Selected products with Phase III or regulatory milestones expected in 2Q13. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Sufentanil NanoTab PCA System

Post-operative pain in patients undergoing major abdominal surgery

Ph III data

2Q13

Actelion Ltd. (SIX:ALTN)/Nippon Shinyaku Co. Ltd. (Tokyo:4516; Osaka:4516)

Selexipag

Pulmonary arterial hypertension PAH)

Interim Ph III GRIPHON data

Mid-2013

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Juxtapid lomitapide

Homozygous familial hypercholesterolemia (hoFH)

MAA action

Mid-2013

Allergan Inc. (NYSE:AGN)/Nektar Therapeutics (NASDAQ:NKTR)

Levadex dihydroergotamine

Acute migraine

PDUFA date

4/15/13

Anacor Pharmaceuticals Inc. (NASDAQ:ANAC)

Tavaborole

Onychomycosis

Submit NDA

Mid-2013

Astellas Pharma Inc. (Tokyo:4503)/Genentech Inc./Roche (SIX:ROG; OTCQX:RHHBY)

Tarceva erlotinib

First-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with EGFR-activating mutations

PDUFA date

2Q13

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO)/Astellas Pharma Inc. (Tokyo:4503)/Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)

Tivopath tivozanib

Advanced renal cell carcinoma (RCC)

FDA panel

5/2/13

Baxter International Inc. (NYSE:BAX)

Gammagard Liquid 10%

Mild to moderate Alzheimer's disease (AD)

Ph III data

2Q13

BioDelivery Sciences International Inc. (NASDAQ:BDSI)

Bunavail (formerly BEMA buprenorphine/naloxone)

Opioid dependence

Submit NDA

Mid-2013

Biogen Idec Inc. (NASDAQ:BIIB)

Plegridy peginterferon beta-1a

Relapsing-remitting multiple sclerosis (RRMS)

Submit BLA and MAA

Mid-2013

Biogen Idec Inc. (NASDAQ:BIIB)

Tecfidera dimethyl fumarate (BG-12)

RRMS

MAA action

2Q13