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EMD Serono Canada Inc.-Raptiva: First Biologic Treatment for Psoriasis to Receive Public Reimbursement in Two Atlantic Provinces

TORONTO, ONTARIO--(Marketwire - Feb. 5, 2008) - EMD Serono Canada Inc. announces that Raptiva(R) (efalizumab) is the first biologic treatment for psoriasis to be approved for coverage through the provincial formularies in both Nova Scotia and New Brunswick.

Effective January 1, 2008, Raptiva(R) was approved for coverage as an Exceptional Status drug through Nova Scotia Pharmacare and the Family Pharmacare Program. Raptiva(R) was also approved for addition to the New Brunswick Prescription Drug Program (NBPDP) Formulary under Special Authorization; effective January 22, 2008. At present time, Raptiva(R) is the only biologic treatment for psoriasis to achieve benefit status in these provinces.

Important step towards providing access to biologics

"Physicians are very excited about the landmark decisions made in Nova Scotia and New Brunswick regarding formulary approval of Raptiva(R) in these provinces. It gives psoriasis patients access to a biologic medication that may provide a safer, more convenient, and more effective treatment versus traditional therapies," said Dr. Marc Bourcier, a dermatologist in Moncton, New Brunswick. "I endorse the Nova Scotia and New Brunswick health authorities for their decision, and hope that other provinces will follow suit."

These approvals are based on the Canadian Expert Drug Advisory Committee's (CEDAC) positive recommendation in 2006 that Raptiva(R) be covered for patients with severe, debilitating psoriasis. EMD Serono Canada Inc. is currently in discussions with other provinces to include Raptiva(R) on their formularies.

New Brunswick and Nova Scotia are receptive to psoriasis patients' needs

The NBPDP provides prescription drug benefits to eligible residents of New Brunswick who fall within one of the defined beneficiary groups. For more information, please visit the NBPDP website at www.gnb.ca/0051/0212/index-e.asp.

Nova Scotia Pharmacare provides assistance to eligible residents through a number of programs to help pay for prescribed medications and supplies listed in the Nova Scotia Formulary. Dermatologists in Nova Scotia will need to ensure that their patients are registered for the new Family Pharmacare Program before an Exceptional Status Form can be submitted to request Raptiva(R) reimbursement. The Nova Scotia Pharmacare website at www.nspharmacare.ca can provide further information on this program.

EMD Serono Canada Inc. provides assistance with reimbursement

The reimbursement specialists at the Clear Support Program(TM), a Raptiva(R) patient support service provided by EMD Serono Canada Inc., can provide reimbursement counseling and ongoing assistance with the administrative process for reimbursement of Raptiva(R) under the respective provincial formularies. The Clear Support Program's(TM) reimbursement specialists are available to answer questions at 1.866.440.4245.

About EMD Serono Canada Inc.

Raptiva(R) is marketed in Canada by EMD Serono Canada Inc.

As a leader in the Canadian biotech pharmaceutical industry, EMD Serono Canada Inc. is driven to improve the quality of patients' lives through the integration of cutting-edge science with state-of-the-art patient support. The company's commitment to discovering and developing innovative products that address unmet medical needs, has lead EMD Serono to market seven biotech drug therapies in theareas of Neurology, Reproductive Health, Metabolic Endocrinology, and Dermatology. EMD Serono Canada Inc. is an affiliate of Merck Serono S.A., Geneva, Switzerland. Merck Serono is a division of Merck KGaA, Darmstadt, Germany. The division was established on January 5, 2007, following the acquisition of Serono S.A. by Merck KGaA.

About Merck KGaA

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 30,962 employees in 61 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. Today, Merck & Co. holds the North American rights to the name, and Merck KGaA holds the rights to the name Merck in the rest of the world. Merck & Co. and Merck Frosst have no affiliation with EMD Serono or Merck KGaA. For more information, please visit www.emdserono.ca or www.merck.de.

About Raptiva(R)

Raptiva(R) is a humanized therapeutic antibody that can provide patients with safe and effective long-term continuous control of their psoriasis. It can be self-administered by patients at home through a single, once-weekly, subcutaneous (under the skin) injection.

Raptiva(R) is generally well tolerated. The most common adverse events observed during Raptiva(R) therapy were mild to moderate flu-like symptoms, headache, fever, chills, nausea, and myalgia. These reactions were greatest with administration of the first dose, decreasing with the second and subsequent doses. Serious adverse events were infrequent and occurred at only a slightly greater frequency in the Raptiva(R) group (2%) than in the placebo group (1%). No cumulative end-organ toxicity or increased malignancy or infection was apparent in patients taking Raptiva(R) in short-term or long-term studies.(1)

Indications: Raptiva(R) 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.(1)

Contraindications: Raptiva(R) is contraindicated in: patients who are hypersensitive to efalizumab, or to any ingredient in the formulation, or Chinese Hampster Ovary cell proteins; patients with history of malignancies or existing malignancies; patients with immunodeficiencies; patients with active tuberculosis and other severe infections.(1)

Adverse Events: The most serious adverse drug reactions (ADRs) observed during treatment with Raptiva(R) in clinical trials or from post-marketing experience are: serious infections, malignancies, thrombocytopenia, hemolytic anemia, arthritis events, and psoriasis worsening and variants. The most common ADRs observed during RAPTIVA therapy were mild to moderate dose-related acute flu-like symptoms including headache (32%), fever (7%), chills (13%), nausea (11%) and myalgia (8%). In large placebo-controlled clinical studies, these reactions were observed in approximately 41% of RAPTIVA-treated patients and in 24% of placebo-treated patients over 12 weeks of treatment. Headache was the most prevalent type of flu-like symptoms. These reactions were greatest with the first dose administration, decreasing with the second and subsequent doses. Severe acute events of headache, chills, fever and myalgia were reported only in the Raptiva(R)-treated subjects affecting 3.6% of subjects.(1)

- Observational, open-label, multi-centre, phase IV study of subcutaneously administered Raptiva(R) (efalizumab) in the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for treatment with Raptiva(R).

REFERENCES:

1. Raptiva(R) Product Monograph, EMD Serono Canada Inc., July 2007.

Raptiva(R) and the Clear Support Program(TM) are registered trademarks of EMD Serono Canada Inc.

Contact:

Barbara Fry
EMD Serono Canada Inc.
Communications
(905) 919-0163
Website: www.nspharmacare.ca

Karen Cutaia
Incipit Integrated Communications
(905) 335-0600

Posted: February 2008


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