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NICE issues positive final guidance recommending the use of Basilea's
Toctino®

ID: 1003591
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(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, August 26, 2009 - Basilea Pharmaceutica Ltd.(SIX:BSLN) announces that the National Institute for Health andClinical Excellence (NICE) today issued its final guidancerecommending the use of Toctino® (alitretinoin) within its licensedindication, as a treatment option for adults with severe chronic handeczema that has not responded to potent topical corticosteroids.The NICE Appraisal Committee recognized that Toctino®, an innovativetherapy shown to be highly effective in Phase III trials, is acost-effective use of National Health Service (NHS) resources. Thefinal guidance is in line with the Final Appraisal Determinationissued in July this year and can be found on the NICE www.nice.org.ukwebsite."We welcome the publication of NICE's positive final guidance. Itconfirms the value Toctino brings to patients and the healthcarecommunity," said Dr. Anthony Man, CEO, Basilea Pharmaceutica Ltd."This decision will allow access to Toctino across England and Walesby patients suffering from severe chronic hand eczema."The NHS will fund Toctino® for patients with severe disease, asdefined by the physician's global assessment and a dermatology lifequality index score of 15 or more. It is stated that NHS must providefunding and resources within three months of the final guidance beingpublished.In March of this year the Scottish Medicine's Consortium acceptedToctino® for use within the NHS Scotland.Chronic hand eczema - a debilitating skin diseaseHand eczema is a common inflammatory skin disease and is oftenchronic and relapsing. It is characterized by thick, scaly skin thatcommonly gives rise to blisters, redness, swelling and painful cracksin the skin. Hand eczema is reported to affect up to ten percent ofthe general population. 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.Toctino® (alitretinoin) is the only therapy approved for severerefractory chronic hand eczemaToctino® was developed by Basilea Pharmaceutica International Ltd. Todate, Toctino® is launched in Denmark, Germany and the UnitedKingdom, and has received marketing authorization in Austria,Belgium, Finland, France, Luxemburg, the Netherlands and Spain. Inaddition, Toctino® has been recommended for approval in Italy and isunder regulatory review in Canada, Switzerland and 15 additionalEuropean countries.In the largest ever phase III clinical trial program in chronic handeczema (CHE), Toctino® was the first treatment to show effectiveclearing of severe CHE, with clear or almost clear hands achieved innearly 50 percent of patients treated 30 mg Toctino®. The once-dailyoral therapy is given for 12 to 24 weeks, depending on patientresponse, and six-month post-treatment observations in patients whoresponded to Toctino® indicate that treatment can provide longperiods free from relapse.Toctino® 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 forToctino® has been developed and implemented.In clinical trials, Toctino® was well tolerated and demonstrated asafety profile consistent with the retinoid class. Overall, the mostfrequently reported adverse events in the phase III clinical trialswere headache and increased levels of blood lipids. Side effects weredose-dependent. A phase III clinical trial on alitretinoin for thetreatment of severe chronic hand eczema is ongoing in the U.S.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 adiversified portfolio including two commercialized drugs (Toctino®,ZEFTERA(TM)/Zevtera(TM)) and one investigational drug in phase III(isavuconazole). Toctino® (alitretinoin) is marketed in the UnitedKingdom, Denmark and Germany and is approved in Austria, Belgium,Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoinhas been recommended for approval in Italy and is under regulatoryreview in Canada, Switzerland and 15 additional European countries.Furthermore a phase III clinical trial on alitretinoin for thetreatment 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). Marketing applications forceftobiprole were submitted in the U.S., the EU and several othercountries. 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., MBA || Head Corporate Communication & | Head Corporate Development || PR | +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/1337069/318418.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;



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Date: 08/26/2009 - 07:15
Language: English
News-ID 1003591
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Firma: Basilea Pharmaceutica AG
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