Generic pharmaceuticals company Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) is a step closer to marketing a generic version of osteoporosis drug Evista (Raloxifene) in Europe.
In September, a US court ruled against Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), and upheld Eli Lilly's patent on its osteoporosis drug Evista. Teva has been trying to launch a generic version of the drug.
At the end of last week, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Raloxifene. The positive opinion specified Teva's 60 mg film-coated tablets, intended for treatment and prevention of osteoporosis in postmenopausal women.
The regulator said that a significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Sales of the branded drug are $1 billion worldwide, including about $350 million outside the US.
The European Medicines Agency is a European Union regulatory body, and is located in London.
The CHMP said that on the basis of quality, safety and efficacy data submitted, it considers there to be a favorable benefit to risk balance for Raloxifene Teva and therefore recommends the granting of the marketing authorization. The most common side effects are vasodilation, flu syndrome, leg cramps and peripheral oedema.
Shares in Teva rose 1.4% on the Tel Aviv Stock Exchange (TASE) today.
Published by Globes [online], Israel business news - www.globes-online.com - on February 21, 2010
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