Synergen Inc. said Thursday that its SLPI product has receivedorphan drug status from the Food and Drug Administration fortreating cystic fibrosis and a congenital defect responsible forgenetic emphysema.

Cystic fibrosis is the most common fatal genetic disease in theUnited States, affecting about 30,000 children and youngadults. Life expectancy of CF patients is 27 years. Some 50,000people have another genetic defect that results in reducedlevels of elastase inhibitor in their lungs, and many developemphysema relatively early in life.

SLPI should come to market in 1994, said Mark Simon, abiotech analyst at Robertson, Stephens & Co. in San Francisco.Synergen has no estimate for the dollar size of the market, saidKen Collins, vice president of finance.

SLPI (secretory leukocyte protease inhibitor) is a naturalinhibitor of elastase, an enzyme responsible for the destructionof lung tissue. Patients with CF and genetic emphysemaproduce excess elastase. Synergen hopes that administration ofSLPI will prevent structural lung damage and help stave offlung infections.

Genentech Inc. of South San Francisco, Calif., is developingDNase, a mucus-dissolving enzyme, to treat CF patients. Otherpossible indications for DNase are bacterial pneumonia, chronicbronchitis and emphysema.

SLPI and DNase are very complementary products, which hitdifferent parts of the cascade of symptoms, said Simon. Trialsof both products are going very well, he said.

Synergen, based in Boulder, Colo., began Phase I clinical trialsof SLPI in December and plans to start Phase II trials later thisyear. The company received a U.S. patent on SLPI in 1988.

Genentech this week began Phase II trials of DNase, whichreceived orphan drug status in January to treat CF. Thecompany has applied for patents, but none have yet issued.

Synergen common stock (NASDAQ:SYGN) closed Thursday at$33, up $2.75.

-- Karen Bernstein BioWorld Staff

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