UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934

Flamel Technologies, S.A.

(Translation of registrant’s name into English)

Parc Club du Moulin à Vent
33 avenue du Dr. Georges Levy
69693 Vénissieux Cedex France
(Address of principal executive offices)

     Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F þ                    Form 40-F o

     Indicate by check mark whether registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes o                    No þ

     If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-                        

 

 

INFORMATION FILED WITH THIS REPORT

Document Index

99.1		Press Release dated October 25, 2007, regarding results of clinical trial of IFN-alpha-XL versus PegIntron
99.2		Press release dated October 25, 2007, regarding projected release date of third quarter results and conference call

SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Exhibit 99.1

For Immediate Release

Flamel Technologies Announces Positive Top Line Results of a
Clinical Trial of IFN-alpha-XL versus PegIntron™ in Patients with
Chronic Hepatitis C Virus Infection

Lyon, France — October 25, 2007 — Flamel Technologies (NASDAQ:FLML) today announced positive preliminary data from a trial comparing the safety, tolerability, and long-acting activity of IFN-alpha-XL versus ViraferonPeg™, marketed in the U.S. as PegIntronÔ, in patients with chronic hepatitis C virus (HCV) infection. Results from the trial show:

	•		A marked reduction in side effects for patients given IFN-alpha-XL compared with those who received PegIntron;
	•		A statistically significant reduction in viral load for the group of patients infected with the Genotype 1 strain of HCV (comprising non-responder patients, relapsed patients and patients who are naive to standard Peg Interferon/ribavirin treatment) who received 27 MIU of IFN-alpha-XL compared with similar patients who received PegIntron; and
	•		A marked reduction in viral load for “non-responder” genotype 1 patients who received IFN-alpha-XL compared with similar patients who received PegIntron.

Flamel plans to present the full data from this clinical trial at a medical conference and is seeking a licensing partner for this product.

The lead investigator of the study, Professor Christian Trepo (Hotel Dieu Hospital — Lyon), remarked, “The results of this study are especially encouraging given the favorable responses in genotype 1 patients, a population that is typically the most difficult to treat. In this study, a statistically significant reduction in viral load was observed in patients who received 27 MIU of Interferon-alpha XL compared with patients administered the standard dose of Peg-Intron. Moreover, the trend we observed in the study suggests that the advantages of Interferon-alpha XL with respect to viral load reduction are cumulative and may become more pronounced during longer treatment regimens.”

Dr. Trepo continued, “I also am very encouraged that the benefit in viral load reduction in patients receiving Interferon-alpha-XL was achieved with fewer adverse events compared with PegIntron. Side effects associated with interferon treatment are frequently debilitating and treatment limiting. These side effects often necessitate dose reduction, which negatively

affects treatment outcome. Many patients even choose to discontinue therapy. These data suggest that IFN-alpha-XL may provide patients with a more tolerable regimen that has potentially better efficacy compared with existing interferon-alpha based therapies. This would be a significant advance in the treatment of a disease that has reached pandemic proportions in the United States and around the world.”

Stephen Willard, Flamel’s chief executive officer, said: “We are very pleased with the results of this second trial. They confirm the results of our earlier trial with respect to reduced side effects as compared with currently marketed products. The viral load results compared head to head against the pegylated product suggest exciting potential benefits in efficacy. A top priority for Flamel will be to engage the right partner to work with in taking this product forward.”

Trial Design

Patients enrolled in the open-label, multi-center trial were randomized into three groups of 12 to 14 patients and received treatment consisting of:

	1)		IFN-alpha XL 18 MIU, dosed twice at 7 day interval; or
	2)		IFN-alpha XL 27 MIU, dosed twice at 7 day interval; or
	3)		Peg-Intron 1.5 µg / kg, dosed twice at 7 day interval.

Viral load was measured regularly until 7 days after the second injection. Adverse events observed in all three arms included fever, flu-like symptoms, headache, white blood count abnormalities, as well as other adverse events. Local tolerance was also assessed. No serious adverse events were reported and no patients withdrew from the study due to adverse events.

About IFN-alpha-XL

IFN-alpha-XL is a new formulation of recombinant Interferon alpha-2b based on Flamel’s proprietary Medusa^® nanoparticle delivery system. Medusa^® is a versatile protein carrier for the development of a wide range of novel and second-generation long-acting native protein and peptide products. IFN-alpha-XL is designed to provide patients with a longer acting and more tolerable approach to interferon therapy compared with approved interferon regimens.

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.

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.

PegIntron™ and ViraferonPeg are registered trademarks of Schering-Plough Corporation.

Contact:

Michel Finance, CFO
Tel: 011-33-472-78-3434
Fax: 011-33-472-78-3435
Finance@flamel.com

Charles Marlio, Director of Strategic Planning and Investor Relations
Tel: 011-33-472-78-3423
Fax: 011-33-472-78-3435
E-Mail: Marlio@flamel.com

Exhibit 99.2

For Immediate Release

Flamel Technologies Announces Projected Release Date of Third
Quarter Results, Conference Call

Lyon, France — October 25, 2007 — Flamel Technologies (Nasdaq: FLML) expects to release its financial results for the third quarter on Tuesday, October 30^th, after the market close. A conference call to discuss the results has been scheduled for Wednesday, October 31^st, at 8:30 AM (EDT). 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: 21502968.

     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; it is the intellectual platform licensed by Glaxo SmithKline for the development of Coreg CR^®. Flamel’s Medusa^® technology is designed to deliver controlled-release formulations of therapeutic proteins and peptides.

Contact:

Michel Finance, Chief Financial Officer
Tel:   (011) (33) 4-7278- 3434
Fax:   (011) (33) 4-7278-3435
Finance@flamel.com

Charles Marlio, Director of Strategic Planning and Investor Relations
FRANCE:   (011) 33-4-72-78-34-34
US                (1) (202) 862-8400
Fax:              202-862-3933
Marlio@flamel.com

This document contains a number of matters, particularly as related to financial projections and 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, 2006.