ALKERMES' PROLEASE DELIVERY OF GROWTH HORMONEENCOURAGING
By Charles Craig
Genentech Inc. agreed to pay Alkermes Inc. up to $30 million tocontinue clinical development of its ProLease sustained drug deliverytechnology, which is designed to reduce frequency of treatments withthe former's FDA-approved recombinant growth hormone.
Richard Pops, Alkermes CEO, said Thursday South San Francisco-based Genentech's decision to expand the collaboration, which beganin January 1995, followed successful completion of a Phase I trialevaluating ProLease's effectiveness in delivering growth hormone to13 adults deficient in the protein.
The positive results, Pops observed, also were the first demonstrationof ProLease's ability to achieve in humans sustained release andbiological activity of large, unstable proteins, such as growthhormone.
Alkermes, of Cambridge, Mass., also is working with Schering-Plough Corp., of Madison, N.J., for delivery of alpha interferon.
ProLease is designed to reduce significantly the need for frequentdrug administrations. The delivery vehicle is a polymericmicrosphere similar to dissolving sutures.
For Genentech's recombinant growth hormone products, Nutropinand Protoprin, ProLease is expected to reduce daily injections toonce a month. Genentech sells the drugs to treat short children whoare deficient in the hormone.
Following the successful study in adults, Alkermes launched a PhaseI/II trial in the U.S. of the ProLease formulation of growth hormonein children.
Genentech committed more than $20 million to Alkermes to supportcontinued clinical development and agreed to contribute another $10million in milestone payments. Alkermes received $3.5 million fromGenentech at the start of their collaboration.
In the Phase I trial, Pops said the adult subjects received a single doseof ProLease growth hormone. During the next month, analysesshowed the participants experienced elevated levels of hormonealong with increases in insulin-like growth factor-1 and insulin-likegrowth factor-1's binding protein, which also are involved instimulating growth.
"A single injection," Pops observed, "elevated levels of those threemarkers for three to four weeks."
Genentech, which dominates U.S. sales of growth hormone drugs,expects ProLease to help the company maintain its position as morecompanies compete for a share of the market. In 1995, Genentech'srevenues from Protoprin and Nutropin totaled nearly $220 million.
Continuation of the Genentech alliance is Alkermes' second majorpartnership expansion within a month.
In late October, Johnson & Johnson, of New Brunswick, N.J., agreedto pay Alkermes up to $20 million to continue clinical developmentof an undisclosed drug with the company's Medisorb sustainedrelease delivery system.
Medisorb is targeted for delivery of small molecule compounds.Although similar to ProLease, Medisorb cannot handle proteins.
Alkermes stock (NASDAQ:ALKS) closed Thursday at $15.50, anincrease of $0.50. Genentech (NYSE:GNE) ended the day up $0.50to $54.25. n
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