The Ares-Serono Group, which has had its recombinant humangrowth hormone on the international market for 10 years, will finallyget a chance to compete in the U.S.
The Swiss drug maker said Tuesday it received approval from theFDA to market its growth hormone, Saizen, for treating growthhormone deficiency in children. The same product, under the tradename Serostim, was approved in August for treating AIDS wasting.
Serono originally filed its new drug application for Saizen in 1989but had to wait until the orphan drug exclusivity expired in 1994 onEli Lilly & Co.'s Humatrope, a recombinant human growth hormonefor treating growth stature insufficiency. But worldwide Serono isselling the product in more than 60 countries for growth hormonedeficiency and in about 30 countries for Turner's syndrome. Thecompany had 1995 growth hormone sales of $95.5 million.
That experience will help Serono as it prepares to compete with anumber of other companies that have growth hormone productsapproved in the U.S., said Gina Cella, director of corporatecommunications for Ares-Serono's U.S. unit, Serono LaboratoriesInc., of Norwell, Mass.
"Our experience with growth hormone is unparalleled, both on thepediatric side and with AIDS wasting," Cella said. "It's a verydifferent scenario than being a brand new entry into the field.
"We're delighted," Cella said of the approval. "It means a lot to thecompany. We've waited a long time. We've maintained ourcommitment and support to the pediatric community for 10 yearswhile we didn't have a product on the market. We're excited we nowhave a product to offer."
Serono's growth hormone is made in mammalian cells and thereforewill face no legal challenge from Genentech Inc., of South SanFrancisco, which has kept some competitors off the market throughenforcement of its patent position. Genentech has been grantedpreliminary injunctions to keep Bio-Technology General Corp., ofIselin, N.J., and Novo Nordisk A/S, of Bagsvaerd, Denmark, fromselling their growth hormones in the U.S. Both had their productapproved in May 1995.
Genentech's products Protropin and Nutropin have held about 75percent of the $350 million U.S. market for growth hormonedeficiency. Lilly, of Indianapolis, has most of the rest withHumatrope. Pharmacia & Upjohn Co., of Kalamazoo, Mich., has alicensing deal with Genentech so its can sell its growth hormone,Genotropin.
Cella said pricing and marketing strategies will be disclosed whenSaizen is launched.
The Saizen approval was the third for Serono in the U.S. in sixweeks. In addition to Serostim the company got approval in Augustfor Fertinex, a follicle stimulating hormone indicated for patientsundergoing certain infertility treatments.
"The significance of having three of our products receive marketingclearance in a six-week period is important for our company and ourpatients," said Ares-Serono CEO Ernesto Bertarelli. "This is yetanother sign of our commitment to developing our presence in theU.S." n
-- Jim Shrine
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