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Japanese Biotechs Weigh Quake, Tsunami Damages

From BioWorld Today (March 15, 2011)

In the wake of a tsunami that's claimed thousands of lives, triggered threats of potential nuclear meltdowns and destroyed the infrastructure in cities along Japan's northeastern coastline, the biopharmaceutical industry in Japan is taking stock of its damages.

The first priority Monday was the safety of workers.

Tokyo-based Astellas Pharma Inc., which has several facilities in the area hit by the Tohoku earthquake and subsequent tsunami, reported that all its staff members are all right.

"That was a huge relief," Jenny Keenei, a spokeswoman for Astellas Pharma U.S., told BioWorld Today. The company is focusing on the safety of it employees and their families. Then it will worry about business, she added.

Astellas has determined that its inventory, most of which is intended for distribution in Japan, is intact. However, the company's ability to deliver those products is uncertain given the massive damage to transportation routes, Keenei said.

Astellas, like its Japanese counterparts Takeda Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd. and Eisai Co. Ltd., made a sizable donation to help tsunami victims. But in what could be a vote of confidence in the future, Astellas also submitted a marketing application Monday to the Japanese Ministry of Health, Labour and Welfare for bixalomer to treat hyperphosphatemia in patients on dialysis with chronic kidney disease.

According to preliminary reports, Daiichi said its staff is accounted for. But the company, which has factories and research labs throughout Japan, is continuing to monitor the situation.

One of its factories is located in Sendai, near the epicenter of Friday's earthquake; another is in the Fukushima prefecture, which is home to the nuclear power plant that experienced two explosions following the quake.

Eisai Co. Ltd., which is also based in Tokyo, has accounted for most of its employees and cites minor damage to its facilities in the Tokyo area.

However, the company has six offices in Sendai. Because of communication problems in the stricken area, the company has not been able to fully determine the damage in that region.

"It will take us some time to assess the long-term impact, if any," Eisai's U.S. spokeswoman Lynn Kenney told BioWorld Today.

Eisai has set up an independent crisis center in the Tohoku region, headed by its deputy president, in response to the disaster.

Another concern for companies is the safety of their customers.

Biogen Idec, of Weston, Mass., has been assured that its employees in Tokyo are fine, but it is still trying to learn the status of the doctors and patients it worked with throughout the devastated area.

Company spokeswoman Christina Chan told BioWorld Today that there is a major multiple sclerosis (MS) center located near the epicenter, but Biogen, which develops MS drugs, has received no word as to the fate of the facility.

Japan's pharmaceutical market is second only to that of the U.S. In its global forecast released in October, IMS Health predicted 5 percent to 7 percent pharma growth in Japan this year, compared with 3 percent to 5 percent growth in the U.S. and 1 percent to 3 percent growth in Canada, Germany, France, Italy, Spain and the UK.

Given the size of Japan's biotech industry, the disaster could have global ramifications. But it's too soon to predict what they will be.

For instance, "the U.S. pharmaceutical market is sourced from around the world, but we can't say at this moment which regulated products may be impacted by the ongoing events in Japan," FDA spokeswoman Erica Jefferson told BioWorld Today.

The agency is continuing to monitor the situation.

Coincidentally, the FDA released a final guidance Monday encouraging companies to develop contingency production plans to use during emergencies that could result in high absenteeism at drug manufacturing facilities.

The guidance, which finalizes a draft published in January 2010, was precipitated by the H1N1 pandemic and "far precedes the tragic events currently unfolding in Japan," Jefferson said.



Posted: March 2011