GENENTECH'S hGH APPROVED IN USA

Genentech has received approval to market its recombinant human growth hormone product, Nutropin, for the treatment of short stature caused by GH deficiency in the USA. The approval came on the same day that Eli Lilly's period of orphan drug exclusivity for its Humatrope (somatropin) product ran out.

Nutropin is Genentech's second hGH product in the market - its Protropin version, first launched in 1985, is slightly different in structure to Nutropin and Humatrope and so was granted a separate orphan exclusivity by the US Food and Drug Administration. Nutropin has already been approved in the USA for the treatment of short stature associated with chronic renal insufficiency (Marketletter November 1, 1993), and is under development as a treatment for short stature in patients with Turner's syndrome.

Protropin, which was first launched in the USA in 1985, currently holds around 75% of the market and had sales in 1993 of $216 million, up 5% over 1992.