BASEL, SWITZERLAND, Jun 15 (MARKET WIRE) —
Basilea Pharmaceutica AG / Basilea announces distribution agreement with
Almirall for Toctino(R) 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(R)
(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(R) in Austria, Belgium, Czech Republic, Italy, Luxembourg,
Mexico, the Netherlands, Poland, Portugal, Slovakia and Spain. Basilea
retains the future right to co-promote Toctino(R) 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(R) 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(R) (alitretinoin)
Toctino(R) was developed by Basilea Pharmaceutica International Ltd.
To date, Toctino(R) 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
In the largest ever phase III clinical trial program in CHE, Toctino(R)
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(R). 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(R) indicate that
treatment can provide long periods free from relapse and improve patient
Toctino(R) 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(R) has been
developed and implemented.
In clinical trials, Toctino(R) 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.
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.
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(R)
(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.
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
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 |
|firstname.lastname@example.org |email@example.com |
| | |
| | |
This press release can be downloaded from www.basilea.com
— End of Message —
Basilea Pharmaceutica AG Grenzacherstrasse 487
P.O Box Basel Switzerland
ISIN: CH0011432447; Listed: Freiverkehr in Boerse Stuttgart, Freiverkehr
in Boerse Berlin, Open Market (Freiverkehr) in Frankfurter
Wertpapierboerse, Freiverkehr in Bayerische Boerse Muenchen;
release (PDF): http://hugin.info/134390/R/1423867/372613.pdf
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