A.P. Pharma Successfully Completes Pre-Clinical Safety Evaluations Of Biochronomer™ System
Plans to Commence Human Clinical Trials in First Half 2002
REDWOOD CITY, Calif. (June 26, 2001) – A.P. Pharma, Inc. (NASDAQ NM: APPA), a company focused on the development of ethical pharmaceuticals utilizing proprietary polymer-based drug delivery systems, today announced that it has successfully completed a series of pre-clinical safety studies on the company's patented polymer-based system, trade named Biochronomer™.
The results of these studies indicate that the first generation of the Biochronomer polymer system is safe following sub-cutaneous administration at dose levels greatly in excess of anticipated clinical use. The company has completed sufficient pre-clinical safety evaluations to initiate focused product development programs.
The Biochronomer system was specifically designed as a bioerodible injectable and implantable drug delivery system. Initial target clinical applications for the Biochronomer system include pain management, inflammation, oncology and ophthalmic and orthopedic applications.
“Our primary focus is on the development and commercialization of our Biochronomer system, and these recently completed studies move us closer to commencing human clinical trials in the first half of 2002,” said Michael O'Connell, A.P. Pharma's president and CEO. “Moreover, these studies provide key data critical to facilitate partnership arrangements and to bring innovative pharmaceutical products to market.”
Additionally, A.P. Pharma in collaboration with Sigma-Aldrich Fine Chemicals (a division of Sigma-Aldrich Corporation, NASDAQ NM: SIAL) has successfully completed critical scale-up processes necessary to manufacture the first generation of the Biochronomer polymers in commercial quantities. The large-scale production of the Biochronomer polymer conducted at Sigma-Aldrich's Sheboygan, Wisconsin site, complies with current Good Manufacturing Practice (cGMP) regulations stipulated by the U.S. Food and Drug Administration (FDA).
About the Biochronomer System
The Biochronomer polymer system is a family of bioerodible polymers specifically designed for drug delivery. The entire family of polymers is a versatile delivery platform, which can deliver drugs over a wide range of time periods. The first generation of this family has been designed for the short-term release of pharmaceutically active materials. This generation of polymers, frequently referred to as the “semi-solid” form of the polymer, has been the internal focus of the company for a variety of commercial applications.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company focused on the development of ethical (prescription) pharmaceuticals utilizing its proprietary polymer-based drug delivery systems. The company's primary focus is the development and commercialization of its bioerodible injectable and implantable systems under the trade name Biochronomerä. Initial targeted areas of application for the company's drug delivery technology include pain management, inflammation, oncology, and ophthalmic and orthopedic applications. The company's product development programs are funded by royalties from topical products currently marketed by pharmaceutical partners, and proceeds from the divestiture of its cosmeceutical product lines. For further information visit the company's website at www.appharma.com.
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Except for historical information, this news release contains certain forward-looking statements that involve risks and uncertainties, including among others, uncertainty associated with timely development, approval, launch and acceptance of new products, establishment of new corporate alliances and progress in research and development programs. Other risks and uncertainties associated with the company's business and prospects are identified in the company's filings with the Securities and Exchange Commission. The company does not undertake to revise these forward-looking statements to reflect events or circumstances occurring in the future.