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Published on 7/6/2006 in the Prospect News Biotech Daily.

Medivir: Lipsovir begins phase 3 clinical study

By Elaine Rigoli

Tampa, Fla., July 6 - Medivir said Lipsovir has entered phase 3 clinical study to show that early initiation of treatment with Lipsovir will prevent the development of labial herpes.

The study will be conducted in the United States and Canada and involves about 50 clinical centers. More than 2,000 patients will be included in the study, and 1,270 will be treated.

The study is expected to be completed during the fall of 2007.

The company said the aim is to achieve Food and Drug Administration approval for market registration at the end of 2008.

The market for treatments of labial herpes in the United States was $383 million in 2005, of which 75% was prescription products with an underlying growth of 17%, according to a news release.

The market picture in Europe is more fragmented and the value is slightly less than half the United States market, the release said.

Medivir said it will seek partners for marketing and sales of Lipsovir at a suitable time.

Medivir develops pharmaceuticals for widely prevalent diseases with proteases as the target enzyme. The company is located in Huddinge, Sweden, and Essex, England.


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