Press Releases
Flamel Announces Preliminary Phase III Data For Genvir In Acute Genital Herpes
Lyon, France, November 2, 1998. Flamel Technologies (NASDAQ:FLML) announced preliminary results of its Phase III clinical study of Genvir, a controlled-release formulation of acyclovir based on Micropump® Technology, for acute genital herpes. The data was released at the CIBC/Oppenheimer Conference in New York last week.
Conducted in France and Germany, the double-blind Phase III study compared Genvir with Zovirax®, the Glaxo Wellcome formulation of acyclovir, and involved 419 patients with recurrences of acute genital herpes. Patients received either Genvir 600mg. taken twice-a-day or Zovirax® 200mg. taken five times-a-day. The principal endpoint in the study was the percentage of patients with healed herpes lesions on Day 5. Results indicate that lesions were healed in 53.6% of Genvir-treated patients as compared to 45.7% of Zovirax®-treated patients. Additionally, the occurrence of new herpes lesions was significantly reduced in the Genvir-treated patients as compared to the Zovirax®-treated patients. The safety profiles of both drugs was excellent and similar. Intent-to-treat and per-protocol analyses found consistent results. These primary efficacy results indicate that Genvir is at least therapeutically equivalent to Zovirax® for the treatment of acute genital herpes. The Company expects to report the final analysis in December.
"Clearly, we are very pleased with the results of this study", commented Dr. Gerard Soula, Flamel Technologies' President and Chief Executive Officer. "Genvir is the second drug to successfully utilize Flamel's proprietary Micropump® delivery technology for the controlled release of drugs best absorbed in the small intestine. The first was Asacard™, a formulation
of aspirin, which has already been approved for marketing in the United Kingdom."
The worldwide market for acute genital herpes treatments is estimated at $300 million, with $150 million in Europe. Zovirax® 200mg. and generic acyclovir, taken five times-a-day, have historically been the standard treatments. Two new branded drugs, Valtrex® and Famvir® also offer twice-a-day dosing with similar results. Flamel expects to file for approval in Europe later in 1999. Licensing discussions with pharmaceutical companies that are focusing on antiviral therapies are underway.
"From a marketing perspective, we anticipate that Genvir will be positioned as a very cost-effective alternative to the two newer drugs as well as the preferred dosing regimen over generic acyclovir," said Dr. Soula.
The Company plans to extend its Micropump technology to other antiviral drugs where cumbersome dosing regimens may result in poor patient compliance and emergence of drug resistance resulting in limited effectiveness.
Flamel Technologies is engaged in the development of advanced polymer technologies for unique life science applications. To meet important medical needs and develop commercially valuable products, the Company is building on its principal technology platforms: the controlled release of therapeutic drugs and proteins with its Micropump® and Medusa® system; the efficient delivery of agrochemical active ingredients with its Agsome™ system; ColCys™ biomaterial-based medical devices; and photochromic materials for eyeglass lenses.
Agsome™, Basulin™ and ColCys™ are trademarks, and Micropump® and Medusa® are registered trademarks of Flamel Technologies.
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 views of Flamel’s 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 Form 20-F dated December 31, 1997.
