Selected products with Phase III or regulatory milestones expected in 2Q14. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

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

Zalviso sufentanil sublingual microtablet system

Pain

Submit MAA; PDUFA date

Mid-2014; 7/27/14

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

Selexipag

Pulmonary arterial hypertension (PAH)

Final Ph III data

Mid-2014

Alchemia Ltd. (ASX:ACL)

HA-Irinotecan

Metastatic colorectal cancer (mCRC)

Ph III data

2Q14

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN)

Asfotase alfa

Hypophosphatasia

Submit BLA and MAA

Mid-2014

ALK-Abello A/S (CSE:ALK-B)/Merck & Co. Inc. (NYSE:MRK)

Grastek grass pollen Allergy Immunotherapy Tablet (AIT)

Timothy grass pollen induced allergic rhinitis with or without conjunctivitis

FDA action

2Q14

ALK-Abello A/S (CSE:ALK-B)/Merck & Co. Inc. (NYSE:MRK)

Ragwitek ragweed Allergy Immunotherapy Tablet (AIT)

Ragweed-induced allergic rhinitis with or without conjunctivitis

FDA action

2Q14

Alkermes plc (NASDAQ:ALKS)

Aripiprazole lauroxil

Schizophrenia

Ph III data

2Q14

Amgen Inc. (NASDAQ:AMGN)

Kyprolis carfilzomib

Multiple myeloma (MM) in patients who have received three or more prior therapies

Ph III FOCUS data

2Q14

Amgen Inc. (NASDAQ:AMGN)

Kyprolis carfilzomib plus Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG) and dexamethasone

MM in patients who have received one to three prior therapies

Ph III ASPIRE data

2Q14

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

Amigal migalastat

Fabry's disease

Additional Ph III data

2Q14

Anthera Pharmaceuticals Inc. (NASDAQ:ANTH)/Amgen Inc. (NASDAQ:AMGN)

Blisibimod

Systemic lupus erythematosus (SLE)

Interim Ph III CHABLIS-SCI data

Mid-2014

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

Isavuconazole

Invasive Aspergillus infections

Submit NDA and MAA

Mid-2014