PARIS Flamel Technologies has released preliminary results of Phase III clinical trials of Genvir, its controlled-release formulation of acyclovir for the treatment of acute genital herpes. The product, which uses the company¿s Micropump technology and is designed for twice-daily administration, proved to be at least as effective as London-based Glaxo Wellcome plc¿s Zovirax, the leading proprietary version of acyclovir on the market.
The trials were carried out in France and Germany and took the form of a double-blind comparison between Genvir and Zovirax on a cohort of 419 patients suffering from recurrences of acute genital herpes. Patients received either 600 mg of Genvir twice a day or 200 mg of Zovirax five times a day, with the main endpoint being the proportion with healed herpes lesions after five days. It was found that lesions were healed in 53.6 percent of patients treated with Genvir, compared to 45.7 percent of those given Zovirax, and that both drugs had excellent and similar safety profiles. Final results are due to be disclosed in December.
Flamel intends to file the product for approval in the European Union in the second half of next year, and said it is negotiating licensing deals with pharmaceutical companies. The worldwide market for acute genital herpes is estimated at $300 million, according to Flamel. The company pointed out that, in addition to Zovirax and generic versions of acyclovir, two new proprietary, twice-a-day formulations recently arrived on the market: Valtrex and Famvir, with a therapeutic efficacy comparable to that of Genvir. But Flamel¿s president and CEO, Girard Soula, believes Genvir will be ¿positioned as a very cost-effective alternative to these two new drugs, as well as the preferred dosing regimen over generic acyclovir.¿
Flamel Technologies, based near Lyon, France, is focused on the development of oral drug delivery systems using advanced polymer technologies for the delivery of controlled-release drugs and biomaterials. Genvir is the second drug using the Micropump delivery system that has been successfully tested, after the controlled-release aspirin Asacard, which has already received marketing approval in the U.K. The company plans to extend its Micropump technology to other antiviral drugs, where cumbersome dosing regimens may result in poor patient compliance and/or the development of resistance that limits the therapeutic effect.