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.
Features and benefits
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
Highlights
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.
Your key questions answered
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
Buy your copy of this report @ http://www.reportsnreports.com/reports/183724-emerging-pharma-catalysts-h2-2012.html
Report Details:
Published: July 2012
No. of Pages: 53
Price: Single User License: US$3800 Corporate User License:US9500
Table Of contents
ABOUT THIS REPORT
PharmaVitae Explorer database
EXECUTIVE SUMMARY
Catalysts
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
Features and benefits
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
Highlights
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.
Your key questions answered
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
Buy your copy of this report @ http://www.reportsnreports.com/reports/183724-emerging-pharma-catalysts-h2-2012.html
Report Details:
Published: July 2012
No. of Pages: 53
Price: Single User License: US$3800 Corporate User License:US9500
Table Of contents
ABOUT THIS REPORT
PharmaVitae Explorer database
EXECUTIVE SUMMARY
Catalysts
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
