BASEL, Switzerland, April 25, 2007 - Basilea Pharmaceutica Ltd. (SWX:BSLN) reported today phase III study results showing that patients with severe chronic hand eczema can benefit from re-treatment with alitretinoin. In two previous randomized clinical trials, alitretinoin was found to be effective in treating severe chronic hand eczema in patients refractory to topical treatments. This pivotal trial demonstrated that patients responsive to initial treatment with alitretinoin can also benefit from additional treatment courses after eventual disease recurrence. The safety profile of alitretinoin observed in this study was consistent with that seen in previous trials. These positive data will be integrated into regulatory submissions planned for later this year.
Severe refractory Chronic Hand Eczema (CHE) is a relapsing disorder for which no approved treatment currently exists. This debilitating disease prevents patients from using their hands normally and requires frequent treatment interventions over time.
The objective of this re-treatment study was to describe the safety and efficacy of a second treatment course of alitretinoin in patients who achieved clear or almost clear hands after a previous initial treatment course. This study included 117 patients who eventually had disease recurrence, and 243 patients who had incomplete response after the initial treatment trial.
Patients who had disease recurrence were randomized in double blind manner to receive another 12 to 24 weeks treatment with either placebo or their previous dose of alitretinoin. Response rates were 80% for the alitretinoin 30mg group (Placebo 8.3%) and 48% for the 10mg group (Placebo 10%). These results indicate that alitretinoin is effective in treating severe refractory CHE in subsequent treatment courses.
Those patients who had either no or an incomplete response in the previous study received 30mg alitretinoin in an open-label fashion for another 12 to 24 weeks. Forty-seven percent (47%) achieved a response as defined by clear or almost clear hands. These results further confirm the efficacy of alitretinoin in patients with CHE refractory to topical therapy.
Alitretinoin was generally well tolerated with a safety profile similar to that reported in previous phase II and phase III clinical studies. The most frequent adverse events were headache and blood lipid elevations.
Dr. Anthony Man, CEO of Basilea said, "Because of the relapsing nature of Chronic Hand Eczema it was important for patients and treating physicians that we further characterize the safety and efficacy of more than one treatment course of alitretinoin. These trial results confirm that alitretinoin is an effective treatment for severe refractory Chronic Hand Eczema. Alitretinoin has the potential to be integrated into pragmatic re-treatment algorithms for these chronically affected patients who have limited treatment options."
About Chronic Hand Eczema (CHE) Hand eczema is a common skin disease and is often chronic and relapsing. It is estimated to affect up to 10% of the general population. The more severe, chronic form of the condition is thought to affect up to 7% of these patients, many of whom do not respond, or no longer respond to topical corticosteroids. Basilea estimates there are at least one million patients in Europe and North America with refractory severe CHE for which currently no approved, effective pharmaceutical treatment is available.
For the patient, severe CHE can be a frustrating and debilitating disease. Patients often suffer for years from erythema, blisters, vesicles, scaling and fissures which can cause chronic pain and functional impairment of the hands. Studies suggest these patients have a significantly reduced quality of life and the majority experience social or emotional distress and sleep disorders. It is reported that up to 20% of sufferers have to leave their jobs and one patient in five takes prolonged sick leave resulting in high socio-economic and individual patient burden.
About Alitretinoin Alitretinoin is an investigational drug being developed in Phase III clinical trials by Basilea as a novel treatment for severe refractory Chronic Hand Eczema (CHE), a complex disease for which no effective treatment options are currently available. Alitretinoin has been shown to be effective in Phase II and Phase III clinical studies in patients with severe refractory CHE.
In a phase II double-blind international multi-center placebo controlled trial of 319 patients with moderate and severe chronic hand eczema refractory to topical treatment, alitretinoin was clinically effective in 29% to 53 % of patients depending on the dose administered. Alitretinoin was generally well tolerated with dose dependent headache observed as the most common side effect.
Basilea's first pivotal phase III international multi-center placebo-controlled BACH trial (Benefit of Alitretinoin in Chronic Hand eczema) showed that alitretinoin was effective in patients suffering from severe refractory CHE, as determined by the endpoint of clear and almost clear hands.
This randomized double-blind phase III pivotal study was the largest therapeutic trial ever performed in chronic hand eczema with 1,032 patients whose severe chronic disease was unresponsive to topical steroids. The patients were randomized either to a once-daily dose of 30mg or 10mg of alitretinoin, or placebo for a treatment duration of up to 24 weeks. Alitretinoin's efficacy was significantly superior to placebo in both the high and the low dose regimen. In the 30mg group 48% of patients and in the 10 mg group 28% of patients reached the primary endpoint. In this study alitretinoin was again generally well tolerated with dose dependent headache and blood lipid elevations as the most commonly observed side effects.
Alitretinoin is a teratogen and therefore pregnancy prevention measures must be in place for all women of child-bearing potential who receive alitretinoin. Within days after discontinuation of therapy, alitretinoin levels return to endogenous levels. In clinical studies the post-treatment contraceptive period was four weeks.
About Basilea Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX:BSLN). Basilea's fully 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 three investigational phase III drugs of which two have shown positive pivotal phase III results. The company is integrating commercialization into its organization, in a first step through co-promoting ceftobiprole with its partner Cilag GmbH International, a Johnson & Johnson company, in North America and major European countries.
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