Genetics Institute Inc., which last year won a lengthypatent dispute over its clot-dissolving drug withGenentech Inc., licensed out development of therecombinant novel plasminogen activator (NPA) toBristol-Myers Squibb Wednesday.

Genetics Institute, of Cambridge, Mass., handed overcontrol of Phase II trials of NPA in the U.S., Canada andEurope to Bristol-Myers, of New York, for what wastermed a small up-front payment. Genetics Institute willreceive $15 million within the next two years if thepharmaceutical maker takes the heart attack drug intoPhase III studies.

If Bristol-Myers progresses to late-stage development, itwill have rights to manufacture and market thethrombolytic worldwide _ except in the Far East whereJapan-based Suntory Ltd. has licensed NPA. GeneticsInstitute also will receive royalties from Bristol-Myersthat increase to 15 percent based on sales.

Genetics Institute's stock (NASDAQ:GENIZ)Wednesday jumped $1.12 to close at $38.

If NPA makes it to the U.S. market it faces stiffcompetition from South San Francisco-based GenentechInc.'s Activase (t-PA), which accounts for 70 percent ofall sales despite being 10 times more expensive thanstreptokinase, the second most popular thrombolytic.Streptokinase is sold by Astra AB and Kabi PharmaciaAB under the name Kabikinase.

NPA is a modified version of t-PA. Genentech andGenetics Institute were locked in a patent fight over thedrugs until June 1994 when the U.S. Court of Appeals forthe Federal Circuit reversed a 1990 jury finding that NPAinfringed Genentech's patents.

Gabriel Schmergel, Genetics Institute's president andCEO, said his company currently is focused on bringingto market several products in the area of hematology andoncology. NPA, he said, was Genetics Institute's onlycardiovascular drug.

"Genentech has a large sales force," Schmergel said. "Itwas not appropriate for our company to build up a salesforce to attempt to compete."

Bristol-Myers, on the other hand, has a variety ofproducts aimed at chronic cardiovascular disorders, suchas hypertension, high cholesterol and heart failure. NPAwould be the drug maker's first acute care interventionfor heart attacks.

Schmergel said joining with Bristol-Myers made moresense than developing NPA alone.

He added Genetics Institute was able to sell Bristol-Myers on NPA because of strong data from Phase II trialsin Japan conducted by Suntory. The Japanesepharmaceutical firm has Phase III studies already underway.

Bristol-Myers officials said Phase II trials of NPA in theU.S. will begin in January for treatment of heart attacks.

William Dunnett, Bristol-Myers spokesman, said thestudies will evaluate NPA against either t-PA orstreptokinase. In the Phase II Japan trials, NPAdemonstrated a rate of success that compared favorablywith t-PA, Dunnett said. n

-- Charles Craig

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