Press Releases
FLAMEL TECHNOLOGIES S.A. AND SMITHKLINE BEECHAM TO TERMINATE COLLABORATION IN VACCINE DELIVERY
LYON, France, FEBRURAY 24, 1997 – Flamel Technologies S.A. (NASDAQ: FLML) today announced the termination of its collaboration with SmithKline Beecham (SB) in the area of vaccine delivery. Flamel has regained its full rights to the technology so as to be able to pursue the area alone or with another partner.
Pursuant to an agreement entered into in December 1994, the parties established a collaborative research and development program aimed at applying Flamel's MedusaTM system for protein and peptide delivery to the oral, mucosal and parenteral delivery of human vaccines. As part of the agreement, Flamel granted SB the exclusive worldwide right to all applications of the MedusaTM system for human vaccines.
Upon execution of the SB agreement, the Company received an initial licensing fee. It has also received payments in connection with the achievement of different research milestones, which included proving the safety and non-immunogenicity of the polymer used for the protein encapsulation and demonstrating the efficacy of a first vaccine formulation in parenteral administration.
However, SB's principal interest is in oral and nasal formulations of vaccines, which both parties agree will require additional efforts. As a result, SB has decided against continuation of the project.
"We regret SmithKline Beecham's decision," said Dr. Gerard Soula, President and Chief Executive Officer of Flamel Technologies S.A., "because we, Flamel, believe strongly in the potential of the Medusa system for delivery of vaccines both for parenteral and for oral administration. Under such circumstances, it was important for Flamel to re-gain its full rights to the technology so as to be able to pursue the area independently or with another corporate partner."SmithKline Beecham (NYSE: SBH) - one of the world's leading healthcare companies - discovers, develops, manufactures, and markets pharmaceuticals, vaccines, over-the-counter medicines, and health-related consumer products, and provides healthcare services including clinical-laboratory testing, disease management, and pharmaceutical-benefit management.
Flamel Technologies is engaged in the development of advanced polymer technologies for unique drug delivery and biomaterial applications. The Company is building on its principal technology platforms - through programs including Micropump and Medusa in drug-delivery, ColCys in biomaterial-based medical devices, and new materials for ophthalmic lens products - to meet important unmet medical needs and develop other commercially valuable products. In June 1996, Flamel completed its initial public offering in the U.S.
NOTE: This press release contains statements which 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 that this transaction will not be consummated, the risk associated with the Company's limited history of operations and historic and future losses, and 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 and the risks associated with key strategic alliances, and other risks detailed in the Company's filings with the Securities and Exchange Commission.
