Medivir: Lipsovir(R) Has Entered Phase III Clinical Study
By Business Wire
STOCKHOLM, Sweden July 6, 2006 Lipsovir(R) (ME-609) is Medivir's labial herpes project. The aim of the phase III study is to show that early initiation of treatment with Lipsovir(R) will prevent the development of labial herpes (cold sores).
The study will be conducted in the US and Canada and involves about 50 clinical centres. More than 2000 patients will be included in the study and 1270 will be treated. The study is expected to be completed during the autumn of 2007. The aim is to achieve FDA approval for market registration at the end of 2008. The study is designed to have prevention of ulcerative lesions as primary endpoint. Present medications have not been able to show such a beneficial effect in phase III studies and Lipsovir(R) could offer patients a unique treatment opportunity.
"It's unique that a Swedish biotech company initiates phase III studies in their own regime. If we succeed in taking Lipsovir the whole way to registration it would be a milestone not just for Medivir but also for the whole sector," comments Medivir's CEO Lars Adlersson.
The market for treatments of labial herpes in the US was USD 383 m in 2005, of which 75% was prescription products with an underlying growth of 17%(1). The market picture in Europe is more fragmented and the value is slightly less than half the US market.
Medivir will seek partner(s) for marketing and sales of Lipsovir(R) at a suitable time.
(1) IMS data
For additional information, please see Medivir's website www.medivir.com
The Medivir group
Medivir develops pharmaceuticals for widely prevalent diseases with proteases as the target enzyme. The goal is to become a self-sustaining, profitable, research-based pharmaceutical company with proprietary products on the market. The company is located in Huddinge, Sweden and Chesterford Research Park, Essex, England.
The group comprises Medivir AB, subsidiary Medivir UK Ltd, Medivir HIV Franchise AB and Medivir Personal AB. At the end of December 2005, the group had 133 employees. In 1996 Medivir was listed on the O list at the Stockholm Stock Exchange (Stockholmsborsen).
Medivir's research portfolio embraces projects on hepatitis C, labial herpes, osteoporosis, rheumatoid arthritis (RA), asthma, multiple sclerosis (MS). Medivir has seven individual projects in development, of which one is entering phase III.
Medivir HIV Franchise AB is focused on the development and divestment of HIV/HBV projects and examining the clinical strategy for shingles drug MIV-606. |
