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NICE issues positive final guidance recommending the use of Basilea's
Toctino® |
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Basel, Switzerland, August 26, 2009 - Basilea Pharmaceutica Ltd.
(SIX:BSLN) announces that the National Institute for Health and
Clinical Excellence (NICE) today issued its final guidance
recommending the use of Toctino® (alitretinoin) within its licensed
indication, as a treatment option for adults with severe chronic hand
eczema that has not responded to potent topical corticosteroids.
The NICE Appraisal Committee recognized that Toctino®, an innovative
therapy shown to be highly effective in Phase III trials, is a
cost-effective use of National Health Service (NHS) resources. The
final guidance is in line with the Final Appraisal Determination
issued in July this year and can be found on the NICE www.nice.org.uk
website.
"We welcome the publication of NICE's positive final guidance. It
confirms the value Toctino brings to patients and the healthcare
community," said Dr. Anthony Man, CEO, Basilea Pharmaceutica Ltd.
"This decision will allow access to Toctino across England and Wales
by patients suffering from severe chronic hand eczema."
The NHS will fund Toctino® for patients with severe disease, as
defined by the physician's global assessment and a dermatology life
quality index score of 15 or more. It is stated that NHS must provide
funding and resources within three months of the final guidance being
published.
In March of this year the Scottish Medicine's Consortium accepted
Toctino® for use within the NHS Scotland.
Chronic hand eczema - a debilitating skin disease
Hand eczema is a common inflammatory skin disease and is often
chronic and relapsing. It is characterized by thick, scaly skin that
commonly gives rise to blisters, redness, swelling and painful cracks
in the skin. 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.
Toctino® (alitretinoin) is the only therapy approved for severe
refractory chronic hand eczema
Toctino® was developed by Basilea Pharmaceutica International Ltd. To
date, Toctino® 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, Toctino® has been recommended for approval in Italy and is
under regulatory review in Canada, Switzerland and 15 additional
European countries.
In the largest ever phase III clinical trial program in chronic hand
eczema (CHE), Toctino® 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 Toctino®. 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 Toctino® indicate that treatment can provide long
periods free from relapse.
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 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.
About Basilea
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 (Toctino®,
ZEFTERA(TM)/Zevtera(TM)) and one investigational drug in phase III
(isavuconazole). Toctino® (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.
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 Corporate Communication & | Head Corporate Development |
| PR | +41 61 606 1233 |
| +41 61 606 1460 | investor_relations@basilea.com |
| media_relations@basilea.com | |
+-------------------------------------------------------------------+
This press release can be downloaded from www.basilea.com
The press release can also be downloaded from the following link:
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement. Copyright © Hugin AS 2009. All rights reserved.
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