Press Releases
Lyon, France, December 17, 2004 Flamel Technologies (NASDAQ:FLML) today announced that it has enrolled the first patient in a dose escalating, randomized Phase I/II study of Flamel's Medusa® formulation of long-acting interferon-alpha. The study is designed to demonstrate the safety profile of the product and to define the maximum tolerable dose. The second objective of the study is to evaluate the pharmacokinetic profile of the long-acting interferon, compared with the immediate release product Viraferon® , which is manufactured by Schering-Plough. The lead investigators are Professors Jean-Pierre Zarski (Grenoble hospital) and Christian Trepo (Hotel Dieu-Lyon hospital).
Dr. Gerard Soula, founder, president and chief executive officer of Flamel Technologies, said: "We are excited by the results of our existing preclinical studies of our long-acting Interferon alpha formulation in monkeys and are eager to confirm these results in humans. We believe this formulation could challenge the PEG version of interferon, by making it a safer product."
A Phase I/II study investigates safety, pharmacokinetics and certain pharmacodynamic parameters of the subject product after a single administration of drug. It is termed Phase I/II because it is performed in patients, rather than healthy volunteers.
Flamel Technologies, S.A. is a biopharmaceutical company principally engaged in the development of two unique polymer-based delivery technologies for medical applications. Micropump® is a controlled release and taste- masking technology for the oral administration of small molecule drugs. Flamel's Medusa® technology is designed to deliver controlled-release formulations of therapeutic proteins.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve significant risks and uncertainties that may cause results to differ materially from those set forth in the statements. Among other risks, there can be no guarantee that the product described in this release will receive regulatory approval, or that it will prove to be commercially successful. This and other risk factors are discussed in the company's 2003 Annual Report on Form 20-F and in the company's periodic reports on Form 6-K. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. 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, 2003.
Viraferon® is a registered trademark of Schering-Plough Corporation.
CONTACT: Flamel Technologies, S.A.
Gerard Soula, (33) 4-72-78-34-34 Fax: (33) 4-72-78-34-35 E-Mail: Soula@flamel.com
or Stephen H. Willard, 202-862-3993 Fax: 202-862-3933 E-Mail: Willard@flamel.com
or Charles Marlio, 202-862-8535 Fax: 202-862-3933 E-Mail: Marlio@flamel.com
