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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 December 2005
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 the 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 dated December 21, 2005

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.
 
 
  By:   /s/ Stephen Willard    
Dated: December 30, 2005    Name:   Stephen Willard   
    Title:   Chief Executive Officer   

3

exv99w1
 

         
Exhibit 99.1
(FLAMEL TECHNOLOGIES)
For Immediate Release
Lyon, France, December 21, 2005   Flamel Technologies (NASDAQ:FLML) announced today that its collaborator, GlaxoSmithKline, has submitted a New Drug Application (NDA) for the controlled release formulation of a currently marketed major GSK drug using Flamel’s Micropump® technology. The filing by GSK will result in the payment of a $2 million milestone under a license agreement between the companies, which was entered into in March of 2003.
“The submission of this NDA is an important milestone for Flamel Technologies,” said Stephen H. Willard, Flamel’s chief executive officer. “I believe it is a significant validation of Flamel’s Micropump technology platform, as well as confirmation of Flamel’s ability to deliver practical success in providing drug delivery solutions from formulation to NDA filing.”
About Flamel Technologies
Flamel Technologies is a drug delivery company with two intellectual property platforms: Micropump, for the controlled release of drugs best absorbed in the small intestine; and Medusa, for the controlled release of proteins and peptides injected subcutaneously. Both of these platforms offer advantages with respect to efficacy and the reduction of side-effects, in addition to the obvious benefits associated with more convenient dosing regimens. For detailed company information, including copies of this and other press releases, see Flamel’s web site www.flamel.com.
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.
The 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.
For further information on the Company, please review Flamel’s Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2004.
Contact:
Stephen H. Willard, Chief Executive Officer
Tel:
Fax:
  (1) 202-862-8400
(1) 202-862-3933
     
Michel Finance, Chief Financial Officer
Tel:
Fax:
  (011) (33) 4-7278- 3434
(011) (33) 4-7278-3435
Finance@flamel.com
     
Charles Marlio, Director of Strategic Planning and Investor Relations
FRANCE:
US
Fax:
  (011) 33-4-72-78-34-34
(1) (202) 862-8400
202-862-3933
Marlio@flamel.com