Merck Serono: Ready-to-Use Formulation of Recombinant Growth Hormone Saizen Recommended for Approval in EuropeBy Merck Serono, PRNE
Sunday, November 14, 2010
Saizen(R) Solution For Injection Eliminates the Need to Reconstitute Powder for Injection
GENEVA, Switzerland, November 15, 2010 - 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. 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
"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
Saizen(R) Solution For Injection is not available in the
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
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
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
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.
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 www.merckserono.com
 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,
Merck Serono S.A. - Geneva, 9 Chemin des Mines, 1202 Genève, Suisse. Media relations: Tel: +41-22-414-36-00.
Tags: Geneva, Merck Serono, November 15, Switzerland