Basilea Pharmaceutica Ag (Ch) - Basilea's Toctino Included In Expert Consensus For Management Of Chronic Hand Eczema In France
Basel, Switzerland, April 28, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces the integration of alitretinoin (Toctino®) for state-of-the-art management of chronic hand eczema in France. The position paper, recently published in the organ of the French Society of Dermatology (Société Française de Dermatologie), was elaborated by an expert panel and recommends Toctino® as the treatment of choice when clinical signs of chronic hand eczema persist under topical corticosteroids.
The comprehensive review provides a practice-oriented expert opinion for the management of chronic hand eczema in France and recommends prompt intervention with oral alitretinoin therapy, the first systemic treatment authorized for the management of severe chronic hand eczema that is unresponsive to topical corticosteroids. The document is published in Annales de dermatologie et de vénéréologie (B. Halioua, M.-A. Richard; Vol 137, No. 4: pp. 315-327; April 2010).
"The inclusion of Toctino as treatment of choice for chronic hand eczema unresponsive to topical corticosteroids into this expert consensus indicates that Toctino has a clear role to play in the management of this very debilitating and painful skin disease," said Hans Christian Rohde, Chief Commercial Officer, Basilea Pharmaceutica International Ltd. "This state-of-the-art guideline supports optimal management of a condition that severely impacts patients' quality of life and their ability to perform everyday activities."
For accessing the position paper Mise au point sur l'eczéma chronique des mains, please visit: http://www.em-consulte.com/showarticlefile/249912/main.pdf
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.
Toctino®, the only therapy approved for severe chronic hand eczema unresponsive to potent topical corticosteroids Toctino® was developed by Basilea Pharmaceutica International Ltd. To date, Toctino® is launched in Denmark, France, Germany, Switzerland and the United Kingdom for the treatment of severe chronic hand eczema. The drug is approved in 11 additional European countries as well as in Canada and has been recommended for approval in 11 further European countries.
In the largest ever phase III clinical trial program in CHE, Toctino® 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 Toctino®. 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 Toctino® indicate that treatment can provide long periods free from relapse and improve patient satisfaction.
Toctino® 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 Toctino® has been developed and implemented.
In clinical trials, Toctino® 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.
About Basilea Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX: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 Toctino® (alitretinoin), for the treatment of severe chronic hand eczema, in Denmark, France, Germany, Switzerland and the United Kingdom. The drug is approved in 11 additional European countries as well as in Canada and has been recommended for approval in 11 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.
Disclaimer 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.
For further information, please contact:
Head Public Relations &
+41 61 606 1460
Barbara Zink, Ph.D., MBA
Head Corporate Development
+41 61 606 1233
The press release can also be downloaded from the following link:
Press release (PDF)<http://hugin.info/134390/R/1409028/361629.pdf>
Posted: April 2010