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 October 2010
Commission
File Number 000-28508
Flamel
Technologies
(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
¨
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 ¨ 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 achievment of milestone and FDA response, dated October
19, 2010, issued by Flamel Technologies S.A.
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.
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Flamel
Technologies, S.A.
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Dated:
October 19, 2010
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By:
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/s/ Stephen H. Willard |
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Name: Stephen
H. Willard
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Title: Chief
Executive Officer
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EXHIBIT INDEX
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Exhibit
Number
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Description
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99.1
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Press
Release regarding achievment of milestone and FDA response, dated October
19, 2010, issued by Flamel Technologies
S.A.
|
Flamel
Technologies Achieves Clinical Milestone with Merck Serono on an Extended
Release Formulation of Interferon beta-1a
Flamel
Receives FDA Response Letter Regarding Coreg CR Citizen’s Petition
Lyon, France – October 19,
2010 – Flamel Technologies (Nasdaq: FLML) announced today that it has achieved a
clinical development milestone under the terms of its license agreement with
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, to develop an
extended release formulation of interferon beta-1a using the Medusa platform. As
a result, Flamel will receive a fee of € 3.0 million. Flamel and Merck Serono
entered in a collaboration agreement in December 2007 to develop an extended
release formulation of interferon-beta-1a.
Stephen
H. Willard, Flamel’s chief executive officer, stated, “We are pleased with the
progress that we have been able to achieve in this important development
program, and believe that our Medusa platform could offer patients the same
active principle as in Merck Serono’s interferon beta-1a, as an extended release
formulation.”
Mr.
Willard continued, “The Medusa platform is distinct from controlled release
platforms of large and small molecules.
Medusa has been shown to enable delivery of therapeutic molecules that retain
full bioactivity. The applicability of Medusa to a wide range of therapeutic
agents is an important advantage of the Medusa platform.”
The
Company also announced that it has received a 14-page response to its April
19, 2010 petition regarding the data to be required of drug product marketing
applications that seek to rely on FDA's previous approval of Coreg
CR. The Company's petition was granted in part and denied in
part. A copy of the response is available on Flamel’s website, www.flamel.com.
The
Company believes that the FDA’s response recognizes the importance of
maintaining appropriate levels of carvedilol phosphate for the entire 24-hour
period of a controlled release product dosing period, with regard to all
indications treated with extended-release carvedilol products. The
FDA response concludes that the Agency intends to apply the standard AUC and
Cmax criteria to the bioequivalence evaluation of any ANDA’s referencing Coreg
CR and that it will examine Tmax and the overall pharmacokinetic profile during
the review process to determine whether any difference between test and
reference products may result in a lack of therapeutic equivalence.
The
Company is aware that URL Mutual has submitted an ANDA for generic carvedilol
phosphate extended-release capsules and that ANDA is pending before
FDA. The Company continues to review the response from the FDA,
and has no basis for determining the likelihood of any approval of a generic
form of Coreg CR or the impact, if any, on such process as a result of Flamel’s
citizen’s petition, or the FDA’s response.
About
Medusa®
Medusa®,
a self-assembled poly-aminoacid nanogel system, is a versatile carrier for the
development of long-acting formulations of proteins, peptides, and other large
molecules. The Medusa® platform has many advantages in that it enables the
controlled delivery of non-modified, non-denatured proteins with full
bioactivity. A new microparticulate adaptation of Medusa® has been developed
that potentially can extend pharmacokinetics to two weeks or more, also without
loss of bioactivity.
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. Flamel's Medusa technology is designed to deliver
controlled-release formulations of therapeutic proteins and peptides and other
molecules, without reduction in bioactivity. Micropump® is a
controlled release and taste-masking technology for the oral administration of
small molecule drugs; it is the intellectual platform licensed by
GlaxoSmithKline for COREG CR®
(carvedilol phosphate).
Contact:
Charles
Marlio, Director of Strategic Planning and Investor Relations
FRANCE:
+ (33) 472 78 3434
Fax: +
(33) 472 78 3435
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,
2009.