SWEDISH OSTEOPOROSIS DRUG BEGINS TRIALS IN HUMANS.
06-Mar-07 The Swedish company Medivir is commencing its first human trial with a new drug against osteoporosis. The company’s researchers have been developing the compound MIV-701 over the last five years with very promising results.
MIV-701 inhibits an enzyme, cathepsin K, which degrades bone, but most probably also contributes to cartilage damage in joint diseases. Laboratory research and comprehensive preclinical studies have shown the drug to be efficacious, thereby greatly reducing degradation of bone.
Over 90% of all pharmaceutical projects fail before reaching trials in humans, which makes these clinical trails with MIV-701 a significant milestone for Medivir.
In the course of the now commenced clinical trial program, Medivir 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 also 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 during a more protracted period.
Osteoporosis is a widely prevalent disease and the need for better treatment is acute. The currently existing pharmaceuticals do not provide adequate efficacy or have serious side-effects. The interest from global pharmaceuticals companies for new treatments has increased in recent years. The clinical need for new drugs in arthritis and bone metastasis is also enormous.
“It feels extremely exciting to participate in the development of a new Swedish drug directed to such an important, widespread disease as osteoporosis. If our expectations on the efficacy and safety of the compound are met, we are looking at a blockbuster market”, says Medivir’s CEO Lars Adlersson.
Several large pharmaceutical companies research in the area, but as yet there is no drug available to patients with the same mechanism of action as MIV-701.
“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”, comments Lars Adlersson.
Every second woman and every fourth man will suffer from osteoporosis. The disorder often leads to fractures of bone and vertebrae, with enormous suffering and social costs in consequence. The global sales of osteoporosis pharmaceuticals is expected to amount to nearly SEK 80 bn in 2008.
FOR FURTHER INFORMATION, PLEASE CONTACT
Rein Piir, CFO and VP, Investor Relations, Medivir AB +46 8 546 831 23 or +46 708 53 72 92