Basilea Completes Patient Recruitment of Alitretinoin Pivotal Phase III Study in Patients with Severe Chronic Hand Dermatitis.


Basel, Switzerland, May 17, 2006
Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today completion of recruitment of over 1000 patients in its BACH study (Benefit of Alitretinoin in Chronic Hand dermatitis). This trial investigates the efficacy and safety of oral alitretinoin in patients with severe chronic hand dermatitis who do not respond to topical corticosteroids.
The BACH study represents the largest randomized placebo-controlled study ever performed in patients suffering from severe chronic hand dermatitis who do not respond to topical corticosteroids. Patients were recruited in 10 European countries and Canada. The trial comprises a treatment phase of once-daily oral alitretinoin for 12 to 24 weeks, with an additional observational follow-up period to assess duration of response. The primary endpoint of the study is defined as the number of patients with severe disease reaching complete or almost complete clearing of symptoms at end of treatment. Trial results are anticipated in early 2007.
Dr. Rienk Pypstra, Head of Development commented, "Basilea has achieved another major milestone through the completion of recruitment in this pivotal phase III trial. This is the most extensive study ever undertaken to investigate a treatment for severe chronic hand dermatitis. We are delighted to have completed recruitment in this indication for which there is no approved therapy available."
Chronic hand dermatitis is a common inflammatory skin disease. Patients who do not respond to topical therapy currently have limited treatment options. The illness results in significant patient disability. Based on epidemiological data and Basilea estimates, approximately 1 million patients in leading markets suffer from severe chronic hand dermatitis and do not respond to topical treatments.
"Severe chronic hand dermatitis has profound occupational, medical and social consequences with one-in-five patients requiring significant time off work and a similar proportion who ultimately need to change their jobs. We are committed to help these patients by developing oral alitretinoin as a novel treatment option," commented Dr. Anthony Man, Chief Executive Officer of Basilea.
About Alitretinoin (BAL4079)
Alitretinoin is an investigational drug that has shown evidence of significant activity in a phase II study involving over 300 patients with moderate to severe chronic hand dermatitis. Observed side effects were typical of the retinoid class. Similar to other systemic retinoids, alitretinoin is a potential teratogen and must not be administered to women who are, or plan to become pregnant. Basilea's phase III studies incorporate a pregnancy risk management program.
About Basilea
Basilea Pharmaceutica Ltd. (BSLN) is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea's fully integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance in the hospital market and on the development of dermatology drugs. Basilea's products are targeted to satisfy high medical and patient needs in the hospital setting. The company owns a diversified product portfolio including three products for severe medical indications in late stages of clinical development.
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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Dr. Barbara Zink
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