GENEVA, Switzerland, July 1 /PRNewswire/ --

- European Commission Approved Product Information Update to Include Data on up to Three Years of Treatment With Raptiva(R), the Longest for any Approved Biological Therapy for Psoriasis

GENEVA, Switzerland, July 1 /PRNewswire/ --

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the European Commission has approved an update of the Summary of Product Characteristics (SPC) for Raptiva(R) (efalizumab) in the treatment of moderate-to-severe chronic plaque psoriasis, a chronic inflammatory systemic disease of the skin. The decision followed a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), which had previously completed a benefit-risk re-assessment of Raptiva(R). The CHMP had concluded, based on the clinical and post-marketing data submitted by Merck Serono, that the benefit-risk profile remains positive for the population in the approved indication.

The SPC has been amended to include efficacy and safety data on up to three years of continuous treatment with Raptiva(R), the longest for any approved biological therapy for psoriasis. The "Clinical efficacy" section of the SPC for Raptiva(R) now includes a new sub-heading on long-term treatment, stating that approximately 50 % of the responding patients treated for more than one year showed a 75 % improvement in the disease, as measured by the standard Psoriasis Area and Severity Index (PASI) score (PASI-75), when all dropouts were considered as non-responders. Regarding undesirable effects, no increase in the incidence of serious infections over time was observed. There was also no evidence of increased risk of any particular malignancy over time with the exception of non-melanoma skin cancer. These data support a long-term favorable safety profile of Raptiva(R) up to three years, which is encouraging for patients who can benefit from long-term continuous treatment with the drug.

"We are delighted with the European Commission decision," said Roberto Gradnik, Head of Merck Serono's European Operations. "The confirmation of the positive benefit-risk profile for Raptiva(R) and the inclusion of long-term data is reassuring news for dermatologists and their psoriasis patients. They can feel comfortable that Raptiva(R) therapy constitutes a safe and efficacious option to manage their disease."

The decision of the European Commission means that the updated SPC for Raptiva(R) is valid immediately in all member states of the European Union. The amendments to the SPC will also be introduced in the package leaflet.

About Raptiva(R)

Raptiva(R) (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(R) is designed to be administered once weekly via subcutaneous injection and can be self-administered by patients at home. Raptiva(R) received EU approval for the "Treatment of adult patients with moderate-to-severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporine, methotrexate and PUVA". Common adverse events observed with Raptiva(R) include headache, infections (e.g., common cold), chills, pain, nausea, asthenia (weakness), and fever, which usually diminish after the initial doses. For complete information on the safety profile of Raptiva(R), the patient information leaflet should be consulted.

Raptiva(R) safety data have now been accumulated from ten years of clinical development and post-marketing experience in psoriasis patients. Raptiva(R) is a medicinal product subject to medical prescription. Treatment with Raptiva(R) should be initiated by a physician specialized in dermatology. The Marketing Authorization Holder of Raptiva(R) in the European Union is Serono Europe Ltd, an affiliate of Merck Serono S.A. The full Summary of Product Characteristics (SPC) for Raptiva(R) is available on http://www.emea.europa.eu/humandocs/Humans/EPAR/raptiva/raptiva.htm

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

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(R)), multiple sclerosis (Rebif(R)), infertility (Gonal-f(R)), endocrine and cardiometabolic disorders (Glucophage(R), Concor(R), Saizen(R), Serostim(R)), as well as psoriasis (Raptiva(R)).

With an annual R&D investment 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 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,681 employees in 60 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.net or http://www.merck.de

Merck Serono, 9 Chemin des Mines, 1202 Geneva, Switzerland; Media Relations: Phone: +41-22-414-36-00.