Lyon,
France, October 23, 2006 Flamel Technologies
(NASDAQ:FLML) is pleased that the U.S. FDA has
approved GlaxoSmithKline's (NYSE: GSK) new drug application of COREG CR (carvedilol phosphate
extended release capsules) for use in treating three key conditions:
COREG CR microparticles are produced by Flamel Technologies at its production facility in Pessac, France, using the company's Micropump® technology platform.
Stephen H. Willard, Flamel's chief executive officer, stated, "We are delighted at the continued success of the COREG CR program. Flamel and GSK have worked closely together to accomplish this goal. I believe that the approval decision from the FDA marks the beginning of a new phase of growth for Flamel."
Flamel Technologies expects to release its third quarter financial results on Wednesday, November 1st, after the market close. A conference call to discuss its third quarter financial results, as well as the recent FDA action regarding COREG CR, has been scheduled for Thursday, November 2nd at 8:30 AM (ET). A question and answer period is expected to follow the discussion of results.
To participate in the conference call, investors in the US and Canada are invited to dial 1-800-374-1498. International callers are invited to call 1-706-634-7261. The Conference ID number is 9397396.
About Flamel Technologies
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 and peptides.
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 document 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.
For further information on
the Company, please review Flamel's Annual Report on the Securities
and Exchange Commission Form 20-F for the year ended December
31, 2005.