Future Pharmaceutical Trends
- Patent & Pipeline –
Chris Peterson, PharmD
Aimee Tharaldson, PharmD
Objectives
• Patent Expiration Overview: 2011-2013
• Traditional Pipeline Highlights
• Specialty Pipeline Overview
2
Objectives
• Patent Expiration Overview: 2011-2013
• Traditional Pipeline Highlights
• Specialty Pipeline Overview
3
Patent Expiration Landscape
$40
$35
$ Billion
$30
$25
$20
$15
$10
$5
$0
4
Patent Expiration Landscape
Next 5 Years
$40
$ Billion
$35
$34
$30
$25
$20
$15
$20
$17
$11.7
$10
$14
$5
$0
2011
2012
2013
2014
2015
5
Patent Expiration Landscape
Next 5 Years
$40
$ Billion
$35
$30
Plavix
$25
Seroquel
$20
Singulair
$15
$10
$5
Lipitor
Zyprexa
Levaquin
Concerta
Diovan
Actos
Lexapro
Cymbalta
OxyContin
Niaspan
Nexium
Celebrex
Actonel
Abilify
Gleevec
Namenda
$0
2011
2012
2013
2014
2015
6
Patent Expirations: 2011
Drug
Taxotere
Xalatan
Concerta*
Femara
Nasacort AQ*
Levaquin
Arixtra
Uroxatral
Combivir*
Zyprexa
Solodyn
(45, 90, 135)*
Lipitor*
Manufacturer
Patent
Sales (US)
Sanofi
Pfizer
J&J
Novartis
Sanofi
J&J
GSK
Sanofi
ViiV
Lilly
Mar 15
Mar 22
May 01
Jun 03
Jun 15
Jun 20
Expired
Jul 18
4Q2011
Oct 23
$1,200
$711
$1,437
$682
$244
$1,523
$340
$248
$328
$2,958
Medicis
Pfizer
Nov 01
Nov 30
$667
$7,245
* Settlement Agreement
7
Patent Expirations: 2011
Drug
Taxotere
Xalatan
Concerta*
Femara
Nasacort AQ*
Levaquin
Arixtra
Uroxatral
Combivir*
Zyprexa
Solodyn
(45, 90, 135)*
Lipitor*
Manufacturer
Patent
Sales (US)
Sanofi
Pfizer
J&J
Novartis
Sanofi
J&J
GSK
Sanofi
ViiV
Lilly
Mar 15
Mar 22
May 01
Jun 03
Jun 15
Jun 20
Expired
Jul 18
4Q2011
Oct 23
$1,200
$711
$1,437
$682
$244
$1,523
$340
$248
$328
$2,958
Medicis
Pfizer
Nov 01
Nov 30
$667
$7,245
* Settlement Agreement
8
Patent Expirations: 2012
Drug
Avandia*
Lexapro*
Seroquel
Avapro
Provigil*
Plavix
Clarinex*
Tricor*
Singulair
Actos*
Xopenex neb*
Geodon
Diovan
Detrol
Atacand
Manufacturer
GSK
Forest
AstraZeneca
BMS
Cephalon
BMS
Merck
Abbott
Merck
Takeda
Sunovion
Pfizer
Novartis
Pfizer
AstraZeneca
Patent
1Q2012
Mar-14
Mar-26
Mar-30
Apr-01
May-17
Jul-01
Jul-01
Aug-03
Aug-17
Aug-20
Sep-01
Sep-21
Sep-25
Dec-04
* Settlement Agreements
Sales (US)
$342
$2,812
$5,172
$486
$1,133
$6,130
$248
$1,345
$4,073
$3,535
$545
$1,281
$3,533
$790
$199
9
Patent Expirations: 2012
Drug
Avandia*
Lexapro*
Seroquel
Avapro
Provigil*
Plavix
Clarinex*
Tricor*
Singulair
Actos*
Xopenex neb*
Geodon
Diovan
Detrol
Atacand
Manufacturer
GSK
Forest
AstraZeneca
BMS
Cephalon
BMS
Merck
Abbott
Merck
Takeda
Sunovion
Pfizer
Novartis
Pfizer
AstraZeneca
Patent
1Q2012
Mar-14
Mar-26
Mar-30
Apr-01
May-17
Jul-01
Jul-01
Aug-03
Aug-17
Aug-20
Sep-01
Sep-21
Sep-25
Dec-04
* Settlement Agreements
Sales (US)
$342
$2,812
$5,172
$486
$1,133
$6,130
$248
$1,345
$4,073
$3,535
$545
$1,281
$3,533
$790
$199
10
Patent Expirations: 2012
Drug
Avandia*
Lexapro*
Seroquel
Avapro
Provigil*
Plavix
Clarinex*
Tricor*
Singulair
Actos*
Xopenex neb*
Geodon
Diovan
Detrol
Atacand
Manufacturer
GSK
Forest
AstraZeneca
BMS
Cephalon
BMS
Merck
Abbott
Merck
Takeda
Sunovion
Pfizer
Novartis
Pfizer
AstraZeneca
Patent
1Q2012
Mar-14
Mar-26
Mar-30
Apr-01
May-17
Jul-01
Jul-01
Aug-03
Aug-17
Aug-20
Sep-01
Sep-21
Sep-25
Dec-04
* Settlement Agreements
Sales (US)
$342
$2,812
$5,172
$486
$1,133
$6,130
$248
$1,345
$4,073
$3,535
$545
$1,281
$3,533
$790
$199
11
Patent Expirations: 2012
Drug
Avandia*
Lexapro*
Seroquel
Avapro
Provigil*
Plavix
Clarinex*
Tricor*
Singulair
Actos*
Xopenex neb*
Geodon
Diovan
Detrol
Atacand
Manufacturer
GSK
Forest
AstraZeneca
BMS
Cephalon
BMS
Merck
Abbott
Merck
Takeda
Sunovion
Pfizer
Novartis
Pfizer
AstraZeneca
Patent
1Q2012
Mar-14
Mar-26
Mar-30
Apr-01
May-17
Jul-01
Jul-01
Aug-03
Aug-17
Aug-20
Sep-01
Sep-21
Sep-25
Dec-04
* Settlement Agreements
Sales (US)
$342
$2,812
$5,172
$486
$1,133
$6,130
$248
$1,345
$4,073
$3,535
$545
$1,281
$3,533
$790
$199
12
Patent Expirations: 2012
Drug
Avandia*
Lexapro*
Seroquel
Avapro
Provigil*
Plavix
Clarinex*
Tricor*
Singulair
Actos*
Xopenex neb*
Geodon
Diovan
Detrol
Atacand
Manufacturer
GSK
Forest
AstraZeneca
BMS
Cephalon
BMS
Merck
Abbott
Merck
Takeda
Sunovion
Pfizer
Novartis
Pfizer
AstraZeneca
Patent
1Q2012
Mar-14
Mar-26
Mar-30
Apr-01
May-17
Jul-01
Jul-01
Aug-03
Aug-17
Aug-20
Sep-01
Sep-21
Sep-25
Dec-04
* Settlement Agreements
Sales (US)
$342
$2,812
$5,172
$486
$1,133
$6,130
$248
$1,345
$4,073
$3,535
$545
$1,281
$3,533
$790
$199
13
Patent Expirations: 2013
Drug
Propecia*
Opana ER*
Reclast
Zometa
Valcyte
OxyContin
Zomig
AcipHex
Temodar
Advicor*
Manufacturer
Merck
Endo
Novartis
Novartis
Genentech
Purdue
AstraZeneca
Eisai
Merck
Abbott
Patent
Jan-01
Jan-01
Mar-02
Mar-02
Mar-15
Apr-16
May-14
May-18
Aug-11
Sep-20
Sales (US)
$154
$369
$405
$768
$289
$3,085
$200
$1,055
$389
$111
Niaspan*
Abbott
Sep-20
$1,129
Cymbalta
Lilly
Dec-11
$3,153
* Settlement Agreement
14
Patent Expirations: 2013
Drug
Propecia*
Opana ER*
Reclast
Zometa
Valcyte
OxyContin
Zomig
AcipHex
Temodar
Advicor*
Manufacturer
Merck
Endo
Novartis
Novartis
Genentech
Purdue
AstraZeneca
Eisai
Merck
Abbott
Patent
Jan-01
Jan-01
Mar-02
Mar-02
Mar-15
Apr-16
May-14
May-18
Aug-11
Sep-20
Sales (US)
$154
$369
$405
$768
$289
$3,085
$200
$1,055
$389
$111
Niaspan*
Abbott
Sep-20
$1,129
Cymbalta
Lilly
Dec-11
$3,153
* Settlement Agreement
15
Objectives
• Patent Expiration Overview: 2011-2013
• Traditional Pipeline Highlights
• Specialty Pipeline Overview
16
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
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
Diabetes Pipeline
Dapagliflozin (AstraZeneca/BMS)
Indication: Type 2 diabetes
Route: 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 diabetes
Route: subcutaneous injection (once weekly)
Comments: “Complete response” received in March
2011. FDA action date is January 28, 2012.
19
Diabetes Pipeline
Insulin Degludec (Novo-Nordisk)
Indication: Diabetes
Route: Subcutaneous injection (three times weekly)
Comments: Long-acting basil insulin. Submission
planned by the end of 2011.
20
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
Respiratory Pipeline
Eklira (aclidinium – Forest)
Indication: COPD
Route: Inhalation (twice daily)
Comments: FDA Action date is Apr 30, 2012.
Glycopyrronium (NVA237 – Novartis)
Indication: COPD
Route: Inhalation (once daily)
Comments: NDA submission planned by the end of
2011.
22
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
CNS Pipeline
Opana ER (oxymorphone e.r. – Endo)
Indication: Chronic pain
Route: Oral (Twice daily)
Comments: “Tamper resistant” formulation. FDA
Action date is Dec 13, 2011.
Remoxy (oxycodone e.r. – Pfizer)
Indication: Chronic pain
Route: Oral (Twice daily)
Comments: “Tamper resistant” formulation.
Complete response issued in in June.
24
CNS Pipeline
Levomilnacipran (Forest)
Indication: Depression
Route: Oral (once daily)
Comments: Isomer of milnacipran (Savella). NDA by
expected “early 2012”.
25
CNS Pipeline
Levadex (dihydroergotamine - MAP)
Indication: Acute migraine
Route: Inhalation
Comments: Asthma-sized inhaler device. FDA Action
date is Mar 26, 2012.
26
FDA Action Dates: CNS
Drug
Manufacturer
Use
Action Date
Onfi
Lundbeck
Seizures
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
4th Quarter
27
FDA Action Dates: Other
Drug
Manufacturer
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
Objectives
• Patent Expiration Overview: 2011-2013
• Traditional Pipeline Highlights
• Specialty Pipeline Overview
29
FDA New Drug Approvals
18
16
14
12
10
8
6
4
2
0
2008
2009
Traditional
2010
2011 (YTD)
Specialty
Source: U.S. Food and Drug Administration
30
Specialty Trend Continues to
Dwarf Traditional
PMPY
Annual Trend
$1,000
30%
$800
25%
20%
$600
15%
$400
10%
$200
5%
$0
0%
2010
2011
2012
2013
2010
2011
2012
2013
Source: Express Scripts’ Drug Trend Report data and Forecasting
Specialty
Traditional
31
Top Specialty Therapy Classes
$37
#1 Inflammatory Conditions
$30
PMPY
#2 Multiple Sclerosis
$22
#3 Cancer
$7
#4 Anticoagulants
Total PMPY = $130
$6
#5 Growth Deficiency
$0
Source: Express Scripts’ Drug Trend Report data
$10
$20
2010 PMPY
$30
$40
Therapy Class Review
•
•
•
•
•
•
Inflammatory Conditions
Multiple Sclerosis
Cancer
Hepatitis C
Cystic Fibrosis
Other Drugs to Watch
33
Inflammatory Conditions
Pipeline Trends
• Oral biologics will compete with
injectables
• More therapies for gout?
• “Biobetters” on the horizon
34
Inflammatory Conditions
Pipeline
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
35
Oral Biologics
Apremilast (Celgene)
Indication: Psoriasis, Psoriatic Arthritis
Route: Oral (twice daily)
Comments: Inhibits inflammatory cytokines;
Approval in 2012 for psoriasis
Tofacitinib (Pfizer)
Indication: Rheumatoid Arthritis, Psoriasis
Route: Oral (twice daily)
Comments: Inhibits JAK; Approval in 2012 for RA
RA = Rheumatoid Arthritis
JAK = Janus Kinase
36
Gout
Ilaris (canakinumab - Novartis)
Indication: Treatment and prevention of acute gout
Route: SQ Injection
Comments: Negative Ad Board, CRL in August
Arcalyst (rilonacept - Regeneron)
Indication: Treatment and prevention of acute gout
Route: SQ Injection
Comments: Approval in 2012?
- Both already on market for CAPS CRL = Complete Response Letter; CAPS = Cryopyrin-Associated Periodic Syndromes
37
Multiple Sclerosis
Pipeline Trends
• More oral disease-modifying drugs
• May see combination use of MS drugs
• Expanded MS use for currently
marketed drugs
38
Multiple Sclerosis Pipeline
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
39
Oral Disease-Modifying
Drugs for MS
Dimethyl Fumarate (BG-12 – Biogen Idec)
Indication: Relapsing Remitting Multiple Sclerosis
Route: Oral (two times daily)
Comments: Approval in 2012; G.I./flushing issues
Laquinimod (Teva / Active Biotech)
Indication: Relapsing Remitting Multiple Sclerosis
Route: Oral (once daily)
Comments: Approval in 2012; May liver enzymes
40
Currently Marketed Drugs
Expand into MS
Lemtrada (alemtuzumab - Genzyme)
Indication: Relapsing Remitting Multiple Sclerosis
Route: 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 Sclerosis
Route: SQ Injection (once monthly)
Comments: Approved for transplant; Infection and
liver toxicity risk
CLL = Chronic Lymphocytic Leukemia; ITP = Immune Thrombocytopenic Purpura
41
Cancer Pipeline Trends
• Cancer treated as a chronic condition
– Oral drugs
– Targeted therapies
• Niche or orphan cancer types
• Pharmacogenomics plays a role
42
2011 Cancer Drug Approvals
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
43
Pharmacogenomics
Zalboraf (vemurafenib – Genentech)
Indication: Malignant Melanoma
Route: Oral (twice daily)
Comments: For patients with BRAF mutation;
Approved Aug. 17th
Xalkori (crizotinib - Pfizer)
Indication: Non-Small Cell Lung Cancer
Route: Oral (twice daily)
Comments: For patients with ALK mutation;
Approved Aug. 26th
44
Cancer Pipeline
- 2011 –
Erwinaze (crisantaspase – EUSA)
Indication: Acute Lymphoblastic Leukemia
Route: IM (every other day)
Comments: Cell growth inhibitor; Approval in 2011
Ruxolitinib (Incyte)
Indication: Myelofibrosis
Route: Oral (twice daily)
Comments: JAK inhibitor; FDA action: Dec 3rd
JAK = Janus Kinase
45
Cancer Pipeline
- 2012 -
Drug
Use
Route
Drug
Axitinib
(Pfizer)
Kidney
Cancer
Oral
NeuVax Vaccine Breast
(Apthera)
Cancer
Inj.
Biovax ID
(Biovest)
Lymphoma
(NHL)
SQ
Omapro
(Cephalon)
Leukemia
(CML)
SQ
Bositinib
(Pfizer)
Leukemia
(CML)
Oral
Perifosine
(Keryx)
Multiple
Myeloma
Oral
Brivanib
(Bristol-Myers)
Liver Cancer
Oral
Regorafenib
(Bayer)
Kidney
Cancer
Oral
Cabozantinib
(Exelixis)
Thyroid
Cancer
Oral
Ridaforolimus
(Merck)
Bone
Sarcomas
Oral
Carfilzomib
(Onyx)
Multiple
Myeloma
IV
Talacteroferrin
alfa (Agennix)
Lung Cancer
(NSCLC)
Oral
Herceptin
(Genentech)
Breast Cancer
(SQ)
SQ
Tivozanib
(Aveo)
Kidney
Cancer
Oral
Lucanix
(NovaRx)
Lung Cancer
(NSCLC)
Inj.
Vismodegib
(Genentech)
Basal Cell
Carcinoma
Oral
NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia;
NSCLC = Non-Small Cell Lung Cancer
Use
Route
46
Cancer Pipeline
- 2012 -
Drug
Use
Route
Drug
Axitinib
(Pfizer)
Kidney
Cancer
Oral
NeuVax Vaccine Breast
(Apthera)
Cancer
Inj.
Biovax ID
(Biovest)
Lymphoma
(NHL)
SQ
Omapro
(Cephalon)
Leukemia
(CML)
SQ
Bositinib
(Pfizer)
Leukemia
(CML)
Oral
Perifosine
(Keryx)
Multiple
Myeloma
Oral
Brivanib
(Bristol-Myers)
Liver Cancer
Oral
Regorafenib
(Bayer)
Kidney
Cancer
Oral
Cabozantinib
(Exelixis)
Thyroid
Cancer
Oral
Ridaforolimus
(Merck)
Bone
Sarcomas
Oral
Carfilzomib
(Onyx)
Multiple
Myeloma
IV
Talacteroferrin
alfa (Agennix)
Lung Cancer
(NSCLC)
Oral
Herceptin
(Genentech)
Breast Cancer
(SQ)
SQ
Tivozanib
(Aveo)
Kidney
Cancer
Oral
Lucanix
(NovaRx)
Lung Cancer
(NSCLC)
Inj.
Vismodegib
(Genentech)
Basal Cell
Carcinoma
Oral
NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia;
NSCLC = Non-Small Cell Lung Cancer
Use
Route
47
Cancer Pipeline
- 2012 -
Drug
Use
Route
Drug
Axitinib
(Pfizer)
Kidney
Cancer
Oral
NeuVax Vaccine Breast
(Apthera)
Cancer
Inj.
Biovax ID
(Biovest)
Lymphoma
(NHL)
SQ
Omapro
(Cephalon)
Leukemia
(CML)
SQ
Bositinib
(Pfizer)
Leukemia
(CML)
Oral
Perifosine
(Keryx)
Multiple
Myeloma
Oral
Brivanib
(Bristol-Myers)
Liver Cancer
Oral
Regorafenib
(Bayer)
Kidney
Cancer
Oral
Cabozantinib
(Exelixis)
Thyroid
Cancer
Oral
Ridaforolimus
(Merck)
Bone
Sarcomas
Oral
Carfilzomib
(Onyx)
Multiple
Myeloma
IV
Talacteroferrin
alfa (Agennix)
Lung Cancer
(NSCLC)
Oral
Herceptin
(Genentech)
Breast Cancer
(SQ)
SQ
Tivozanib
(Aveo)
Kidney
Cancer
Oral
Lucanix
(NovaRx)
Lung Cancer
(NSCLC)
Inj.
Vismodegib
(Genentech)
Basal Cell
Carcinoma
Oral
NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia;
NSCLC = Non-Small Cell Lung Cancer
Use
Route
48
Oral Drugs for Cancer
Axitinib (Pfizer)
Indication: Renal Cell Carcinoma
Route: Oral (twice daily)
Comments: Angiogenesis inhibitor; FDA approval
expected in April 2012
Ridaforolimus (Merck)
Indication: Soft-Tissue and Bone Sarcomas
Route: Oral (once daily x 5 days each week)
Comments: mTOR inhibitor; Approval in April 2012
49
Hepatitis C Pipeline Trends
• Oral protease inhibitors hit the market
• Watch for more direct acting antivirals
• Novel interferons in 2-3 years
50
Hepatitis C Pipeline
- Protease Inhibitors -
Drug
Manufacturer
Victrelis (boceprevir) Merck
Approved
Dosing*
Approval
TID
May 13th
TID
May 23rd
Incivek (telaprevir)
Vertex
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
51
Hepatitis C Pipeline
- Polymerase Inhibitors 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
52
Hepatitis C Pipeline
- Novel Interferons -
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
53
Cystic Fibrosis Pipeline
Trends
New drugs to:
• Increase mucus clearance
• Treat underlying disease
• Fight lung infections
54
Cystic Fibrosis Pipeline
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
55
Cystic Fibrosis Pipeline
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 -
56
Cystic Fibrosis Pipeline
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 -
57
Cystic Fibrosis Pipeline
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 -
58
Other Drugs to Watch
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
59
Other Drugs to Watch
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
60
Other Drugs to Watch
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
61
Other Drugs to Watch
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
62
Other Drugs to Watch
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
63
Other Drugs to Watch
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
64
Other Drugs to Watch
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
65
Other Drugs to Watch
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
66
Questions?
67