Basilea's Toctino(R) receives marketing authorization in Canada
Market Wire, November, 2009
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 obtained
regulatory approval from Health Canada.
“We are delighted that Health Canada has approved the use of Toctino
for patients with severe chronic hand eczema unresponsive to potent
topical steroids. These patients have often suffered with this
chronic debilitating condition for many years. Our rigorous, well
designed clinical studies have clearly shown that Toctino has the
potential to benefit a significant number of patients suffering from
chronic hand eczema,” said Dr. Anthony Man, CEO Basilea Pharmaceutica
Ltd.
Toctino has recently been launched in France and is already being
marketed in Denmark, Germany and the United Kingdom for the treatment
of adults with severe chronic hand eczema unresponsive to potent
topical corticosteroids. Toctino has also received marketing
authorization in Austria, Belgium, Finland, Luxemburg, the
Netherlands, Spain and Switzerland. Further, Toctino has been
recommended for approval in Italy. Alitretinoin is under regulatory
review in 15 additional European countries.
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. It is characterized by thick,
scaly skin that commonly gives rise to blisters, redness, swelling
and painful cracks in the skin. 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 Toctino (alitretinoin)
Toctino was developed by Basilea Pharmaceutica International Ltd.
Health Canada approved Toctino for the treatment of severe chronic
hand eczema refractory to high potency topical corticosteroids in
adults.
Toctino is a 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 naturally occurring, physiologic retinoid that is
thought to work in CHE through anti-inflammatory and immunomodulatory
effects.
Alitretinoin 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 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.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SIX Swiss Exchange (SWISS: 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 Denmark, France, Germany and the United Kingdom. It
is approved in Austria, Belgium, Canada, Finland, Luxemburg, the
Netherlands, Spain and Switzerland. Alitretinoin has been recommended
for approval in Italy and is under regulatory review in 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). Ceftobiprole is under
regulatory review in the U.S., in the EU and several other countries.
The company has set up commercial organizations in Canada, Denmark,
France, Germany and UK, 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 malabsorption implicitly contains certain
forward-looking statements concerning Basilea Pharmaceutica Ltd
Nov 18, 2009
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