BASEL, SWITZERLAND--(Marketwire - August 27, 2010) -
Basilea Pharmaceutica AG / Basilea announces distribution agreement with
Actelion for Toctino® in Canada processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, August 27, 2010 - Basilea Pharmaceutica Ltd. (SWISS: 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 (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 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 (SWISS: ATLN)
as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®).
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 |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com
[HUG#1440878]
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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/1440878/385186.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
