GENEVA, Switzerland,
November 15, 2010 /PRNewswire/ --
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has
successfully completed the Decentralized Procedure (DCP) allowing
for approval of Saizen(R) Solution For Injection (somatropin) in
the 18 participating Member States[1]. Marketing authorizations
enabling commercial sales in the individual countries are expected
over the next several months.
Saizen(R) Solution For Injection is a liquid formulation of
Merck Serono's recombinant growth hormone Saizen(R) indicated in
Europe for the treatment of growth
hormone deficiency in children and adult patients, as well as for
growth promotion in Children Born Small for Gestational Age, and in
children with Turner Syndrome or Chronic Renal Failure. To
accommodate individual patient needs, the new formulation will be
available in cartridges of 6 mg, 12 mg and 20 mg, designed for
exclusive use with Merck Serono's electronic injection device
easypod(TM) and needle-free auto-injector cool.click(TM) 2.
"Since the launch of Saizen, Merck Serono has continuously
developed new options to facilitate the delivery of Saizen therapy.
Used in conjunction with easypod, the different cartridge options
for Saizen Solution For Injection offer the flexibility to
administer in a single injection a wide range of doses from 0.15 mg
to 6.4 mg, which is the highest dose available in Europe for a liquid formulation. This
flexibility allows physicians to tailor recombinant growth hormone
treatment to patient individual needs," said Fereydoun Firouz, Head of the Merck Serono
Global Business Unit Fertility and Endocrinology.
"Adherence to treatment is one of the most important factors
behind success of growth hormone treatment and I believe that
simplifying the injection process can help patient be more adherent
with their treatment regimen," said Professor Pierre Chatelain, of Hôpital Mère-Enfant (Claude
Bernard University, Lyon, France).
"The introduction of Saizen Solution For Injection coupled with the
use of easypod allows patients to manage their daily injection and
healthcare professionals to assess growth using accurate patient
injection information. He added: "easypod is the only device that
records patient injections."
In Europe, the launch of
Saizen(R) Solution For Injection will be rolled out in the course
of 2011 following the granting of the national marketing
authorizations.
Saizen(R) Solution For Injection is not available in
the United States.
About Growth Hormone Deficiency (GHD)
Growth hormone deficiency occurs when the pituitary gland in the
brain is unable to release or produce adequate amounts of growth
hormone. In children, growth hormone deficiency causes slow growth,
and without treatment, few will reach their full height potential
as an adult.
It is estimated that the incidence of growth hormone deficiency
in children is between 1 in 4,000 and 1 in 10,000.
Adult growth hormone deficiency can also be a significant
problem which affects 3 in 10.000 each year. It is recognized as a
specific clinical syndrome.
About Saizen(R) (somatropin)
Saizen(R) and Saizen(R) Solution for Injection are formulations
of recombinant human growth hormone (GH).
Saizen(R) is currently registered in 79 countries (indications
vary according to countries) for the treatment of:
- GH deficiency in children
- GH deficiency in adult patients
- Children born Small for Gestational Age (not registered for
this indication in the US)
- Turner's syndrome (not registered for this indication the US)
- GH deficiency in children associated with chronic renal
failure (not registered for this indication in the US)
Saizen(R) should not be used in patients with active malignancy,
diabetic retinopathy, or in Prader-Willi syndrome patients with
severe obesity or respiratory impairment.
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 alfa), 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 more than EUR 1 billion, 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 7.7 billion in 2009,
a history that began in 1668, and a future shaped by approximately
40,000 (including Merck Millipore) employees in 64 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.
For more information, please visit http://www.merckserono.com or
http://www.merck.de
[1] Member States of the DCP are : Austria, Czech
Republic, Hungary,
Germany, Greece, Finland, France, Estonia, Latvia, Slovakia, Iceland, Ireland, Italy (reference member state), Spain, Sweden, Norway, Portugal, United Kindgom.