Press Releases
Lyon, France, December 8, 2004 Flamel Technologies (NASDAQ:FLML) today announced that it has enrolled the first patient in a cross-over randomized Phase I/II study of Flamel's Medusa® formulation of long-acting interleukin-2 in comparison with Proleukin®. Proleukin® is the only treatment currently approved for renal cancer. The study is being done at the Necker Hospital in Paris, France. The lead investigators are Professors Herve Fridman and Nicolas Thiounn.
Pre-clinical studies of Flamel's long-acting interleukin-2 versus Proleukin® in monkeys showed an increase in the duration of action of the drug, with a lower blood concentration of drug after injection (Cmax ). Flamel's formulation resulted in measurable increases in levels of lymphocyte CD4 and CD8, and the soluble fraction of CD25 in the monkeys studied, which are considered surrogate markers for stimulation of the body's immune system.
Dr. Gerard Soula, founder, president and chief executive officer of Flamel Technologies, said: "We are very excited by the results of our existing preclinical studies of our long-acting interleukin-2 formulation and are eager to confirm these results in humans. These results, if reproduced in humans, could suggest a boosting effect on the immune system, which plays an important role in the body's defense against viral disease, such as hepatitis and HIV, as well as certain types of cancer."
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.
Proleukin® is a registered trademark of Chiron 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
