By Randall Osborne

Staff Writer

Alkermes Inc. and Genentech Inc. won FDA approval of Nutropin Depot, a long-acting injectable form of human growth hormone for pediatric deficiencies.

Peter Ginsberg, an analyst with US Bancorp Piper Jaffray in Minneapolis, said Nutropin sales are expected to total "at least $500 million at peak," three to five years after the hormone is introduced.

"We're assuming an April 1 launch, which I think is very much in hand with this approval," Ginsberg said.

South San Francisco-based Genentech and Alkermes, of Cambridge, Mass., had to step up operations when they learned the FDA had granted an expedited, six-month review.

"They had to work very quickly to get their ducks in a row, and they did that," Ginsberg said.

Sales are expected to reach $40 million in fiscal 2001, and $135 million in fiscal 2002, he said.

In April, Alkermes and Genentech expanded their collaboration to develop Nutropin Depot, in a deal worth up to $75 million more to Alkermes. (See BioWorld Today, April 16, 1999, p. 1.)

Genentech spokesman Betsy Rosenberg noted the hormone is the first clinically tested recombinant protein to be delivered in a long-lasting form, using an extended-release drug delivery system (called ProLease, developed by Alkermes). She said Nutropin Depot is likely to "lead to less disruption in lifestyle for families," since children may be more easily persuaded to take the shot less often.

"All you can do is look at a child having to take growth hormone every day, and you could say that Nutropin Depot potentially enhances compliance," Rosenberg said.

Ginsberg agreed, saying the pediatric growth-hormone market probably will expand as a result of the new approval.

"I talked to one mother who had to chase her child around the house every day to give the injection," he said. "This is a $1.5 billion worldwide market right now. We think it's quite clear Nutropin Depot will get a significant portion [of the enlarged market]."

The good-news item is the latest in a series for Genentech this month. The company started a Phase III trial of its anti-CD11a (hu1124) product for moderate to severe plaque psoriasis, and said it will enter Phase III trials with its recombinant humanized monoclonal antibody to vascular endothelial growth factor (rhuMab-VEGF) in combination with chemotherapy in metastatic colorectal and metastatic non-small cell lung cancer. Genentech also disclosed positive preliminary data from Phase III asthma efficacy studies of its anti-IgE9 (rhuMAb-E25) drug. (See BioWorld Today, Dec. 21, 1999, p. 1; Dec. 17, 1999, p. 1; and Dec. 20, 1999, p. 1.)

"Both companies are winners [in the Nutropin Depot approval], but especially Alkermes, because it's the company's first product," Ginsberg said.

Alkermes' stock (NASDAQ:ALKS) closed Thursday at $53.62, up $2.625. Genentech's shares (NYSE:DNA) ended the day at $139.25, up $6.25.