Press Release

Basilea's Toctino(R) (alitretinoin) receives marketing authorization in France

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Posted 21 October 2008 @ 12:21 am ET

BASEL, SWITZERLAND -- (Marketwire) -- 10/21/08 --

Basel, Switzerland, October 21, 2008 - 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 French Health Products Safety Agency (Agence Française deSécurité Sanitaire des Produits de Santé [AFSSAPS]).

Following the recommendation for regulatory approval under theEuropean decentralized procedure, Toctino® has received nationalregulatory approval in France. Basilea will submit a pricing andreimbursement dossier to the French authorities based on theapproval.

Marketing applications for the use of alitretinoin in the treatmentof severe chronic refractory hand eczema are also under regulatoryreview in Canada and in Switzerland.

About chronic hand eczema

Hand eczema is a common inflammatory skin disease and is oftenchronic and relapsing. It is one of the most common occupational skindiseases and a frequent reason for patients to consult adermatologist. 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. CHE causes significant economic and occupational burdenwith total costs alone in Europe estimated to eleven billion Euro peryear. The most important patient burden is impaired use of the handsand a considerable impact on patients' quality of life.

About Toctino® (alitretinoin)

Toctino® (alitretinoin) was developed by Basilea PharmaceuticaInternational Ltd.The AFSSAPS approved Toctino® for the use in adults who have severeCHE that is unresponsive to treatment with potent topicalcorticosteroids.Patients whose CHE is predominantly characterized by fissured, thickscaly skin are more likely to respond than those in whom the eczemais mainly characterized by blisters.Toctino® (alitretinoin) is a convenient once-daily capsule to betaken with food. The recommended starting dose is 30 mg in mostpatients and a treatment course lasts up to 24 weeks depending onresponse.Alitretinoin belongs to the well studied family of retinoids. Allretinoids are teratogens. Therefore pregnancy is a contraindicationto alitretinoin therapy and strict pregnancy prevention measures mustbe in place for all women of child-bearing potential who receivealitretinoin. A comprehensive pregnancy prevention program has beendeveloped and implemented. In clinical trials alitretinoin was welltolerated and has a safety profile overall consistent with theretinoid class. Side effects were generally dose-dependent andreversible.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,and listed on the SWX Swiss Exchange (SWISS: BSLN). Basilea's integratedresearch and development operations are currently focused on newantibacterial and antifungal agents to fight drug resistance and onthe development of dermatology drugs. Basilea's products are targetedto satisfy high medical and patient needs in the hospital andspecialty care setting. The company owns a diversified portfolioincluding two commercialized drugs (alitretinoin, ceftobiprole) andone investigational drug (isavuconazole) in phase-III. Alitretinoin(Toctino®) is marketed in the United Kingdom and in Denmark. It isapproved in Germany, Finland and France. Alitretinoin has beenrecommended for approval in six additional EU Member States.Alitretinoin is under regulatory review in Canada and Switzerland.Ceftobiprole is marketed in Canada and is under review by regulatoryauthorities in the U.S., the EU, in Switzerland and in several othercountries. The company has set up commercial organizations in UK,Denmark and in Germany while it is building sales and marketingorganizations to commercialize alitretinoin and to co-promoteceftobiprole in North America and in other European countries,subject to approval.

Disclaimer

This 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 ||----------------------------------+--------------------------------|| Jean-Christophe Britt, Ph.D. | Barbara Zink, Ph.D., MBA || Corporate Communication & Public | Head Corporate Development || Relations | +41 61 606 1233 || +41 61 606 1354 | investor_relations@basilea.com || media_relations@basilea.com | |+-------------------------------------------------------------------+

This press release can be downloaded from www.basilea.com

The press release can also be downloaded from the following link:

Press release (PDF): http://hugin.info/134390/R/1261327/276204.pdf

This announcement was originally distributed by Hugin. The issuer issolely responsible for the content of this announcement.

Copyright © Hugin AS 2008. All rights reserved.


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