Genentech Inc. announced Tuesday that its treatment for cysticfibrosis, Pulmozyme, has been launched in the United Kingdom.The U.K. was the seventh country to approve the recombinantdornase alfa, which is currently sold in the U.S., Canada,Austria, Sweden, Spain and the Netherlands.
Pulmozyme was unanimously recommended for approval bythe European Committee for Proprietary Medicinal Products(CPMP) in January, and was subsequently licensed by the U.K.Medicines Control Agency, the government agency thatoversees prescription drugs under Britain's single-payerprogram.
Genentech of South San Francisco, Calif., applied for marketingapproval for Pulmozyme simultaneously in the U.S., Canada andEurope in March 1993 and expects further European approvalsin the near future.
The company estimated that about 6,000 people in the U.K. areaffected by cystic fibrosis (about one-fifth the number of U.S.patients). The drug will be priced the same in the U.K as it is inthe U.S. -- $27 per 2.5-mg ampule, which comes to a yearlycost of $9,855, a Genentech representative said.
Several analysts have predicted that based on a 20 percentmarket penetration during 1994, Genentech will achieveworldwide Pulmozyme sales of more than $90 million in itsfirst year on the market. With a similar penetration over theremainder of 1994, the U.K. could bring Genentech $10 millionin Pulmozyme sales.
Pulmozyme will be marketed in the U.K. (and, pendingnecessary approvals, in Germany, the Netherlands and Ireland)by Genentech Europe Ltd., a subsidiary of Genentech based inBasel, Switzerland. The drug will be marketed elsewhere inEurope by F. Hoffmann-La Roche Ltd., which will handlecustomer service, finance and distribution for all of Europe.
Genentech's stock (NYSE:GNE) closed at $48.25 per share onTuesday, down 63 cents.
-- Karl A. Thiel Business Editor
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