GENEVA, October 24 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that it has submitted a supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labor and Welfare for a new indication of GONAL-f(R) / GONALEF(R) (follitropin alfa for injection) for ovulation induction in infertile women. The sNDA submission is supported by a Phase III single-blinded controlled study conducted in Japanese women with no or irregular ovulation (anovulation or oligoovulation), including Polycystic Ovary Syndrome, which demonstrated the efficacy and safety of GONAL-f(R).
The submission of GONAL-f(R) in Japan for female infertility confirms our company's commitment to provide patients with a full portfolio of infertility medications for every stage of the reproductive cycle. When approved, women in Japan would have access to the leading recombinant human follicle-stimulating hormone delivered in the only ready-to-use pre-filled pen available on the market, to help them build families, said Franck Latrille, Executive Vice President Head of Commercial International at Merck Serono.
The sNDA submission file includes three presentations of GONAL-f(R) in a prefilled pen, for ready-to-use self-injection, designed to improve treatment convenience and accurate dosage delivery (GONAL-f(R) prefilled pen 300 IU, 450 IU, 900 IU). The GONAL-f(R) prefilled pen is specifically designed for infertility treatment and allows for multidose presentations. The sNDA file also includes GONAL-f(R) in 75 IU vial presentation.
Since 2006, GONAL-f(R) has been marketed in Japan under the brand name GONALEF(R), where it is indicated for male infertility in combination with human Chorionic Gonadotropin (hCG), for the induction of spermatogenesis in men with hypogonadotropic hypogonadism (MHH). The approved presentations for this indication include GONAL-f(R) 75 IU and 150 IU vials, as well as the recently approved GONAL-f(R) prefilled pen presentations (300 IU, 450 IU, 900 IU).
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) FbM (follitropin alfa), to stimulate the ovaries and produce eggs; 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.
GONAL-f(R) 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(R) has been approved in 100 countries worldwide - among which 74 countries have approved GONAL-f(R) 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(R) 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 all markets where GONAL-f(R) is approved for this indication, the therapy needs to be in combination with human Chorionic Gonadotropin (hCG).
Important: GONAL-f(R) (follitropin alfa for injection) should only be prescribed by physicians specializing in fertility or reproductive health. GONAL-f(R) 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(R) 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(R). Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.
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 approved for male and female infertlity. GONAL-f(R) RFF Pen and 75 IU vial is approved for women only.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. EMD Serono operates as an affiliate of Merck KGaA, Darmstadt, Germany, in North America.
Merck Serono has leading brands serving patients with cancer (Erbitux(R)), multiple sclerosis (Rebif(R)), infertility (Gonal-f(R)), endocrine and cardiometabolic disorders (Glucophage(R), Concor(R), Euthyrox(R), Saizen(R), Serostim(R)), as well as psoriasis (Raptiva(R)).
With an annual RD 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.
Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 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.
Merck Serono, 9 Chemin des Mines, 1202 Geneva, Switzerland, Media Relations, Tel.: +41-22-414-36-00