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
For the
month of December 2009
Commission
File Number 000-28508
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 x
|
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 x
|
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 regarding initiation of clinical trial of IFN-Alpha-2b XL in
patients with hepatitis C, dated December 18, 2009.
2
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.
| Flamel Technologies S.A. | |||
|
Dated: December
18, 2009
|
/s/ Stephen H. Willard | ||
| Stephen H. Willard | |||
| Chief Executive Officer | |||
3
EXHIBIT
INDEX
|
Exhibit
Number
|
Description
|
|
99.1
|
Press
release regarding initiation of clinical trial of IFN-Alpha-2b XL in
patients with hepatitis C, dated December 18,
2009.
|
4
For
Immediate Release
Flamel
Technologies Announces the Initiation of a Phase 2a
Clinical
Trial of Flamel’s IFN-Alpha-2b XL in Patients with Chronic
Hepatitis
C Virus Infection
Lyon,
France –
December 18, 2009 - Flamel Technologies
(NASDAQ:FLML)
today announced the initiation of a Phase 2a clinical trial of Flamel’s
Interferon alpha-2b XL (IFN-alpha-2b XL), which is based on
Flamel’s Medusa® platform
for controlled release of biologics. IFN-alpha-2b XL is being
developed as a controlled release of unmodified interferon alpha-2b for the
treatment of chronic hepatitis C virus (HCV). This Phase 2a randomized study,
known as ANRS HC 23 COAT-IFN (COnfirmation of Anti-viral activity and Tolerance of Interferon
alpha-2b XL), is sponsored by the Agence
Nationale de Recherche sur le SIDA et les Hépatites
Virales (ANRS).
The Phase 2a study is designed to evaluate IFN-alpha-2b XL in
combination with ribavirin in genotype-1 chronic hepatitis C patients who are
either naïve to treatment or previous non-responders to standard interferon
therapy (PEGylated interferon plus ribavirin).
The
study will evaluate two doses of Interferon-alpha-2b XL (27 and 36 MIU)
administered once a week for 12 weeks in combination with weight-based ribavirin
in treatment-naïve and non-responder hepatitis C patients with genotype-1 HCV.
The comparator arm of patients also comprises sub-groups of either treatment
naïve or non-responder genotype-1 patients, each of which will be administered
with PegIntron®
(1.5µg/kg) once a week for 12 weeks in combination with weight-based
ribavirin. A total of 84 patients (28 patients by arm which will be
equally split into naïve and non-responder patients) is expected to be enrolled
in the trial. The study will assess viral response: the primary
endpoint will be viral load reduction at week 4 and week
12. Investigators will also be looking at the percentage of patients
achieving Rapid Virological Response, or RVR, defined as an undetectable viral
load at week 4, and Early Virological Response, or EVR, defined as a viral load
reduction greater than 2 log at week 12. Another endpoint that
investigators will be assessing closely is the safety and tolerability data for
both doses of Interferon-alpha-2b XL versus PegIntron. Results from
the study will be used to select the doses of Interferon–alpha 2b XL for the
pivotal confirmatory clinical trial.
Roger
Kravtzoff, Flamel’s Director of Preclinical and Clinical Development commented:
“We are very pleased to pursue the clinical development of this very promising
product. Better safety and efficacy will be important outcomes for
the next generation of interferon products, which we believe will continue to be
part of the standard of care for HCV treatment, even with the advent of new
small molecule drugs currently in clinical development. The potential
benefits of IFN-alpha-2b XL have been highlighted by the results of the Phase 1b
trial which indicated:
|
|
·
|
Better
tolerance, characterized by a marked reduction in side effects
for patients given IFN-alpha-2b XL compared to those who
received PegIntron; and
|
|
|
·
|
Better
antiviral activity, characterized
by:
|
|
|
-
|
A
statistically significant reduction in viral load for genotype-1 patients
compared to similar patients who received
PegIntron.
|
|
|
-
|
A
marked reduction in viral load for “non-responder” patients compared to
similar patients who received
PegIntron.
|
If these
results are confirmed in the COAT-IFN study using longer treatment, we believe
that IFN-alpha-2b XL provides a better therapeutic option to treat
patients.”
The
principal investigator of the study, Professor Christian Trepo (Hôtel
Dieu Hospital - Lyon), remarked: “The results of the prior phase 1b study were
encouraging in that the most difficult to treat patients, namely genotype-1
non-responders, experienced a greater reduction in viral load when given 27 MIU
of IFN-alpha-2b XL than patients administered the standard dose of
PegIntron. Moreover, the trend we observed in the study suggests that
the advantages of Interferon-alpha-2b XL with respect to viral load reduction
are cumulative and may become more pronounced during the longer treatment
regimens used in the COAT-IFN study.”
“This is
especially positive, I believe, as these patients also experienced significantly
fewer adverse events than patients in the comparator PEGinterferon
group. Side effects associated with interferon treatment are
debilitating and treatment limiting. Therapeutic outcomes are often
negatively affected by the adverse events experienced by HCV carrier patients to
the extent that dose reductions become necessary. Many patients may
even choose to discontinue therapy. The previous Phase 1b results
suggest that IFN-alpha-2b XL potentially provides at least equivalent and
possibly better therapeutic benefits with fewer side effects in comparison to
existing interferon-alpha based therapies. Indeed, entering the age of new
anti-HCV molecules, what is most urgently wanted is the improvement of tolerance
of the still needed interferon-alpha which is the number one hurdle of
therapy. The confirmation of improved efficacy in the most hard to
treat, genotype-1 non-responder patients will be most useful, especially in the
future context of multiple therapies involving protease and polymerase
inhibitors.”
About
IFN-alpha-2b XL
IFN-alpha-2b
XL is a new formulation of recombinant Interferon alpha-2b based on Flamel’s
proprietary Medusa nanoparticle delivery system. Medusa is a
versatile biologics carrier for the development of a wide range of novel and
second-generation long-acting native protein and peptide products. IFN-alpha-2b
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 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.
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, peptides and other biologics.
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,
2008.
PegIntron
is a registered trademark of Schering-Plough Corporation.
Contact
Flamel
Charles
Marlio, Director of Strategic Planning and Investor Relations
Tel:
011-33-472-78-3434
Fax:
011-33-472-78-3435
E-Mail:
Marlio@flamel.com