By Randall Osborne

Blocked by litigation from marketing its own human growth hormone in the U.S., Bio-Technology General Corp. (BTG) signed a co-promotional agreement with the Ares-Serono Group, under which BTG will market the Swiss company's line of pediatric growth products.

"It's meaningful," said Leah Berkovits, spokeswoman for Iselin, N.J.-based BTG. "We'll get a share of the revenues, and it's something that was not projected, in terms of our normal course of business."

The deal covers U.S. marketing of Geneva, Switzerland-based Serono's Saizen (somatropin) for treating children with growth failure due to inadequate levels of growth hormone; Geref (sermorelin acetate), which stimulates the release of growth hormone from the pituitary gland and is used for treating idiopathic growth hormone deficiency in children; and Geref Diagnostic, a complementary product for diagnosis of growth disorders.

With the agreement, the sales force marketing those products is tripled.

A lawsuit by Genentech Inc., of South San Francisco, barred BTG from selling its own human growth hormone, Bio-Tropin, in the U.S. until the ongoing litigation is resolved. (See BioWorld Today, April 10, 1996, p. 1.)

"There's a preliminary injunction in place," Berkovits said. Genentech's patent expires in 2003, she added.

Sales of Bio-Tropin elsewhere in the world have been strong, but BTG's lead product is Oxandrin, an orally active testosterone analogue sold in the U.S. for promoting weight gain in a variety of diseases, including cancer and AIDS.

"Bio-Tropin has been overtaken by Oxandrin," Berkovits said. Sales in 1997 for Oxandrin totaled $28 million, compared with $16.7 million for Bio-Tropin.

Early last year, BTG began a Phase III multicenter clinical trial of its recombinant superoxide dismutase, OxSODrol, to prevent lung damage in premature infants. In February 1998, an independent Data Safety and Monitoring Committee examined findings from the first 180 patients and said it wanted to expand its analysis, which requires data on 115 more babies. (See BioWorld Today, Jan. 10, 1997, p. 1.)

The committee is evaluating the complete data, and its analysis is expected "in the next few weeks," Berkovits told BioWorld Today.

Moving toward the market in Israel is BTG's genetically engineered hepatitis B vaccine.

"We hope to see approval later this year," Berkovits said.

BTG will produce and market the third-generation vaccine in Israel and possibly other countries, while paying a royalty to Biogen Inc., of Cambridge, Mass., which owns the patent on the drug.

As of March 31, BTG had $39.6 million in cash, with net income for the quarter of $3.3 million. The company's stock (NASDAQ:BTGC) closed Thursday at $8.843, down $0.031. *

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