Reaching New Frontiers in Psoriasis Treatment

Main Category: Eczema / Psoriasis
Article Date: 19 Nov 2004 - 0:00 PDT

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Serono launches Raptiva� as the first biological treatment approved for psoriasis in the European Union -

Speaking at a press conference at the 13th Meeting of the European Academy of Dermatology and Venereology (EADV), leading European dermatologist Prof. Carlo Pincelli hailed a new frontier in the treatment of psoriasis following the launch of Serono's Raptiva� (efalizumab) as the first biological treatment approved for moderate-to-severe chronic plaque psoriasis in the European Union.

Raptiva�, which can be self-injected by patients just once-weekly, selectively targets the T-cells that are now known to be involved in the development of psoriasis symptoms. Most experts believe this new treatment to be a major advance on current treatments. .

According to Prof. Carlo Pincelli, Department of Neuropsychosensorial Pathology, Section of Dermatology, University of Modena & Reggio Emilia, Modena, Italy, new treatments have brought us to a "new frontier in the treatment of psoriasis".

"We have long sought better treatments which have a favourable safety profile and can easily be integrated into a patient's life," he said. "Now with biological treatments like Raptiva� we will have a treatment option which will give long-term sufferers, especially those who cannot be satisfied with current treatments, a chance to live a more normal life".

This view was supported by Prof. Dr. Wolfram Sterry, Director of the Clinic of Dermatology, Venereology and Allergology at the Charit� in Berlin & President of the DDG (German Dermatological Society) "Biological treatments, such as Raptiva�, give us new hope of providing patients with improved therapies that will be easier to manage and will provide effective and safe, long-term control of their condition and ultimately improve their quality of life," he added.

In September 2004, Raptiva� became the first biological treatment for psoriasis to be authorised for marketing in the 25 countries of the European Union (EU).

In the prospective CLEAR trial presented earlier this year, Raptiva� demonstrated its benefits in moderate-to-severe psoriasis patients for whom other therapies have failed or are inappropriate.

On October 5, 2004, Serono announced the launch of Raptiva� in Germany for adult patients with moderate-to-severe plaque psoriasis. The company has also launched Raptiva� in Switzerland, the UK, Denmark, Sweden, Australia, Argentina Brazil and Mexico. Raptiva� has also been available since November 2003 in the U.S., where it is marketed by Genentech for the treatment of moderate to severe chronic plaque psoriasis in adults aged 18 or older who are candidates for systemic therapy or phototherapy.

About Raptiva�

Raptiva� is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis symptoms. Raptiva� is designed to be administered once weekly via subcutaneous injection and can be self-administered by patients at home.

Raptiva� 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 cyclosporine, methotrexate and PUVA'.

Serono has the rights to develop and market Raptiva� worldwide outside of the United States and Japan. Development and marketing rights in the United States remain with Genentech Inc. (NYSE:DNA) and its U.S. partner XOMA (Nasdaq: XOMA).

More than 3,500 patients in the U.S. and Europe have been included in Raptiva� trials to date, creating the largest existing database of patients taking part in studies with a biological therapy for psoriasis.

Adverse events observed with Raptiva include headache, non-specific infection (e.g., common colds), chills, pain, nausea, asthenia (weakness), and fever. Further, there was no evidence of accumulation or cumulative toxicity. At 30-months, the occurrence of serious adverse events was infrequent which is consistent with data from previous Raptiva Phase III studies.

About Psoriasis

Psoriasis is a T-cell mediated disease which occurs when skin cells grow abnormally, resulting in thick, red, scaly, inflamed patches. Plaque psoriasis, the most common form of the disease is characterized by inflamed patches of skin ("lesions") topped with silvery white scales. Psoriasis can be limited to a few spots or involve extensive areas of the body, appearing most commonly on the knees, elbows, trunk, and scalp. 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 cure.

Background material

For free B-roll, video and other content about Raptiva�, psoriasis and Serono, please visit the Serono Media Center http://www.thenewsmarket.com/Serono. You can download print-quality images and receive broadcast-standard video digitally or by tape from this site. Registration and video is free to the media.

About Serono

Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif�, Gonal-F�, Luveris�, Ovidrel�/Ovitrelle�, Serostim�, Saizen�, Zorbtive� and Raptiva�. In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are approximately 30 ongoing development projects.

In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a net income of US$390.0 million, making it the third largest biotech company in the world. Its products are sold in over 90 countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).

For more information, please contact:

Corporate Media Relations:
Tel: +41 22 739 36 00
Fax: +41 22 739 30 85
http://www.serono.com

Investor Relations, USA
Tel: +1 781 681 2552
Fax: +1 781 681 2912

Corporate Investor Relations:
Tel: +41 22 739 36 01
Fax: +41 22 739 30 22
Reuters: SEO.VX / SRA.N
Bloomberg: SEO VX / SRA US

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