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.

In addition, responses to other markers of bone turnover, including the marker of bone resorption urinary deoxpyridinoline, the marker of bone formation serum bone-specific alkaline phosphatase and the marker of cathepsin K activity serum crosslinked C-terminal peptide were evaluated in the study.

This randomized, double-blind, multicenter study included 43 women with breast cancer and metastatic bone disease who received oral odanacatib 5mg daily or intravenous zoledronic acid 4mg on day one. The mean age of women was 60 years. The primary endpoints of the study were the marker of bone resorption urinary N-telopeptide of type I collagen corrected for creatinine (uNTx; pmol BCE/micromol creatinine) and safety.

Christopher Wynne, study investigator, said: "These findings show that odanacatib reduced several well-characterized biochemical markers of bone turnover in cancer patients with metastasis to bone, indicating this investigational medicine has the potential to slow the accelerated rate of bone destruction associated with bone metastases."

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Favorable phase 3 data for Merck's oral medicine telcagepant, formerly known as MK-974, were similar to those seen in earlier mid-stage studies. Merck plans to seek U.S. approval next year for the drug.

Merck said the trial pitted telcagepant against Zomig, rather than far-better-selling Imitrex, because the AstraZeneca drug is also considered a highly effective treatment.

The study involved 1,380 adult patients tested after experiencing a single moderate or severe migraine attack. Patients received either 150-milligram or 300-milligram doses of telcagepant, a five milligram dose of Zomig, or a placebo. The average age of patients was 43, and about 85 percent were women, in view of the fact that most migraine sufferers are female.

Effectiveness of the drugs was assessed by their ability to meet five criteria after two hours: pain relief, pain freedom, absence of sensitivity to sound, absence of sensitivity to light and absence of nausea.

Merck said that the overall effectiveness of the 300-milligram dose of telcagepant was found to be comparable to Zomig, and significantly more effective than placebo. About 55 percent of patients who received high-dose telcagepant reported reduction of pain at two hours, compared with 56 percent for Zomig and 28 percent for those taking placebos.

An estimated 27 percent of patients getting the Merck drug reported being pain-free at two hours, compared with 31 percent for Zomig and 10 percent for placebo. Telcagepant and Zomig were about equally successful in controlling sensitivity to sound and light, two hardships that often accompany migraine headaches.

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As a result of the termination of the respiratory joint venture, Schering- Plough expects to receive payments totaling $105 million from Merck as specified in the joint venture agreements which Schering-Plough will recognize over the remaining three quarters of 2008.

The FDA issued on April 25, 2008 a not-approvable letter for the proposed fixed-dose combination of loratadine and montelukast.

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