Selected products with Phase III or regulatory milestones expected in 2013. (A) Merging with Vivalis S.A. (Euronext:VLS); Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Accentia Biopharmaceuticals Inc. (OTCQB:ABPI)

BiovaxID vaccine

Follicular non-Hodgkin's B cell lymphoma (NHL)

Submit MAA; NDS

1Q13

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Sufentanil NanoTab PCA System (ARX-01)

Post-operative pain

Ph III data; submit NDA

1Q13; 3Q13

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

Selexipag

Pulmonary arterial hypertension (PAH)

Interim Ph III data

Mid-2013

Active Biotech AB (SSE:ACTI)

Anyara naptumomab estafenatox

Renal cell carcinoma (RCC)

Ph III data

1Q13

Active Biotech AB (SSE:ACTI)/Ipsen Group (Euronext:IPN; Pink:IPSEY)

Tasquinimod

Metastatic castration-resistant prostate cancer (CRPC)

Ph III data

YE13

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

Solorel macimorelin

Diagnose adult growth hormone deficiency

Submit NDA

1Q13

Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS)/Handok Pharmaceutical Co. Ltd. (KSE:002390)/Yakult Honsha Co. Ltd. (Tokyo:2267)

Perifosine

Multiple myeloma (MM)

Ph III data

1Q13

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN)

Soliris eculizumab

Shiga-toxin producing Escherichia coli hemolytic uremic syndrome

Ph III data

Mid-2013

Alimera Sciences Inc. (NASDAQ:ALIM)/pSivida Corp. (NASDAQ:PSDV; ASX:PVA)

Iluvien fluocinolone acetonide

Diabetic macular edema (DME)

Resubmit NDA

1Q13

Alkermes plc (NASDAQ:ALKS)

ALKS 9070 extended-release aripiprazole

Schizophrenia

Ph III data

YE13

Amarin Corp. plc (NASDAQ:AMRN)

Vascepa icosapent ethyl

Hypertriglyceridemia

Submit sNDA

February

Amgen Inc. (NASDAQ:AMGN)

Talimogene laherparepvec

Metastatic melanoma

Ph III data

2013

Amgen Inc. (NASDAQ:AMGN)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

AMG 386

Ovarian cancer

Ph III data

2013

Anacor Pharmaceuticals Inc. (NASDAQ:ANAC)

Tavaborole

Onychomycosis

Submit NDA

Mid-2013

Antares Pharma Inc. (NASDAQ:ATRS)/Uman Pharma Inc.

Vibex MTX methotrexate

Rheumatoid arthritis (RA)

Submit NDA

Early 2013

Apricus Biosciences Inc. (NASDAQ:APRI)

MycoVa terbinafine

Onychomycosis

Submit NDS

4Q13

AstraZeneca plc (LSE:AZN; NYSE:AZN)/Bristol-Myers Squibb Co. (NYSE:BMY)

Dapagliflozin

Type II diabetes

Resubmit NDA

Mid-2013

Basilea Pharmaceutica AG (SIX:BSLN)/Astellas Pharma Inc. (Tokyo:4503)

Isavuconazole

Aspergillus infections in patients with renal impairment and rare fungal infections

Ph III data

2H13

Baxter International Inc. (NYSE:BAX)

BAX 326 recombinant Factor IX (rFIX)

Hemophilia B

Submit MAA

2013

Baxter International Inc. (NYSE:BAX)

Gammagard Liquid 10%

Mild to moderate Alzheimer's disease

Ph III data

1H13