Flamel Technologies, Inc

Flamel Technologies Announces Negative Response of French Authorities on Filing of Genvir^® for Registration.

Lyon, France, September 27, 2001 - Flamel Technologies (NASDAQ:FLML) announced today that it has received notification from the French Pharmaceutical Regulatory Agency that Flamel’s controlled-release acyclovir product, Genvir^®, which was filed for approval in August, 2000, has been refused regulatory approval pending a second study which would compare Genvir^® to valacylovir. The study filed by Flamel last year used Zovirax^® as the reference product. The decision was made by the Agence Francaise de Securitie Sanitaire des Produit de Sante, which made additional requests with regard to the new study.

“The French Agency is asking for a second Phase III trial in comparison with Valtrex^® to confirm and expand on the result of the first clinical trial,” said Dr. Gérard Soula, president and CEO of Flamel. “However, it was already our strategy to conduct this trial in the US in order to compare our unique extended release formulation of acyclovir with the second generation drugs for the treatment of genital herpes.We are currently exploring our timing and options with respect to such a study and are actively seeking a partner for this product.”

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-encapsulation technology is designed to deliver therapeutic proteins. Micropump^® is a controlled release technology for the oral administration of small molecule drugs. Flamel’s expertise in polymer science has also been instrumental in the development of a photochromic eyeglass lens product now marketed by Corning Inc. Additionally, Flamel has developed new herbicide delivery systems now being tested by Monsanto and has patented a biomaterial, ColCys™.

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, 1999.