Follistim® Introduced In Japan In A Further Indication For The Treatment Of Infertility

Main Category: Fertility
Article Date: 11 Apr 2007 - 9:00 PDT

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Follistim®, the first recombinant FSH approved in Japan for use in IVF and ICSI, is now also available in Japan for the induction of ovulation in infertile women. Follistim's availability in this new indication means that women and their doctors in Japan now have at their disposal a modern fertility treatment in a ready-to-use solution. It is applicable in a full range of fertility treatments associated with assisted reproductive technologies (ART).

Follistim (also branded as Puregon®) was approved by the Japanese health authorities for use in ART in August 2005, and at that time, it was the first fertility drug manufactured by recombinant DNA technology to become available on the Japanese market. This breakthrough represented a long-awaited generation change in the treatment of infertility in Japan. Such a shift has also been reflected in the withdrawal of some older types of fertility hormone manufactured from the urine of menopausal women. Follistim is the only recombinant fertility hormone to be specifically approved in Japan for both ovulation induction and controlled ovarian stimulation associated with IVF/ICSI.

"Japan is one of the world's leaders in the treatment of infertility," said Willem de Laat executive vice president Medical Affairs. "Some important innovations and developments have been pioneered here, and it's appropriate that a modern fertility hormone like Follistim is now available in a broad range of treatments. Japan is an important market for Organon and we are sure its availability in this new indication will further develop our association with Japanese fertility clinics."

Ovulation induction is a fertility treatment usually indicated for women who have healthy fallopian tubes but hormonal disorders which prevent regular ovulation. A course of treatment with a fertility drug such as Follistim aims to stimulate the ovaries such that ovulation can occur and conception can be achieved naturally or through insemination. Because of the risk that multiple follicles might develop in the ovary, ovulation induction treatment is always carefully monitored.

Studies have shown that Follistim, produced genetically from laboratory cell lines, offers a more pure form of follicle stimulating hormone (FSH) than the earlier types derived from human urine. Follistim consists of pure FSH, is free of urinary proteins, and has excellent batch to batch consistency. It can reduce the total amount of drug used in each treatment cycle and can be injected under the skin (subcutaneously) rather than deep into the muscle, thereby minimizing pain and reactions at the injection site. Follistim was first introduced as Puregon® in 1996 in Europe, and since then more than 1 million children worldwide have been born following its use in infertility treatment.

Organon Japan has submitted new drug application files to the Japanese health authorities for two further innovations in the treatment of infertility: first, the Follistim Pen®, a simple convenient and easy to use delivery device designed to make injections less painful; and second, Orgalutran®, a GnRH antagonist whose use will decrease the treatment time in IVF by two or three weeks.

The new indication for Follistim in Japan comes at a time when fertility rates in the country remain low. At the end of 2006, a report from the National Institute of Population and Social Security Research for the Japanese ministry of health forecast a 30% decline in Japan's population over the next 50 years - from a total of 127 million to below 90 million. For the first time ever - in 2005 - Japan's mortality rate was higher than its birth rate (of 1.29 children per couple). The trend, said commentators, was caused by women marrying at a later age, deferring their first pregnancy and having fewer children.

Although the latest population figures from Japan suggest a modest upturn in the figures (a slightly higher birth total than mortality total), one consequence of the overall demographic trend is certain to be an increased prevalence of infertility among couples of an older reproductive age. This will likely have significant implications, not least a greater demand for infertility investigation and treatment. Follistim will help clinics meet an increasing demand with a consistently pure product shown in trials to be effective and easily administered.

* Follistim was first introduced in 1996 in Europe under the brand name Puregon, and in the USA under the brand name Follistim. 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 to generate multiple eggs for IVF and ICSI. More information about Follistim can be found at (http://www.follistim.com).

* Follistim/Puregon, recombinant FSH, is identical to the follicle stimulating hormone (FSH) produced by the human pituitary gland and belongs to the group of hormones known as gonadotropins; these play an important role in the regulation of human fertility and reproduction. Follistim is licensed in Japan for women undergoing controlled ovarian stimulation (COS) for assisted reproductive technologies (ART) and now for ovulation induction.

* Follistim/Puregon is Organon's number one product and a cornerstone of its innovations in biotechnology. Infertility treatments remain central to the company's R&D activities.

About Organon

Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

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