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Basilea announces distribution agreement with Almirall for Toctino(R) in selected European markets and Mexico

^{Published on 2010-06-14 22:40:06 - Market Wire}
 

BASEL, SWITZERLAND--(Marketwire - June 15, 2010) -

Basilea Pharmaceutica AG / Basilea announces distribution agreement with Almirall for Toctino® in selected European markets and Mexico processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.

Basilea Pharmaceutica Ltd. (SWISS: [ BSLN ]) announced today that Basilea Pharmaceutica International Ltd. has entered into an exclusive distribution agreement with Almirall, S.A. for Basilea's Toctino® (alitretinoin), a once-daily oral treatment for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids, in selected European markets and Mexico.

Basilea has appointed Almirall as its exclusive distributor for Toctino® in Austria, Belgium, Czech Republic, Italy, Luxembourg, Mexico, the Netherlands, Poland, Portugal, Slovakia and Spain. Basilea retains the future right to co-promote Toctino® in selected markets covered under the agreement.

Under the terms of the agreement, Basilea will be eligible for upfront and milestone payments totaling EUR 27 million, including up to EUR 16 million in upfront payments and milestones related to the launch of Toctino® in two key markets of the territory.

"We are very pleased to further expand the commercial availability of Toctino through this partnership with Almirall, a leading dermatology company in Europe. Almirall has a well-established and significant sales force with a successful track record in markets where Basilea has not yet established a full commercial sales presence, including in Almirall's home market Spain," said Dr. Anthony Man, CEO Basilea Pharmaceutica Ltd. "Through this partnership Toctino will be available sooner and to more patients than otherwise possible in these selected markets."

About Toctino® (alitretinoin)

Toctino® was developed by Basilea Pharmaceutica International Ltd.

To date, Toctino® is marketed in Denmark, France, Germany, Switzerland and the United Kingdom for the treatment of severe chronic hand eczema (CHE). The drug is approved in 15 additional European countries as well as in Canada and has been recommended for approval in seven further European countries.

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, 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 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.

Conference call

Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Tuesday, June 15, 4 p.m. (CEST), during which the company will discuss today's press release.

Dial-in numbers are:

+41 (0) 91 610 56 00 (Europe and ROW)

+1 (1) 866 291 4166 (USA)

+44 (0) 207 107 0611 (UK)

A playback will be available 1 hour after the conference call until Thursday, June 17, 6 p.m. (CEST). Participants requesting a digital playback may dial:

+41 (0) 91 612 4330 (Europe)

+1 (1) 866 416 2558 (USA)

+44 (0) 207 108 6233 (UK)

and will be asked to enter the ID 10274 followed by the # sign.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SWISS: [ BSLN ]). Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting. Its integrated research and development operations are currently focused on antibiotics and antifungals, as well as on the development of dermatology and oncology drugs, all areas in which the medical challenge of rising resistance or non-response to current treatment options is commonly encountered. The company owns a broad and diversified portfolio. Basilea is marketing Toctino® (alitretinoin), for the treatment of severe chronic hand eczema, in Denmark, France, Germany, Switzerland and the United Kingdom. The drug is approved in 15 additional European countries as well as in Canada and has been recommended for approval in seven further European countries. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Basilea has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. for its phase III compound isavuconazole for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan. Full rights to a third late-stage product, ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, will be transferred from Cilag GmbH International, a Johnson & Johnson company, back to Basilea.

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.

For further information, please contact:

 +-------------------------------------+-----------------------------------+ |Media Relations |Investor Relations | +-------------------------------------+-----------------------------------+ |Adesh Kaul |Barbara Zink, Ph.D., MBA | |Head Public Relations & |Head Corporate Development | |Corporate Communications | | |+41 61 606 1460 |+41 61 606 1233 | |[ media_relations@basilea.com ] |[ investor_relations@basilea.com ] | | | | | | | +-------------------------------------+-----------------------------------+ 

[HUG#1423867]

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Basilea Pharmaceutica AG Grenzacherstrasse 487
P.O Box Basel Switzerland

ISIN: CH0011432447; 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/1423867/372613.pdf ]