Subject: Genentech Sells Rights To Synthetic Protein Used by Hemophiliacs
Date: Published: 9/12/84 64 lines
Source:  Wall Street Journal.  Copyright Dow Jones Inc. 

   Genentech Sells Rights
   To Synthetic Protein
   Used by Hemophiliacs

   SOUTH SAN FRANCISCO, Calif. -- Genentech Inc. said it
granted to the Cutter Biologicals division of Miles
Laboratories Inc. production and marketing rights to its
synthetic Factor VIII, a blood-clotting protein used by
hemophiliacs.
   Miles Laboratories is the U. S. health-care subsidiary of
Bayer AG of West Germany.
   Cutter said it expects that it may take two years before
the product goes to human clinical trials of its safety and
efficacy.  The successful production of the synthetic protein
was first announced last April by Genentech, which said its
scientists had used recombinant DNA technology.
   To stem uncontrolled bleeding, hemophiliacs currently use
natural Factor VIII, which is extracted from human plasma.
There has been evidence linking the natural protein to AIDS,
or acquired immune deficiency syndrome.  So far, 43
hemophiliacs have contracted AIDS, according to the U. S. 
Centers for Disease Control.
   Genentech contends that its synthetic protein would be
highly purified, 4,000 times more active than the currently
available product and thus able to be administered in smaller
quantities to patients.
   The world-wide market for the clotting protein is
estimated at $150 million a year, one-third of that in the
U. S. Injections of the natural protein currently can cost
individual hemophiliacs between $10,000 and $20,000 a year,
Genentech has said.
   While Cutter and several other manufacturers still market
the natural protein, a Cutter spokesman said the company
"ultimately" will switch all its production to the synthetic
variety, pending approval by the Food and Drug
Administration.  "We expect it's the sole product that will be
desired by the hemophiliac community," said R. J. Modersbach,
a spokesman for Cutter.
   Neither Genentech nor Cutter has announced pricing plans
for the synthetic product.
   Under the proposed agreement with Genentech, Cutter would
receive exclusive commercial production rights world-wide.
After two years of marketing the product, Cutter then would
share with Genentech the marketing rights to the product in
the U. S. and Canada.
   As previously reported, Speywood Laboratories Ltd., in
Britain, Genentech's research partner in developing the
synthetic protein, retains marketing rights in certain other
countries.
   Though more precise terms of the accord weren't specified,
Cutter is to pay Genentech an undisclosed sum of cash in the
product's development phases, as well as subsequent
royalties.
   A definitive agreement is expected to be ratified soon by
both companies' boards, Genentech said.

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