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Flamel Technologies (NASDAQ:FLML) announced that Professor Christian Trepo presented the results of its clinical trial of Flamel's Medusa formulation, Alpha Interferon XL (IFN-alpha XL), in an oral session at the Annual Meeting of the European Association for the Study of the Liver today. The clinical trial, in which patients were each injected over a two-week period, was designed to compare the pharmacokinetics and pharmacodynamics of IFN-alpha XL versus ViraferonPeg™ (marketed in the U.S. as PegIntron™) in patients with chronic hepatitis C virus (HCV) infection. Flamel's product, like PegIntron, is a once-weekly injection based upon interferon alpha 2b. Flamel's IFN-alpha XL demonstrated superior antiviral activity and a favorable safety profile as compared with PegIntron.
"We are pleased to be able to communicate these results with the leading experts in the hepatitis field," said Dr. Roger Kravtzoff, PhD, Flamel's Director of Preclinical and Clinical Development. "We believe that interferon therapy will continue to be an essential component for the treatment of HCV, even with the advent of novel small molecule treatments. However, existing interferon therapy is limited in terms of efficacy and tolerability. IFN-alpha XL offers the potential to address substantially both of these areas of unmet medical need."
The phase Ib, randomized, parallel-groups study was conducted in HCV patients allocated to either IFN-alpha XL 18MIU, IFN-alpha XL 27MIU, or PegIntron 1.5 micrograms/Kg. The effects of two sequential administrations of each treatment, at one week interval, were compared. Viral load kinetics and safety parameters were monitored during the two post-dosing periods, i.e., up to day 14.
The antiviral activity profile of IFN-alpha XL 27MIU was similar to that of PegIntron following the first dosing in genotype 1 patients (n=9 in both groups), including patients who were either non-responders, or who had relapsed or were naive to previous standard pegylated interferon therapy. Following the second injection, IFN-alpha XL 27MIU showed a significantly greater antiviral activity at day 14 than PegIntron (-0.57 vs. -0.21 log, p=0.042). In non-responder genotype 1 patients, IFN-alpha XL 27MIU (n=6) showed a similar antiviral activity to PegIntron (n=6) during the first dosing period, and nearly significant superiority at the end of the second dosing period.
Remarkably, IFN-alpha XL 27 MIU was associated with a reduced mean number of treatment-related adverse events per patient vs. PegIntron (5.3 AEs per patient versus 7.6 AEs per patient), including less systemic treatment-related AEs (i.e., fever and white blood cell abnormalities) and a nearly 50% decrease in injection site reactions. No serious or severe AEs occurred in any group. The full presentation is available on Flamel's website: http://www.flamel.com/techAndProd/flamel-ifn-easl.pdf
First Quarter Earnings Announcement
Flamel plans to release its earnings announcement for the first quarter on May 13th after the market close. A conference call to discuss these results is scheduled for 8:30 AM (EDT) May 14, 2008. The dial-in number is (1) 800-374-1498 (Conference ID number: 44916095). International callers are invited to dial-in (1) 706-634-7261.
About IFN-α XL
IFN-alpha-XL is a new formulation of recombinant interferon alpha-2b based on Flamel's proprietary Medusa® nanoparticle delivery system. It is designed to provide patients with more efficacious and better-tolerated interferon therapy compared with approved interferon regimens.
Medusa®, a self-assembled poly-aminoacid nanoparticle system, is a versatile carrier for the development of novel long-acting formulations of proteins, peptides, and other molecules. The Medusa® platform has many advantages in that it enables the controlled delivery of fully-human, non-denatured proteins with full bioactivity. Flamel believes that this will lead to a third-generation of protein-based drugs offering greater effectiveness and reduced toxicity and side-effects to patients. A new microparticulate adaptation of Medusa® has been developed that potentially can extend pharmacokinetics to two weeks or more, offering an infusion-like release profile, also without loss of bioactivity.
About Hepatitis C
Hepatitis C virus (HCV) is a blood-borne pathogen that causes inflammation of the liver. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 75 percent of people infected with HCV will develop chronic infections; and 60 to 70 percent of these people will subsequently develop chronic hepatitis. HCV infection is the most common blood-borne viral infection in the United States. Approximately 4 million people in the United States are infected with HCV and the World Health Organization estimates that 170 million people worldwide - 3 percent of the world's population - are infected with HCV.
Current treatment regimens require frequent administration of Interferon-alpha for periods of up to a year or longer. Weekly dosing of pegylated Interferon-alpha is considered necessary for sustained efficacy and is expected to remain an important component of the standard of care for the foreseeable future. Treatment with Interferon-alpha is associated with dose-dependent adverse events that can be classified as either acute or of later onset. The typical acute toxicity profile tends to occur after every injection and thus causes difficulties for repeated administration. Current interferon alpha treatment regimens are limited by side effects, especially long-term side effects such as psychological depression and myelosuppression, and efficacy. Addressing these limitations is essential to improving the treatment of HCV.
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.
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. This 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.
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, 2006.
ViraferonPeg™ and PegIntron™ are registered trademark of Schering-Plough Corporation.
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Charles Marlio, Director of Strategic Planning
and Investor Relations
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