Flamel Technologies Announces Completion of Human Proof of Concept Study for Controlled-Release Antibiotic.
Lyon, France, October 23, 2001 - Flamel Technologies (NASDAQ:FLML) announced today the completion of a pharmacokinetic human study for a controlled-release formulation of a prominent antibiotic, using Flamel’s proprietary Micropump® technology. The study, conducted and funded by an undisclosed partner, showed Micropump's ability to extend the release profile of this drug known to be absorbed primarily in the small intestine.
"We are very pleased to have completed this study which we
believe further validates the potential of our Micropump technology and its
applicability to the controlled release of antibiotics”, said Dr. Gerard Soula,
president and chief executive officer of Flamel.These results, which were
obtained from one of our four undisclosed Micropump® partnerships
with major worldwide pharmaceutical companies, follow our previous successful
human data for the controlled release of antivirals (acyclovir) and
antidiabetics (metformin).We believe that this combination of human clinical
studies highlights the versatility of our Micropump technology and suggests a
wealth of potential applications which we are eager to pursue.”
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. 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.