NICE issues positive Final Appraisal Determination recommending the
use of Basilea's Toctino
Basel, Switzerland, July 16, 2009 - Basilea Pharmaceutica Ltd.
(SIX:BSLN) announces that the National Institute for Health and
Clinical Excellence (NICE) today issued the Final Appraisal
Determination (FAD) recommending the use of ToctinoÂ® (alitretinoin)
within its licensed indication, as a treatment option for adults with
severe chronic hand eczema that has not responded to potent topical
The FAD published today will become the Institute's final guidance to
the National Health Service (NHS) at the end of August, according to
NICE's publication schedule, assuming no appeals are made by the
"The positive Final Appraisal Determination is an important milestone
for Basilea and is confirmation of the value Toctino brings to
patients and the healthcare community," said Dr. Anthony Man, Chief
Executive Officer, Basilea Pharmaceutica Ltd. "The NICE
recommendation should provide patients in England and Wales who
suffer from severe chronic hand eczema a real chance to obtain hands
cleared of eczema and the possibility to resume normal activities."
NICE determined that ToctinoÂ®, an innovative therapy shown to be
highly effective in phase III trials, is a cost-effective use of NHS
resources. ToctinoÂ® is recommended for patients with severe disease,
which is defined by a physician's global assessment and a dermatology
life quality index score of 15 or more.
In March of this year the Scottish Medicine's Consortium determined
ToctinoÂ® should be made available to patients in Scotland.
The FAD can be found on the NICE www.nice.org.uk website.
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.
ToctinoÂ® (alitretinoin) is the only therapy approved for severe
chronic hand eczema unresponsive to potent topical corticosteroids
ToctinoÂ® was developed by Basilea Pharmaceutica International Ltd. To
date, ToctinoÂ® is launched in Denmark, Germany and the United
Kingdom, and has received marketing authorization in Austria,
Belgium, Finland, France, Luxemburg, the Netherlands and Spain. In
addition, ToctinoÂ® has been recommended for approval in Italy and is
under regulatory review in Canada, Switzerland and 15 additional
In the largest ever phase III clinical trial program in chronic hand
eczema (CHE), ToctinoÂ® 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 30 mg ToctinoÂ®. 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 ToctinoÂ® indicate that treatment can provide long
periods free from relapse.
ToctinoÂ® 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
ToctinoÂ® has been developed and implemented.
In clinical trials, ToctinoÂ® 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. A phase III clinical trial on
alitretinoin for the treatment of severe chronic hand eczema is
ongoing in the U.S.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated
research and development operations are currently focused on new
antibacterial, antifungal and oncology agents to fight drug
resistance and on the development of dermatology drugs. Basilea's
products are targeted to satisfy high medical and patient needs in
the hospital and specialty care setting. The company owns a
diversified portfolio including two commercialized drugs (ToctinoÂ®,
ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug in phase III
(isavuconazole). ToctinoÂ® (alitretinoin) is marketed in the United
Kingdom, Denmark and Germany and is approved in Austria, Belgium,
Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoin
has been recommended for approval in Italy and is under regulatory
review in Canada, Switzerland and 15 additional European countries.
Furthermore a phase III clinical trial on alitretinoin for the
treatment of severe chronic hand eczema is ongoing in the U.S.
Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM)
and in Switzerland under Zevtera(TM). Marketing applications for
ceftobiprole were submitted in the U.S., the EU and several other
countries. The company has set up commercial organizations in UK,
Denmark, Germany and Canada, while it is building sales and marketing
organizations in other countries to commercialize alitretinoin and to
co-promote ceftobiprole, subject to approval.
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:
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