Lipsovir® has entered phase III clinical study

Lipsovir® (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® 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® 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® at a suitable time. 1) IMS data For additional information; please contact Rein Piir, CFO & VP, Investor Relations; +46 8 546 831 23 or +46 708 537 292 For additional information, please see Medivir’s website www.medivir.com