Lipsovir® marketing authorization in Europe now approved

The European regulatory authorities have now approved Medivir’s marketing authorisation application in 14 European countries. The trademark for the product in Europe will be XerclearTM. The label for XerclearTM, that is the approved indication text, is unique for a topical cold sore product in Europe: ”Treatment of early signs and symptoms of recurrent herpes labialis (cold sores) to reduce the progression of cold sore episodes to ulcerative lesions in immunocompetent adults and adolescents (12 years of age and older)”. XerclearTM thus has a distinct competitive edge in Europe as well as US, where the product was approved on 31 July 2009 with a similarly strong label. The remaining step in the process towards product launch in the 14 European countries takes place at the national level, and includes determination of the local packaging and OTC/RX status. This process is expected to be completed by year-end. Invitation to a Press Conference Medivir will host a teleconference today at 14:30am (Central European summer time) with focus on the European approval for XerclearTM (Lipsovir®). To participate in the teleconference, please call +46 8 30 17 91 using the participant code 568511#. This teleconference will be recorded and available for download from 16 October 2009 – for details, please see our website under the ”News” heading. Medivir will be represented by Rein Piir CFO/VP Investor Relations and Eva Arlander VP Pharma & Project Director for XerclearTM. For additional information, please contact: Ren Piir CFO and VP Investor Relations, Medivir +46 8 5468 3123 or, +46 708 537 292. For more information on Medivir, please see our website:

About Us

Medivir is a pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitors and nucleotide/nucleoside science and we are dedicated to innovative pharmaceuticals that meet great unmet medical needs. Medivir's clinical pipeline consists of remetinostat for cutaneous T-cell lymphoma, currently in phase II, birinapant in combination with Keytruda for solid tumors, currently in phase I, MIV-818, a nucleotide prodrug drug for liver cancer that recently entered into a phase I clinical trial, and MIV-711, a potentially disease-modifying osteoarthritis candidate drug with fresh and promising data from the recent phase IIa extension study. Medivir is listed on the Nasdaq Stockholm Mid Cap List (ticker: MVIR).


Documents & Links