Genentech Inc., which spent about 7 years developing an easier-to-use liquid form of its recombinant growth hormone Nutropin, saidWednesday the FDA cleared the product for marketing.
Nutropin AQ (aqueous) will be used for the same indications as thefreeze-dried powder form of the drug, which is approved for childrenwhose short stature is caused by growth hormone inadequacy orchronic renal insufficiency. The powdered form of Nutropin has beenmarketed since 1993. A similar product, Protropin, for growthhormone inadequacy, was approved in 1985.
Kathleen Rinehart, spokeswoman for South San Francisco-basedGenentech, said liquid Nutropin was designed for more convenientuse by eliminating the preparation required to convert the powderinto an injectable form for patient administration.
Rinehart said Nutropin AQ eventually may replace both powderedforms of the growth hormone _ Nutropin and Protropin. The priceof the drug, an average $18,000 annually per patient, will not beaffected by the change in composition.
Genentech received approval of Nutropin AQ as it prepares for theintroduction by Pharmacia & Upjohn Co. of the first competinggrowth hormone drug in the U.S. in nearly 10 years. Pharmacia &Upjohn, of Kalamazoo, Mich., received FDA approval of Genotropinin August 1995 and expects to begin selling it in the first half of1996.
Genentech and Eli Lilly and Co., of Indianapolis, whose growthhormone Humatrope was approved in 1987, have had the estimated$350 million U.S. growth hormone market to themselves, withGenentech accounting for about 75 percent of sales.
Genentech has kept other would-be competitors _ Novo NordiskA/S, of Bagsvaerd, Denmark, and Bio-Technology General Corp., ofIselin, N.J. _ out of the U.S. through aggressive litigation of patentinfringement claims.
Pharmacia & Upjohn faces no such court challenge based on a 10-year co-development and co-marketing deal in which Genentechlicensed its growth hormone patents to Pharmacia AB, of Stockholm,Sweden. Pharmacia and Upjohn Co. merged last year. Under the1985 agreement with Genentech, Pharmacia could begin selling itsgrowth hormone in the U.S. as of November 1995.
Rinehart said the major challenge in creating Nutropin AQ involvedmaking sure the large growth hormone protein remained stable anddid not break apart in liquid form. Genentech also conducted clinicalstudies to demonstrate the aqueous Nutropin was as effective as thepowdered form and did not cause more troublesome side effects.
Genentech submitted a new drug application for Nutropin AQ inNovember 1994. Rinehart said the product is the first liquid growthhormone to reach the market.
Genentech's stock (NYSE:GNE) closed Wednesday at $52.87, down25 cents. n
-- Charles Craig
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