Healthcare Industry News: ceftobiprole
News Release - December 17, 2008
Basilea Pharmaceutica opens U.S. phase III study on alitretinoin for the treatment of severe chronic hand eczemaBASEL, SWITZERLAND--(Healthcare Sales & Marketing Network)--Dec 17, 2008 -- Basilea Pharmaceutica Ltd. (Swiss:BSLN.SW ) announces that it has opened a clinical phase III study on alitretinoin in the U.S. The "HANDEL" trial (HAND Eczema research of aLitretinoin) is the first ever multi-centered, controlled clinical study for patients with severe chronic hand eczema (CHE) performed in the U.S.
"There is a real sense of excitement within the dermatology community with the start of this important trial," said Dr. Donald Belsito, HANDEL Lead Investigator and Director of Dermatology at University of Kansas Medical Center. "Chronic hand eczema is a debilitating condition, and there are currently no FDA approved treatment options for patients unresponsive to potent topical steroids."
Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd. said, "Alitretinoin has already been approved in several EU Member States as therapy for severe chronic hand eczema unresponsive to potent topical steroids. This study is designed to evaluate the safety and efficacy of the drug in a U.S. patient population."
The HANDEL study is a double-blind, placebo-controlled, randomized clinical trial that will investigate the efficacy and safety of alitretinoin in the treatment of severe CHE that has not responded to potent topical steroids. In the HANDEL trial participants will be randomized to receive oral alitretinoin or placebo for up to 24 weeks. The primary endpoint of the clinical trial is the response rate as measured by the achievement of clear or almost clear hands according to the Physician's Global Assessment. Assessments of safety will be similar to that employed in previous large studies. Likewise a pregnancy risk management plan for female patients of childbearing age will be established. The study will take place at approximately 90 sites across the United States and is planned to enroll 600 patients.
Alitretinoin is a naturally occurring, physiologic retinoid that is thought to work in CHE through anti-inflammatory and immunomodulatory effects. The oral retinoid has been launched in Denmark, Germany and the United Kingdom under the trade name ToctinoŽ for the treatment of adults with severe chronic hand eczema unresponsive to potent topical corticosteroids. ToctinoŽ has also received marketing authorization in Finland and France and has been recommended for approval in six additional EU Member States. Launches in other European countries are expected to begin in the first half of 2009. Alitretinoin is also under regulatory review in Canada and Switzerland.
The regulatory submissions for alitretinoin in Europe and Canada were based on an ex-U.S. Phase III clinical trial program in which more than 1600 patients with hand eczema were included in therapeutic studies. The primary efficacy endpoint of the trials was a clinical response defined as clear or almost clear hands. A six month post-treatment observation period measured the rate of relapse among all patients who achieved the protocol defined clinical response.
Alitretinoin is a known potent 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 in the HANDEL trial. Further details on this study will soon be posted on www.clinicaltrials.gov
About chronic hand eczema
Hand eczema is a common skin disease which is often chronic and relapsing. Severe chronic hand eczema is characterized by thick, scaly skin that commonly gives rise to blisters, redness, swelling and painful cracks in the skin,. Studies suggest these patients have a significantly reduced quality-of-life and substantial occupational disability, including prolonged sick leave and unemployment, as well as low self-esteem and social phobia.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (Swiss:BSLN.SW ). Basilea's integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance and on the development of dermatology drugs. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting. The company owns a diversified portfolio including two commercialized drugs (alitretinoin, ceftobiprole) and one investigational drug (isavuconazole) in phase III. Alitretinoin (ToctinoŽ) is marketed in the United Kingdom, Denmark and Germany and is approved in Finland and France. Alitretinoin has been recommended for approval in six additional EU Member States and is under regulatory review in Canada and Switzerland. ceftobiprole is marketed in Canada. It is approved in Switzerland and received a positive opinion from the European Committee for Medicinal Products for Human Use. The company has submitted marketing applications for ceftobiprole in the U.S. and several other countries. The company has set up commercial organizations in UK, Denmark, Germany and Canada, while it is building sales and marketing organizations in other countries to commercialize alitretinoin and to co-promote ceftobiprole, subject to approval.
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.
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This press release can be downloaded from www.basilea.com
1. Burns T et al. Rook's Textbook of Dermatology. 7th edition. 2004.Blackwell Science
2. Menne T and Maibach H. Hand Eczema, 2nd Edition. 2000. Dermatology: Clinical and Basic Science Series
Source: Basilea Pharmaceutica
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