Swiss biotech Basilea Pharmaceutica saw its shares decline Friday after the European Committee for Medicinal Products for Human Use confirmed its previous negative opinion on the marketing authorization application for ceftobiprole to treat complicated skin and soft tissue infections. The news comes as Basilea's Japanese partner Astellas Pharma said it was expanding a late-stage trial of the antifungal isavuconazole, delaying the release of data up to 18 months.
For ceftobiprole, the CHMP indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about the reliability of the results, according to a Basilea statement. It therefore recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization.
The body's decision comes months after it issued a negative opinion for the drug, stating that Phase III studies supporting the MAA had not been conducted in compliance with good clinical practice in some sites. Basilea's partner Janssen-Cilag had requested re-examination of the negative opinion under standard procedures.
Separately, a Basilea spokesman tells Reuters that he is unable to predict when isavuconazole will hit the market with expansion of the Phase III trial. Treatment of first new patients in the Phase III program is anticipated in the third quarter of the year. Patient recruitment is anticipated to be completed in 2012, and the first trial results from the Phase III program are expected in 2013.
"The implementation of these protocol amendments that allow for a swift continuation of patient recruitment and the anticipated expansion of patient numbers underscore Astellas' and our strong commitment to pursue the best development path for this innovative treatment," says Professor Achim Kaufhold, Basilea's CMO. "Despite the change to the initially anticipated timelines, we believe that the envisaged changes will further strengthen the competitive positioning of isavuconazole in an evolving medical field."
"Overall, all these amendments bring the study up-to-date, which should finally also facilitate the data review for approval as well as lower the risk of a potential rejection by the regulatory authorities," Helvea analyst Olav Zilian, tells Reuters.
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