Recently Released Market Study: Emerging Pharma Catalysts: H2 2012

New Pharmaceuticals research report from Datamonitor is now available from Fast Market Research

by Bill Thompson

(WireNews+Co) - Boston, MA - 28 October 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.

Scope
- 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.

Reasons to Get this Report
- 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

View Full Report Details (http://www.fastmr.com/prod/464847_emerging_pharma_catalysts_h2_2012.aspx) (http://www.fastmr.com/prod/464847_emerging_pharma_catalysts_h2_2012.aspx)

Partial 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

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