12:00 AM
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Jul 05, 2010
 |  BioCentury  |  Finance

2H10 milestones

2H10 milestones

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...

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