Healthcare Industry News: Repligen
News Release - November 4, 2013
A.P. Pharma Makes Key Management AppointmentsPaul Marshall Appointed Senior Vice President, Technical Operations
Brian Drazba, CPA Appointed Vice President, Finance and Chief Financial Officer
REDWOOD CITY, Calif.--(Healthcare Sales & Marketing Network)--A.P. Pharma, Inc. (OTCBB:APPA.OB), a specialty pharmaceutical company, today announced the appointment of Paul Marshall as senior vice president of technical operations and Brian Drazba as vice president of finance and chief financial officer. Mr. Marshall will be responsible for A.P. Pharma’s manufacturing operations, including for APF530, the Company’s lead product candidate for the prevention of chemotherapy-induced nausea and vomiting. He has served as a consultant to A.P. Pharma for the last three months since leaving Amylin Pharmaceuticals, where he was Senior Vice President Operations in charge of global manufacturing prior to that company being sold to Bristol-Myers Squibb in 2012. Mr. Drazba will lead the financial operations and fiduciary reporting responsibilities for the Company. He comes to A.P. Pharma from ISTA Pharmaceuticals where he was vice president finance and chief accounting officer helping to grow that company into the third largest branded prescription eye care business in the United States.
“As A.P. Pharma approaches the resubmission of its new drug application for APF530, we are committed to having the right expertise in place to guide the organization through 2014 and beyond,” said Barry D. Quart, Pharm.D., A.P. Pharma’s Chief Executive Officer. “Both Paul and Brian have proven experience in their given disciplines and we believe they will have a rapid, positive impact on the organization’s development. We welcome them to our team and look forward to their value-add perspectives.”
Mr. Marshall has 27 years of experience in the development and commercialization of pharmaceutical products, including manufacturing and supply chain responsibility for 14 approved drugs and biologics, 3 of which achieved blockbuster (sales >$1B) status. Since 2006, Mr. Marshall has held ascending executive positions within Amylin Pharmaceuticals, Inc., including Senior Vice President, Operations. Prior to his work at Amylin, Mr. Marshall held executive manufacturing positions at Amgen, Inc. and Baxter International. He has held management positions at Creative BioMolecules, Welgen Manufacturing Partnership (now Amgen, Rhode Island), Repligen Corporation and Damon Biotech. Mr. Marshall received a Bachelor of Science and a Master of Science in Biology from the University of Massachusetts at Dartmouth and completed three years of post-graduate work concentrating in hematology and coagulation research at Brown University.
Mr. Drazba brings nearly 30 years of financial management experience to A.P. Pharma. Most recently, he was vice president of finance and chief accounting officer for ISTA Pharmaceuticals Inc. where he led the financial reporting, analysis, and tax functions. From 1992 to 2006, Mr. Drazba held positions of increasing responsibility within Insight Health Corp. (American Health Services Corp.), including senior vice president and chief accounting officer. Prior to his tenure at Insight Health, Mr. Drazba was employed by Arthur Andersen & Co. He is a licensed Certified Public Accountant in California and holds a Bachelor of Arts from University of San Diego.
A.P. Pharma's lead product candidate, APF530, is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV. APF530 contains the 5-HT3 antagonist granisetron formulated in the Company's proprietary Biochronomer™ drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for APF530 because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks. The Company's lead product, APF530, is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting. For further information, please visit the Company's web site at www.appharma.com.
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the potential approval of APF530 and the potential timing for such approval, if approved at all, as well as risks relating to qualifying for listing on the NASDAQ Capital Market, capital resources and liquidity, satisfactory completion of clinical studies, progress in research and development programs, launch and acceptance of new products and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law.
Source: A.P. Pharma
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