Genentech Inc. announced Tuesday that it has received FDAapproval to market Nutropin, its recombinant human growthhormone (hGH) for the treatment of growth failure in childrencaused by inadequate levels of natural growth hormone.
The approval of the company's new drug application (NDA)coincides with the expiration of Eli Lilly and Co.'s patentprotection on Humatrope, its own hGH product currentlymarketed for the same indication. Genentech filed its NDAseven years ago.
Nutropin was first approved last November for the treatmentof growth failure due to chronic renal insufficiency prior tokidney transplantation, just 157 days after the submission ofthe company's marketing application.
Nutropin differs slightly from Protropin, Genentech's other hGHproduct already approved for growth hormone inadequacy inchildren. However, Nutropin is chemically identical toHumatrope. Genentech has orphan exclusivity for the use ofNutropin to treat growth failure associated with chronic renalinsufficiency, which affects about 3,000 children annually.
Genentech of South San Francisco, Calif., stressed that it is theonly company with an hGH product approved for twoindications. It is also the only company with two different hGHproducts approved for the same indication. The product willsell at $420 per 10 mg, a company representative said, orabout $18,000 per year -- comparable to the price ofHumatrope. The company estimated the number of childrensuffering from growth failure at 15,000 to 20,000.
The expiration of Lilly's Humatrope patent opens the market toseveral other competitors with chemically identical products,including Ares-Serono Group of Switzerland and Bio-Technology General Corp.
Genentech's stock (NYSE:GNE) closed at $47.38 per share onTuesday, down 50 cents.
-- Karl A. Thiel Business Editor
(c) 1997 American Health Consultants. All rights reserved.