Basilea's Toctino® receives marketing authorization in Canada
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Basel, Switzerland, November 18, 2009 - Basilea Pharmaceutica Ltd.announces that Toctino® (alitretinoin), a new once-daily oraltreatment for adults with severe chronic hand eczema (CHE)unresponsive to potent topical corticosteroids, has obtainedregulatory approval from Health Canada."We are delighted that Health Canada has approved the use of Toctinofor patients with severe chronic hand eczema unresponsive to potenttopical steroids. These patients have often suffered with thischronic debilitating condition for many years. Our rigorous, welldesigned clinical studies have clearly shown that Toctino has thepotential to benefit a significant number of patients suffering fromchronic hand eczema," said Dr. Anthony Man, CEO Basilea PharmaceuticaLtd.Toctino® has recently been launched in France and is already beingmarketed in Denmark, Germany and the United Kingdom for the treatmentof adults with severe chronic hand eczema unresponsive to potenttopical corticosteroids. Toctino® has also received marketingauthorization in Austria, Belgium, Finland, Luxemburg, theNetherlands, Spain and Switzerland. Further, Toctino® has beenrecommended for approval in Italy. Alitretinoin is under regulatoryreview in 15 additional European countries.Chronic hand eczema - a debilitating skin diseaseHand eczema is a common inflammatory skin disease and is oftenchronic and relapsing. Hand eczema is reported to affect up to tenpercent of the general population. It is characterized by thick,scaly skin that commonly gives rise to blisters, redness, swellingand painful cracks in the skin. The more severe, chronic form of thecondition is thought to affect five to seven percent of thesepatients, causing impaired use of their hands and a considerableimpact 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 chronichand eczema refractory to high potency topical corticosteroids inadults.Toctino® is a once-daily capsule to be taken with food. Therecommended starting dose is 30 mg in most patients and a treatmentcourse lasts up to 24 weeks depending on response.Alitretinoin is a naturally occurring, physiologic retinoid that isthought to work in CHE through anti-inflammatory and immunomodulatoryeffects.Alitretinoin is a known teratogen (a substance that can cause birthdefects when women are exposed during pregnancy). Strict pregnancyprevention one month before, during, and one month after cessation oftreatment as well as monthly pregnancy testing are required for womenof childbearing age. A comprehensive pregnancy prevention program hasbeen developed and implemented. In clinical trials alitretinoin waswell tolerated and has a safety profile overall consistent with theretinoid class. Side effects were generally dose-dependent.About BasileaBasilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integratedresearch and development operations are currently focused on newantibacterial, antifungal and oncology agents to fight drugresistance and on the development of dermatology drugs. Basilea'sproducts are targeted to satisfy high medical and patient needs inthe hospital and specialty care setting.The company owns a diversified portfolio including two commercializeddrugs (Toctino®, ZEFTERA(TM)/ Zevtera(TM)) and one investigationaldrug in phase III (isavuconazole). Toctino® (alitretinoin) ismarketed in the Denmark, France, Germany and the United Kingdom. Itis approved in Austria, Belgium, Canada, Finland, Luxemburg, theNetherlands, Spain and Switzerland. Alitretinoin has been recommendedfor approval in Italy and is under regulatory review in 15 additionalEuropean countries. Furthermore a phase III clinical trial onalitretinoin for the treatment of severe chronic hand eczema isongoing in the U.S.Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM)and in Switzerland under Zevtera(TM). Ceftobiprole is underregulatory 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 marketingorganizations in other countries to commercialize alitretinoin and toco-promote ceftobiprole, subject to approval.DisclaimerThis communication expressly or implicitly contains certainforward-looking statements concerning Basilea Pharmaceutica Ltd. andits business. Such statements involve certain known and unknownrisks, uncertainties and other factors, which could cause the actualresults, financial condition, performance or achievements of BasileaPharmaceutica Ltd. to be materially different from any futureresults, performance or achievements expressed or implied by suchforward-looking statements. Basilea Pharmaceutica Ltd. is providingthis communication as of this date and does not undertake to updateany forward-looking statements contained herein as a result of newinformation, future events or otherwise.For further information, please contact:+-------------------------------------------------------------------+| Media Relations | Investor Relations ||--------------------------------+----------------------------------|| Adesh Kaul | Barbara Zink, Ph.D. || Head Public Relations & | Head Corporate Development || Corporate | || Communications | +41 61 606 1233 || +41 61 606 1460 | investor_relations(at)basilea.com || media_relations(at)basilea.com | |+-------------------------------------------------------------------+This press release can be downloaded from www.basilea.comThe press release can also be downloaded from the following link:http://hugin.info/134390/R/1355720/329188.pdf --- End of Message ---Basilea Pharmaceutica AGGrenzacherstrasse 487
P.O Box Basel SwitzerlandWKN: A0B9GA; ISIN: CH0011432447; Index: SLIFE, SMCI, SPI, SPIEX, SBIOM;Listed: Main Market in SIX Swiss Exchange;
Datum: 18.11.2009 - 07:15 Uhr
Sprache: Deutsch
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