Selected products with Phase III or regulatory milestones expected in 2014. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

A.P. Pharma Inc. (OTCBB:APPA)

Sustol granisetron

Prevent acute and delayed chemotherapy-induced nausea and vomiting (CINV)

Resubmit NDA

1Q14

AB Science S.A. (Euronext:AB)

Masican masitinib

Systemic indolent mastocytosis

Ph III data

YE14

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)

Pimavanserin

Parkinson's disease psychosis

Submit NDA

YE14

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)/Gruenenthal Group

Zalviso sufentanil

Pain

Submit MAA

Mid-2014

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

Selexipag

Pulmonary arterial hypertension (PAH)

Final Ph III data

Mid-2014

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

Tasquinimod

Metastatic castration-resistant prostate cancer (CRPC)

Ph III data

2014

Active Biotech AB (SSE:ACTI)/Teva Pharmaceutical Industries Ltd. (NYSE:TEVA)

Laquinimod

Relapsing-remitting multiple sclerosis (RRMS)

CHMP recommendation

January

Adamas Pharmaceuticals Inc./Forest Laboratories Inc. (NYSE:FRX)

Arimenda (ADS-8704)

Moderate to severe Alzheimer's dementia

Submit NDA

1H14

ADMA Biologics Inc. (OTCQB:ADMA)

RI-002

Primary immunodeficiency disease

Prelim Ph III data

4Q14

Alchemia Ltd. (ASX:ACL)

HA-Irinotecan

Metastatic colorectal cancer (mCRC)

Ph III data

1H14

Alcobra Ltd. (NASDAQ:ADHD)

Metadoxine (MG01CI)

Adult ADHD

Ph III data

2H14

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN)

Asfotase alfa (ENB-0040)

Hypophosphatasia

Submit BLA and MAA

Mid-2014

Alfa Wassermann S.p.A./Salix Pharmaceuticals Inc. (NASDAQ:SLXP)

Rifaximin

Diarrhea-predominant irritable bowel syndrome (IBS-D)

Ph III TARGET 3 data

2Q14

Alkermes plc (NASDAQ:ALKS)

Aripiprazole lauroxil

Schizophrenia

Ph III data

1H14

Amgen Inc. (NASDAQ:AMGN)

Trebananib

Recurrent ovarian cancer

Ph III data

2H14

Amgen Inc. (NASDAQ:AMGN)

Subcutaneous evolocumab

Hyperlipidemia

Ph III LAPLACE-2, GAUSS-2 and RUTHERFORD-2 data

1Q14

Ampio Pharmaceuticals Inc. (NYSE-M:AMPE)

Ampion

Osteoarthritis of the knee

Submit BLA

3Q14

Arcion Therapeutics Inc./BioDelivery Sciences International Inc. (NASDAQ:BDSI)

Topical clonidine gel

Painful diabetic neuropathy

Ph III data

YE14

AstraZeneca plc (LSE:AZN; NYSE:AZN)

Lesinurad

Gout

Submit MAA and NDA

2H14

Avanir Pharmaceuticals Inc. (NASDAQ:AVNR)/OptiNose Inc.

AVP-825

Moderate to severe acute migraine pain

Submit NDA

1Q14

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

Isavuconazole

Invasive Aspergillus infections

Submit regulatory application

1H14

Biogen Idec Inc. (NASDAQ:BIIB)/AbbVie Inc. (NYSE:ABBV)

Daclizumab high-yield process (DAC HYP)

RRMS

Ph III DECIDE data

2014

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)/Catalyst Pharmaceutical Partners Inc. (NASDAQ:CPRX)/Jazz Pharmaceuticals plc (NASDAQ:JAZZ)

Firdapse amifampridine

Lambert-Eaton myasthenic syndrome (LEMS)

Top-line Ph III data

3Q14