GONAL-f Approved in Japan for Ovulation Induction in Infertile Women

GONAL-f Approved in Japan for Ovulation Induction in Infertile Women

GENEVA, Switzerland, July 16 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that the Japanese Ministry of Health, Labor and Welfare has granted approval to extend the indication of GONAL-f(R) (follitropin alfa for injection) to infertile women suffering from irregular or no ovulation (oligoovulation or anovulation) due to a dysfunction in the hypothalamic- pituitary system or polycystic ovarian syndrome. GONAL-f is a recombinant follicle-stimulating hormone currently approved in Japan for the treatment of male infertility.

The extended marketing authorization includes GONAL-f in 75 IU (International Units) vial and GONAL-f prefilled pen in 300 IU, 450 IU and 900 IU.

"Today in Japan, it is estimated that one in 10 couples suffer from infertility. With the fast approval of GONAL-f for infertile female patients, we are pleased to provide Japanese women access to the leading infertility treatment," said Franck Latrille, Executive Vice President Commercial International at Merck Serono. "To increase choice and convenience for patients, GONAL-f will be available in several strengths and formats including ready to use prefilled pens for injection," he added.

In Japan, GONAL-f has been indicated since 2006 to treat male hypogonadotropic hypogonadism (MHH) in combination with human Chorionic Gonadotropin (hCG), for the induction of spermatogenesis. The supplemental New Drug Application (sNDA) for ovulation induction in females was filed by Merck Serono in October 2008.

GONAL-f is currently approved in 77 countries for the treatment of male infertility and in 100 countries for female infertility. In 2008, global sales of Gonal-f rose by 5.9% to EUR460 million, compared to the previous year.

About Merck Serono and Fertility Treatment

Merck Serono is the world leader in fertility treatments, and the only company to offer a full portfolio of fertility drugs for every stage of the reproductive cycle and recombinant versions of the three hormones needed to treat infertility: GONAL-f(R) (follitropin alfa), to stimulate the ovaries and produce eggs in women and spermatogenesis induction in men; Luveris(R) (lutropin alfa), to stimulate follicular development in women who are profoundly LH deficient; Cetrotide(R) (cetrorelix acetate) to prevent a premature ovulation; Ovitrelle(R) (choriogonadotropin alfa), to help follicles mature and release eggs; and Crinone(R) (progesterone gel), to help establish and maintain a pregnancy.

About GONAL-f(R)

GONAL-f is a highly consistent recombinant human follicle-stimulating hormone (r-hFSH) Filled by Mass (FbM), prescribed to supplement or replace naturally occurring FSH, an essential hormone to treat infertility.

GONAL-f has been approved in 100 countries worldwide - among which 74 countries have approved GONAL-f prefilled pen - including Europe and the US with indications of stimulation of the growth of ovarian follicles and ovulation in women. It is the most widely prescribed gonadotropin in the world.

For males, GONAL-f has been approved in 77 countries worldwide, including Japan, for gonadal dysfunction associated with absence of sperm in the semen or male hypogonadotropic hypogonadism. In certain markets where GONAL-f is approved for this indication, the therapy needs to be in combination with human Chorionic Gonadotropin (hCG). In the US, GONAL-f(R) Multi-Dose, available as the GONAL-f(R) 1050 IU vial or GONAL-f(R) 450 IU vial is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure as well as for ovulation induction and the development of multiple follicles in the ovulatory female patient participating in an Assisted Reproductive Technology (ART). GONAL-f(R) RFF Pen and 75 IU vial is approved for women only in the US.

Important: GONAL-f (follitropin alfa for injection) should only be prescribed by physicians specializing in fertility or reproductive health. GONAL-f is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including: Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. GONAL-f is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use GONAL-f. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.

Merck Serono has leading brands serving patients with cancer (Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alpha), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of around EUR 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,700 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

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