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EISAI AMERICA PREPARING IND FOR PROTON PUMP INHIBITOR (E-3810)

Executive Summary

EISAI AMERICA PREPARING IND FOR PROTON PUMP INHIBITOR (E-3810), which will be the first FDA filing for the U.S. subsidiary of Eisai Co., Ltd., Japan's sixth largest pharmaceutical company. The proton pump inhibitor, now in Phase II trials in Japan, is the lead project in Eisai's effort to develop and register a product on its own in the U.S. market. The firm is attempting to bring the proton pump inhibitor through the U.S. and Japanese regulatory processes simultaneously. The U.S. IND will be shepherded by a one-year-old organization in Teaneck, N.J. called Eisai America, Inc. The Japanese firm has had operations in the U.S. since 1981, when it established Eisai U.S.A., Inc. in Los Angeles, to market its vitamin E products and automatic ampoule inspection machinery (AIM) equipment for detection of foreign matter in injectable drugs. That subsidiary was moved east to Teaneck in 1988 and now is located adjacent to the group handling U.S. clinical trials and IND/NDA filings. The company set up a similar regulatory approval operation in London in 1988. The U.S. and European registration efforts are part of a five-year plan "the aim of which is to win a place among the world's top 20 pharmaceutical manufacturers by the turn of the century," Eisai said in its 1989 annual report. On Oct. 20, Eisai opened a 47,000 sq. ft. basic research laboratory, the Eisai Research Institute of Boston, in Andover, Massachusetts. The R&D facility will conduct basic research of new compounds for development of prescription pharmaceuticals. Current plans call for new compounds to be sent to Japan for intermediate development. Initially staffed with 17 researchers and eight support staff, the institute will eventually employ an estimated 40 individuals. Eisai intends to staff the institute with researchers trained in the U.S. The head of the research lab's advisory board is organic chemist Yoshito Kishi, a tenured professor at Harvard since 1974 and winner of the 1988 Javits Neuroscience Investigator award. The university says that Kishi is best known for his synthesis of complex organic toxins including tetrodotoxin (pufferfish toxin) and saxitoxin (paralytic shellfish poison). The 50-year old Eisai company is headquarted in Tokyo and employs 4,000 people worldwide. Gross 1987 sales were $1.3 bil. and "about 80% of revenue now comes from sales of ethical drugs," stated Eisai President Haruo Naito, grandson of the company's founder. Included in the company's product line in Japan is the Squibb monobactam, Azactam. In addition to prescription pharmaceuticals, Eisai's Japanese product line includes OTC drugs, vitamins, cosmetics, veterinary products and quality-control machinery for pharmaceutical manufacturing. According to Eisai's 1989 annual report, the company is currently focusing pharmaceutical R&D on "geriatric and stress-related diseases" in response to Japan's aging population. Major products under development in Japan include indomethacin farnesil (E-0710), described as an anti-hypertensive, cronassial (E-0704) for peripheral neuropathies, and iloprost (E-1030) as an anti-platelet.
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