Selected products up for approval in 2012. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Access Pharmaceuticals Inc. (OTCBB:ACCP)/ RHEI Pharmaceuticals Inc.

MuGard mucoadhesive oral rinse

Treat and prevent oral mucositis

Regulatory action in China

1H12

Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS)/Keryx Biopharmaceuticals Inc. (NASDAQ:KERX)

Perifosine

Refractory metastatic colorectal cancer (mCRC)

FDA action

4Q12

Affymax Inc. (NASDAQ:AFFY)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Peginesatide (formerly Hematide)

Anemia in chronic kidney disease (CKD) patients

PDUFA date

3/27/12

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA)

Adasuve loxapine with schizophrenia or bipolar disorder

Acute agitation in patients

PDUFA date

2/4/12

Amarin Corp. plc (NASDAQ:AMRN)

AMR101 (formerly Miraxion)

Hypertriglyceridemia

PDUFA date

7/26/12

Amgen Inc. (NASDAQ:AMGN)/Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568)

Xgeva denosumab

Prevent bone metastasis in men with castration-resistant prostate cancer (CRPC)

FDA panel; PDUFA date

2/8/12; 4/26/12

Amylin Pharmaceuticals Inc. (NASDAQ:AMLN)/Alkermes plc (NASDAQ:ALKS)

Bydureon exenatide once weekly using Alkermes drug delivery technology

Type II diabetes

PDUFA date

1/28/12

Arena Pharmaceuticals Inc. (NASDAQ:ARNA)/Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)

Lorcaserin

Obesity

FDA action

2012 (submitted complete response to FDA in January)