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Flamel Technologies Announces Filing of Genvir™, A Twice daily controlled release acyclovir for Herpes treatment   

LYON, FRANCE August 10, 2000:  Flamel Technologies S.A. (NASDAQ: FLML) today announced the filing of GENVIR, its proprietary formulation of Acyclovir, an anti-viral drug, developed using its Micropump® technology. GENVIR combines the proven safety and efficacy of acyclovir with the convenience of the twice daily dosing schedule of second generation antiviral products for herpes.

The filing, which was made in France, is expected to ultimately result in pan-European approval of the product.   

 According to analysts, the worldwide market for treatment of herpes infection is more than $1.3 billion, with acyclovir and related pro-drugs accounting for more than two thirds of sales. Acyclovir is currently administered  five times a day, whereas GENVIR, with its twice-a-day dose, is poised to compete favorably not only with conventional acyclovir, but also with the more expensive second generation antivirals.

 “This is a very exciting development for our company, demonstrating the strength of our Micropump technology,” said Gérard Soula, president and chief executive officer of Flamel, “We believe this to be the first registration of a controlled release anti-viral medication anywhere in the world. This is also the first product which Flamel has independently brought from conceptualization to registration.”

“As demonstrated by our comprehensive phase III clinical package, GENVIR’s twice daily dosing schedule, encouraging better patient compliance, and its pricing competitiveness make this product an attractive licensing opportunity with strong sales potential,” said Dr. Michael Myers, head of sales, marketing and business development at Flamel. “We anticipate strong sales of this product through a number of international partners, while we work to bring additional products to market using our proprietary Medusa® and Micropump® technologies both independently and in partnership with major pharmaceutical companies.”

 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® nano-encapsulation technology is designed to deliver therapeutic proteins.  Micropump® is a controlled release technology for the oral administration of small molecule drugs.  Flamel’s expertise in polymer science has also been instrumental in the development of a photochromic eyeglass lens product now marketed by Corning Inc.  Additionally, Flamel has developed new herbicide delivery systems now being tested by Monsanto and has patented a biomaterial, ColCys™.

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, 1999.