HUDDINGE, Sweden, Sept. 30, 2002 (PRIMEZONE) -- Medivir's (Stockholm:MVIRb) antiviral MIV-210 is active against HIV and HBV (hepatitis B virus, viral jaundice) and is in phase I clinical trials. The compound has a promising profile in several respects compared with antivirals already on the market and projects in the pipeline. Medivir has presented new data on MIV-210 in the HBV and HIV indications at the ICAAC meeting (Interscience Conference in Antimicrobial Agents and Chemotherapy) currently underway in San Diego, USA.
MIV-210 is a nucleoside analogue and is patented to 2018. A number of preclinical studies have been run in parallel with the clinical trials, and some of these have now been completed. The aim of these studies has been to confirm the utility of MIV-210 as a pharmaceutical against both HBV and HIV and promising results have been obtained.
The Presented Results
A phase I clinical trial has shown that MIV-210 administered to healthy volunteers has a very good oral bioavailability (ie, it can be administered as tablets) and achieves high blood plasma levels. Phase I clinical trials with repeat dosing will now be finalised and evaluated.
The activity of MIV-210 against HBV has been investigated in cell culture, where MIV-210 has also proven to retain activity against HIV, which has become resistant to the market's current gold standard lamivudine. Such resistance arises during extended treatment of HBV patients with lamivudine.
MIV-210 has also been evaluated in woodchucks. These animals often have a natural, chronic infection with a hepatitis virus, which is extremely similar to human HBV. Treatment of woodchucks with chronic viral hepatitis is the current best known model for evaluating new HBV antivirals. In this model, MIV-210 reduces the amount of hepatitis virus in the blood to less than one ten-millionth of the pre-treatment levels.
In around 20% of the treated animals, this effect continued beyond the cessation of therapy, which no other antiviral has managed to achieve in this model. Additionally, the amount of virus in the liver was reduced to one thousandth of the pre-treatment level. No potential side effects were noted during the 10 week treatment or 8 week follow-up periods.
In comparison to the currently marketed HBV antivirals or those in the pipeline, MIV-210 stands out as a promising compound. As with HIV treatment, HBV treatment will demand combinations of different antivirals. In contrast to HIV, a proportion of HBV patients can be cured from the disease. This proportion is likely to increase as new, more potent antivirals and combinations reach the market.
MIV-210 is also active against HIV, both in cell culture and in in vivo models. New results show that MIV-210 has a unique resistance profile and retains its activity against HIV which has become resistant against all relevant antivirals on the market.
The Market
The number of patients with HBV or HIV/AIDS is growing. Resistance development against existing antivirals is an ever greater and faster growing problem within both fields, which speaks in MIV-210's favour.
There are currently more than 350 million chronically infected HBV patients. Around 5-6 million of these infected individuals are in the West, while around 100 million are in China. The number of patients who are currently treated is comparatively low but is growing quickly as new antivirals are introduced. Sales of HBV antivirals in 2001 were around 0.6 billion dollars, despite their limited efficacy during treatment.
The number of HIV/AIDS patients in the West amounts to more than 1.5 million, a very great proportion of which already display antiviral resistance. The number of patients with multiresistant HIV is rising rapidly and there is an enormous need for new antivirals. A newly executed study at an American centre showed that 70% of patients had HIV, which was resistant to currently available nucleoside analogue treatment. Sales of nucleoside analogue HIV antivirals in 2001 amounted to 2.7 billion dollars, which is expected to rise to 6 billion dollars by 2005.
Current HIV therapy employs combination therapy with several antivirals from different classes and with differing resistance profiles. The three main classes of HIV antiviral are nucleoside analogues inhibiting the HIV polymerase "reverse transcriptase" (NRTI), non-nucleoside polymerase inhibitors (NNRTI) and protease inhibitors (PI).
Development of MIV-210 (NRTI) and other HIV compounds in Medivir's portfolio including MIV-310 (NRTI) which has shown activity against multiresistant HIV in phase IIa clinical trials and MV026048 (NNRTI outlicensed to Roche) creates opportunities for new combination treatments able to arrest viral propagation even with HIV which is resistant to currently available antivirals. MIV-210 and MIV-310 have different resistance profiles.
The future of MIV-210
In parallel with the on-going clinical phase I trials on healthy volunteers, planning is underway for treatment of HIV patients with multiresistant HIV in a coming phase IIa clinical trial. Similarly, MIV- 210 will also be evaluated in HBV patients. Medivir's ambition is to continue the clinical development of this very promising compound, and to seek a partner at the appropriate stage.
Teleconference
Medivir will hold a teleconference on September 30, 2002 at 1300 SE time. Jonas Frick, CEO & President of the Medivir Group, Johan Harmenberg, Vice President of Pharmaceutical Development and Rein Piir, CFO & Vice President of Investor Relations, will provide an update on the project and comment on the study results. Please ring +44 (0)20 8240 8240, code Medivir to participate. The teleconference will be recorded and after 1400 on September 30, 2002 will be accessible for 5 days. To access the recording, ring +44 (0)20 8288 4459 using the code 465 662.
For further information please contact:
Jonas Frick CEO & President of the Medivir Group +46 8 608 3100 Rein Piir CFO & Vice President of Investor Relations, Medivir +46 8 608 3123 or +46 708 53 72 92
The Medivir Group
Medivir is an innovative, specialist pharmaceuticals research and development corporation. Medivir's research is focused on developing substances into new pharmaceuticals based on proteases and polymerases as target enzymes. Research and development is pursued at Cambridge, U.K. and Huddinge, Sweden. The group comprises Medivir AB, the subsidiaries Medivir U.K. Ltd. and CCS AB, plus second-tier subsidiaries CCS (U.K.) Ltd. and Nordic Care Sweden AB. Medivir has been quoted on the Stockholm Stock Exchange O-list since 1996, and on the Attract 40 list since July 1, 2002.
Medivir's research portfolio includes projects against HIV, jaundice, shingles, cold sores, osteoporosis, asthma, MS (multiple sclerosis) and RA (rheumatoid arthritis).
Medivir has four projects in clinical development phases, two of which are entering phase III after completing phase II. One project is in phase I and one is in phase II.
Medivir's preclinical research encompasses a number of projects, one of which is entering, and two are in, the optimization phase. One project is in its late preclinical development phase. Medivir also has some ten specific activities in early preclinical research.
Information on Medivir on www.medivir.se
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