Basilea's Toctino® recommended for approval in 15 additional European
countries
(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, December 14, 2009 - Basilea Pharmaceutica Ltd.announces that Toctino® (alitretinoin) was recommended for regulatoryapproval under the Repeat-use Procedure in 13 additional EuropeanUnion (EU) Member States as well as in Norway and Iceland. Toctino®is a new once-daily oral treatment for adults with severe chronichand eczema (CHE) unresponsive to potent topical corticosteroids."We are very pleased about the recommendation for approval from the15 European countries that were included in the procedure. Subject tonational approval and price and reimbursement decisions, theavailability of Toctino for patients and physicians will continue toexpand across Europe," said Dr. Anthony Man, CEO of BasileaPharmaceutica Ltd.The various EU Member States and European countries concluded thatthe profile of Toctino® is favorable for the use in adults who sufferfrom severe CHE that is unresponsive to treatment with potent topicalcorticosteroids. The recommendation for approval is the final stepbefore national marketing licenses are granted.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. Todate, Toctino® has been launched in Denmark, France, Germany and theUnited Kingdom for the treatment of adults with severe chronic handeczema unresponsive to potent topical corticosteroids. Toctino® hasalso received marketing authorization in Austria, Belgium, Canada,Finland, Luxemburg, the Netherlands, Spain and Switzerland. Further,Toctino® has been recommended for approval in 16 European countries.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 (isavuconazole) in phase III clinical development. Toctino®(alitretinoin) is marketed in Denmark, France, Germany and the UnitedKingdom and is approved in Austria, Belgium, Canada, Finland,Luxemburg, the Netherlands, Spain and Switzerland. Toctino® has beenrecommended for approval in 16 European countries. Furthermore, aphase III clinical trial on alitretinoin for the treatment of severechronic 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 underregulatory review in the U.S., in the EU and several other countries.Basilea has set up commercial organizations in Canada, France,Germany, the Nordics and the United Kingdom, while it is buildingsales and marketing organizations in other countries to commercializealitretinoin and to co-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., MBA || 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/1360861/332224.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: 14.12.2009 - 07:15 Uhr
Sprache: Deutsch
News-ID 9560
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 765 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Basilea's Toctino® recommended for approval in 15 additional European
countries"
steht unter der journalistisch-redaktionellen Verantwortung von
Basilea Pharmaceutica AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
