Selected products with Phase III or regulatory milestones expected in 2H14. (A) Uses PEGylation technology from Nektar Therapeutics (NASDAQ:NKTR); (B) Lymphoseek is already approved for intraoperative lympathic imaging in breast cancer and melanoma patients and sentinel lymph node detection in patients with squamous cell carcinoma of the head and neck (SCCHN); (C) Uses antisense chemistry from Isis Pharmaceuticals Inc. (NASDAQ:ISIS); Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)

Pimavanserin

Parkinson's disease psychosis

Submit NDA

YE14

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Zalviso sufentanil sublingual microtablet system

Manage moderate to severe acute pain in a hospital setting

PDUFA date

7/27/14

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

Tasquinimod (TASQ)

Metastatic castration-resistant prostate cancer (CRPC)

Ph III 10TASQ10 data

2H14

ADMA Biologics Inc. (OTCQB:ADMA)

RI-002 intravenous immune globulin

Primary immunodeficiency disease

Prelim Ph III data

4Q14

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

Macimorelin acetate (AEZS-130)

Diagnose adult growth hormone deficiency

PDUFA date

11/5/14

Alchemia Ltd. (ASX:ACL)

HA-Irinotecan

Metastatic colorectal cancer (mCRC)

Top-line Ph III data

3Q14

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN)

Asfotase alfa

Hypophosphatasia

Complete rolling BLA and submit MAA

2H14

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

Iluvien fluocinolone acetonide intravitreal implant

Diabetic macular edema (DME)

PDUFA date

9/26/14

Alkermes plc (NASDAQ:ALKS)

Aripiprazole lauroxil

Schizophrenia

Submit NDA

3Q14

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

Mitizax allergy immunotherapy tablet

House dust mite-induced allergic rhinitis

Submit reg app in EU

2H14

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

Mitizax allergy immunotherapy tablet

House dust mite-induced allergic asthma

Submit reg app in EU

2H14

Almirall S.A. (Madrid:ALM)

Aclidinium bromide/formoterol fumarate

Chronic obstructive pulmonary disease (COPD)

MAA action

4Q14

Amgen Inc. (NASDAQ:AMGN)

Kyprolis carfilzomib

Multiple myeloma (MM)

Ph III FOCUS data

3Q14

Amgen Inc. (NASDAQ:AMGN)

Kyprolis carfilzomib in combination with Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG)

MM

Interim Ph III ASPIRE data

3Q14

Amgen Inc. (NASDAQ:AMGN)/Astellas Pharma Inc. (Tokyo:4503)

Evolocumab

Dyslipidemia

Submit reg app

2H14

Amgen Inc. (NASDAQ:AMGN)/Pfizer Inc. (NYSE:PFE)

Palbociclib in combination with Femara letrozole from Novartis AG (NYSE:NVS; SIX:NOVN)

First-line treatment of estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer in postmenopausal women

Submit NDA

3Q14

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

Trebananib

Recurrent ovarian cancer

Ph III data

2H14

Amicus Therapeutics Inc. (NASDAQ:FOLD)

Amigal migalastat

Fabry's disease

Ph III data

3Q14

Ampio Pharmaceuticals Inc. (NYSE-M:AMPE)

Ampion

Osteoarthritis (OA) of the knee

Top-line Ph III data; submit BLA

3Q14; 2H14