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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
$0
$5
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$25
$30
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$ B
illi
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2011 Express Scripts, Inc.All Rights Reserved
Patent Expiration LandscapeNext 5 Years
2011 2012 2013 2014 2015$0
$5
$10
$15
$20
$25
$30
$35
$40
$34
$20
$11.7
$17$14
$ B
illi
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2011 Express Scripts, Inc.All Rights Reserved
Patent Expiration LandscapeNext 5 Years
2011 2012 2013 2014 2015$0
$5
$10
$15
$20
$25
$30
$35
$40
Lipitor
Zyprexa
Levaquin
Concerta
Plavix
Seroquel
Singulair
Diovan
Actos
Lexapro
$ B
illi
on
Cymbalta
OxyContin
Niaspan
Nexium
Celebrex
Actonel
Abilify
Gleevec
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 $340
Uroxatral 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 $340
Uroxatral 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 Pipeline
Xarelto (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 17
Xarelto (rivaroxaban) Bayer/J&J A-Fib (new indication) Nov 5
Azilsartan/chlorthalidone Takeda Hypertension Dec 23
Eliquis (apixaban) BMS/Pfizer A-Fib 2012
ethyl 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 17
Dapagliflozin BMS/AZ Diabetes Oct 28
Janumet XR Merck Type 2 diabetes Nov 11
Alogliptin Takeda Type 2 diabetes Jan 26
Alogliptin/pioglitazone Takeda Type 2 diabetes Jan 26
Bydureon Lilly/Amylin Type 2 diabetes Jan 28
Insulin decludec Novo Nordisk Diabetes 2012
Pioglitazone/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 4
Omnaris HFA Nasal Sunovion Allergic rhinitis Apr 06
Eklira Forest COPD Apr 30
QNaze Teva Allergic Rhinitis May 24
glycopyrronium (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 Date
Onfi Lundbeck Seizures 4th Quarter
CPI-300 IntelGenx Depression Nov 13
Opana E.R. (TR) Endo Pain Dec 13
Fentanyl SL Spray Insys Pain Jan 4
Adasuve Alexza Agitation Feb 4
Levadex MAP Migraine Mar 26
MoxDuo QRxPharma Pain May 11
IPX066 Impax Parkinson’s disease
2012
Levomilnacipran Forest Depression 2012
Telcagepant Merck Migraine 2012
27
2011 Express Scripts, Inc.All Rights Reserved
FDA Action Dates: OtherDrug Manufacture
r Use Action Date
Saflutan Merck Glaucoma 4Q2011
Alendronate, effervescent
EffRx Osteoporosis Nov 11
Bio-T Gel Teva HRT Nov 14
Plan B One Step (OTC) Teva Contraceptive Dec 7
Anturol Antarex Overactive Bladder
Dec 8
Civanex Winston Osteoarthritis Dec 31
Ivermectin Cream Topaz Head Lice Feb 7
Prochieve Watson Preterm Birth Feb 26
Avanafil Vivus Erectile dysfunction
Apr 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)0
2
4
6
8
10
12
14
16
18
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 Approved
Humira* (Abbott) Ulcerative Colitis
SQ Feb 2012
Apremilast (Celgene) Psoriasis, PA Oral 2012
Tofacitinib (Pfizer) RA, Psoriasis Oral 2012
Arcalyst* (Regeneron) Gout SQ 2012
Ilaris* (Novartis) Gout SQ 2012
Benlysta* (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 Biologics
Apremilast (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 Approval
BG-12 Biogen Idec Oral 2012
Laquinimod Teva / Active Biotech
Oral 2012
Lemtrada* Genzyme IV 2012
Teriflunomide Sanofi Oral 2012
Zenapax* Biogen Idec / Abbott
SQ 2012
Tovaxin Opexa SQ 2013
Peg-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
enzymes
40
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 risk
41
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
Pharmacogenomics
Zalboraf (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
Oral
46
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
Oral
47
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
Oral
48
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 Cancer
Axitinib (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* Approval
Victrelis (boceprevir)
Merck TID May 13th
Incivek (telaprevir)
Vertex TID May 23rd
ABT-450 Abbott QD 2013
TMC-435 Tibotec (J&J) / Medivir
QD 2013
ACH-1652 Achillion QD 2014
BI-201335 Boehringer Ingelheim
QD 2014
Vaniprivir Merck BID / QD 2014
BMS-650032 Bristol-Myers Squibb BID / QD 2015
Danoprevir InterMune / Genentech
TID / 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* Approval
IDX-184 Idenix QD 2013
mericitabine Roche BID 2014
ANA-598 Anadys BID 2014
Filibuvir Pfizer TID / BID 2014
PSI-7997 Pharmasset QD 2014
VX-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 2013
Peg-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 2012
Aeroquin Mpex Inhaled 2012
Arikase Transave Inhaled 2012
Bronchitol Pharmaxis Inhaled 2012
VX-770 Vertex Oral 2012
2011 Express Scripts, Inc.All Rights Reserved
Cystic Fibrosis Pipeline
56
Drug Manufacturer Route Approval
Ataluren PTC Therapeutics Oral 2012
Aeroquin Mpex Inhaled 2012
Arikase Transave Inhaled 2012
Bronchitol Pharmaxis Inhaled 2012
VX-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 2012
Aeroquin Mpex Inhaled 2012
Arikase Transave Inhaled 2012
Bronchitol Pharmaxis Inhaled 2012
VX-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 2012
Aeroquin Mpex Inhaled 2012
Arikase Transave Inhaled 2012
Bronchitol Pharmaxis Inhaled 2012
VX-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 10/07/11
Iluvien (Alimera) DME Intra-vitreal
11/12/11
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 10/07/11
Iluvien (Alimera) DME Intra-vitreal
11/12/11
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 10/07/11
Iluvien (Alimera) DME Intra-vitreal
11/12/11
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 10/07/11
Iluvien (Alimera) DME Intra-vitreal
11/12/11
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 10/07/11
Iluvien (Alimera) DME Intra-vitreal
11/12/11
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 10/07/11
Iluvien (Alimera) DME Intra-vitreal
11/12/11
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 10/07/11
Iluvien (Alimera) DME Intra-vitreal
11/12/11
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 10/07/11
Iluvien (Alimera) DME Intra-vitreal
11/12/11
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