Lyon, France, October 20, 2003 – Flamel Technologies S.A. (NASDAQ:FLML) today announced that the required waiting period has expired under the Hart-Scott-Rodino Act related to its previously announced licensing and commercialization agreement with Bristol-Myers Squibb to develop and market Basulin®, the first controlled release, unmodified human insulin to be developed as a once-daily injection for patients with type 1 or type 2 diabetes. This clearance eliminates the remaining condition to the license agreement and will result in a $20 million up-front payment from Bristol-Myers Squibb to Flamel within fifteen days in accordance with the licensing and commercialization agreement.
Flamel Technologies, S.A. is a biopharmaceutical company principally engaged in the development of two unique polymer-based delivery technologies for medical applications. Flamel's Medusa® nano-particulate technology is designed to deliver therapeutic proteins and peptides. Flamel's Micropump® technology is a controlled release and taste-masking technology for the oral administration of small molecule drugs.
This document contains a number of matters, particularly as related to the status of various research projects and technology platforms, that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The presentation reflects the current view of management with respect to future events and is subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks 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, and the risks associated with Flamel's reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2002. Flamel assumes no obligation to update any forward-looking statements. Flamel assumes no obligation to update any forward-looking statements.