At least 117 Phase III or regulatory milestones are expected in 2H12. (A) Assumes 10-month review; (B) Assumes Priority Review; Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

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

APF530 long-acting granisetron

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

Resubmit NDA

YE12

Abbott Laboratories (NYSE:ABT)

Intestinal gel of levodopa/carbidopa

Advanced Parkinson's disease (PD)

Submit NDA

YE12

Accentia Biopharmaceuticals Inc. (OTCQB:ABPI)

BiovaxID vaccine

Indolent follicular B cell non-Hodgkin's lymphoma (NHL)

Submit MAA and NDS

YE12

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

Macitentan

Pulmonary arterial hypertension (PAH)

Submit regulatory applications

4Q12

Active Biotech AB (SSE:ACTI)

Anyara naptumomab estafenatox

Renal cell cancer (RCC)

Ph III data

2H12

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

Laquinimod

Relapsing-remitting multiple sclerosis (RRMS)

Submit MAA

2H12

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Lomitapide

Homozygous familial hypercholesterolemia (hoFH)

PDUFA date

12/29/12

Almirall S.A. (Madrid:ALM)

LAS41007

Non-melanoma skin cancer

Submit regulatory application

2H12

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

Aclidinium bromide

Bronchospasm associated with chronic obstructive pulmonary disease (COPD)

PDUFA date; MAA action

July; 2H12

Amarin Corp. plc (NASDAQ:AMRN)

AMR101

Hypertriglyceridemia

PDUFA date

7/26/12

Amgen Inc. (NASDAQ:AMGN)

Talimogene laherparepvec

Melanoma

Ph III data

2H12

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

Amigal migalastat (AT1001)

Fabry's disease

Ph III Study 011 data

3Q12

Antares Pharma Inc. (NYSE-M:AIS)/BioSante Pharmaceuticals Inc. (NASDAQ:BPAX)

LibiGel testosterone

Hypoactive sexual desire disorder (HSDD) in menopausal women

SPA; top-line Ph III data

3Q12; YE12

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA)

Ponatinib

Chronic resistant or intolerant chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)

Submit MAA and NDA

3Q12

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO)/Astellas Pharma Inc. (Tokyo:4503)/Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)

Tivozanib

Advanced RCC

Submit NDA

3Q12

Basilea Pharmaceutica AG (SIX:BSLN)

Ceftobiprole

Severe pneumonia in the hospital setting

Submit MAA

2H12

Bayer AG (Xetra:BAYN)/Onyx Pharmaceuticals Inc. (NASDAQ:ONXX)

Regorafenib

Gastrointestinal stromal tumors (GIST); metastatic colorectal cancer

Submit NDA (GIST); PDUFA date (colorectal)

2H12; October

BioAlliance Pharma S.A. (Euronext:BIO)

Sitavig acyclovir Lauriad

Recurrent orofacial herpes

PDUFA date

YE12 (A)

BioDelivery Sciences International Inc. (NASDAQ:BDSI)

BEMA Buprenorphine/Naloxone

Opioid dependence

Pivotal trial data

3Q12

Biogen Idec Inc. (NASDAQ:BIIB)

BG-12

Multiple sclerosis (MS)

PDUFA date

YE12 (A)

Biogen Idec Inc. (NASDAQ:BIIB)/Knopp BioSciences LLC

Dexpramipexole

Amyotrophic lateral sclerosis (ALS)

Ph III data

4Q12

Biogen Idec Inc. (NASDAQ:BIIB)/Swedish Orphan Biovitrum AB (SSE:SOBI)

Long-acting rFactor IX (FIXFc)

Hemophilia B

Ph III data

2H12

Biogen Idec Inc. (NASDAQ:BIIB)/Swedish Orphan Biovitrum AB (SSE:SOBI)

Long-lasting rFACTOR VIII (rFVIIIFc)

Hemophilia A

Ph III data

2H12

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)

GALNS (BMN-110)

Mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome)

Ph III data

4Q12

BioMimetic Therapeutics Inc. (NASDAQ:BMTI)

Augment Bone Graft

Alternative to the use of autograft in foot and ankle fusions

Submit amendment to PMA

Mid-2012