Genentech Inc. on Wednesday released financial results for itssecond quarter, reporting increased earnings due to strongproduct sales -- especially of Activase (tissue plasminogenactivator) -- and contract revenues.

The South San Francisco, Calif., company (NYSE:GNE) also tookthe opportunity to announce that its product for treating cysticfibrosis, Pulmozyme, is coming up for FDA Advisory Committeereview in early August, and that its "new" human growthhormone, Nutropin (a nature-identical recombinant version ofthe molecule), is now the subject of a product licenseapplication (PLA) filed with FDA on Tuesday.

Also boosting revenues is a settlement of a lawsuit filed lastyear by Schering Corp., which agreed to pay Genentech some$18.2 million in fixed license fees through 1996.

Genentech's earnings for the second quarter of 1993 were$10.4 million, or 9 cents a share, tripling earnings of $3.4million, or 3 cents per share, in the comparable 1992 period.Second quarter 1993 revenues increased 25 percent over thesame period in 1992, to $169.8 million from $136 million.

As far as product sales, "the release of the GUSTO trial resultson April 30 (see BioWorld, May 3) has had a positive impact onActivase sales," the company said. They increased by 14percent in one quarter (to $55.8 million in the second quarterfrom $49.2 million in the first quarter) and by 25 percent($44.6 million) over the second quarter of 1992.

Sales of Protropin (human growth hormone) increased 7percent in the second quarter of 1993, to $53.7 million, from$50.4 million in the comparable 1992 period.

Pulmozyme, Genentech's recombinant DNase for treating theconditions of cystic fibrosis, is scheduled to appear before theFDA's Pulmonary-Allergy Drugs Advisory Committee on Aug. 9.This is indeed a speedy time to review; Genentech filed thePLA on March 30. Only Taxol (for treating advanced ovariancancer), at five months, and AZT (for treating AIDS) at about sixmonths, have come close to such short time frames.

Nutropin, on which Genentech filed a PLA for treating shortstature associated with chronic renal insufficiency in children,is the company's second version of recombinant human growthhormone. The first version, Protropin, is a methylated form ofthe hormone; Nutropin is non-methylated (and identical to theversion that Eli Lilly and Co. has been marketing since 1987 asHumatrope).

Schering Corp., a subsidiary of Schering-Plough Corp.(NYSE:SGP) of Madison, N.J., filed a suit in Newark in June 1992,contesting Genentech's claims pertaining to production ofSchering's recombinant alpha interferon, Intron-A.

The U.S. patent, No. 4,704,362, covers intermediates involved inthe production of all recombinant proteins in microbial cells.Genentech said it has licensed the patent to 31 companies.

Intron-A is marketed in 59 companies for up to 16 indications,including hairy cell leukemia, Kaposi's sarcoma, venereal wartsand hepatitis C. Schering had 1992 sales of $478 million on thedrug (nearly double 1991 revenues of $251), spokesman SteveGalpin Jr. told BioWorld, and does not expect the license fee topose a material impact.

The 18.2 million license fee also entitles Schering to a licenseunder Genentech's newly issued U.S. Patent No. 5,221,619.Schering, claiming the biotechnology company had threatenedto sue it in January 1992, did not admit infringement butwanted to avoid litigation and resolve the issues, Galpin said.

Genentech's stock was up 50 cents a share on Wednesday,closing at $44.25.

-- Jennifer Van Brunt and Nancy Garcia

(c) 1997 American Health Consultants. All rights reserved.