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Emerging Pharma Catalysts: H2 2012

NEW YORK, Sept. 20, 2012 /PRNewswire/ -- announces that a new market research report is available in its catalogue:


Emerging Pharma Catalysts: H2 2012


An analysis of upcoming catalysts that will affect selected companies in the Emerging Pharma peer set and Datamonitor's prediction of the outcome of these binary events. These catalysts include both PDUFA dates and expected Phase III trial results for key pipeline drugs.Focuses on the background and factors affecting the outcome of selected FDA drug approval decisions and Phase III trial results for covered companies Includes coverage of Amylin, ArQule, BioMarin, Elan, Exelixis, Ironwood, Medivation, NPS, Onyx, Regeneron, Rigel, Salix, Santarus, United Therapeutics Many important regulatory and clinical catalysts will occur in the second half of 2012 that will have a sizable impact both directly on the companies in Datamonitor's Emerging Pharma peer set and also indirectly on the wider market.Identify important catalysts that will have a large impact on the prospects for these Emerging Pharma companies and their products Assess the background and clinical data surrounding each of the listed products Analyze the factors affecting each catalyst and obtain Datamonitor's opinion on the outcome




ABOUT THIS REPORT•PharmaVitae Explorer database




PDUFA DATES•Regeneron - Zaltrap: PDUFA – August 4

- Eylea: PDUFA – September 21


•Salix - Crofelemer: PDUFA – September 5


•Ironwood - Linaclotide: PDUFA – September 8

- Linaclotide clinical trials


•NPS Pharmaceuticals - Gattex PDUFA – September 28

- Gattex should win approval based on positive Phase III data and CHMP positive opinion


•Amylin - Metreleptin: PDUFA – October 3

- Ultra-rare nature of lipodystrophy lowers bar for approval


•Santarus - Uceris: PDUFA – October 16

- Uceris clinical trials


•United Therapeutics - Oral treprostinil: PDUFA – October 26


•Medivation - Enzalutamide: PDUFA – November 21


•Onyx - Regorafenib: PDUFA – November 23

- Positive data make approval likely, but uptake may be low


•Exelixis - Cabozantinib: PDUFA – November 29

- Cabozantinib looks likely to be approved based on strong Phase III data



PHASE III TRIAL RESULTS•ArQule: tivantinib – non-small cell lung cancer - Tivantinib: Phase III results – H2 2012

- Interim analysis of MARQUEE trial expected in H2 2012


•BioMarin: Firdapse – Lambert-Eaton myasthenic syndrome - Firdapse Phase III results – H2 2012

- Phase III LMS-002 trial


•BioMarin: GALNS – mucopolysaccharidosis IVA - GALNS Phase III results – H2 2012

- Phase II trials

- Phase III trial


•Elan: bapineuzumab – Alzheimer's disease - Bapineuzumab Phase III results – H2 2012

- Phase II trials

- Phase III trials


•Rigel: fostamatinib – rheumatoid arthritis - Fostamatinib Phase III results – H2 2012

- Phase III program: OSKIRA and head-to-head clinical trials



APPENDIX•References - Datamonitor Reports


•Exchange rates




•Table: Emerging Pharma catalysts, H2 2012

•Table: Recently launched Emerging Pharma products

•Table: Regeneron catalysts, H2 2012

•Table: Zaltrap colorectal cancer clinical trials

•Table: Summary of results from the Phase III VELOUR trial

•Table: Overview of pivotal Phase III data for Eylea and Lucentis in macular edema secondary to CRVO

•Table: Salix catalysts, H2 2012

•Table: Salix Phase III trials in diarrhea indication

•Table: Ironwood catalysts, H2 2012

•Table: Ironwood Pharmaceuticals' Phase III clinical trial program, including four pivotal trials and two safety studies

•Table: NPS Pharmaceuticals catalysts, H2 2012

•Table: NPS Phase III trials for small bowel syndrome

•Table: Amylin catalysts, H2 2012

•Table: Santarus catalysts, H2 2012

•Table: Overview of pivotal Phase III data for Uceris in ulcerative colitis

•Table: United Therapeutics catalysts, H2 2012

•Table: Medivation catalysts, H2 2012

•Table: Pivotal Phase III PREVAIL and AFFIRM trials for enzalutamide in prostate cancer

•Table: Onyx catalysts, H2 2012

•Table: Summary of efficacy results from the Phase III CORRECT trial

•Table: Exelixis catalysts, H2 2012

•Table: Phase II results for GALNS in MPS IVA

•Table: Phase II trial summary for bapineuzumab in Alzheimer's disease

•Table: Phase III trial summary for bapineuzumab in Alzheimer's disease

•Table: Summary of ongoing Phase III trials for FosD in rheumatoid arthritis

•Table: Exchange rates, 2012




•Figure: PharmaVitae Explorer




Companies Mentioned

Arrow Electronics, Inc., Bunzl plc, Dendreon Corporation, Hutchison 3G UK Limited, Incyte Corporation, Janssen Pharmaceuticals, Inc., Merck KGaA, Schindler Holding Ltd., Seattle Genetics, Inc., Telenor ASA, United Therapeutics Corporation, Zain Group




To order this report:

Pathology Industry: Emerging Pharma Catalysts: H2 2012


Nicolas Bombourg
US: (805)652-2626
Intl: +1 805-652-2626



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