Selected products with Phase III or regulatory milestones expected in 2H10

Company

Product

Indication

Event

Milestone

Actelion Ltd. (SIX:ATLN)

Pivlaz clazosentan

Prevent the occurrence of cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH)

Ph III data

October

Adventrx Pharmaceuticals Inc.(NYSE-A:ANX)

Exelbine vinorelbine emulsion (ANX-530)

Non-small cell lung cancer (NSCLC)

Submit NDA

4Q10

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA)/Biovail Corp. (TSX:BVF; NYSE:BVF)

Staccato loxapine (AZ-004)

Agitation in patients with schizophrenia or bipolar disorder

PDUFA date

10/11/10

Alkermes Inc. (NASDAQ:ALKS)

Vivitrol naltrexone

Opioid dependence

FDA panel meeting; PDUFA date

9/16/10; 10/12/10

Allos Therapeutics Inc. (NASDAQ:ALTH)

Folotyn pralatrexate

Peripheral T cell lymphoma (PTCL)

Submit MAA

4Q10

Almirall S.A. (Madrid:ALM)/Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD)/ Forest Laboratories Inc. (NYSE:FRX)/Astellas Pharma Inc. (Tokyo:4503)

Linaclotide

Irritable bowel syndrome with constipation (IBS-C)

Ph III data

4Q10

Amgen Inc. (NASDAQ:AMGN)

Prolia denosumab

Prevent or delay bone metastases in prostate cancer patients

Ph III data

4Q10

Amylin Pharmaceuticals Inc. (NASDAQ:AMLN)/ Eli Lilly and Co. (NYSE:LLY)

Bydureon exenatide once weekly; uses drug delivery technology from Alkermes Inc. (NASDAQ:ALKS)

Type II diabetes

PDUFA date

10/22/10

Anika Therapeutics Inc. (NASDAQ:ANIK)

Monovisc

Pain caused by osteoarthritis (OA) of the knee

FDA action

2H10

Antares Pharma Inc. (NYSE-A:AIS)

Anturol (AP-1034)

Overactive bladder (OAB) syndrome

Prelim Ph III data

3Q10

Arena Pharmaceuticals Inc. (NASDAQ:ARNA)

Lorcaserin (APD356)

Weight management

FDA panel meeting; PDUFA date

9/16/10; 10/22/10

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA)/ Merck & Co. Inc. (NYSE:MRK)

Ridaforolimus (MK-8669)

Metastatic soft-tissue and bone sarcomas

Final Ph III data

4Q10

AstraZeneca plc (LSE:AZN; NYSE:AZN)/Bristol-Myers Squibb Co. (NYSE:BMY)/Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768)

Saxagliptin / metformin

Type II diabetes

PDUFA date

10/29/10

AstraZeneca plc (LSE:AZN; NYSE:AZN)

Brilinta ticagrelor

Reduce major adverse cardiac events in patients with acute coronary syndrome (ACS)

FDA panel meeting; PDUFA date

7/28/10; 9/16/10

AstraZeneca plc (LSE:AZN; NYSE:AZN)

Zactima vandetanib

Advanced medullary thyroid cancer (MTC)

Submit NDA; submit MAA

3Q10

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

Dapagliflozin

Type II diabetes

Submit regulatory applications

YE10

AstraZeneca plc (LSE:AZN; NYSE:AZN)/Forest Laboratories Inc. (NYSE:FRX)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Ceftaroline acetate

Community-acquired bacterial pneumonia; complicated skin and skin structure infection (cSSSI)

Submit MAA

3Q10

Avanir Pharmaceuticals Inc. (NASDAQ:AVNR)

Zenvia dextromethorphan/ quinidine

Pseudobulbar affect (PBA)

PDUFA date

10/30/10