Genentech Inc. submitted a new drug application for Nutropin Depot, a long-acting formulation of recombinant human growth hormone that uses Alkermes' ProLease injectable delivery system.
Betsy Rosenberg, spokeswoman for South San Francisco-based Genentech, said the major news came in June, when the company disclosed positive Phase III trial results at the Endocrine Society meeting in San Diego. (See BioWorld Today, June 15, 1999, p. 1.)
"This is just to say we filed," she said, adding that approval is expected to take about a year.
Nutropin Depot combines Cambridge, Mass.-based Alkermes4 ProLease delivery vehicle - a polymeric microsphere which utilizes the same polymer used in dissolving sutures - with Genentech4s human growth hormone. The resulting product provides a sustained release of human growth hormone that allows for once-a-month or twice-a-month dosing regimens compared to daily injections to treat short children with growth hormone deficiencies. About 20,000 children in the U.S. suffer from growth hormone deficiency, which requires them to take daily injections.
Several months ago, Genentech and Alkermes expanded their deal for the product by up to $75 million. (See BioWorld Today, June 16, 1999, p. 1.)
Alkermes stock (NASDAQ:ALKS) closed Monday at $24, down $1.25. Genentech's shares (NYSE:GNE) ended the day at $82.187, unchanged due to halted trading after F. Hoffman-La Roche exercised a buyout option. (See BioWorld Today, June 4, 1999, p. 1.) - Randall Osborne