Genentech and Alkermes Announce Plans to Advance ProLease Human Growth Hormone to Phase III Clinical Trials

Business Wire, Nov 24, 1997

SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Nov. 24, 1997-- Based on results of a U.S. Phase II trial of ProLease(R) human growth hormone (hGH), Genentech, Inc. (NYSE:GNE) and Alkermes, Inc. (NASDAQ:ALKS) announced today that they will advance clinical studies of this potential therapy to pivotal Phase III clinical trails in growth hormone deficient children.

ProLease hGH is a sustained release formulation of Genentech's human growth hormone based on Alkermes' ProLease injectable sustained release drug delivery system. Growth hormone is encapsulated in biodegradable microspheres that slowly release hGH over a period of weeks.

The Phase II study is being conducted to evaluate the safety and efficacy of ProLease hGH. Subcutaneous injections of ProLease hGH have been administered to 64 patients at 12 sites in the United States. Phase II data will be presented at a scientific meeting in 1998.

"Based upon the Phase II data, we plan to initiate Phase III development of ProLease hGH by early 1998," said Arthur D. Levinson, Ph.D., Genentech's President and Chief Executive Officer.

Growth hormone deficiency, a pituitary disorder resulting in short stature and other physical ailments, affects approximately 20,000 children nationwide.

Alkermes, Inc. develops products based on sophisticated drug delivery technologies. Alkermes' focus is on two important drug delivery opportunities: (1) controlled, sustained release of injectable drugs lasting several days to several weeks; and (2) the delivery of drugs into the brain past the blood-brain barrier. In addition to its Cambridge, Massachusetts headquarters, Alkermes operates a manufacturing facility in Ohio and a medical affairs office in Cambridge, England.

Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Eleven of the currently marketed biotechnology products stem from Genentech science, six of which Genentech markets directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.

CONTACT: Genentech, Inc.

Betsy Rosenberg, 650/225-7848 (Media)

Susan Bentley, 650/225-1034 (Investors)

or

Alkermes, Inc.

Richard F. Pops, 617/494-0171 (Media)

Lisa Burns, 212/213-0006 (Investors)