An FDA advisory committee narrowly rejected recommendingapproval for Swiss pharmaceutical maker Ares-Serono Group'sSerostim, a recombinant human growth hormone that would havecompeted with at least three others on the U.S. market.

Geneva-based Ares-Serono's U.S. subsidiary, Serono Laboratories,of Norwell, Mass., sought approval of Serostim for treatment ofAIDS wasting, or cachexia. The disorder, in which patients lose 10percent or more of their body weight, usually indicates theprogression of HIV to AIDS. Growth hormone treatments, Serono'sstudies showed, reversed wasting.

The Endocrinologic and Metabolic Drugs Advisory Committee,along with the Antiviral Drugs Advisory Committee, voted 8-to-7Friday against the drug, citing troubles with higher mortality ratesand doubting the true effects of the drug. The panel said it wouldsupport accelerated approval of Serostim, allowing the company tomarket it on a limited basis until further trials are conducted.

Serono has provided Serostim to AIDS patients for a year under atreatment investigational new drug (IND) application, which wasapproved by the FDA in February 1995.

Serono Laboratories, in a statement issued Monday, said it intends towork with the FDA and HIV community to demonstrate the benefit ofthe product. Trials in AIDS wasting are ongoing in Europe andJapan. Serono said it remains hopeful the agency will consider fullapproval as quickly as possible.

If Serostim was cleared for marketing, it would have joined acrowded field of three recently approved growth hormone drugs andtwo that have been on the market since the mid-1980s. The other fivetarget short children with growth hormone deficiencies, not AIDSwasting.

Genentech Inc.'s Protropin was the first recombinant growthhormone approved by the FDA in 1985. A companion product,Nutropin, for short children with chronic renal insufficiency, wascleared in 1993.

Genentech, of South San Francisco, dominates the more than $350million annual growth hormone market, accounting for 75 percent ofthe U.S. sales. Indianapolis-based Eli Lilly and Co.'s Humatrope wasapproved in 1987 and captures the other 25 percent.

About 20,000 children are treated with growth hormone, whoseannual cost can vary from $5,000 for a child to $20,000 for ateenager.

In addition to aggressive marketing, Genentech has protected salesthrough litigation claiming patent infringement. Lilly paid Genentech$145 million to settle an eight-year patent fight.

Genentech currently is embroiled in court battles against NovoNordisk A/S, of Bagsvaerd, Denmark, and Bio-Technology GeneralCorp., of Iselin, N.J.

Novo Nordisk's Norditropin and Bio-Technology General's Bio-Tropin were approved by the FDA in May 1995. Genentech keptboth drugs off the market with preliminary injunctions won in U.S.District Court in New York.

Last week the U.S. Appeals Court for the Federal Circuit threw outthe injunction against Novo, clearing the way for it to begin sellingNorditropin. An appeals court decision in Bio-Technology General'scase is expected soon.

Without the injunctions, Novo Nordisk and Bio-Technology Generalcould sell their hormone drugs while the lawsuits progress.

The other player in the market is Pharmacia & Upjohn Co., ofKalamazoo, Mich. Its Genotropin was approved by the FDA inAugust 1995.

Pharmacia & Upjohn will face no court challenges from Genentechdue to a 1985 licensing agreement between the two.

In preparation for more competition, Genentech developed a liquidform of its growth hormone for more convenient patientadministration. The FDA approved Nutropin AQ (aqueous) inJanuary 1996.

In seeking a label for AIDS wasting, Serono's potential market wouldhave been much larger than that for children suffering from hormonedeficiencies. As many as 160,000 AIDS patients are believed to havecachexia. However, the expensive cost of the drug could affect itsuse.

In other action by the FDA advisory committee, Lilly's Humalog, arecombinant insulin analogue, was recommended for approval.

Lilly officials said the diabetes drug is designed to act faster thandrugs based on normal human insulin in controlling glucose levels._ Jim Shrine contributed to this report. n

-- Charles Craig Staff Writer

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