HUDDINGE, Sweden, Feb. 7, 2003 (PRIMEZONE) -- The continued phase I clinical study, multiple dosing in healthy volunteers, for the antiviral MIV-210 has now started. The study is being performed in the United Kingdom and is expected to be completed during the second half of 2003.
The goal of the study is to further ensure the compounds safety after multiple oral dosing and to further investigate its good oral bioavailability and pharmacokinetic properties to establish dose levels for entering phase II trials.
MIV-210 is a polymerase inhibitor effective against both multiple drug resistant HIV-1 and hepatitis B (HBV) in vitro and in vivo. The development plan for the compound includes clinical phase II studies in both HIV and hepatitis B patients. Medivir has a second drug in clinical development targeting multidrug resistant HIV-1, namely MIV-310 (alovudine) which is in clinical phase II. MIV-210 and MIV-310 have shown synergistic effects against HIV-1 in vitro.
There are more than 1.5 million of HIV/AIDS patients in the Western world of whom a considerable portion harbour drug resistant HIV-strains. The number of patients with multiresistant HIV is increasing rapidly and there is a considerable need for new antivirals. Current HIV therapy employs combinations of several antivirals from different classes with different resistance profiles. MIV-210 has in vitro been found to inhibit HIV-1 strains that are resistant to other polymerase inhibitors. Sales of polymerase inhibitors against HIV-1 amounted to $3.5 billion US during 2001.
There are more than 350 million chronically infected hepatitis B patients worldwide, of whom 5-6 million are in the Western world and approximately 100 million are in China. The number of patients treated is comparatively low but growing rapidly as new antivirals are introduced. The emergence of HBV strains resistant to the available medications will increase the need for new antivirals. Sales of HBV antivirals in 2001 were approximately $0.6 billion US despite their limited efficacy.
For further information, please contact: Medivir Bo Oberg, CEO +46 8 5468 3100 Medivir Rein Piir, CFO/VP IR +46 708 53 7292
The Medivir Group
Medivir is an innovative and specialized research company active in the pharmaceuticals sphere, located in Cambridge, U.K., and Huddinge, Sweden. Medivir's research focuses on the development of new pharmaceutical compounds as inhibitors of target enzymes with protease or polymerase activity.
The group comprises Medivir AB, the subsidiaries Medivir UK Ltd. and CCS AB, plus second-tier subsidiaries CCS (UK) Ltd. and Nordic Care Sweden AB. Medivir has been listed on the Stockholm Stock Exchange since 1996.
The research portfolio includes projects against HIV, viral hepatitis, shingles, cold sores, osteoporosis, rheumatoid arthritis, asthma, multiple sclerosis and organ/graft rejection. Medivir has four projects in clinical development. Of these, two are moving towards Phase III trials after having completed Phase II trials. One is in Phase I and the other is in Phase II. Medivir's pre-clinical research encompasses a number of projects, of which one is in the late pre-clinical development stage and a further three are in, or are entering the lead optimization phase. Furthermore, ten activities are in the explorative stage.
For more information about Medivir, visit the company's web site at www.medivir.com
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