Merck Serono Initiates the First Observational Study to Evaluate Adherence and Clinical Outcomes of Growth Hormone Saizen(R) in Patients Using easypod(TM)

GENEVA, February 14, 2011 /PRNewswire/ -- Merck Serono, the pharmaceutical division of Merck KGaA, Darmstadt, Germany, today announced the enrollment of the first patients in ECOS, the Easypod Connect Observational Study. ECOS is the first long-term multi-national, observational study to assess the level of pediatric patients' adherence to Saizen(R) [somatropin (rDNA origin) for injection] therapy, Merck Serono's human recombinant growth hormone, delivered via its electronic auto-injector easypod(TM), which records injection data. Another objective of the study is to explore the potential impact of adherence on clinical outcomes in patients receiving Saizen(R) via easypod(TM).

ECOS aims at following at least 1000 pediatric patients, receiving Saizen(R) therapy in approved indications and dosages, over a period of up to 5 years. During their patients' medical visit, the investigators will monitor patients' injections history with the easypod(TM) built-in dose memory, which will be downloaded to a data storage software and internet platform.

"To date, treatment adherence has only been reported subjectively by patients receiving growth hormone therapy. ECOS will objectively reveal the adherence level of patients. The study will allow clinicians to identify patients who adhere poorly to treatment, and consequently we hope to be able to optimize the management and the response of an individual patient in the long term," said Prof. Peter Davies, chairman of the ECOS Scientific Steering Committee at The University of Queensland, Australia.

"Merck Serono's goal is to help children reach their full height potential by offering innovative solutions. Investigators will be able to capitalize on the built-in injection history memory of easypod(TM) to accurately measure the level of adherence and its potential impact on patients' growth outcomes while providing the medical community with country-specific data that may benefit the clinical management of growth hormone therapy," said Fereydoun Firouz, Head of the Global Business Unit, Fertility and Endocrinology, at Merck Serono.

Patients aged between 2 and 18 years, without a fused growth plate, and treated by Saizen(R) therapy using easypod(TM) are eligible to participate. An assessment of patient adherence will be performed on regular basis according to local practice. Yearly analyses of the data collected will be published over the 5 years of patient follow-up.

ECOS study is not planned to be performed in the US.

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.

Non childhood related 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 (rDNA origin) for injection]

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)
    - Growth failure in prepubertal 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 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 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 over 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 rheumatology.

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 33,600 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