Basilea Announces Phase III Study On Alitretinoin In The USA

"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.

About alitretinoin

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 Toctino® for the treatment of adults with severe chronic hand eczema unresponsive to potent topical corticosteroids. Toctino® 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. PhaseIII 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 skin1,2.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.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). 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 (Toctino®) 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.

 

Press Release Reproduced With the Kind Permission of Basilea Pharmaceutica Ltd

 

Page created: 23 December 2008