Flamel Technologies, Inc

FLAMEL ANNOUNCES RESULTS OF ITS PHASE I STUDY OF ONCE-DAILY CONTROLLED RELEASE METFORMIN

Lyon, France, September 25, 2000 – Flamel Technologies (Nasdaq: FLML)today announced the successful results of a Phase I study of its proprietary formulation of controlled-released Metformin ("Metformin XL"), developed using its Micropump^® technology. Metformin is a drug used in the treatment of Type II diabetes, alone or in combination with other anti-diabetic drugs like insulin.

According to analysts, the worldwide market for treatments for type II diabetes is growing at a rapid rate. Current sales of metformin, which were approximately $1.3 billion in 1999 and are projected to exceed $2 billion in 2000, are for a product which is administered two to three times daily. A once-daily controlled-release dose of metformin, such as the one formulated by Flamel, may improve patient compliance and further increase consumer acceptance of the product. Furthermore, the company believes that this product, developed using its proprietary microparticulate technology, potentially provides improved versatility in final dosage form selection over other once daily metformin products.

Metformin XL is the third compound developed using Flamel’s proprietary Micropump^® technology. Previous products are controlled release aspirin (Asacard^® ), which is approved for sale in ten European Union countries, and controlled release acyclovir (Genvir^® ), currently in registration. Genvir^® is believed to be the first controlled-released anti-viral product to be commercially developed by any company. Flamel’s Micropump^® technology is an oral multiparticulate delivery system utilized for controlled release, taste masking and bioavailability enhancing applications.

"As a result of the high dosage requirement of once-daily metformin, we believe that the dosage form versatility afforded by the multiparticulate nature of Flamel’s formulation makes this product a very attractive licensing opportunity," said Dr. Michael Myers, executive vice president for business development of Flamel. "We are actively pursuing our goal of making this a global product and are currently in discussions with partners in each of the major pharmaceutical markets."

"Metformin is the third significant application of our Micropump technology, further illustrating the robustness of this technology across a range of molecules with significant delivery challenges," commented Dr. Gerard Soula, chairman and chief executive officer of Flamel. "We are continuing to demonstrate the application of our Micropump^® and Medusa^® technologies to provide delivery solutions for a broad range of compounds alone and in partnership with major pharmaceutical companies worldwide."

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® technology is a controlled-released injectable system based on the company’s proprietary polymers. Medusa is used for delivery of therapeutic proteins, peptids and small molecules. As noted above, Micropump^® technology is an oral multiparticulate delivery system utilized for controlled release, taste masking and bioavailability applications. 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^TM .

This document contains a number of matters 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.