GENEVA, Switzerland, July 16 -- 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.
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 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
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
For more information, please visit http://www.merckserono.com or
SOURCE: Merck Serono
Merck Serono, 9 Chemin des Mines, 1202 Geneva, Switzerland. Media Relations,