Selected products with Phase III or regulatory milestones expected in 2012. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Abbott Laboratories (NYSE:ABT)

Duodopa levodopa/carbidopa

Advanced Parkinson's disease (PD) in patients with severe motor fluctuations

Final Ph III data

YE12

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Sufentanil NanoTab PCA System

Post-operative pain in patients undergoing major abdominal surgery

Ph III data

2012

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

Macitentan (formerly Actelion-1, ACT-064992)

Pulmonary arterial hypertension (PAH)

Ph III data

1H12

Active Biotech AB (SSE:ACTI)

Anyara

Renal cell carcinoma (RCC)

Ph II/III data

2012

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Lomitapide

Homozygous familial hypercholesterolemia (hoFH)

Submit NDA and MAA

1Q12

Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS)

Solorel macimorelin

Diagnose adult growth hormone deficiency (AGHD)

Submit NDA

Early 2012

Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS)/Keryx Biopharmaceuticals Inc. (NASDAQ:KERX)

Perifosine

Refractory metastatic colorectal cancer (mCRC)

Ph III data; submit NDA

1Q12; 2Q12

Agennix AG (Xetra:AGX)

Talactoferrin oral

Refractory non-small cell lung cancer (NSCLC)

Ph III data

1H12

Algeta ASA (OSE:ALGETA)/Bayer AG (Xetra:BAY)

Alpharadin radium-223

Bone metastases in patients with castration-resistant prostate cancer (CRPC)

Submit regulatory applications

Mid-2012

Almirall S.A. (Madrid:ALM)/Forest Laboratories Inc. (NYSE:FRX)

Aclidinium bromide/formoterol

Chronic obstructive pulmonary disease (COPD)

Ph III data

1H12

Amicus Therapeutics Inc. (NASDAQ:FOLD)/GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Amigal migalastat

Fabry's disease

Ph III data

3Q12

Anacor Pharmaceuticals Inc. (NASDAQ:ANAC)

Tavaborole

Onychomycosis

Ph III data

YE12

Anthera Pharmaceuticals Inc. (NASDAQ:ANTH)/Eli Lilly and Co. (NYSE:LLY)/Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507)

Varespladib methyl

Acute coronary syndromes (ACS)

Topline Ph III data

2Q12

Arena Pharmaceuticals Inc. (NASDAQ:ARNA)/Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)

Lorcaserin

Obesity

Submit MAA

1H12

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA)

Ponatinib

Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients resistant or intolerant to dasatinib or nilotinib; chronic myelogenous leukemia (CML)

Submit NDA

Mid-2012

Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL)/BioSpecifics Technologies Corp. (NASDAQ:BSTC)/Asahi Kasei Pharma Corp./Pfizer Inc. (NYSE:PFE)

Xiaflex collagenase clostridium histolyticum

Peyronie's disease

Ph III data

2Q12

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO)/Astellas Pharma Inc. (Tokyo:4503)

Tivozanib

Advanced RCC

Submit NDA and MAA

2012

Basilea Pharmaceutica AG (SIX:BSLN)

Ceftobiprole

Pneumonia

Submit MAA

2H12

Basilea Pharmaceutica AG (SIX:BSLN)

Toctino alitretinoin

Chronic refractory hand eczema

Topline Ph III HANDEL data

1Q12