Basilea announces distribution agreement with Almirall for Toctino® in selected European markets and Mexico
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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.
Basel, Switzerland, June 15, 2010 - Basilea Pharmaceutica Ltd. (SIX: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 (SIX: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(at)basilea.com |investor_relations(at)basilea.com |
|
+----------------------------------------+-------------------------------------+
This press release can be downloaded from www.basilea.com
[HUG#1423867]
--- End of Message ---
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
Unternehmensinformation / Kurzprofil:
Datum: 15.06.2010 - 07:16 Uhr
Sprache: Deutsch
News-ID 22392
Anzahl Zeichen: 0
contact information:
Town:
Basel
Kategorie:
Business News
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