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Pfizer says may win six Japan approvals this year

Thu Feb 28, 2008 1:34am EST

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TOKYO, Feb 28 (Reuters) - Pfizer Inc (PFE.N) said on Thursday that six of its drugs could be approved in Japan this year, including the cancer drug Sutent.

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Regulatory hurdles have long meant that many commercially important drugs approved overseas take a long time to make it to market in Japan, but authorities have recently made changes to speed up the approval process.

As a result, the world's second-largest drug market is gaining in importance for international companies, especially as tighter scrutiny by regulators in the U.S. market and spiralling development costs have made it difficult to launch new blockbuster drugs.

Salomon Azoulay, head of Pfizer's Japan development, told reporters that other drugs that may gain approval include Macugen for age-related vision problems and rifabutin for fighting an HIV-related bacterial infection.

Revatio for high blood pressure in the arteries around the lungs was approved in January, as was smoking cessation drug Champix.

Celebrex, approved last year for arthritic pain, may also be approved for lower back pain, he added.

The U.S. drug maker is also hopeful that it will get the green light for Caduet, a combination drug of high blood pressure medicine Norvasc and cholesterol treatment Lipitor, although that may not come this year, said Azoulay.

Japanese authorities in the past have been seen as reluctant to approve combination drugs, but that is slowly changing, Western drug executives say.

But Pfizer, which has cut 10,000 jobs worldwide in the last year and has been lowering other costs, also faces a tough challenge in Japan this year as Norvasc has just lost patent protection in the country. (Reporting by Edwina Gibbs)



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