Basilea Reports Positive Phase III Results for Alitretinoin
BASEL, Switzerland, Feb. 19, 2007 (PRIME NEWSWIRE) -- Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today that its placebo-controlled pivotal phase III BACH trial (Benefit of Alitretinoin in Chronic Hand dermatitis) successfully met its primary objective. Alitretinoin was effective in patients suffering from severe and refractory chronic hand dermatitis, as determined by the stringent endpoint of clear and almost clear hands. Currently, no approved treatment exists for this debilitating disease which prevents patients from using their hands normally. These positive data will form the basis of regulatory submissions later this year.
The positive outcome of this study may allow alitretinoin to become the first product available to treat an estimated one million patients who suffer from severe refractory Chronic Hand Dermatitis (CHaD).
This randomized double-blind phase III pivotal study is the largest therapeutic trial ever performed in chronic hand dermatitis. In the study, 1032 patients whose severe chronic disease was unresponsive to potent topical steroids 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. The primary endpoint of the study was the proportion of patients whose hands were rated as clear or almost clear by the Physicians Global Assessment.
Alitretinoin's efficacy was significantly superior to placebo in both the high and the low dose regimen. The difference between the active groups and placebo were highly statistically significant. In the 30mg group 48% of patients (p less than 0.001) and 28% in the 10mg group (p=0.004) reached the primary endpoint. The response in the placebo group was 17%.
Alitretinoin was generally well tolerated with a safety profile consistent with that reported in the phase II clinical study. The most frequent adverse events were headache and blood lipid elevations. These were dose-dependent and reversible.
"Patients with severe chronic hand dermatitis often fail on topical treatments. Alitretinoin has the potential to become a new treatment standard for those who currently face social and professional disability and handicap due to intractable disease," commented Professor Thomas Ruzicka of the Ludwig-Maximillian University Munich, Germany, one of the world's largest dermatology clinics.
Dr. Anthony Man, Basilea's CEO observed, "These are compelling data. Patients' responses to treatment with alitretinoin were remarkable, particularly for this population whose disease is long-term and unresponsive to other treatments. For the first time, patients who currently have no effective treatment available may have a viable option." Dr. Man continued, "These results highlight the benefits to patients which Basilea's focus on high unmet medical needs can bring. This is the second of Basilea's compounds which has successfully completed phase III this year. Subject to the appropriate regulatory approvals, alitretinoin may become an important driver of Basilea's future growth. Basilea is now building a marketing and sales capability focused on the hospital and specialty sectors to bring these new medicines to patients and to treating physicians."
About Chronic Hand Dermatitis (CHaD)
Hand dermatitis 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 CHaD for which currently no approved, effective pharmaceutical treatment is available.
For the patient, severe CHaD 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.
Alitretinoin is an investigational drug being developed by Basilea as a novel treatment for severe refractory Chronic Hand Dermatitis (CHaD), a complex disease for which no effective treatment options are currently available. Alitretinoin was effective in clinical studies in patients with severe refractory CHaD. 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.
Other Products in Phase III Development
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin that has demonstrated positive Phase III trial results in complicated skin and skin structure infections. Ceftobiprole has shown a low potential to select for resistance in-vitro and exhibits in-vitro activity against a wide spectrum of bacteria - including resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA) -- that cause many hospital and community-acquired infections. Top-line results of a second phase III study in skin infections were announced in early 2007. The FDA has granted ceftobiprole fast track status and the first registration filing is planned mid 2007. Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International, a Johnson & Johnson company. Ortho-McNeil, Inc., another Johnson & Johnson company, will market ceftobiprole in the U.S. and its affiliate company, Janssen-Cilag, will market the product in Europe, Japan and China. Basilea has exercised its co-promotion option on ceftobiprole in North America and major European countries. Basilea will participate in the anticipated launch and promotion of ceftobiprole in these markets.
Isavuconazole has a potent, broad-spectrum activity against both yeasts and molds. This new triazole is developed as a water-soluble pro-drug to allow safe and simple intravenous administration without contraindication in renally impaired patients. In addition, taken as convenient once daily or once weekly capsules, the prodrug results in excellent bioavailability. Basilea successfully completed its phase II trial with both high clinical cures rates and a safety profile comparable to gold standard therapy but with potentially a more flexible dosing schedule. Clinical drug interaction studies illustrated attractive pharmacokinetic features and the potential for less drug-drug interactions than a number of broad-spectrum antifungal drugs in current use.
Isavuconazole is in phase III clinical trials for the primary treatment of invasive candida and aspergillus infections.
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. Basilea is building a sustainable hospital and specialty pharmaceutical business. The company is integrating commercialization into its organization, in a first step through co-promoting ceftobiprole.
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Monday, February 19, 2007, 4 p.m. (CET).
Dial-in numbers are: +41 (0) 91 610 56 00 (Europe und ROW) +1 (1) 866 291 4166 (USA) +44 (0) 207 107 0611 (UK)
The playback will be available 1 hour after the conference call for 48 hrs. Participants requesting a digital playback may dial:
+41 (0) 91 612 4330 (Europe) +1 (1) 866 416 2558 (USA) +44 (0) 207 108 6233 (UK) and will be asked to enter the ID 583 followed by the # sign.
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.
This press release can be downloaded from www.basilea.com
Posted: February 2007