At least four drugs approved in 2011 - Eylea aflibercept, Incivek telaprevir, Yervoy ipilimumab and Zytiga abiraterone acetate - are anticipated to exceed $500 million in sales in 2012. Of those, Incivek has already passed $1 billion. However, demand for the HCV drug reversed course in 2012. In July 2012, Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) cited two factors for the decrease in the number of HCV patients initiating Incivek treatment: doctors waiting for all-oral combination therapies; and an increase in the number of HCV clinical trials (see BioCentury, Nov. 12, 2012).

For the first nine months of 2012, Eylea sales were $561.9 million. Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), which launched the drug in the U.S. for wet age-related macular degeneration (AMD) in November 2011, saw its share price triple in 2012.

Melanoma drug Yervoy from Bristol-Myers Squibb Co. (NYSE:BMY) posted nine-month sales of $495 million, while prostate cancer drug Zytiga from Johnson & Johnson (NYSE:JNJ) had $697 million in sales for the same period. BMS gained ipilimumab through its 2009 acquisition of Medarex Inc., while J&J got Zytiga from its 2009 acquisition of Cougar Biotechnology Inc., which received rights to the product from BTG plc (LSE:BTG) in 2004.

(A) 2011 approval and nine-month sales in 2012 unless otherwise noted; (B) U.S. sales reported by Amylin Pharmaceuticals Inc. and BMS, which acquired Amylin in August 2012; (C) U.S. sales reported by Human Genome Science Inc., which was acquired by GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in August 2012; $M

Company

Product

Indication

2011 approval (A)

9-mo sales in 2012 (A)

AstraZeneca plc (LSE:AZN; NYSE:AZN)

Caprelsa vandetanib

Advanced or metastatic medullary thyroid cancer

EU (approved Feb 2012)/U.S.

$19.0

Bayer AG (Xetra:BAYN)

Gadovist gadobutrol injection

Detect and visualize areas with disrupted blood-brain barrier and/or abnormal CNS vascularity

U.S.

€149.0 ($193.0)

Bristol-Myers Squibb Co. (NYSE:BMY)

Yervoy ipilimumab

Unresectable or metastatic melanoma

EU/U.S.

$495.0

Bristol-Myers Squibb Co. (NYSE:BMY)

Nulojix belatacept

Prevent organ rejection in kidney transplant patients who are Epstein-Barr virus (EBV) seropositive

EU/U.S.

$7.0

Bristol-Myers Squibb Co. (NYSE:BMY)/ Alkermes Inc. (NASDAQ:ALKS)

Bydureon exenatide once weekly using Alkermes' drug delivery technology

Type II diabetes

EU/U.S. (approved Jan 2012)

$54.8 (U.S. sales) (B)

Bristol-Myers Squibb Co. (NYSE:BMY)/ Pfizer Inc. (NYSE:PFE)

Eliquis apixaban

Prevent venous thromboembolism (VTE)

EU(sales reported by BMS)

$1.0

BTG plc (LSE:BGC)/ Johnson & Johnson (NYSE:JNJ)

Zytiga abiraterone acetate

Metastatic castration-resistant prostate cancer (CRPC)

Canada/EU/ U.S.

$697.0

Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568)/ Roche (SIX:ROG; OTCQX:RHHBY)

Zelboraf vemurafenib

Unresectable or metastatic melanoma in patients with BRAF V600E mutations

EU (approved Feb 2012)/U.S.

CHF157.0 ($168.1)

Depomed Inc. (NASDAQ:DEPO)

Gralise gabapentin

Post-herpetic neuralgia (PHN)

U.S.

$9.7

Fibrocell Science Inc. (OTCBB:FCSC)

LAVIV azficel-T

Improve the appearance of moderate to severe nasolabial fold wrinkles

U.S.

$0.1

Forest Laboratories Inc. (NYSE:FRX)

Viibryd vilazodone

Major depressive disorder (MDD)

U.S.

$102.2

Gilead Sciences Inc. (NASDAQ:GILD)/ Johnson & Johnson (NYSE:JNJ)

Complera emtricitabine/ rilpivirine/tenofovir(Eviplera- EU)

HIV-1 infection in treatment- naive patients

EU/U.S.

$224.4

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Benlysta belimumab

Systemic lupus erythematosus (SLE)

EU/U.S.

$69.3 (U.S. 6 mo sales ended 6/30/12) (C)

Incyte Corp. (NASDAQ:INCY)/ Novartis AG (NYSE:NVS; SIX:NOVN)

Jakafi ruxolitinib

Myelofibrosis

U.S.

$100.3

InterMune Inc. (NASDAQ:ITMN)

Esbriet pirfenidone

Idiopathic pulmonary fibrosis (IPF)

EU

$18.0

Meda AB (SSE:MEDAA)/Valeant Pharmaceuticals International Inc. (NYSE:VRX; TSX:VRX)/GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Potiga ezogabine (Trobalt retigabine - EU)

Partial onset seizures

EU/U.S.

£4 ($6.5)

Merck & Co. Inc. (NYSE:MRK)

Victrelis boceprevir

Chronic HCV genotype 1 infection in combination with standard of care

EU / U.S.

$387.0

Optimer Pharmaceuticals Inc. (NASDAQ:OPTR)/Astellas Pharma Inc. (Tokyo:4503)/Cubist Pharmaceuticals Inc. (NASDAQ:CBST)

Dificid fidaxomicin (Dificlir - EU)

Clostridium difficile-associated diarrhea (CDAD)

Canada (launched July 2012)/EU (launched May 2012)/U.S.

$45.6 (U.S. & Canada sales)

Pacira Pharmaceuticals Inc. (NASDAQ:PCRX)

Exparel bupivacaine

Post-operative pain

U.S. (launched Apr 2012)

$6.8 (6 mo sales ended 9/30/12)

Pfizer Inc. (NYSE:PFE)

Xalkori crizotinib

Non-small cell lung cancer (NSCLC)

U.S.

$78.0

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN)/Bayer AG (Xetra:BAYN)

Eylea aflibercept ophthalmic solution

Wet age-related macular degeneration (AMD)

U.S.

$561.9

Seattle Genetics Inc. (NASDAQ:SGEN)/ Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Adcetris brentuximab vedotin

Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL)

U.S.

$102.8

Vertex Pharmaceuticals Inc.

Incivek telaprevir

Chronic HCV genotype 1 infection

EU/Japan/

$1,004.2

(NASDAQ:VRTX)/Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508)/ Johnson & Johnson (NYSE:JNJ)

(Incivo - EU; Telavic - Japan)

U.S.

(Japan & U.S. sales)

XenoPort Inc. (NASDAQ:XNPT)/ GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Horizant gabapentin enacarbil

Moderate to severe primary restless legs syndrome (RLS); postherpetic neuralgia

U.S.

$4.4