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Medivir: cold sore treatment faces generic threat

Posted on: Tue, 04 Aug 2009 13:14:00 EDT

Symbols: MVRBF

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Aug 04, 2009 (Datamonitor via COMTEX) --
MVRBF | Quote | Chart | News | PowerRating -- Medivir's Lipsovir has received approval in the US for the early treatment of recurrent cold sores. Despite offering some benefits in terms of severity and healing time, Datamonitor believes that it will be difficult for Lipsovir to gain significant market traction due to the availability of generic acyclovir.

The approval covers Lipsovir's use in adults and children over 12 years of age for the early treatment of recurrent cold sores, to reduce the risk of cold sores, and to shorten the healing time for those which are not prevented. The drug is a combination of an anti-inflammatory agent hydrocortisone and acyclovir, an antiviral.

The FDA's approval of Lipsovir was based on the outcome of a Phase III program which comprised almost 3,000 patients in five studies and compared Lipsovir to the current gold-standard acyclovir, as well as placebo. The studies demonstrated that treatment with Lipsovir prevented the development of cold sores in 42% of patients in comparison to 35% in the acyclovir-only arm and 26% in the placebo arm.

Although the Lipsovir results were statistically significant, the drug appears to offer only a modest improvement over acyclovir in terms of prevention. That said, in those patients who nevertheless developed a cold sore, Lipsovir significantly reduced severity and reduced healing time by 1.5 days in comparison to placebo. Lipsovir was also well tolerated in all Phase III studies.

Medivir anticipates EU approval for Lipsovir in November or December 2009. However, the company lacks the infrastructure to successfully launch and market Lipsovir in the US by itself and is still seeking a suitable partner to facilitate commercialization. Medivir has stated that it will not launch Lipsovir until partnering efforts have been successful, aiming at a US launch in the first half of 2010. Datamonitor believes that while Lipsovir, which is available on prescription only, offers some improvements in terms of prevention and healing, the biggest threat for the drug will be the competition by generic acyclovir, which is well established and likely to be cheaper than Lipsovir.

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