HUDDINGE, Sweden, Aug. 13, 2004 (PRIMEZONE) -- Medivir and Novartis have resolved the issue of partly overlapping patents in the USA relating to the Medivir ME-609 project by means of a free, two-way licence agreement. This agreement gives Medivir exclusive rights to topical combination products containing the antiviral agent acyclovir, such as ME-609, or omaciclovir (H2G), Medivir's antiviral substance. Novartis is granted a non-exclusive licence to certain antiviral combination products such as penciclovir, while Medivir will retain the exclusive rights to its formulation patent relating to combinations containing penciclovir. In countries outside of the USA, including the EU, there is no conflict between the Medivir and Novartis patents.
The European patent authority granted a product patent to Medivir's ME-609 herpes project at the end of March 2004. The European patent covers all topical drugs containing the antiviral substance acyclovir and the glucocorticoid hydrocortisone for the treatment of herpes infections. The patents in Europe and the USA will remain valid until 2016. The formulation patents are valid until 2019.
The ME-609 project is currently being run under the company's own auspices, and preparations for phase III trials are in progress, including discussions with the FDA. ME-609 may be the first drug to prevent the occurrence of cold sores. There are at present no other products with the same unique concept undergoing clinical development. Medivir judge that the current market is underdeveloped as a consequence of the fact that existing drugs only alleviate symptoms to a moderate extent but do not prevent the outbreak of cold sores. Despite their less than perfect effect, existing drugs worth a total of more than USD 500 million were sold in the USA and Europe in 2003.
As a part of the preparations for coming phase III trials with ME-609 a phase I irritation study has been done. The former big phase II study against labial herpes with Medivir's combination has shown both safety and efficacy. These combined results have made it possible to start a new project against genital herpes if a broadening of the market potential would be interesting.
For more information, please contact Medivir:
Rein Piir, CFO/IR, phone +46 8 5468 3100 or +46 708 537292
About Medivir
Medivir is an innovative and specialised research company that develops pharmaceuticals with the aim of becoming a sustainable and profitable pharmaceuticals company. The company is located in Huddinge, Sweden and Cambridge, UK.
Medivir's research focuses on developing new pharmaceutical compounds based on polymerases and proteases as target enzymes. The Group comprises Medivir AB, its subsidiary Medivir UK Ltd. and Medivir Personal AB. At the end of March 2004, the Group had 120 employees. In 1996, Medivir was listed on Stockholmsborsen.
The research portfolio includes projects in the area of HIV infection, hepatitis, shingles, cold sores, osteoporosis, rheumatoid arthritis (RA), asthma and multiple sclerosis (MS). Medivir has five individual projects in the clinical development phase, all with a unique clinical profile. The company's broad pre-clinical research portfolio includes five defined projects and some ten activities in different pre-clinical phases.
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