Magazine article Drug Topics

Two New Fertility Drugs Offer Convenient Self-Administration

Magazine article Drug Topics

Two New Fertility Drugs Offer Convenient Self-Administration

Article excerpt

Two new fertility drugs-Gonal-F (follitropin alfa for injection), from Serono Laboratories, and Follistim (follitropin beta for injection), from Organon Inc.-appear ready to decrease the long-time shortage of fertility treatments. The drugs are strikingly similar and received Food & Drug Administration marketing clearance on Sept. 29.

Both drugs are non-urine-based recombinant follicle-stimulating hormones indicated for ovulation induction as well as for use in assisted reproductive technologies, such as in vitro fertilization. Their main selling point seems to be that both follitropin alfa and follitropin beta offer a higher degree of purity and consistency associated with genetically engineered products. Both can also be self-administered by patients and are therefore more convenient to use than older-generation urine-based fertility drugs. The urine-based preparations require the aid of a healthcare provider or the patient's partner to inject them deep into muscle tissue, according to Serono and Organon.

Serono is playing up follitropin alfa as a product that "offers women the convenience of subcutaneous self-administration and the high degree of purity and consistency inherent in a recombinant product." Meanwhile, Organon is promoting follitropin beta as "the first recombinant fertility drug that can be self-administered, enabling patients to treat themselves at home."

Historically, infertility drugs have been produced by extracting fertility hormones, or gonadotropins, from the urine of postmenopausal women. This labor-intensive process requires daily collection of the raw material from women donors, and, given natural fluctuations in urine composition, the manufacturing process is often difficult and complicated. Scott Chappel, Ph.D., Serono's executive v.p. of science and technology, said, "The use of recombinant technology eliminates these issues and delivers a consistent product, free of urinary substances."

Gene Memoli, pharmacist and director of reimbursement and disease management at Grieb's Pharmacy, a Darien, Conn., store which specializes in care for infertile couples, started receiving stock of both fertility drugs in October, just as Serono and Organon began detailing physicians about the new treatments. According to Memoli, the drugs will likely compete against each other based on price, but as yet it's unclear whether the new arrivals will win the price war against the older, less expensive urinebased fertility treatments.

Memoli said Follistim's AWP is $71.31 and Gonal-F's is $78.85. They'll compete against Fertinex (urofollitropin), the urine-based fertility treatment that Serono also manufactures, he said. Launched in May, Fertinex costs $67.95. "Fertinex replaced Serono's Metrodin and, like Gonal-F and Follistim, is a follicle-stimulating hormone, so the price of Gonal-F and Follistim are significantly higher," he noted. "I think we'll most likely see physicians prescribing them once they change their protocols."

Organon's follitropin beta can be administered either subcutaneously or intramuscularly. It was studied in the world's largest randomized in vitro fertilization study, which included 981 women undergoing in vitro fertilization at 18 centers in Europe. The results showed that it is safe and effective as compared with urofollitropin, which in 1996 was the most widely used folliclestimulating hormone treatment in the United States.

Follitropin beta mimics naturally produced follicle-stimulating hormone by promoting the development of follicles within the ovary. …

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