Geneva, Switzerland, November 18, 2011 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for its variation application to extend the indication of Rebif (interferon beta-1a), its leading treatment for relapsing forms of multiple sclerosis (MS). The positive CHMP opinion is for the use of Rebif 44 micrograms three times weekly in patients who have experienced a single demyelinating event, an early sign of the disease, and who are at high risk of converting to MS.
"This is an important step towards making Rebif available across Europe to patients with early signs of multiple sclerosis," said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono. "It is part of our on-going commitment to improving access to Rebif for patients with this devastating disease, and supporting its appropriate use."
In addition to updating the indication section, the CHMP recommendation includes an update of the posology section adding the approved posology of Rebif in the first demyelinating event indication, and an update of the pharmacodynamic properties section summarising the design of the REFLEX1 study together with its main results. The CHMP recommendation provides the basis for an amendment of the marketing authorisation to reflect the variation by the European Commission, which is expected within three months from the opinion.
The submission of a type II variation to extend the indication of Rebif was supported by the results of the REFLEX study. The REFLEX study was conducted with the HSAfree2 formulation of Rebif, which is now available in all European Union countries, Australia, Canada and Switzerland, as well as a number of countries in Asia, Latin America, Africa and the Middle East. The HSA-free formulation of Rebif is not available in the United States.
Merck Serono has a long-standing commitment to the therapeutic area of MS. The company continues to invest in discovering and developing treatment options in this area, including active life-cycle management initiatives targeting numerous aspects of Merck Serono’s foundation therapy Rebif (formulation, indication, delivery devices). In addition, the company continues to strengthen existing – and identify new – collaborations to advance research and bring therapies to market.
1. - REFLEX: REbif FLEXible dosing in early multiple sclerosis: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of the HSA-free formulation of Rebif (44 micrograms three times a week and 44 micrograms once a week) in Subjects at High Risk of Converting to Multiple Sclerosis
2. - HSA-free formulation of Rebif = human serum albumin-free formulation of Rebif About Rebif®
Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. Interferons are thought to help reduce inflammation. The exact mechanism is unknown.
Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*. Rebif® is available in a 22 micrograms and 44 micrograms ready-to-use pre-filled syringe and a titration pack (8.8 micrograms). Rebif® is also now available in two multidose cartridges [132 micrograms (three doses of 44 micrograms) and 66 micrograms (three doses of 22 micrograms)] for the use with the RebiSmart™ electronic auto-injection device, in several EU member countries, Switzerland and Canada, as well as in Australia. RebiDose™, a single-use disposable pen, which is pre-filled with Rebif®, is approved in the European Union, Australia and Canada, and was launched in several EU member countries in 2011. RebiSmart™ and RebiDose™ are not available in the United States.
Rebif® should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.
* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown. About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. 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.
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