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Executive Summary

Gensia will begin human safety testing of its first purine-based compound in the U.K. during September, the San Diego-based R&D startup noted in a Sept. 6 release. Gensia noted that "initial pre-clinical experiments suggest the drug may minimize the cardiac tissue damage associated with a myocardial infarction." Designated GPI-I-110 by Gensia, the compound will be studied for use after heart attacks and in high risk patient populations to see if pre-MI use further limits cardiac damage, the company indicated. Gensia noted its plans for the purine drug clinical program in an announcement of a letter of intent with the Swedish pharmaceutical company KabiVitrum to co-develop Gensia's purine and pyrimidine-based research compounds in Europe. "The letter of intent provides that KabiVitrum will be responsible for the clinical development of Gensia's purine- and pyrimidine-based therapeutic products in Europe," Gensia said. In return, KabiVitrum will receive exclusive marketing rights in Europe, with the exception of the U.K., where the two companies will share co-marketing rights. In addition, KabiVitrum has also agreed to fund a basic research program at Gensia "on purine/pyrimidine technology for the treatment of cardiovascular, cerobraovascular and neurological diseases," Gensia President and CEO David Hale noted. The equity and basic research agreement will provide Gensia "with up to $ 25 mil." over the next five years. The company would not disclose further details of the funding arrangement. The financial support will supplement approximately $ 16 mil. raised through private placements by Gensia, including $ 11 mil. in late 1987. KabiVitrum's co-development assistance will "significantly reduce" Gensia's drug development costs and will provide data from European studies that can be used to support an NDA filing in the U.S., Hale said. The agreement is expected to be finalized by December. In addition to the KabiVitrum agreement in Europe, Gensia is in "active negotiations" with potential partners for the Asian market, Hale said. He said that "discussions are under way" in the U.S. As a result of the company's progress toward establishing a network of strategic alliances, Hale said that Gensia "does not feel compelled to do a public offering in the near future." The letter of intent also includes an option for KabiVitrum to market in Scandinavia a drug system under development at Gensia for the diagnosis of cardiac disease. Gensia's second area of focus in its R&D program is a class of compounds known as exercise stimulating agents. These drugs are being studied to determine whether they can elicit an acute, measurable cardiovascular response in combination with a computer-controlled delivery system. This combination drug/device system is scheduled to enter clinical trials in March 1989, Hale said. Founded in late 1986, Gensia is headed by Hale, who was president and CEO of Hybritech when it was acquired by Lilly in 1986. Hale left Hybritech in May 1987 to join Gensia. Prior to joining Hybritech in 1982, Hale was VP-general manager of Becton Dickinson's BBL Microbiology Systems division. In the past year and a half, Gensia has been aggressively constructing a senior management team. Beginning in June 1987, Gensia hired Ron Tuttle, PhD, a former Key R&D exec, as VP-new drug development. Last fall, the company brought on board James Gourzis, MD/PhD, former president of MedRand, as VP-medical affairs; Jack Reich as VP-regulatory affairs; and Arthur Johnson, formerly at McGaw, as VP and chief financial officer. This past summer, Gensia hired former Reckitt & Colman exec Steve Harris to head the firm's European operations.

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