Michelle SladeAssociate Editor
The Ares-Serono Group announced Thursday that its Gonal-Fhuman follicle stimulating hormone (r-hFSH) produced theworld's first human birth from a recombinant infertilitytreatment.
The mother of the twins, born last week in Switzerland,received Gonal-F under a multinational clinical trial expected tobe completed by mid-1993.
This Phase III trial is evaluating the use of Gonal-F instimulating ovarian follicular development in womenundergoing in vitro fertilization (IVF) and embryo transfer(IVF-ET). So far, European and U.S. trials have resulted in morethan 20 pregnancies.
Infertility affects one out of every 12 couples of child-bearingage, Serono said.
Providing all goes well at the regulatory level, Hisham Samra,president of Serono Laboratories Inc. of Norwell, Mass., theAmerican subsidiary of Ares-Serono, estimated internationalmarketing approval for Gonal-F by mid-1994.
Follicle stimulating hormone (FSH) of urinary origin has beenused to stimulate follicle and egg maturation for in-vitrofertilization and embryo transfer in women who don't ovulateproperly, and in males to initiate or improve sperm production.
Gonal-F is identical to the natural hFSH molecule and, Samrasaid, is one of the first recombinant human glycoproteins to beobtained from mammalian host cells.
Compared with urine-originating FSH, Gonal-F can be producedin almost unlimited quantities, Samra said, solving problems ofraw material (urine) collections. In addition, said Samra, Gonal-F is purer and can be injected subcutaneously rather than bypainful intermuscular methods.
Gonal-F was developed by Ares-Serono's biotechnology facility,Ares Advanced Technology (AAT) of Randolph, Mass. AAT wasoriginally the human fertility division of Integrated GeneticsLaboratories Inc. (IGLI) of Framingham, Mass., which Ares-Serono acquired for about $12 million in early 1989 afterGenzyme Corp. topped Serono's $28 million bid to purchase allof IGLI.
Prior to the acquisition, IGLI was under contract to Ares-Serono for the specific research, which led to the discovery ofthe Gonal-F molecule. "The only change was that we actuallyacquired the division," Samra said. "The original researchfunding was always ours."
Ares-Serono owns the patents covering the only geneticengineering process to produce biologically active recombinantfertility hormones.
The company's current lead product is Pergonal, a urine-derived infertility treatment consisting of a fixed dual hormonecombination, but Samra expects this to "change dramatically incoming years."
Samra said recombinant methods will be able to produce eachof these hormones as single entities, which as such may beused for broader applications.
Ares-Serono, a major European pharmaceutical manufacturer,makes assays and hormones for the OB/GYN market, naturaland recombinant human growth hormones, and a variety ofover-the-counter products.
(c) 1997 American Health Consultants. All rights reserved.