Selected products with Phase III or regulatory milestones expected in 2H13. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

AbbVie Inc. (NYSE:ABBV)

Humira adalimumab

Axial spondyloarthritis

FDA panel

7/23/13

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Sufentanil NanoTab PCA System (ARX-01)

Post-operative pain

Submit NDA

3Q13

Acorda Therapeutics Inc. (NASDAQ:ACOR)/ SK Biopharmaceuticals Co. Ltd.

Diazepam nasal spray

Acute repetitive seizures

Submit NDA

2H13

Actelion Ltd. (SIX:ATLN)

Opsumit macitentan

Pulmonary arterial hypertension (PAH)

PDUFA date

October

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Lojuxta/Juxtapid lomitapide

Homozygous familial hypercholesterolemia (hoFH)

MAA action

3Q13

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN)

Soliris eculizumab

Shiga-toxin producing Escherichia coli hemolytic uremic syndrome (STEC-HUS)

Submit regulatory application

YE13

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

Iluvien fluocinolone acetonide

Chronic diabetic macular edema (DME)

PDUFA date

10/17/13

ALK-Abello A/S (CSE:ALK-B)/Torii Pharmaceutical Co. Ltd. (Tokyo:4551)/Merck & Co. Inc. (NYSE:MRK)

Mitizax allergy immunotherapy tablet

House dust mite-induced allergic asthma

Ph III data

3Q13

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

Aclidinium bromide and formoterol

Chronic obstructive pulmonary disease (COPD)

Submit MAA and NDA

4Q13

Amarin Corp. plc (NASDAQ:AMRN)

Vascepa icosapent ethyl

Adult patients with high triglycerides with mixed dyslipidemia

FDA panel; PDUFA date

10/16/13; 12/20/13

Ampio Pharmaceuticals Inc. (NYSE:AMPE)

Ampion non-steroidal anti-inflammatory

Osteoarthritis (OA) of the knee

Ph III data

3Q13

Anacor Pharmaceuticals Inc. (NASDAQ:ANAC)

Tavaborole

Onychomycosis

Submit NDA

Mid-2013

Antares Pharma Inc. (NASDAQ:ATRS)

Otrexup methotrexate

Rheumatoid arthritis (RA)

PDUFA date

10/14/13

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

Blisibimod

Systemic lupus erythematosus (SLE)

Interim Ph III data

2H13

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA)

Iclusig ponatinib

Newly diagnosed chronic myelogenous leukemia (CML)

Ph III EPIC data

3Q14

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

Forxiga dapagliflozin

Type II diabetes

Resubmit NDA

Mid-2013

Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL)

Xiaflex collagenase clostridium histolyticum

Peyronie's disease

PDUFA date

9/6/13