Basilea Pharmaceutica Receives $5.5 Milestone Payment From Distribution Agreement For Toctino(R) With Almirall

BASEL, SWITZERLAND--(Marketwire - November 02, 2010) -

Basilea Pharmaceutica AG / Basilea receives milestone payment from distribution agreement for Toctino® with Almirall Processed and transmitted by Thomson Reuters. The issuer is solely responsible for the content of this announcement.

Basel, Switzerland, November 2, 2010 - Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that it has received a milestone payment of EUR 5.5 million under its distribution agreement for Toctino® (alitretinoin) with Almirall, S.A.

The milestone payment of EUR 5.5 million relates to Italy where Toctino® will become available in the coming weeks and local market access activities have been initiated in the individual regions throughout Italy.

Chronic hand eczema - a debilitating skin disease

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.

Toctino® (alitretinoin), the only therapy approved for severe chronic hand eczema unresponsive to potent topical treatments

Toctino® was developed by Basilea Pharmaceutica International Ltd.

In Italy, Toctino® is approved for the use in adults who have severe chronic hand eczema (CHE) that is unresponsive to treatment with potent topical corticosteroids.

Basilea is marketing Toctino® in France, Germany, the United Kingdom, Switzerland and Denmark and has appointed distributors for Toctino® in other selected European markets, Canada and Mexico.

In the largest ever phase III clinical trial program in CHE, Toctino® was the first treatment to show effective clearing of severe CHE, with clear or almost clear hands achieved in nearly 50 percent of patients treated with 30 mg Toctino®. The once-daily oral therapy is given for 12 to 24 weeks, depending on patient response, and 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 Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SWISS: 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 distributors for Toctino® in other selected European markets, Canada 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 for the treatment of potentially life-threatening resistant bacterial infections, are being transferred back to Basilea from Cilag GmbH International, a Johnson & Johnson company.

Disclaimer

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.

This press release can be downloaded from www.basilea.com


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Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland


Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;

Press Release (PDF): http://hugin.info/134390/R/1457811/397379.pdf




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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE


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