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Executive Summary

GENETICS INSTITUTE SECOND GENERATION TPA CLINICALS will begin in 1989, the company noted in a Nov. 29 press announcement of an outlicensing agreement with Suntory for rights in Japan. Genetics Institute is retaining worldwide manufacturing rights as well as all marketing rights to the U.S. and Europe. Potential advantages of the second generation tissue plasminogen activator over Genentech's Activase, the only approved TPA product to date, include "greater ease of use and a lower dosage requirement than TPA which may result in fewer side effects," according to the release. The company also noted "the absence of antigenic reactions sometimes seen with streptokinase," another thrombolytic agent. Genetics Institute reported in 1987 that, based on the results of studies in dogs, the company's initial Phase I study would use a single 5-10 mg injection of second generation TPA. The recommended dosage for Activase is 100 mg administered over two to three hours. Genentech's clinical development program, which used doses as high as 150 mg, noted a higher incidence of intracranial bleeding at the higher doses. "Based on our progress in preclinical research and process development, we expect to be very competitive, both in terms of efficacy and cost, with other thrombolytic drugs now on the market or in clinical trials," Genetics Institute President Gabriel Schmergel remarked. The company is currently in late clinical development with a first generation TPA product, which has been licensed to Wellcome for worldwide marketing. The agreement with Suntory, which includes licensing fees, manufacturing income and product royalties, indicates an evolving business strategy that emphasizes licensing later in the product development process. "By self-funding a project through preclinical research and then seeking regional licensing arrangement, we can obtain access to significant additional financial and marketing resources, while retaining control over development of the product in the U.S.," Schmergel explained.

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