Press Releases
FLAMEL TECHNOLOGIES S.A. ANNOUNCES A
COLLABORATION WITH NIRO
LYON, FRANCE, January 16, 1998 – Flamel Technologies S.A. (NASDAQ: FLML) announced the signature of a collaboration with Aeromatic-Fielder (NIRO Group), a world leader in fluidized-bed spray coating technology.
Flamel will install spray-coating equipment from NIRO in its pharmaceutical manufacturing facility, which it acquired in January 1997 from SmithKline Beecham. This equipment will be used in the manufacturing of Flamel's products based on its Micropump™ controlled-delivery technology, the first of which is Asacard, a cardiovascular aspirin currently under registration in Europe. This equipment will provide Flamel with the capability to manufacture clinical batches, pilot batches and full industrial-size batches of product under GMP conditions, giving it full control of its development, scale-up and manufacturing operations. Under the collaboration, NIRO will bring its equipment technology and help to maintain the equipment at state of the art conditions. Remaining time on the equipment will be made available to NIRO and its customers on a contract basis.
Since the plant acquisition, Flamel's pharmaceutical manufacturing facility has been audited by the French health authorities and is now approved to produce products for sale to most countries in Europe. Flamel currently supplies various formulations of cimetidine to SmithKline Beecham as part of a supply agreement running to the end of 1999.
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 – Micropump™ and Medusa® in drug-delivery, Agsome™ in delivery of agrochemical active ingredients, 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.
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.
