Competition for sales of recombinant human growth hormone ismoving from the courtroom to the marketplace in the U.S., but thenewest challenger, Novo Nordisk A/S, said Tuesday people shouldnot expect lower prices for the expensive treatments.

Novo Nordisk Pharmaceuticals Inc., the Denmark-based company'sU.S. subsidiary in Princeton, N.J., has received FDA approval ofNorditropin for treatment of short children with growth hormoneinsufficiency.

Norditropin is the first growth hormone product to compete in theU.S. with similar drugs sold by Genentech Inc., of South SanFrancisco, and Eli Lilly and Co., of Indianapolis.

Genentech's Protropin and Nutropin account for 75 percent of theU.S. growth hormone market and Lilly's Humatrope captures theother 25 percent. Genentech's Nutropin also is approved for growthfailure in children due to renal insufficiency. Total U.S. sales ofgrowth hormones in 1994 was about $340 million.

Lars Barfod, Novo Nordisk's vice president of marketing, said themajor sales battles will be fought for the approximately 3,500children a year diagnosed with the disease.

"There are about 20,000 youngsters currently treated with the growthhormones in the U.S.," he said. "We think we will get a significantshare of new patients."

Barfod said Norditropin initially will be priced the same as theproducts sold by Genentech and Lilly. Depending on the weight ofthe patient, treatment for one year can range from $5,000 in smallchildren to $20,000 for teenagers.

"It is not our intention to compete on price alone," Barfod said,adding that Novo Nordisk will try to make its product more attractivewith "added-value services," such as those offered in its Norditropintherapy management program.

Genentech spokesman Jim Weiss said his company has had numerousgrowth hormone therapy programs in place for years. He said theentrance of other products on the U.S. market has been anticipated.

"We will be competitive," he added. "We have a long-standingrelationship in this marketplace."

Barfod noted that outside the U.S. _ where Norditropin competeswith products from Genentech, Lilly, Bio-Technology General andAres-Serono Group _ price has not been one of the battlegrounds.All the products are sold for about the same amount, which is higherthan that in the U.S.

Novo Nordisk, which markets Norditropin in 66 countries, said its1994 worldwide sales of $220 million outpace those of Genentech,Lilly and Switzerland-based Ares-Serono.

Henrik Aagaard, president of Novo Nordisk North America, said,"Norditropin is the fastest growing of all the hormone products."

Both Bio-Technology General, whose growth hormone is sold asBioTropin, and Ares-Serono, whose product is called Saizen, areawaiting FDA action on their marketing applications.

Leah Berkovitz, spokeswoman for Iselin, N.J.-based Bio-TechnologyGeneral, said BioTropin is approved in seven countries and is not yeta major competitor. But she said the company expects moreEuropean approvals and FDA clearance this year.

"There is room for some price adjustment," Berkovitz said. "It's ahigh-cost drug with a high profit margin and there's some room foradjustment."

Patent Battles Are Pending

Genentech was first on the U.S. market in 1985 with Protropin.Despite Genentech's FDA-granted orphan drug status, giving it anexclusive market position for seven years, Lilly's growth hormonewas approved in 1987. Lilly also was granted orphan drug status bythe FDA and the two companies dominated sales until last year whenLilly's protection expired. Genentech has orphan drug status onNutropin _ approved in 1993 for children with renal insufficiency_ until 2000.

Legal action is among strategies Genentech has tried to keep itsmarket position dominant. The company has filed patent infringementlawsuits against all growth hormone makers, except Ares-Serono,which manufactures its recombinant DNA product using mammaliancells for expression. The others use bacteria.

Lilly settled its patent fight with Genentech earlier this year, agreeingto pay Genentech $145 million. Genentech's court battles with NovoNordisk and Bio-Technology General have been consolidated in U.S.District Court in New York.

Novo Nordisk and Bio-Technology General won an initial roundwhen the International Trade Commission (ITC) in January let standan administrative law judge's dismissal of Genentech's cases againstthe two. The ITC decision cleared the way for Novo Nordisk andBio-Technology General to sell their products in the U.S. if theyreceived FDA approval.

Aagaard said his company is confident it will prevail in future courtfights with Genentech.

He added that "at some point" Novo Nordisk will seek approval toexpand the label for Norditropin. Outside the U.S., the drug also issold for adult replacement growth hormone therapy and for growthfailure in children with renal insufficiency.

Aagaard said the FDA guidelines for promoting drugs are specific,prohibiting sales campaigns for off-label uses. He said Novo Nordiskwill not market Norditropin for any other indication than theapproved one _ treatment of children with growth hormoneinsufficiency.

Novo Nordisk wasted no time launching its marketing campaign.Some pediatricians received faxes Tuesday about the FDA approval.

Study Advocates Broader Drug Use

Genentech has been criticized for aggressive marketing in allegedlytrying to sell growth hormone for short children who are notdiagnosed with hormone insufficiencies. The FDA is examining thecompany's sales practices, but Genentech has said it does not engagein off-label promotion of drugs.

A study released Tuesday by Stanford University Medical Centerresearchers is certain to fuel the overall debate over use of growthhormone.

Raymond Hintz, a Stanford professor of pediatric endocrinology andthe study's principal author, reported that trials of 42 children whodid not fit in the technical definition of hormone deficient, but whowere shorter than 98 percent of those in their age group, benefitedfrom the hormone treatments.

The multi-center trials were conducted at 10 universities and thepatients were treated daily or three times a week for up to sevenyears.

"These are children in the lower 2 percent of the childhoodpopulation in terms of growth," Hintz said. "They are as short andgrowing as slowly as children who have a physical problems withtheir pituitary glands."

Medical treatment generally is triggered when children secrete lessthan 10 nanograms of hormone per milliliter of blood. Hintz said hisstudy shows that criterion is arbitrary.

"What this study means," he said, "is that that line is not as neat a lineas we hoped and that there are some very short children who coulduse the treatment and might not be getting it."

Hintz said he realizes the conclusions of his research may bemisinterpreted. "It's an over-extension to use this study to treat everykid who's a little short," he said.

The study was sponsored by Genentech, but Hintz said it wasindependent.

"This was a study that we thought should be done," he added, "andnobody else was going to support it."

Novo Nordisk's stock (NYSE:NVO) closed Tuesday at $27, up 12cents. Genentech (NYSE:GNE) was down 25 cents to $47.12. Lilly(NYSE:LLY) was down 62 cents to $73.25. n

-- Charles Craig

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

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