e6vk
 
 
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 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 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.
             
    Flamel Technologies S.A.    
 
           
Dated: July 13, 2009
  By:   /s/ Stephen H. Willard    
 
  Name:   Stephen H. Willard    
 
  Title:   Chief Executive Officer    

 


 

EXHIBIT INDEX
     
Exhibit    
Number   Description
99.1
  Press release regarding collaboration with Baxter International Inc. to formulate longer acting forms of blood clotting factors, dated July 13, 2009.

 

exv99w1
Exhibit 99.1
     
(BAXTER LOGO)
  (FLAMEL TECHNOLOGIES LOGO)
 
   
FOR IMMEDIATE RELEASE
   
 
   
Media Contacts
  Media and Investor Contact
Marie Kennedy, (805) 372-3543
  Charles Mosseri-Marlio, (401) 480 9729
Doreen Eaton, (805) 372-3417
   
 
   
Investor Contacts
   
Mary Kay Ladone, (847) 948-3371
   
Clare Trachtman, (847) 948-3085
   
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.”
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. 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®.
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 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.
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