Pharma Growth Strategies Publishes Exclusive Pharmaceutical/Biotech Industry Report for Public Release

Report Addresses Last Great Frontier in U.S. Regulatory Intelligence: FDA Approvable and Related NDA/BLA Actions

Langhorne, PA April 18, 2006 - Pharma Growth Strategies, LLC (“PGS”), a specialized management consultant to the pharmaceutical and biotechnology industries has announced the release of its first industry intelligence report to the general public. Entitled: “FDA’s Approvables and Related NDA/BLA Actions,” the authoritative report provides an in-depth exploration of this gray area of U.S. drug regulatory actions. According to the report’s author and president of PGS, Fredric Cohen, M.D., the report contains information of direct relevance to many managers in new-drug R&D and marketing:

“Understanding how and why FDA takes certain actions on first NDAs/BLAs for novel therapeutic drugs is unquestionably a must-have component of key pre-submission knowledge for any manager that assists with the development or marketing of novel therapeutic drugs.”

The report is available for purchase at http://www.pharmagrowth.com/approvables.html . Covering the period from 1998 through 2005, this authoritative report presents detailed listings, summaries and analyses of first-submission new molecular entity new drug applications (NME-NDAs) and biologics licensing applications (BLAs) for over 100 approved therapeutic drug products.

Included in the analyses are:
• Listings of all products that received an "approvable" decision prior to marketing approval between 1998 and 2005 with key regulatory data;
• Additional detailed listings for therapeutic NMEs and therapeutic recombinant proteins for over 100 products that met above criteria (about 1,500 data points);
• Statistics and descriptions summarizing above data including overall effects of approvable actions on approval timing; "survival" analyses of NME-NDAs, exploration of factors predicting NDA approval delay; issues cited as reasons for approvable decisions and their relative importance, including recent trends;
• Actionable implications of key findings for managers;
• Definitions and descriptions, with links to additional information, of all possible FDA NDA/BLA actions and regulations that govern these actions;
• Prototypical recent Action Letters from CDER and CBER (with some others available upon request);
• A listing of 100 additional therapeutic drug products whose NME-NDAs were approved by CDER without an intervening approvable action;

About Pharma Growth Strategies, LLC
Pharma Growth Strategies, LLC, (“PGS”), founded in 2004 by Fredric Cohen, M.D., is a specialized management consultant to the pharmaceutical and biotechnology industries and the affiliated industries that support them. Since its founding, PGS has offered a variety of services to mid- and senior-level managers in drug R&D and marketing aimed at enhancing internal value-creation efforts through exploration and application of scientifically derived best practices. Deploying its network of highly selected area experts, PGS offer its clients a full suite of services to meet their most demanding strategic needs.

For further inquiries contact: Fredric Cohen, MD, President, Pharma Growth Strategies, LLC
215-860-3336 or email fred@pharmagrowth.com

Contact: Fredric Cohen, M.D.
Pharma Growth Strategies LLC
Phone 215 860 3336
Email fred@pharmagrowth.com
13 Summit Square Center #132, Langhorne, PA 19047-1098
Pharma Growth Strategies, LLC