Follistim(R), first follicle stimulating hormone produced by recombinant DNA technology FSH launched in Japan

Main Category: Fertility
Article Date: 07 Aug 2005 - 11:00 PDT

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Follistim(R), Japan's first recombinant FSH for use in fertility treatments such as IVF or ICSI, will be introduced by Organon's Japanese affiliate Organon Nippon on August 11, 2005. Follistim(R) (follitropin beta, rec-FSH), is licensed for use in controlled ovarian stimulation (COS) for assisted reproductive technologies (ART) and is the first and only recombinant FSH approved in Japan for this indication.

The introduction of Follistim(R) means that women and their doctors in Japan now have at their disposal a modern fertility treatment in a ready-to-use solution that has been shown in trials to generate a high number of eggs for fertilization. Prof. Harumi Kubo, a fertility expert at Toho University in Tokyo and Vice-President of the Japanese Society of Fertility and Sterility explained the impact which Follistim(R) is likely to have in Japan: "Follistim is the first recombinant product in this category in Japan and therefore represents a long-awaited generation change in the treatment of infertility."

Follistim(R), produced genetically from laboratory cell lines, by recombinant DNA technology, offers an improved quality profile. Contrary to the existing urinary-derived hormones, Follistim consists of more than 99% pure FSH, is free of urinary proteins, and has excellent batch to batch consistency. It can reduce the total amount of drug per treatment cycle and can be injected under the skin subcutaneously rather than deep into the muscle, thereby minimizing pain and local injection site reactions. Studies have shown that Follistim(R) provides high efficacy measured in terms of the numbers of eggs for collection and embryos for transfer and storage, as well as the pregnancy rate including fresh and frozen treatment cycles.

The launch of Follistim(R) in Japan comes at a time when fertility rates in the country have declined markedly over recent years. The latest figures show that fertility rates in Japan hit a post-World War II record low in 2004, of just 1.29 children per couple, far below the rate needed to maintain population levels.

One reason for this trend is certain to be an increased prevalence of infertility among couples of reproductive age. This will likely have significant implications, not least a greater demand for infertility investigation and treatment. Over 15,000 babies were born in 2002 after ART treatment, already representing 1.5% of all life births in Japan. Follistim(R) will help clinics meet an increasing demand with a consistently pure product shown in trials to be easily administered and effective.

About Organon

Organon, headquartered in Roseland, NJ, creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel. Notes

Follistim(R) was first introduced in 1996 in Europe under the brand name Puregon(R), and in then in the USA under the brand name Follistim(R). Since then it has been widely used as a standard treatment for ovarian stimulation, either to induce ovulation for natural conception or donor insemination or (not licensed indications in Japan) to generate multiple eggs for IVF and ICSI.

Follistim(R) / Puregon(R) is recombinant FSH, a highly effective and widely used prescription fertility medication made from state of the art recombinant DNA technology. This hormone is identical to the follicle-stimulating hormone (FSH) produced by the pituitary gland and belongs to the group of gonadotropins, which play an important role in human fertility and reproduction. Follistim is licensed in Japan for women undergoing controlled ovarian stimulation (COS) for assisted reproductive technologies (ART).

http://www.organon.com/news

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