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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 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.
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
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Document Index |
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99.1
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Press Release dated December 21, 2005 |
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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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By: |
/s/ Stephen Willard
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Dated: December 30, 2005 |
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Name: |
Stephen Willard |
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Title: |
Chief Executive Officer |
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exv99w1
Exhibit 99.1
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 Flamels 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, Flamels chief executive officer. I believe it is a significant validation of Flamels
Micropump technology platform, as well as confirmation of Flamels 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 Flamels 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 Flamels reliance on outside parties and key strategic alliances.
For further information on the Company, please review Flamels Annual Report on the Securities and
Exchange Commission Form 20-F for the year ended December 31, 2004.
Contact:
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Stephen H. Willard, Chief Executive Officer
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Tel:
Fax:
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(1) 202-862-8400
(1) 202-862-3933 |
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Michel Finance, Chief Financial Officer
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Tel:
Fax:
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(011) (33) 4-7278- 3434
(011) (33) 4-7278-3435
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Finance@flamel.com |
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Charles Marlio, Director of Strategic Planning and Investor Relations
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FRANCE:
US
Fax:
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(011) 33-4-72-78-34-34
(1) (202) 862-8400
202-862-3933
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Marlio@flamel.com |