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Basilea announces distribution agreement with Actelion for Toctino® in Canada


Basel, Switzerland - Basilea Pharmaceutica Ltd. (SIX:BSLN) announced today that Basilea Pharmaceutica International Ltd. has entered into an exclusive distribution agreement with Actelion Pharmaceuticals Canada Inc. for Basilea’s Toctino® (alitretinoin), a once-daily oral treatment for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids.

Basilea has appointed Actelion as its exclusive distributor for Toctino® in Canada. Under the terms of the agreement, Basilea will be eligible for upfront and milestone payments totaling up to about CAD 3.7 million. Actelion will purchase Toctino® from Basilea and bear all costs related to selling the product in Canada.
“After carefully evaluating different commercialization strategies for Toctino in the Canadian dermatology market, we have concluded that partnering Toctino allows us to optimize the value of the asset in this market,” said Dr. Anthony Man, CEO Basilea Pharmaceutica Ltd. “Actelion has a well-established and significant commercial organization in Canada with a proven track record in successfully marketing specialty products. We and Actelion look forward to making Toctino available to patients in Canada in the fourth quarter of 2010.”

About Toctino® (alitretinoin)

Toctino® was developed by Basilea Pharmaceutica International Ltd.

Basilea markets Toctino® in France, Germany, the United Kingdom, Switzerland and Denmark for the treatment of severe chronic hand eczema (CHE). The drug is approved in 16 additional European countries and has been recommended for approval in six further European countries.

Health Canada approved Toctino® for the treatment of severe CHE refractory to high potency topical corticosteroids in adults.

In the largest ever phase III clinical trial program in CHE, Toctino® was the first treatment to show effective clearing of severe CHE unresponsive to potent topical corticosteroids, with clear or almost clear hands achieved in nearly 50 percent of patients treated with 30 mg Toctino®. The once-daily oral therapy for adults is given for 12 to 24 weeks, depending on patient response. Six-month post-treatment observations in patients who responded to Toctino® indicate that treatment can provide long periods free from relapse and improve patient satisfaction.

Toctino® is a known teratogen (a substance that can cause birth defects when women are exposed during pregnancy). Strict pregnancy prevention one month before, during, and one month after cessation of treatment as well as monthly pregnancy testing are required for women of childbearing age. A comprehensive pregnancy prevention program for Toctino® has been developed and implemented.
In clinical trials, Toctino® was well tolerated and demonstrated a safety profile overall consistent with the retinoid class. Overall, the most frequently reported adverse events in the phase III clinical trials were headache and increased levels of blood lipids. Side effects were dose-dependent and reversible.

About chronic hand eczema
Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. Hand eczema is reported to affect up to ten percent of the general population. The more severe, chronic form of the condition is thought to affect five to seven percent of these patients, causing impaired use of their hands and a considerable impact on their ability to perform everyday activities.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Its fully integrated research and development operations are currently focused on antibiotics, antifungals and oncology drugs, as well as on the development of dermatology drugs, targeting the medical challenge of resistance and non-response to current treatment options in the hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only approved treatment for severe chronic hand eczema unresponsive to potent topical corticosteroids, in Denmark, France, Germany, Switzerland and the United Kingdom and has appointed Almirall, S.A. as its distributor for Toctino® in other selected European markets and Mexico. Furthermore, a phase III clinical program on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. The company has entered into a global partnership with Astellas Pharma Inc. for its phase III compound isavuconazole, a potential best-in-class azole antifungal, for the treatment of life-threatening invasive fungal infections. Full rights to ceftobiprole, the first approved anti-MRSA broad-spectrum cephalosporin antibiotic, for the treatment of potentially life-threatening resistant bacterial infections, are being transferred from Cilag GmbH International, a Johnson & Johnson company, back to Basilea.

About Actelion
Actelion is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion’s first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion’s over 2,300 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (SIX:ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®).

This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.


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