Healthcare Industry News: antibiotic
News Release - May 3, 2010
Basilea's Toctino(R) receives marketing authorization in ItalyBASEL, SWITZERLAND, May 3--(HSMN NewsFeed) - Basilea Pharmaceutica AG / Basilea's ToctinoŽ receives marketing authorization in Italy processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, May 03, 2010 - Basilea Pharmaceutica Ltd. announces that ToctinoŽ (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]).
Following the recommendation for regulatory approval under the European decentralized procedure, ToctinoŽ has received national regulatory approval in Italy and was accepted for reimbursement.
Chronic hand eczema - a debilitating skin disease
Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. Hand eczema is reported to affect up to ten percent of the general population. The more severe, chronic form of the condition is thought to affect five to seven percent of these patients, causing impaired use of their hands and a considerable impact on their ability to perform everyday activities.
ToctinoŽ (alitretinoin), the only therapy approved for severe chronic hand eczema unresponsive to potent topical treatments
ToctinoŽ was developed by Basilea Pharmaceutica International Ltd.
The AIFA approved ToctinoŽ for the use in adults who have severe CHE that is unresponsive to treatment with potent topical corticosteroids.
In the largest ever phase III clinical trial program in CHE, ToctinoŽ was the first treatment to show effective clearing of severe CHE, with clear or almost clear hands achieved in nearly 50 percent of patients treated 30 mg ToctinoŽ. The once-daily oral therapy is given for 12 to 24 weeks, depending on patient response, and six-month post-treatment observations in patients who responded to ToctinoŽ indicate that treatment can provide long periods free from relapse and improve patient satisfaction.
ToctinoŽ is a known teratogen (a substance that can cause birth defects when women are exposed during pregnancy). Strict pregnancy prevention one month before, during, and one month after cessation of treatment as well as monthly pregnancy testing are required for women of childbearing age. A comprehensive pregnancy prevention program for ToctinoŽ has been developed and implemented.
In clinical trials, ToctinoŽ was well tolerated and demonstrated a safety profile overall consistent with the retinoid class. Overall, the most frequently reported adverse events in the phase III clinical trials were headache and increased levels of blood lipids. Side effects were dose-dependent and reversible.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (Swiss:BSLN ). Its integrated research and development operations are currently focused on antibiotics and antifungals, as well as on the development of dermatology and oncology drugs, all areas in which the medical challenge of rising resistance or non-response to current treatment options is commonly encountered. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting.
The company owns a broad and diversified portfolio. Basilea is marketing ToctinoŽ (alitretinoin), for the treatment of severe chronic hand eczema, in Denmark, France, Germany, Switzerland and the United Kingdom. The drug is approved in 13 additional European countries as well as in Canada and has been recommended for approval in nine further European countries. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Basilea has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. for its phase III compound isavuconazole for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan. Full rights to a third late-stage product, ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, will be transferred from Cilag GmbH International, a Johnson & Johnson company, back to Basilea.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
This press release can be downloaded from www.basilea.com
Source: Basilea Pharmaceutica
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