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DewDiligence

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Re: DewDiligence post# 53887

Sunday, 04/27/2008 10:58:12 PM

Sunday, April 27, 2008 10:58:12 PM

Post# of 253509
FLML Presents Phase-1b Results of Interferon Alpha XL

http://biz.yahoo.com/bw/080425/20080425005291.html

>>
Friday April 25, 10:30 am ET

MILAN, Italy--(BUSINESS WIRE)--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.
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