GENEVA, October 24, 2011 /PRNewswire/ --
- A new approach to monitoring injection data collected by easypod™ auto-injector in patients receiving a growth hormone treatment with Saizen®
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced the launch of easypod™ Connectin Europe. easypod Connect is a software designed to display patients' adherence information from easypod™ electronic auto-injector used exclusively with Saizen®[somatropin (rDNA origin) for injection] on a secured online database.
"Poor adherence may negatively impact treatment outcomes[1,2,3,4,5], especially in chronic conditions, such as growth hormone deficiency", said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono. "easypod Connectis a new approach enabling health care providers to monitor patients' adherence to growth hormone treatment, with the goal of better understanding its impact on treatment outcomes and more objectively adapting the treatment regimen to a single patient".
During patients' visit, after receiving patients' consent, injection history will be uploaded from the easypodinto a secured online database. easypod Connect provides the healthcare professional user with reports and different graphical representations of the injection history, which facilitates both monitoring and analysis of patients treatment adherence.
A specific module of easypod Connect is already used in ECOS*, the easypod Connect Observational Study, initiated at the end of 2010. This module offers investigators participating in the study the additional functionality to combine and manage injection patient records with growth and/or clinical outcome data. Patients' enrollment in ECOS has already been initiated in eight countries.
"As a company, we believe that we need to assess various aspects that may influence the impact of our medicines in the real world. By monitoring injections and thereby adherence to growth hormone, easypod Connect gives health care providers important information to consider when making decisions for their patients to improve treatment outcomes and Merck Serono is investigating ways to use this data with payers** to assess the cost consequences of non-adherence or non responsiveness to treatment[3,4,5,6,7,8]", added Thomas Bols, Vice President of Corporate Health Policy and Market Access at Merck Serono.
easypod Connect has been registered and marketed in Canada and Australia. In Europe, easypod connect is CE-marked. It is currently available in France and will be rolled out in other European countries in the coming months. It has not been submitted for use in US.
easypod is a delivery device that functions independently of easypod Connect.
*ECOS aims at following at least 1000 pediatric patients, receiving Saizen® therapy in approved indications and dosages, over a period of up to 5 years. The multinational study is being conducted outside of the US.
**subject to applicable local laws and regulations.
Cutfield et al. Final height in idiopathic growth hormone deficiency: The KIGS experience. KIGS International Board. Acta Paediatr Suppl.1999; 88:72-75.
Cole et al. Growth hormone (GH) provocation tests and the response to GH treatment in G H deficiency. Arch Dis Child. 2004; 89:1024-1027.
Haverkamp et al. Observations of Nonadherence to Recombinant Human Growth Hormone Therapy in Clinical Practice. Clinical Ther. 2008 ; 30 (2)
Adherence to Long-term Therapies: Evidence for Action, WHO 2003. http://www.emro.who.int/ncd/Publications/adherence_report.pdf
Cutfield et al., Non-Compliance with Growth Hormone Treatment in Children Is Common and Impairs Linear Growth. PLoS One. 2011; 6 (1).
Golay et al. Pharmacoeconomic aspects of poor adherence: can better adherence reduce healthcare costs? Journal of Medical Economics. 2011: 14 (5), 2011, 594-608
Haverkamp et al. A review of biopsychosocial strategies to prevent and overcome early-recognized poor adherence in growth hormone therapy of children. Journal of Medical Economics. 2011: 14 (4), 448-457
Chatelain et al. The economic value of the easypod™ electronic auto injector in improving the response to growth hormone (GH) in children with idiopathic growth hormone deficiency (IGHD): A cost-consequence analysis, Poster presentation, ISPOR 13th European Congress, Nov. 6-9, 2010, Prague, Czech Republic.
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.
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.
SOURCE Merck Serono S A