Merck Serono Received European Approval for Three Pre-filled, Ready-To-Use Pen Injectors for Fertility Treatment

By Merck Serono S A, PRNE
Sunday, July 3, 2011

GENEVA, July 4, 2011 -

Merck Serono, a division of Merck KGaA, Darmstadt, Germany,
today announced that the European Commission (EC) has granted an
approval for three pre-filled, ready-to-use pen injectors for
fertility treatment. This “family of pens” is designed for
self-administration of the liquid formulations of its three
recombinant gonadotropins used in fertility treatments:
GONAL-f® (follitropin alfa) 300 IU, 450 IU and 900 IU,
Luveris® (lutropin alfa) 450 IU and Ovidrel®/
Ovitrelle® 250 micrograms (choriogonadotropin alfa).

“Merck Serono is continuously working on improving its
administration devices in order to meet patients’ and healthcare
professionals’ needs”, said Dr. Bharat Tewarie, Senior Vice
President Global Business Unit Fertility and Metabolic
Endocrinology at Merck Serono. “Fertility treatment specialists
were involved from the beginning in the development of the new
devices for the Merck Serono gonadotropins portfolio for fertility
treatment.  We are pleased to introduce today the specially
designed injection devices that combine key features recommended by

The newly approved prefilled pens were designed to facilitate
daily administration by patients during their fertility treatment.
The pens immediately confirm that a complete dose was delivered, or
indicate the missing amount if an incomplete dose is injected.
 Other key features include a new graduated scale on reservoir
for patients to check the amount of medication remaining in the pen
and a bi-directional dose dial allowing them to correct the dose
dialed, if needed[1,2].

With a complete portfolio of gonadotropins, Merck Serono offers
fertility specialists the ability to tailor treatment to patients’
needs. Since the birth of the first IVF baby, nearly 4.3 million
babies worldwide have been born with help from in-vitro
fertilization techniques[3]. Merck
Serono has helped thousands of infertile couples to realize their
dream of becoming parents, and continues to seek new solutions that
meet patients’ treatment needs.

The New GONAL-f® prefilled pens are approved and
launched in Australia, New Zealand, Canada and Switzerland, and are
approved in Europe. Ovidrel® / Ovitrelle® prefilled pen
is approved in Australia, New Zealand and Europe.
Luveris® prefilled pen is approved in Australia, Canada
and Europe.

[1] Christen et al. Expert
Opinion in Drug Delivery 2011.

[2] Abbotts  et
al. Patients Preference and Adherence

[3] ESHRE, Focus on
Reproduction - Sept. 2010

About Merck Serono and Fertility

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®
(follitropin alfa), to stimulate the ovaries and produce eggs in
women and spermatogenesis induction in men; Luveris®
(lutropin alfa), to stimulate follicular development in women who
are profoundly LH deficient; Cetrotide® (cetrorelix
acetate) to prevent a premature ovulation; Ovitrelle®
(choriogonadotropin alfa), to help follicles mature and release
eggs; and Crinone® (progesterone gel), to help establish
and maintain a pregnancy.

About GONAL-f®

GONAL-f is a highly consistent recombinant human
follicle-stimulating hormone (r-hFSH) available in Filled by Mass
(FbM) form, 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® Multi-Dose, available as the
GONAL-f® 1050 IU vial or GONAL-f® 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®
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. As all medicines,  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 patients who exhibit
prior hypersensitivity to FSH preparations and tumours of the
hypothalamus or the pituitary gland. It is also contraindicated for
women with ovarian enlargement or ovarian cyst of unknown
aetiology, Gynaecological haemorrhages of unknown aetiology and
ovarian, uterine or mammary carcinoma. Nursing women should not use
GONAL-f. Common side effects in women include OHSS, ovarian cysts,
headache, abdominal pain, abdominal distension, abdominal
discomfort, nausea, vomiting, diarrhoea and injection site
disorders. For complete product details, see full prescribing

About Luveris®

Luveris® (lutropin alfa) is a recombinant human luteinising
hormone (r-hLH) developed to support follicular growth in women
with severe FSH and LH deficiency. In the body, LH causes the
release of eggs (ovulation) during the menstrual cycle. Luveris® is
used together with FSH, which also stimulates ovulation. Luveris®
is approved in more than 70 countries.

About Ovitrelle®/Ovidrel®

Ovitrelle®/Ovidrel® is the world’s first and only recombinant
chorionic gonadotropin (r-hCG).  Ovitrelle®/Ovidrel® is
administered after the stimulation for the growth of follicles (or
eggs) by another hormone (FSH). Approved in more than 80 countries,
Ovitrelle®/Ovidrel® is indicated to induce final follicular
maturation and trigger ovulation in women with no ovulation, and to
induce final follicular maturation for women undergoing ART, such
as in-vitro fertilization.

About Merck

Merck is a global pharmaceutical and chemical company with total
revenues of € 9.3 billion in 2010, a history that began in 1668,
and a future shaped by more than 40,000 employees in 67 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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About Merck Serono

Merck Serono is the biopharmaceutical division of Merck KGaA,
Darmstadt, Germany, a global pharmaceutical and chemical company.
Headquartered in Geneva, Switzerland, Merck Serono discovers,
develops, manufactures and markets prescription medicines of both
chemical and biological origin in specialist indications. In the
United States
and Canada, EMD Serono operates as a separately
incorporated affiliate of Merck Serono.

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

With an annual R&D expenditure of over € 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 rheumatology.

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Merck Serono is a division of Merck.  



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