Basilea's Toctino® receives marketing authorization in Switzerland
(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, October 14, 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 been approved bythe Swiss regulatory authority Swissmedic."We are delighted that this innovative Basilea drug receivedmarketing authorization in our home market. Toctino is the firstlicensed treatment for patients suffering from severe chronic handeczema who do not respond to potent steroid therapy," said Dr.Anthony Man, CEO of Basilea. "We look forward to bring Toctino topatients and physicians in Switzerland soon."Basilea submitted a pricing and reimbursement dossier to the Swissauthorities.Toctino® has been launched in Denmark, Germany and the United Kingdomfor the treatment of adults with severe chronic hand eczemaunresponsive to potent topical corticosteroids. Toctino® has alsoreceived marketing authorization in Austria, Belgium, Finland,France, Luxemburg, the Netherlands and Spain. Further, Toctino® hasbeen recommended for approval in Italy. Alitretinoin is underregulatory review in Canada and 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 across Europe. It is characterizedby thick, scaly skin that commonly gives rise to blisters, redness,swelling and painful cracks in the skin. The more severe, chronicform of the condition is thought to affect five to seven percent ofthese patients, causing impaired use of their hands and aconsiderable impact on their ability to perform everyday activities.Toctino® (alitretinoin), the only therapy approved for severe chronichand eczema unresponsive to potent topical treatmentsToctino® was developed by Basilea Pharmaceutica International Ltd.Swissmedic approved Toctino® for the use in adults who have severerefractory chronic hand eczema that is unresponsive to at least 4weeks of extended topical treatment. The initial treatment includesthe avoidance of contact to the causative irritant/noxa, skinprotection and potent topical corticosteroids.Toctino® (alitretinoin) is a once-daily capsule to be taken withfood. The recommended starting dose is 30 mg in most patients and atreatment course 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 United Kingdom, Denmark and Germany and is approvedin Austria, Belgium, Finland, France, Luxemburg, the Netherlands,Spain and Switzerland. Alitretinoin has been recommended for approvalin Italy and is under regulatory review in Canada and 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 UK, Denmark,Germany and Canada, 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 1460 | +41 61 606 1233 || media_relations(at)basilea.com | investor_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/1347329/323911.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: 14.10.2009 - 07:15 Uhr
Sprache: Deutsch
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