Published:
Basilea's Toctino(R) (alitretinoin) receives first national marketing authorization in the UK
Basel, Switzerland, September 8, 2008 - Basilea Pharmaceutica Ltd.
announces that Toctino® (alitretinoin), a new once-daily oral
treatment for adults with severe chronic hand eczema (CHE)
unresponsive to potent topical corticosteroids, has been approved by
the Medicines and Healthcare products Regulatory Agency (MHRA) in the
United Kingdom.
Following the recommendation for regulatory approval under the
European decentralized procedure, Toctino® received its first
national regulatory approval in the UK.
arketing applications for the use of alitretinoin in the treatment
of severe chronic refractory hand eczema are also under regulatory
review in Canada and in Switzerland.
About chronic hand eczema
Hand eczema is a common inflammatory skin disease and is often
chronic and relapsing. It is one of the most common occupational skin
diseases and a frequent reason for patients to consult a
dermatologist. 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. CHE causes significant economic and occupational burden
with total costs alone in Europe estimated to eleven billion Euro per
year. The most important patient burden is impaired use of the hands
and a considerable impact on patients' quality of life.
About Toctino® (alitretinoin)
Toctino® (alitretinoin) was developed by Basilea Pharmaceutica
International Ltd.
The MHRA approved label for Toctino® indicates "for use in adults who
have severe chronic hand eczema that is unresponsive to treatment
with potent topical corticosteroids."
Patients whose CHE is predominantly characterized by fissured, thick
scaly skin are more likely to respond than those in whom the eczema
is mainly characterized by blisters.
Toctino® (alitretinoin) is a convenient once-daily capsule to be
taken with food. The recommended starting dose is 30 mg in most
patients and a treatment course lasts up to 24 weeks depending on
response.
Alitretinoin is a derivative of vitamin A and belongs to the well
studied family of retinoids. All retinoids are teratogens. Therefore
pregnancy is a contraindication to alitretinoin therapy and strict
pregnancy prevention measures must be in place for all women of
child-bearing potential who receive alitretinoin. A comprehensive
pregnancy prevention program has been developed and implemented. In
clinical trials alitretinoin was well tolerated and has a safety
profile overall consistent with the retinoid class. Side effects were
generally dose-dependent and reversible.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SWX Swiss Exchange (SWX: BSLN). Basilea's integrated
research and development operations are currently focused on new
antibacterial and antifungal 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 (alitretinoin, ceftobiprole) and
one investigational drug (isavuconazole) in phase-III. Alitretinoin
is approved in the United Kingdom, has been recommended for approval
in ten additional EU Member States and is under regulatory review in
Canada and Switzerland. Ceftobiprole is marketed in Canada and is
under review by regulatory authorities in the U.S., the EU, in
Switzerland and in several other countries. The company has set up
commercial organizations in UK, Denmark and in Germany while it is
building sales and marketing organizations to commercialize
alitretinoin and to co-promote ceftobiprole in North America and in
other European countries, 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:
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| Media Relations | Investor Relations |
|----------------------------------+--------------------------------|
| Jean-Christophe Britt, Ph.D. | Barbara Zink, Ph.D., MBA |
| Corporate Communication & Public | Head Corporate Development |
| Relations | +41 61 606 1233 |
| +41 61 606 1354 | investor_relations@basilea.com |
| media_relations@basilea.com | |
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