EMD Serono Canada Inc.

EMD Serono Canada Inc.

February 23, 2009 13:08 ET

EMD Serono Canada Inc.: Health Canada Recommends Suspension of Raptiva® in Canada

MISSISSAUGA, ONTARIO--(Marketwire - Feb. 23, 2009) - Based on a recommendation by Health Canada, EMD Serono Canada Inc., the Canadian affiliate of Merck Serono(1) who markets Raptiva® in Canada, is suspending Raptiva® from the Canadian marketplace due to safety concerns, including the occurrence of Progressive Multifocal Leukoencephalopathy (PML) in patients taking this medication. In Canada, Raptiva® is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.

Although many patients may have benefited or are still benefiting from treatment with Raptiva®, this action is necessary to ensure patient safety is paramount. Within a few months from now the product will no longer be available on the Canadian market.

Prescribers in Canada are advised not to issue any new prescriptions for Raptiva® and to review the treatment of patients currently taking this medicine to assess the most appropriate alternatives as soon as possible.

Merck Serono(1), a division of Merck KGaA, Darmstadt, Germany, announced on February 19, 2009, that the European Medicines Agency (EMEA) has recommended to the European Commission the suspension of the marketing authorization for Raptiva® in the European Union. A benefit/risk analysis conducted in Europe by the EMEA has determined that the benefit/risk ratio in the approved indication for Raptiva® has become unfavourable following safety concerns.

Over the recent months, Merck Serono was notified of three virologically confirmed cases of progressive multifocal leukoencephalopathy (PML) in patients treated with Raptiva® (efalizumab). Two cases were reported in 2008 to Genentech - which markets Raptiva® in the United States. Both cases occurred in patients aged 70 or older, who received Raptiva® for approximately four years. The first case was reported at the end of September 2008, the second at the end of October 2008. The patients have subsequently died. In the second half of January 2009, a third virologically confirmed PML case was reported in a patient aged 47 from Germany, who had been treated with Raptiva® for a little over three years.

Raptiva® was approved in Canada in 2005, and approximately 500 Canadian patients are currently being treated with Raptiva®. Since its approval in the United States in 2003, approximately 46,000 patients have been treated with Raptiva® worldwide, based on data from clinical trials and post-marketing experience.

About Raptiva®

Raptiva® (efalizumab) is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that are critically involved in the psoriatic skin inflammation. Raptiva® is designed to be administered once weekly via subcutaneous injection and can be self-administered by patients at home. In Canada, Raptiva® is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.

Merck Serono(1) has the rights to develop and market Raptiva® worldwide outside of the United States and Japan. To date, Raptiva® is available in 66 countries, amongst them many countries in Europe, Latin America, Asia as well as Australia and Canada. Raptiva® is licensed from Genentech, Inc., and Genentech retains development and marketing rights in the United States, where Raptiva® has been available since November 2003.

About Psoriasis

Psoriasis is a T-cell mediated disease, which is characterized by abnormal cell growth of keratinocytes and chronic inflammation clinically visible as thick, red, scaly, inflamed patches and plaques. Plaque psoriasis, the most common form of the disease, is characterized by sharp-edged inflamed patches of skin ("lesions") topped with silvery white scales. Psoriasis can be limited to a few spots, typically knees and elbows, but can also involve extensive areas of the body. Although it is highly visible, psoriasis is not a contagious disease. While there are a number of medications that may help control the symptoms of psoriasis, there currently is no known permanent cure.

About Merck Serono(1)

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD 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 cardiometabolic disorders (Glucophage®, metformin); (Concor®, bisoprolol); (Euthyrox®, levothyroxine); (Saizen® and Serostim®, somatropin). Not all products are available in all markets.

With an annual R&D expenditure of around 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 autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,800 employees in 59 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 www.merckserono.com or www.merck.de.

About EMD Serono Canada Inc.

EMD Serono Canada provides innovative drug therapies that address unmet medical needs in the areas of neurodegenerative diseases, fertility, endocrinology and dermatology. EMD Serono Canada Inc. is an affiliate of Merck Serono(1), Geneva, Switzerland. Merck Serono(1) is a division of Merck KGaA, Darmstadt, Germany. In Canada, Merck Serono(1) operates as EMD Serono.

For more information, please go to www.emdserono.ca.

(1) Merck Serono (Geneva, Switzerland) is the division for innovative prescription pharmaceuticals of Merck KGaA, a global pharmaceutical and chemical group based in Darmstadt, Germany. Its North American business operates in the United States and Canada as EMD Serono.

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