Healthcare Industry News: metabolic disease
News Release - January 30, 2007
Merck Serono Launches easypod(R), First Electronic Growth Hormone Injection Deviceeasypod® Was Designed to Improve Ease of Usage, Reliability and Convenience
GENEVA, Switzerland, January 30 (HSMN NewsFeed) -- Merck Serono (virt-x: SERO and NYSE: SRA) announced today the launch of a unique growth hormone injection device, easypod®, for the once-daily administration of Saizen® (somatropin), the company's recombinant growth hormone deficiency therapy. easypod® is the first of its kind in this therapeutic area and was designed to improve patients' ease of daily use, reliability and convenience. It has been developed in conjunction with patients and healthcare professionals and as a result has been specifically designed to meet their needs and simplify patients' daily treatment.
Dr Jovanna Dahlgren, Assistant Professor, Queen Silvia's Children's Hospital, Gothenburg, Sweden, said: "We are extremely encouraged by the response to easypod® from our young patients and their parents, as well as from nurses and physicians. It has been extremely well received, bringing additional benefits to the often sensitive task of administering daily therapy to children and young adults and supporting their adherence to that therapy. Above all, this device is easy to use and reliable."
Hans Christian Rohde, current Head of Global Therapeutic Area, Endocrinology, Merck Serono, commented: "This breakthrough technology reaffirms our commitment to innovation in metabolic diseases, especially in growth hormone deficiencies where compliance is a major limitation to treatment success. This is a significant advance in our patient drug device portfolio in this therapeutic area that will support our efforts to improve patient treatment and will distinguish us from existing injection devices."
easypod® is used in three simple key steps and delivers one daily injection subcutaneously to children and adults, designed to minimize discomfort and pain. The device enables healthcare professionals to pre-set dosing levels, reducing the possibility of dose miscalculation. No daily dose adjustment is required by the patient, and the injected dose is confirmed after delivery, giving the patients and their carers confidence in administration. The device also records the number of doses administered, allowing a physician to monitor patient compliance to therapy.
easypod® has been approved in Europe and is already available in Sweden, Norway, Finland, Canada, Australia, Italy and Germany, where it has been met with an extremely positive response from patients and healthcare professionals alike. January 2007 onwards will see the roll out of the device in other regions around the world.
About Growth Hormone Deficiency
Growth hormone deficiency occurs when the pituitary gland in the brain is unable to release or produce sufficient amounts of growth hormone. The problem can be congenital (malfunction of the pituitary gland and hypothalamus), idiopathic (unknown cause) or traumatic accidents or tumours.
In children, growth hormone deficiency causes slow growth and, without treatment, many will end with short stature as an adult. Growth hormone deficiency can also develop in adults as a result of tumours or surgery around the pituitary gland area. Growth hormone deficiencies in adults are a significant problem with a number of physiological consequences: changes in body composition (including central obesity), effects on lipids in the blood, changes in muscle strength and bone composition, increase in cardiovascular risk and psychological well-being (social isolation and depression).
Merck Serono Easy to Use Devices
Growth retardation affects children and requires chronic, long-term treatment with daily injections of recombinant growth hormone. Merck Serono is the only company to offer innovative needle and needle-free options to children and adults with growth hormone deficiency to help simplify treatment administration and encourage compliance.
Saizen® (somatropin) is a recombinant human growth hormone and is therapeutically equivalent to the natural growth hormone produced by the body. It is indicated for treating growth hormone deficiency in children and adults, as well as for treating Small for Gestational Age, Turner's Syndrome and Chronic Renal Failure outside the US.
easypod® is an easy to use device that administers a subcutaneous injection in three simple key steps - attach needle, inject dose, detach needle. As the dose is pre-set for each patient by the physician or healthcare professional, the risk of miscalculating the dose is reduced and no daily dose adjustment is needed. Patients' confidence is improved thanks to an immediate confirmation of the injected dose and the permanent display of the number of injections left in the cartridge. It also tracks the number of doses administered allowing physicians to monitor patient adherence to therapy. easypod® is CE marked by Serono Europe Ltd, an affiliate of Merck Serono S.A.
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Merck Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Merck Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on February 28, 2006. These factors include any failure or delay in Merck Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, the outcome of any government investigations and litigation. Merck Serono is providing this information as of the date of this press release, and has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.
About Merck Serono
Merck Serono is a global biotechnology leader, with sales in over 90 countries. The Company is the world leader in reproductive health, with Gonal-f®, Luveris® and Ovidrel®/Ovitrelle®. It has strong market positions in neurology, with Rebif®, as well as in metabolism and growth, with Saizen®, Serostim® and Zorbtive(TM). The Company has recently entered the psoriasis area with Raptiva®. Merck Serono's research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology and autoimmune diseases.
Bearer shares of Merck Serono S.A., the holding company, are traded on the virt-x (SERO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
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 about 35,000 employees (including Merck Serono) in 56 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 a 73% interest and free shareholders own the remaining 27%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
Source: Merck Serono
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