GENEVA, Switzerland, November 8 /PRNewswire/ --
- Innovative Device Designed for Simple Everyday Use by Patients and Caregivers
Merck Serono, a division of Merck KGaA, announced today that its US affiliate, EMD Serono, Inc. received US Food and Drug Administration (FDA) approval of easypod(R), an innovative delivery system for the administration of Saizen(R) [somatropin (rDNA origin) for injection], a treatment for growth hormone deficiency. The first of its kind device in this therapeutic area, easypod(R) was designed in conjunction with patients and healthcare professionals for ease of daily use, reliability and convenience.
"In today's high-technology world, it is necessary to continue to innovate by developing delivery systems with easy-to-use settings and real-time data that empower patients and healthcare professionals to help improve patient care," said Fereydoun Firouz, CEO & President, EMD Serono. "easypod(R) is an example of our commitment to breakthrough thinking and technology designed to answer unmet patient and caregiver needs."
In developing easypod(R), patients, caregivers and healthcare professionals were surveyed for input on how to improve upon delivery systems for growth hormone therapy. The device was designed to help patients administer a subcutaneous daily injection, reliably and in just three simple key steps. A key feature of easypod(R) is preset dosing, which means that patients no longer have to set their dose every day. It also tracks the number of doses administered, allowing physicians to monitor patient adherence to therapy.
easypod(R) is intended for use with Saizen(R) click.easy cartridges after training from a healthcare provider. Although infrequent, injection site reactions can occur. easypod(R) and Saizen(R) click.easy are available by prescription only. Refer to http://www.saizenus.com for full prescribing information.
easypod(R) is currently available in Argentina, Australia, Austria, Brazil, Canada, Colombia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Norway, Portugal, Slovak Republic, Spain, Sweden, Switzerland, Turkey, United Kingdom and will be available in the United States soon.
About Saizen(R) (somatropin (rDNA origin) for injection)
In the United States, Saizen(R) is indicated for the treatment of children and adults with growth hormone deficiency. 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.
Merck Serono also offers the only needle-free drug delivery device for growth hormone. cool.click(R), exclusively for use with Saizen(R), lessens the fear and anxiety that patients may experience with subcutaneous injections. one.click(R) is the first auto-injector pen with a hidden needle for growth hormone in the United States and allows the insertion of the needle and injection of medication all in one step, with the simple click of a button.
About Growth Hormone Deficiency
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. More than 50,000 adults in the United States are growth hormone deficient, and 6,000 new cases are reported each year. It is recognized as a specific clinical syndrome.
About Merck Serono
Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck, was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.
Merck Serono has leading brands serving patients with cancer (Erbitux(R)), multiple sclerosis (Rebif(R)), infertility (Gonal-f(R)), metabolic and cardiometabolic disorders (Glucophage(R), Concor(R), Saizen(R), Serostim(R)), as well as psoriasis (Raptiva(R)). With an annual R&D investment of EUR 1bn, we are committed to growing our business in specialist-focused therapeutic areas such as Neurodegenerative Diseases and Oncology, as well as new therapeutic areas potentially arising out of our research and development in Autoimmune and Inflammatory Diseases.
Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 30,962 employees in 61 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.
Merck Serono, Media Relations, Tel: +41-22-414-36-00, 9 Chemin des Mines, 1202 Geneva, Switzerland