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Published on 7 March 2007

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Osteoporosis drug begins trials in humans

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Swedish drug firm Medivir is starting its first human trial with a new drug for treating osteoporosis. Company researchers have been developing the compound MIV-701 over the last five years, with what they say are promising results. MIV-701 inhibits the enzyme cathepsin K, which degrades bone but probably also contributes to cartilage damage in joint diseases. Medivir says laboratory research and comprehensive preclinical studies have shown the drug to be efficacious, greatly reducing bone degradation.

The clinical trial will investigate how an oral-dosage form of MIV-701 is taken up and tolerated by the body. By studying biomarkers, it should also be possible to make a preliminary assessment of the compound’s efficacy on osteoporosis, and other skeletal disorders such as arthritis and bone metastases. In the early stages, the drug is administered in single, escalating doses, and in a later stage the trial subjects are treated with multiple doses over a more protracted period.

Osteoporosis is a widely prevalent disease and the need for better treatment is acute. Current drugs do not provide adequate efficacy or have serious side-effects. Interest in new treatments on the part of global pharmaceutical companies has increased in recent years. Additionally, the clinical need for new drugs for treating arthritis and bone metastasis is also enormous. Medivir CEO Lars Adlersson said: “If our expectations on the efficacy and safety of the compound are met, we are looking at a blockbuster market.”

Several large drug companies are undertaking research in the area, but as yet there is no drug available to patients with the same mechanism of action as MIV-701.

Mr Adlersson went on: “We intend to present data from the newly begun trials during 2007. This will be an important cornerstone for a good partnership agreement with a global pharmaceutical company which can help us with the continued development and marketing. Through such a partnership Medivir should also be able to secure significant revenues long before the potential pharmaceutical hits the market.”

BusinessWire 06/03/2007



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