Press Releases
FLAMEL TECHNOLOGIES FILES FOR EUROPEAN APPROVAL FOR ASACARD™ CARDIOVASCULAR ASPIRIN
– Launch of New Clinical Study to Support Product Marketing Campaign –
LYON, FRANCE – September 3, 1998 – Flamel Technologies S.A. (Nasdaq: FLML) today announced that G.D. Searle has filed for European approval for Asacard™, using the mutual recognition procedure. Asacard is a controlled-release cardiovascular aspirin developed by Flamel and licensed in Europe to G.D. Searle. Searle received regulatory approval for the product in the United Kingdom in February 1998.
In parallel with the European regulatory filing, Searle and Flamel have decided to launch a Phase IV clinical study to support the marketing campaign for Asacard. The study will enroll several hundred patients who have a history of cardiovascular events, and it will require approximately 12 months to complete. Consequently, the two parties have decided to defer the expected U.K. product launch until they have the results of the Phase IV study, which will provide important marketing data for a pan-European launch of the product.
"With Searle having begun the registration process for Asacard in the European Union, we are proud to announce that we have reached an important milestone within the timeframe we had envisioned. While there will be a short-term loss, we are pleased our partner is investing in this Phase IV study to expand the long-term potential for Asacard. We believe the study will furnish the evidence of safety benefits necessary to support the pricing levels that we feel appropriately represent the overall value of this product," stated Gerard Soula, President and Chief Executive Officer of Flamel Technologies.
Flamel Technologies applies its advanced polymer
technologies to the development of proprietary applications in drug delivery,
agrochemical delivery, biomaterials, and selected other applications. The
Company is seeking to meet important unmet medical needs, through programs
including Micropump® and Medusa® in drug delivery, Agsome™
in agrochemical delivery, ColCys™ in biomaterial-based medical devices, and in
photochromic ophthalmic lens materials.
Asacard™, ColCys™, and Agsome™ are trademarks, and Micropump® and Medusa® are registered trademarks of Flamel Technologies.
This press release contains statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties, including, but not limited to, the risk associated with the Company’s limited history of operations and historic and future losses, the risk that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products in development, the impact of competitive products and pricing, reliance on outside parties, the risks associated with key strategic alliances, and other risks detailed in the Company’s filings with the Securities and Exchange Commission.
