Merck Serono's Commitment to Advance Multiple Sclerosis Care and Research Underscored by Data to Be Presented at AAN 2011 Meeting

GENEVA, April 8, 2011 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that new data from the company's multiple sclerosis (MS) portfolio will be presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN) taking place from April 9 to 16, in Honolulu, Hawaii. The data presented will focus on Rebif(R) (interferon beta-1a), an established therapy for relapsing forms of MS, and Cladribine Tablets, an oral short-course disease-modifying therapy currently approved and available under the trade name Movectro(R) in Australia and Russia as a treatment of relapsing-remitting MS and under regulatory review in Canada and other countries. In the United States, the company received a complete response letter from the Food and Drug Administration on Cladribine Tablets on February 28 and has requested an end-of-review meeting to discuss next steps.

"We are committed to providing treatments that meet the individual needs of people living with multiple sclerosis at the various stages of the disease," said Dr. Bernhard Kirschbaum, Merck Serono's Head of Global Research and Development. "The data to be presented at the upcoming AAN meeting further enhance our understanding of the clinical effects of Rebif(R) and Cladribine Tablets and underscore our commitment to advance multiple sclerosis care, research and outcomes."

The following abstracts have been accepted for presentation at the 63rd AAN Annual Meeting:

Rebif(R) (interferon beta-1a)

Platform presentation

- Magnetic Resonance Imaging Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Two Dosing Frequencies of Subcutaneous Interferon Beta-1a in Patients with Clinically Isolated Syndrome (REFLEX*) (presentation S21.006, Wednesday, April 13, 2011, 2:15 PM)

Poster presentations

- Clinical and Magnetic Resonance Imaging Predictors of Long-Term Outcomes in Patients with Relapsing-Remitting Multiple Sclerosis: Additional Analyses (poster P05.045, Wednesday, April 13, 2011, 2:00 PM)

- The CoMPaRe Study Comparing the MusiQoL and MSQoL-54 Instruments in Patients with Multiple Sclerosis (MS) Receiving Long-Term Therapy with Subcutaneous (sc) Interferon (IFN) Beta-1a: Further Assessment of Construct Validity (poster P06.058, Thursday, April 14, 2011, 7:30 AM)

- Efficacy of Two Dosing Frequencies of Subcutaneous Interferon Beta-1a on Risk of Conversion to Multiple Sclerosis in Patients with Clinically Isolated Syndrome: Results of a Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial (REFLEX*) (poster P07.194, Thursday, April 14, 2011 2:00 PM)

* The formulation used in REFLEX is currently not approved in the United States

RebiSmart(TM) (electronic device for self-injection of Rebif(R))

Poster presentation

- Final Results from a 12-Week, Phase IIIb Trial To Evaluate an Electronic Autoinjector in Patients with Relapsing Multiple Sclerosis (poster P04.194, Wednesday, April 13, 2011, 7:30 AM) (RebiSmart(TM) is currently not approved in the United States)

Cladribine Tablets

Poster presentations

- Investigating the Relationship Between Cladribine-Mediated Changes in Lymphocyte Counts and Clinical/Magnetic Resonance Imaging Outcomes in Patients with Relapsing-Remitting Multiple Sclerosis: Correlation Analyses from the Double-Blind, 96-week CLARITY Study (poster P02.174, Tuesday, April 12, 2011, 7:30 AM)

- Tolerability Profile of Cladribine Tablets Therapy for Patients with Relapsing-Remitting Multiple Sclerosis: Factors Contributing to Treatment Completion in the Double-Blind, 96-Week, Placebo-Controlled CLARITY Study (poster P03.243, Tuesday, April 12, 2011, 2:00 PM)

- Effects of Cladribine Tablets in Lymphocyte Subtypes: Insights from the Phase III, 96-Week, Double-Blind CLARITY Study (poster P03.216, Tuesday, April 12, 2011, 2:00 PM)

- Evaluation of the Treatment Effect of Cladribine Tablets in the Cohort of Patients Who Had Failed Prior Treatment with Injectable Disease Modifying Drugs: The CLARITY Relapsing Remitting Multiple Sclerosis Study (poster P04.197, Wednesday, April 13, 2011, 7:30 AM)

- Safety and Efficacy of Cladribine Tablets for Relapsing-Remitting Multiple Sclerosis in Patients with High Disease Activity: Results from the Phase III, 96-Week CLARITY Study (poster P07.195, Thursday, April 14, 2011, 2:00 PM)

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(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alfa), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride), (Egrifta(TM), tesamorelin), as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of over EUR 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 EUR 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 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.merck.de