Genentech Inc. said Wednesday it filed a new drugapplication (NDA) seeking approval of Nutropin for athird indication _ the treatment of growth failureassociated with Turner's syndrome.

Turner's syndrome is a genetic defect that causes medicalproblems in females, including short stature and physicaldeformities. About 4,000 girls in the U.S. who sufferfrom short stature associated with Turner's syndromemay be eligible for Nutropin therapy, Genentech said.

Nutropin, a recombinant human growth hormone, alreadyis approved for growth hormone inadequacy in childrenand for growth failure due to chronic renal insufficiency.Protropin, Genentech's other approved growth hormoneproduct, also is used to treat growth hormone inadequacyin children.

Genentech, of South San Francisco, based its NDA ontwo long-term studies that showed improvement in thegrowth rate and an overall increase in the adult height ofNutropin-treated girls with Turner's syndrome, comparedto their projected adult height or historical controls.

"We've been studying and researching this indication for12 years," said Kathleen Rinehart, Genentech's corporatecommunications manager. "It shows our commitment tothis group and to growth hormone. It's exciting for thesepatients that there potentially is going to be a treatmentfor them."

Another company developing treatments for Turner'ssyndrome, Bio-Technology General Corp., of Iselin, N.J.,has two products that have completed Phase III trials:ethinyl estradiol, a hormone, and the steroid Oxandrin,which currently is in a treatment investigational new drugprogram.

Jennings Will Return To His Post

In unrelated action involving Genentech, a federal districtcourt judge in Minneapolis late Tuesday acquitted acompany sales and marketing executive who was accusedin a kickback case related to Nutropin. (See BioWorldToday, Aug. 8, 1994, p. 1.)

Edmon Jennings, vice president of sales and marketing atGenentech, was acquitted on the three charges he faced ina 51-count indictment alleging he, Caremark Inc., andthree Caremark executives conspired to pay a Minnesotapediatric endocrinologist $1.1 million between 1986 and1993 to promote Protropin sales.

Caremark, of Northbrook, Ill., distributes Protropin in theU.S. Its three officials also were acquitted on all charges.Caremark, however, pleaded guilty to similar charges inJune and agreed to pay $161 million in fines.

Jennings, who has been with the company nine years, willreturn to Genentech with the same title.

Genentech's stock (NYSE:GNE) gained 25 centsWednesday to close at $48.13 per share. n

-- Jim Shrine Staff Writer

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