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Shionogi’s New Flu Treatment May Go on Sale Next Year (Update2)

By Kanoko Matsuyama

Sept. 9 (Bloomberg) -- Shionogi & Co. forecast its experimental treatment peramivir will earn annual sales of about 5 billion yen ($54 million) in Japan on demand from hospitals for patients critically ill with influenza including swine flu.

Shionogi plans to file data to Japan’s health ministry in November for approval to market the flu medication and expects to sell it as early as October next year, Takuko Y. Sawada, head of development at the Osaka, western Japan-based company, said in an interview.

If approved, peramivir would compete with antiviral drugs such as Roche Holding AG’s Tamiflu and GlaxoSmithKline Plc’s Relenza. Sawada said peramivir, which has completed all three typically required trial stages, is administered directly into the blood stream, allowing it to be effective more rapidly.

“It’s a good drug for severely ill flu patients, for whom it’s critical that antivirals are effective with a high degree of certainty,” Sawada said in Osaka yesterday. There is demand for intravenously administered drugs for such patients, she said.

Shionogi fell 0.2 percent to close at 2,095 yen on the Tokyo Stock Exchange. The shares have declined 8.7 percent this year, lagging behind the benchmark Topix index’s 9.4 percent gain.

Relenza is usually inhaled, while Tamiflu comes in pill form. Relenza administered in an unapproved intravenous form helped save a cancer patient with swine flu whose immune system was weakened by chemotherapy, the Lancet medical journal reported this month.

BioCryst Payment

Shionogi agreed in March 2007 to pay as much as $35 million to Birmingham, Alabama-based BioCryst Pharmaceuticals Inc. for rights to develop and sell peramivir in Japan.

Sales at Shionogi, also the maker of the Crestor cholesterol pill, rose 6.2 percent to 228 billion yen in the year ended March 31. Net income fell 38 percent to 16 billion yen on costs related to an acquisition.

The company is the first among three drugmakers to seek approval in Japan for flu treatments under development. Daiichi Sankyo Co. said in July it aims to submit data for laninamivir, a longer acting form of Relenza, by March 2010. Fujifilm Holdings Corp.’s Toyama Chemical Co. unit plans to apply for approval for its favipiravir treatment by March 2011.

Shionogi is considering making the active ingredient in peramivir itself in future to ensure supplies, Sawada said. For now, the company will import the ingredient from a U.S. maker to produce courses for about 3 million people next year, she said, without identifying the supplier or providing a more specific timeframe.

Swine Flu Toll

Swine flu, also known as H1N1, has killed at least 2,837 people globally since the outbreak in April, according to the World Health Organization.

In Japan, 11,636 cases have been confirmed as of Sept. 1, according to the country’s Infectious Disease Surveillance Center. Seven people in the nation have died out of the 579 people hospitalized since the outbreak began in May, Japan’s health ministry said on its Web site.

Shionogi will present detailed data from its phase-three peramivir studies at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy starting place this week in San Francisco.

To contact the reporter on this story: Kanoko Matsuyama in Tokyo at at kmatsuyama2@bloomberg.net.

Last Updated: September 9, 2009 03:02 EDT

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