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 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.

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[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.

Merck Serono

CONTACT: Merck Serono S.A. - Geneva, 9 Chemin des Mines, 1202 Genève,Suisse. Media relations: Tel: +41-22-414-36-00.