UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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 June 2005
Flamel Technologies S.A.
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 Form 20-F or Form 40-F.
| Form 20-F x | 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 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 June 13, 2005 related to the announcement of a patent filing for the combination of Asacard® with COX-2 inhibitors. | |
99.2
|
Press release dated June 14, 2005 related the announcement of a patent filing for Trigger Lock™ system to prevent opioid misuse and abuse. |
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. |
||||
| Dated: June 14, 2005 | By: | /s/ Stephen H. Willard | ||
| Name: | Stephen H. Willard | |||
| Title: Executive Vice President, Chief Financial Officer and General Counsel |
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3
Exhibit 99.1
For Immediate Release
Flamel announces patent filing for
“combination of Asacard® with COX-2 inhibitors”
LYON, France — June 13, 2005 — Flamel Technologies, S.A. (“Flamel”) NASDAQ: FLML announced today that it has filed a patent application with the U.S. Patent and Trademark Office regarding the combination of its proprietary formulation of aspirin, delivered with Flamel’s Micropump® technology, with a COX-2 inhibitor, including both conventional and selective COX-2 inhibitors.
Examples of non-selective COX-2 inhibitors include products such as naproxen. Examples of selective COX-2 inhibitors include products such as Vioxx® and Celebrex®.
Flamel has filed a patent with claims on the combination of COX-2 inhibitors with Asacard®, our Micropump® enabled formulation of aspirin, to address the problems of thrombosis observed with patients who are taking COX-2 inhibitors.
“The rationale of this combination,” explained Dr Gerard Soula, Flamel’s Founder, Chairman, and Chief Executive Officer, “is that COX-1 provides for the formation of thromboxane, which is the cause of thrombosis. Aspirin is well known to block COX-1, and that’s why it is used for cardiovascular disease treatment. However, aspirin also can create severe side effects such as ulceration, by blocking COX-1 throughout the body. We have developed a controlled release aspirin which we believe is capable of selectively inhibiting the COX-1 which generates the thromboxane in the portal vein, while not inhibiting the presence of COX-1 in the rest of the body. This can serve to potentially reduce bleeding in the stomach which can be caused by aspirin. This product was developed with the scientific help of the late Sir John Vane, a Nobel laureate for his work on aspirin and its mechanism of action. Sir John was a member of our Scientific Advisory Board for 10 years until he passed away last year.”
Flamel’s Asacard formulation has been approved in eleven countries in Europe, but has not yet been marketed. The association of Asacard with a branded product such as a selective COX-2 inhibitor or even standard NSAID’s could permit patients to benefit from the efficacy of these anti-inflammatory drugs, while lessening the risk of thrombosis and reducing the side effects associated with aspirin itself.
Dr. Soula added, “We are very excited to have this new opportunity for our ASACARD product and are actively promoting the concept with the pharmaceutical industry. This is typical of the innovative concepts which are the key strengths which drive the success of Flamel, for now and in the future.”
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 therapeutic proteins. Micropump® is a controlled release and taste-masking technology for the oral administration of small molecule drugs.
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 presentation 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.
These and other risks are described more fully in Flamel’s Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2003.
Contact:
Flamel Technologies S.A.
Gerard Soula, (33) 4-72-78-34-34
Fax: (33) 4-72-78-34-35
Soula@flamel.com
or
Stephen H. Willard, 202-862-3993
Fax: 202-862-3933
Willard@flamel.com
or
Charles Marlio, 202-862-8535
Fax: 202-862-3933
Marlio@flamel.com
Exhibit 99.2
For Immediate Release
Flamel announces patent filing for Trigger Lock™ System to
Prevent Opioid Misuse and Abuse
LYON, France — June 14, 2005 — Flamel Technologies, S.A. (“Flamel”) NASDAQ: FLML announced today that it has filed a PCT (Patent Cooperation Treaty) patent application with the European Patent Office regarding its Trigger Lock™ technology, based on its Micropump® platform, for the prevention of opioid misuse and abuse.
Opioid derivatives are increasingly prescribed for the treatment of severe and chronic pain. Nevertheless, many experts feel that patients suffering such pain are under-served due to concerns about the potential misuse and abuse of the medications doctors would otherwise prescribe. Sales of these pain treatments totalled over $6 billion in 2004.
It is estimated that a substantial portion of these drugs are taken by drug abusers, who manipulate the currently-marketed long-acting formulations so as to achieve an immediate release of the active ingredients. This practice is common in the U.S. and Europe.
Flamel has already filed four patents describing claims to lessen and avoid the potential abuse and misuse of these much-needed medications. The fifth patent announced today describes further claims to avoid the misuse of the active ingredients in the event they are sought to be used other than as prescribed. “The concept is to effectively trap the drug if the drug is improperly extracted by drug abusers from the delivery system”, said Dr. Gerard Soula, Flamel’s founder, president and chief executive officer. “The details of this invention will be communicated to potential partners only under a confidentiality agreement.”
This technology would appear to have application across the opioid class, including products such as oxycodone, which is off patent, oxymorphone, hydromorphone, tramadol and others.
Flamel believes this invention responds to the questions being addressed by governmental agencies to avoid the misusage of opioid drugs and is actively promoting the concept with potential partners. The company is pleased to be able to contribute a potential solution to the abuse of these drugs and is hopeful that this solution will allow physicians to address the under-served chronic-pain and severe-pain needs of their patients.
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 therapeutic proteins. Micropump® is a controlled release and taste-masking technology for the oral administration of small molecule drugs.
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 presentation 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.
These and other risks are described more fully in Flamel’s Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2003.
Contact:
Flamel Technologies S.A.
Gerard Soula, (33) 4-72-78-34-34
Fax: (33) 4-72-78-34-35
Soula@flamel.com
or
Stephen H. Willard, 202-862-3993
Fax: 202-862-3933
Willard@flamel.com
or
Charles Marlio, 202-862-8535
Fax: 202-862-3933
Marlio@flamel.com