Merck Serono Announces About 30,000 Patients Treated With easypod™, First Electronic Growth Hormone Injection Device

GENEVA, September 28, 2011 /PRNewswire/ --

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that about 30,000 patients^[1] have been treated using Merck Serono's growth hormone injection device, easypod™ since its introduction. Launched in January 2007, easypod™ is the first electronic injection device in this therapeutic area.  easypod™ has features like preset dosing designed to ease treatment administration as well as to monitor patients' adherence to the company's recombinant growth hormone therapy, Saizen^® ([somatropin (rDNA origin) for injection]).

The impact of patients' adherence to Saizen^® therapy on growth is currently being assessed in a multinational observational study, ECOS^[2], a long-term observational study, analyzing injection data recorded in easypod^[TM]. Yearly analyses of the data collected will be published over a period of up to five years of patient follow-up.

"Merck Serono is committed to helping patients in need of growth hormone to reach their full height potential by offering innovative injector devices", said Dr. Bharat Tewarie, Senior Vice President Global Business Unit Fertility and Endocrinology at Merck Serono. "We are pleased that easypod™ has been extremely well received. Caregivers and health care professionals are able to accurately monitor the amount and frequency of treatment administration, which are thought to play a major role in the outcome of this chronic treatment".

Merck Serono conducted a multi-center observational 3-month survey^[3] in 824 pediatric patients in need of growth hormone who started using easypod™ auto-injector. One of the important conclusions was that over 90% of the children in the survey stated a desire to continue using the device.

easypod™ is intended to administer daily subcutaneous injections of growth hormone. The device enables healthcare professionals to pre-set dosing levels, which may reduce the possibility of dose miscalculation by patients. No daily dose adjustment is required by the patient, and the injected dose is confirmed after delivery, informing the patients and their caregivers of the proper administration. The device also records the number of doses administered and the time the injection has been made, allowing a physician to monitor patient adherence to therapy and to open a dialogue with his/her patients on any variation to the treatment regimen that could be identified.  While infrequent, injection site reactions can occur with patients using easypod™, which should only be used according to the instruction manual and only after proper training from a healthcare provider.

easypod™ can be used to deliver some of Saizen^® 8mg click.easy^® freeze-dried preparationafter reconstitution with solvent or Saizen^® ready-to-use liquid formulation, Saizen^® Solution For Injection^[4]. easypod™ has been approved and launched in more than 40 countries so far, including the EU and the United States .

^[1]Data on file

^[2]Easypod Connect Observational Study protocol (data on file)

ECOS is not conducted in the US.

^[3]Bozzola et al. Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their patients. BMC Endocrine Disorders, 2011, 11:4

^[4]Following the decentralized approval in Europe obtained in December 2010, Saizen^® Solution For Injection has been launched in eight countries. Launches are currently rolled out in Europe, following the granting of national marketing authorizations. Saizen^® Solution For Injection is not available 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^{[® ]}[somatropin (rDNA origin) for injection]

Saizen^® and Saizen^® Solution for Injection are formulations of recombinant human growth hormone (GH).

Saizen^® 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^® should not be used in patients with active malignancy, diabetic retinopathy, or in Prader-Willi syndrome patients with severe obesity or respiratory impairment.

Saizen^®  Solution for Injection is not available in all markets.

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.

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 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.merckgroup.com