Assisted Reproduction - Follistim(reg) (Puregon(reg)) Approved in Japan

Main Category: Fertility
Article Date: 14 Apr 2005 - 12:00 PDT

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Organon has received approval for Follistim(reg) - its recombinant Follicle-Stimulating Hormone (rec-FSH) - in Japan. Follistim is now licensed for use in Controlled Ovarian Hyperstimulation (COH) for assisted reproductive technologies (ART); and is the first and only recombinant FSH approved* in Japan.

Japan - which has 578 ART centers compared to 428 in the USA - is a very important market for Organon. Recent figures show that a total of 83,652 ART cycles were carried out in Japan in 2002 - compared to 115,392 in the USA - with the number of cycles increasing by around 10% annually. [2] The sales for gonadotropins in 2004 are estimated to be about 5.4 billion yen (54 million US $) of which half are estimated to be for Controlled Ovarian Hyperstimulation and half for Ovulation Induction (OI). Over 15,000 babies were born after ART in Japan in 2002 accounting for about 1.5% of the annual birth rate.

Follistim was first introduced in Europe in 1995 under the brand name Puregon(reg). In contrast to traditional products derived from the urine of menopausal women, Follistim is very pure and effective and has reduced the total doses needed for assisted conception. It reduces the number of injections required by women and can be injected under the skin subcutaneously rather than deep into the muscle reducing pain. Women treated with Follistim also have more eggs for collection, higher quality eggs and more embryos for transfer and storage than those treated with traditional urinary FSH products leading to higher pregnancy rates.

Organon's Japanese affiliate Organon Nippon is preparing to introduce Follistim in the course of this year. Drugs used for controlled ovarian hyperstimulation are not reimbursed by the Japanese National Health Insurance.

Organon - with shared head offices in Roseland, NJ, USA and Oss, The Netherlands - creates, manufactures 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 remain or become 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.

1 The approval relates only for use for Controlled Ovarian Hyperstimulation not ovulation induction.
2 Figures from the Japanese Society of Obstetrics and Gynecology.

http://www.organon.com

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