Merck Serono to Present New Data on Multiple Sclerosis at the American Academy of Neurology's 64th Annual Meeting

GENEVA, April 20, 2012 /PRNewswire/ --

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that new data from the company's multiple sclerosis (MS) portfolio will be presented at the American Academy of Neurology's 64^th Annual Meeting (AAN), taking place from April 21 to 28, in New Orleans, Louisiana. The data presented will focus on Rebif^® (interferon beta-1a), an established therapy for relapsing forms of MS, and ONO-4641 (S1P receptor agonist), an investigational oral drug in Phase II for the treatment of relapsing-remitting MS, for which Merck KGaA signed a collaboration agreement with Ono Pharmaceuticals in October 2011.

"Presentations to be made at the upcoming AAN meeting further improve our understanding of the clinical effects of Rebif^® and show phase II results on our new investigational drug ONO-4641," said Dr Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono. "We are committed to advancing multiple sclerosis care, research and outcomes in order to provide treatments for people living with this devastating disease."

The following abstracts have been accepted for presentation at the 64^th AAN Annual Meeting:

Rebif^® (interferon beta-1a)

Data blitz^[1] presentation followed by a poster presentation

- Efficacy of two dosing frequencies of subcutaneous interferon beta-1a on the risk of conversion from a first demyelinating event to multiple sclerosis and on MRI measures of disease: 3-year results of Phase III, double-blind, multicentre trials (REFLEX and REFLEXION) (presentation #014, Wednesday, April 25, 2012, 6:24 PM)*

* The formulation used in these studies is currently not approved in the United States.

Poster presentations

- Subcutaneous interferon β-1a in children and adolescents with multiple sclerosis: an international retrospective study of 307 patients (poster session P04.119, Wednesday, April 25, 2012)**

- Disease characteristics, dosing, and outcomes of subcutaneous interferon β-1a treatment differ between children and adolescents with multiple sclerosis (poster P04.120, Wednesday, April 25, 2012)**

** This retrospective cohort study examines both Rebif and the serum-free formulation of Rebif.
The serum-free formulation of Rebif is currently not approved in the United States.

- Association of Targeted Blood Biomarkers with Interferon Beta-1a Treatment Administration, Magnetic Resonance Imaging Activity, and Treatment Response (poster P02.089, Tuesday, April 24, 2012)

ONO-4641 (S1P receptor agonist)

- Data blitz^[1] presentation followed by a poster presentation

- A double-blind, placebo-controlled, Phase 2, 26-week DreaMS trial of a selective S1P receptor agonist ONO-4641 in patients with Relapsing-Remitting Multiple Sclerosis (presentation #013, Wednesday, April 25, 2012, 6:21 PM)

^[1] A "data blitz" presentation is a 3 minute oral presentation included in a 45 minutes oral session.

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^® can either be administrated with the RebiSmart™ electronic auto-injection device or with the RebiDose™ single-use disposable pen. Rebif^® can also be administered with the autoinjector Rebiject™ II or by manual injection using ready-to-use pre-filled syringes. These injection devices are not available in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif^® in early multiple sclerosis. The extension of the indication of the formulation of Rebif^® is unavailable 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. With headquarters in Geneva, Switzerland, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurodegenerative diseases, oncology and rheumatology.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of €10.3 billion in 2011, 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 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.

For more information, please visit http://www.merckserono.com or http://www.merckgroup.com