Myers)
Liver Cancer
Oral
Cabozantinib (Exelixis)
Thyroid Cancer
Oral
Carfilzomib (Onyx)
Multiple Myeloma
IV
Herceptin (Genentech)
Breast Cancer (SQ)
SQ
Lucanix (NovaRx)
Lung Cancer (NSCLC)
Inj.
Drug Use Route
NeuVax Vaccine (Apthera)
Breast Cancer
Inj.
Omapro (Cephalon)
Leukemia (CML)
SQ
Perifosine (Keryx)
Multiple Myeloma
Oral
Regorafenib (Bayer)
Kidney Cancer
Oral
Ridaforolimus (Merck)
Bone Sarcomas
Oral
Talacteroferrin alfa (Agennix)
Lung Cancer (NSCLC)
Oral
Tivozanib (Aveo)
Kidney Cancer
Oral
Vismodegib (Genentech)
Basal Cell Carcinoma
Oral48
NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer
2011 Express Scripts, Inc.All Rights Reserved
Oral Drugs for CancerAxitinib (Pfizer)
Indication: Renal Cell CarcinomaRoute: Oral (twice daily)Comments: Angiogenesis inhibitor; FDA
approval expected in April 2012
Ridaforolimus (Merck)Indication: Soft-Tissue and Bone SarcomasRoute: Oral (once daily x 5 days each week)Comments: mTOR inhibitor; Approval in April
2012
49
2011 Express Scripts, Inc.All Rights Reserved
Hepatitis C Pipeline Trends
• Oral protease inhibitors hit the market• Watch for more direct acting antivirals• Novel interferons in 2-3 years
50
2011 Express Scripts, Inc.All Rights Reserved
Hepatitis C Pipeline- Protease Inhibitors -
51
Drug Manufacturer Dosing* ApprovalVictrelis (boceprevir)
Merck TID May 13th
Incivek (telaprevir)
Vertex TID May 23rd
ABT-450 Abbott QD 2013TMC-435 Tibotec (J&J) /
MedivirQD 2013
ACH-1652 Achillion QD 2014BI-201335 Boehringer
IngelheimQD 2014
Vaniprivir Merck BID / QD 2014BMS-650032 Bristol-Myers Squibb BID / QD 2015Danoprevir InterMune /
GenentechTID / BID 2015
* TID = Three Times Daily; BID = Twice Daily; QD = Once Daily
Approved
2011 Express Scripts, Inc.All Rights Reserved
Hepatitis C Pipeline- Polymerase Inhibitors -
52
Drug Manufacturer Dosing* ApprovalIDX-184 Idenix QD 2013mericitabine Roche BID 2014ANA-598 Anadys BID 2014Filibuvir Pfizer TID / BID 2014PSI-7997 Pharmasset QD 2014VX-222 Vertex BID 2014
* QD = Once Daily; BID = Twice Daily; TID = Three Times Daily
2011 Express Scripts, Inc.All Rights Reserved
Hepatitis C Pipeline- Novel Interferons -
53
Drug Manufacturer Route Approval
Locteron Biolex SQ 2013Peg-Interferon Lambda
Bristol-Myers Squibb
SQ 2013
IFN-Alpha-2b XL Flamel Technologies
SQ 2014
Interferon Omega Boehringer Ingelheim
Implant 2014
2011 Express Scripts, Inc.All Rights Reserved
Cystic Fibrosis Pipeline Trends
New drugs to:• Increase mucus clearance• Treat underlying disease• Fight lung infections
54
2011 Express Scripts, Inc.All Rights Reserved
Cystic Fibrosis Pipeline
55
Drug Manufacturer Route Approval
Ataluren PTC Therapeutics Oral 2012Aeroquin Mpex Inhaled 2012Arikase Transave Inhaled 2012Bronchitol Pharmaxis Inhaled 2012VX-770 Vertex Oral 2012
2011 Express Scripts, Inc.All Rights Reserved
Cystic Fibrosis Pipeline
56
Drug Manufacturer Route Approval
Ataluren PTC Therapeutics Oral 2012Aeroquin Mpex Inhaled 2012Arikase Transave Inhaled 2012Bronchitol Pharmaxis Inhaled 2012VX-770 Vertex Oral 2012
- Increase Mucus Clearance -
2011 Express Scripts, Inc.All Rights Reserved
Cystic Fibrosis Pipeline
57
Drug Manufacturer Route Approval
Ataluren PTC Therapeutics Oral 2012Aeroquin Mpex Inhaled 2012Arikase Transave Inhaled 2012Bronchitol Pharmaxis Inhaled 2012VX-770 Vertex Oral 2012
- Treat Underlying Disease -
2011 Express Scripts, Inc.All Rights Reserved
Cystic Fibrosis Pipeline
58
Drug Manufacturer Route Approval
Ataluren PTC Therapeutics Oral 2012Aeroquin Mpex Inhaled 2012Arikase Transave Inhaled 2012Bronchitol Pharmaxis Inhaled 2012VX-770 Vertex Oral 2012
- Fight Infections -
2011 Express Scripts, Inc.All Rights Reserved
Other Drugs to Watch
59
Drug (Manufacturer)
Indication Route Approval
Soliris (Alexion) aHUS IV 10/07/11Iluvien (Alimera) DME Intra-
vitreal11/12/11
Eyela (Regeneron) AMD Intra-vitreal
11/18/11
rFactor XIII (Novo N.) FXIII Deficiency
IV 12/23/11
Velcade (Millenium) Multiple Myeloma
SQ 01/23/12
Corlux (Corcept) Cushing Disease
Oral 02/17/12
Peginesatide (Affymax)
Anemia IV/SQ 03/27/12
aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration
2011 Express Scripts, Inc.All Rights Reserved
Other Drugs to Watch
60
Drug (Manufacturer)
Indication Route Approval
Soliris (Alexion) aHUS IV 10/07/11Iluvien (Alimera) DME Intra-
vitreal11/12/11
Eyela (Regeneron) AMD Intra-vitreal
11/18/11
rFactor XIII (Novo N.) FXIII Deficiency
IV 12/23/11
Velcade (Millenium) Multiple Myeloma
SQ 01/23/12
Corlux (Corcept) Cushing Disease
Oral 02/17/12
Peginesatide (Affymax)
Anemia IV/SQ 03/27/12
aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration
2011 Express Scripts, Inc.All Rights Reserved
Other Drugs to Watch
61
Drug (Manufacturer)
Indication Route Approval
Soliris (Alexion) aHUS IV 10/07/11Iluvien (Alimera) DME Intra-
vitreal11/12/11
Eyela (Regeneron) AMD Intra-vitreal
11/18/11
rFactor XIII (Novo N.) FXIII Deficiency
IV 12/23/11
Velcade (Millenium) Multiple Myeloma
SQ 01/23/12
Corlux (Corcept) Cushing Disease
Oral 02/17/12
Peginesatide (Affymax)
Anemia IV/SQ 03/27/12
aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration
2011 Express Scripts, Inc.All Rights Reserved
Other Drugs to Watch
62
Drug (Manufacturer)
Indication Route Approval
Soliris (Alexion) aHUS IV 10/07/11Iluvien (Alimera) DME Intra-
vitreal11/12/11
Eyela (Regeneron) AMD Intra-vitreal
11/18/11
rFactor XIII (Novo N.) FXIII Deficiency
IV 12/23/11
Velcade (Millenium) Multiple Myeloma
SQ 01/23/12
Corlux (Corcept) Cushing Disease
Oral 02/17/12
Peginesatide (Affymax)
Anemia IV/SQ 03/27/12
aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration
2011 Express Scripts, Inc.All Rights Reserved
Other Drugs to Watch
63
Drug (Manufacturer)
Indication Route Approval
Soliris (Alexion) aHUS IV 10/07/11Iluvien (Alimera) DME Intra-
vitreal11/12/11
Eyela (Regeneron) AMD Intra-vitreal
11/18/11
rFactor XIII (Novo N.) FXIII Deficiency
IV 12/23/11
Velcade (Millenium) Multiple Myeloma
SQ 01/23/12
Corlux (Corcept) Cushing Disease
Oral 02/17/12
Peginesatide (Affymax)
Anemia IV/SQ 03/27/12
aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration
2011 Express Scripts, Inc.All Rights Reserved
Other Drugs to Watch
64
Drug (Manufacturer)
Indication Route Approval
Soliris (Alexion) aHUS IV 10/07/11Iluvien (Alimera) DME Intra-
vitreal11/12/11
Eyela (Regeneron) AMD Intra-vitreal
11/18/11
rFactor XIII (Novo N.) FXIII Deficiency
IV 12/23/11
Velcade (Millenium) Multiple Myeloma
SQ 01/23/12
Corlux (Corcept) Cushing Disease
Oral 02/17/12
Peginesatide (Affymax)
Anemia IV/SQ 03/27/12
aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration
2011 Express Scripts, Inc.All Rights Reserved
Other Drugs to Watch
65
Drug (Manufacturer)
Indication Route Approval
Soliris (Alexion) aHUS IV 10/07/11Iluvien (Alimera) DME Intra-
vitreal11/12/11
Eyela (Regeneron) AMD Intra-vitreal
11/18/11
rFactor XIII (Novo N.) FXIII Deficiency
IV 12/23/11
Velcade (Millenium) Multiple Myeloma
SQ 01/23/12
Corlux (Corcept) Cushing Disease
Oral 02/17/12
Peginesatide (Affymax)
Anemia IV/SQ 03/27/12
aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration
2011 Express Scripts, Inc.All Rights Reserved
Other Drugs to Watch
66
Drug (Manufacturer)
Indication Route Approval
Soliris (Alexion) aHUS IV 10/07/11Iluvien (Alimera) DME Intra-
vitreal11/12/11
Eyela (Regeneron) AMD Intra-vitreal
11/18/11
rFactor XIII (Novo N.) FXIII Deficiency
IV 12/23/11
Velcade (Millenium) Multiple Myeloma
SQ 01/23/12
Corlux (Corcept) Cushing Disease
Oral 02/17/12
Peginesatide (Affymax)
Anemia IV/SQ 03/27/12
aHUS = Atypical Hemolytic Uremic Syndrome; DME = Diabetic Macular Edema; AMD = Age-related Macular Degeneration
2011 Express Scripts, Inc.All Rights Reserved
Questions?
67