Bio-Technology General Corp. (BTG) announced Monday that itsrecombinant human growth hormone (hGH) has received aproduct license in Japan.

JCR Pharmaceuticals Co. Ltd., BTG's marketing partner in Japan,will launch the product, Growject, as soon as its price isincluded on the National Health Insurance listing.

JCR already markets the non-recombinant, pituitary gland-derived version of growth hormone in Japan, explained LeahBerkovits, BTG's manager, administration. The gland-derivedhormone was never banned in Japan as it was in othercountries, Berkovits said. When the price is established, whichBerkovits expects to be in the second quarter, "JCR will switchto BTG's recombinant hGH and phase out the pituitary product."

The Japanese market for this product is dominated by the likesof Ares-Serono, Sumitomo (which handles Genentech Inc.'sproduct), Yamanouchi, Eli Lilly and Co., and Nikken (which alsomarkets a pituitary-gland-derived growth hormone), accordingto Berkovits.

European sales of BTG's recombinant hGH should be startingimminently. "Hopefully, we'll see sales starting this quarter,"Berkovits told BioWorld.

Those sales will be handled by the Ferring Group of Sweden, aprivate pharmaceutical company specializing in hormonaldrugs and peptide proteins, which became BTG's Europeanmarketing partner in November 1992, just days after BTGformally ended its 1988 agreement with SmithKline Beechamfor marketing hGH in Europe.

BTG has negotiated 30 percent royalties on sales with bothmarketing partners, Berkovits told BioWorld.

BTG is also marketing recombinant hGH in Israel and in SouthKorea. It can't enter the U.S. market on this product until atleast March 1994, when Lilly's orphan drug exclusivity fortreating short stature expires.

Vector Securities International research assistant John Kregerestimated the combined European and Japanese sales of allhuman growth hormone products as being $554 million in1993 -- with 41 percent of those sales in Japan (about $227million). For comparison, Kreger estimated 1993 sales in theU.S. at $294 million.

Sim Fass, president of BTG of New York, said that annual hGHsales are nearing $300 million in Japan. "We now expect humangrowth hormone revenues from both Japan and Europe tocommence this year, and to move us substantially closer toprofitability," he said.

BTG's stock closed at $5.13 a share on Monday, down 13 cents.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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