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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 July 2009
Commission File Number 000-28508
Flamel Technologies S.A.
(Translation of registrants 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.
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.
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 collaboration with Baxter International Inc. to formulate longer acting forms
of blood clotting factors, dated July 13, 2009.
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:
July 13, 2009
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By:
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/s/ Stephen H. Willard
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Name:
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Stephen H. Willard
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Title:
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Chief Executive Officer |
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EXHIBIT INDEX
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Exhibit |
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Number |
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Description |
99.1
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Press release regarding collaboration with Baxter International Inc. to formulate longer acting forms
of blood clotting factors, dated July 13, 2009.
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exv99w1
Exhibit 99.1
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FOR IMMEDIATE RELEASE |
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Media Contacts
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Media and Investor Contact |
Marie Kennedy, (805) 372-3543
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Charles Mosseri-Marlio, (401) 480 9729 |
Doreen Eaton, (805) 372-3417 |
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Investor Contacts |
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Mary Kay Ladone, (847) 948-3371 |
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Clare Trachtman, (847) 948-3085 |
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Baxter and Flamel Technologies Announce Collaboration to
Formulate Longer Acting Forms of Blood Clotting Factors
DEERFIELD, Ill and LYON, France, July 13, 2009 Baxter International Inc. (NYSE: BAX) and
Flamel Technologies, SA (NASDAQ: FLML) announced today that they have entered into agreement to
formulate controlled release applications of blood clotting factor replacement therapies using
Flamels Medusa® Technology. The work between the two companies will focus on developing
longer-acting formulations with the objective of reducing the frequency of infusions required to
treat blood clotting disorders in hemophilia. Pursuant to the agreement between the two companies,
Flamel will receive technology access fees totaling 2.5 million. Baxter will pay all development
costs for the program and have an exclusive right to negotiate a license to the Medusa platform.
We continue to develop and advance novel therapies that improve patient convenience by
decreasing the frequency of infusions to help people living with hemophilia lead a more normal
life, said Hartmut J. Ehrlich, MD, vice president of global research and development in BioScience
at Baxter. We look forward to this partnership using Flamels Medusa® Technology as a novel
approach to address this goal.
We are pleased to be working with Baxter to develop longer-acting formulations of factor
replacement therapies for hemophilia patients, said Stephen H. Willard, Flamels chief executive
officer. Baxter is an ideal partner for these molecules due to its extensive expertise in the
field. Our work with Baxter allows us to leverage our expertise in drug delivery to create
solutions for the administration of intravenous formulations of therapeutic proteins. This program
has the potential to develop more convenient solutions for people living with hemophilia, their
families, and physicians.
About Hemophilia
There are two types of hemophilia: hemophilia A (sometimes called classical hemophilia) and
hemophilia B (sometimes called Christmas disease). Both are caused by a low level or absence of one
of the proteins in the blood (called factors) that control bleeding. Hemophilia A is caused by a
deficiency of factor VIII, and hemophilia B is caused by a deficiency of factor IX.
There is no difference between the two types of hemophilia, except that hemophilia B is about
five times less common than hemophilia A. According to the World Federation of Hemophilia, more
than 400,000 people in the world have hemophilia.
About Medusa
The Medusa platform uses biodegradable polymers to adsorb therapeutic large molecules through
hydrophobic interaction, with no loss of bioactivity, for controlled release applications. The
Medusa polymer is amphiphilic and spontaneously forms stable nanoparticles in water. They are
robust over a wide range of pH values and can be stored as either stable liquid or stable dry forms
that can be easily reconstituted in water.
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. Flamels
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®.
About Baxter
Baxter International Inc., through its subsidiaries, develops, manufactures and markets
products that save and sustain the lives of people with hemophilia, immune disorders, infectious
diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global,
diversified healthcare company, Baxter applies a unique combination of expertise in medical
devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning expectations related to agreements
entered into between Baxter International Inc. and Flamel Technologies, S.A. and Flamels Medusa
Technology. The statements are based on assumptions about many important factors, including the
following, which could cause actual results to differ materially from those in the forward-looking
statements: risks that products in the development stage may not achieve scientific objectives or
milestones; future actions of regulatory bodies and other governmental authorities, including the
FDA and foreign counterparts; product quality or patient safety concerns; product development
risks; the impact of competitive products and pricing; any impact of the commercial and credit
environment on Baxter, Flamel or any of their customers and other risks identified in Baxter most
recent filing on Form 10-K and other Securities and Exchange Commission filings, all of which are
available on Baxters website, and in Flamels most recent Securities and Exchange Commission
filing on Form 20-F. Neither Baxter nor Flamel undertakes to update its forward-looking statements.
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