Tuesday, Sep 11, 1984

Cutter To Receive Factor VIII License From Genentech

Emeryville, Calif. -- September 11, 1984 --

Cutter Biological, a division of Miles Laboratories, Inc., and Genentech, Inc. announced today that basic terms of an agreement have been reached to grant Cutter rights to the production and marketing of a blood-clotting protein, Factor VIII, produced by Genentech's recombinant DNA technology.

Under the proposed agreement, Cutter would receive exclusive commercial production rights worldwide. After Cutter's first two years of marketing, Genentech would share rights in the United States and Canada. The agreement will reflect an earlier contract between Genentech and Speywood Laboratories Limited of the United Kingdom, under which Speywood has marketing rights in certain countries.

Terms of the Cutter-Genentech agreement have not been announced but will include cash payments by Cutter during the development phases and subsequent royalties to Genentech. A final, definitive agreement is expected to be approved in the near future by the boards of Genentech and Miles, the U.S. health care subsidiary of Bayer AG, Leverkusen, West Germany.

"This joint development agreement is an ideal match of Genentech's leadership in recombinant DNA technology and Cutter's expertise in blood products," said Robert A. Swanson, president and chief executive officer of Genentech. "It will enable us to get a highly purified, plentiful supply of Factor VIII into the marketplace as quickly as possible."

Factor VIII is a blood-clotting protein that is missing or inactive in person with hemophilia A, a condition which can be marked by uncontrolled internal bleeding, especially in the joints. Recombinant DNA technology could provide a product that is as much as 4,000 times more active than currently available Factor VIII, thus requiring considerably lower volumes to be administered.

Factor VIII is a blood-clotting protein that is missing or inactive in persons with hemophilia A, a condition which can be marked by uncontrolled internal bleeding, especially in the joints. Recombinant DNA technology could provide a product that is as much as 4,000 times more active than currently available Factor VIII, thus requiring Genentech revealed in April that company scientists had successfully produced functional Factor VIII through the new technology. The event marked the first genetically engineered production of the critically needed blood-clotting protein.

"Genentech has demonstrated a technological lead in the application of recombinant DNA technology to blood clotting," according to Dr. W.F. Schaeffler, executive vice president in charge of the Cutter Group.

"This is important to us in accelerating our program to introduce this product into the marketplace. We are determined to remain in the forefront in the care of those afflicted with hemophilia and in the application of advanced technologies to improve treatment of this disease throughout the world," Dr. Schaeffler said.

Cutter plans to produce a Factor VIII product under the Genentech technology for clinical testing in humans, according to Jack Ryan, president of Cutter Biological. "Based on this," he added, "Cutter is in a strong position to have the first commercially available Factor VIII product from recombinant DNA technology."

Cutter is a major U.S. producer and marketer of Factor VIII and other biological products currently produced from human plasma. Its products are sold internationally.

Cutter was acquired by Bayer AG in 1974 and in 1983 was merged into the more recently acquired Miles Laboratories, Inc. of Elkhart, Indiana. Bayer AG is a worldwide producer of chemical and pharmaceutical products.ng considerably lower volumes to be administered.

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