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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
Flamel s 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 Flamel s 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, Flamel s 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.
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.
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. 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 .
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 Flamel s 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 Baxter s website, and in Flamel s most recent Securities and Exchange Commission
filing on Form 20-F. Neither Baxter nor Flamel undertakes to update its forward-looking statements.