BioWorld International Correspondent

Positive news on two fronts during the past week provided Basilea Pharmaceutica AG with a share-price boost of about 6 percent.

Basel, Switzerland-based Basilea and its development partner, Johnson & Johnson, disclosed recently they had filed a new drug application for Ceftobiprole, a broad-spectrum cephalosporin antibiotic, for treatment of complicated skin and skin structure infection (cSSSI). A U.S. drug launch could follow early next year.

Basilea also remains on track to file in the second half of 2007 for European Union and Canadian approval for alitretinoin (9-cis retinoic acid) in chronic, refractory hand eczema, following the release Monday of positive safety and efficacy data from several Phase III clinical trials. Those extend previously disclosed Phase III efficacy data. (See BioWorld International, Feb. 21, 2007).

Basilea, which grossed CHF324 million (US$263 million), including an overallotment option, from a share offering back in March, now has added about CHF24 million more to its balance sheet in the form of a milestone payment from New Brunswick, N.J.-based Johnson & Johnson, following the ceftobiprole NDA.

"The filing came maybe one or two months earlier than expected," Cologne, Germany-based analyst Markus Metzger, of Bank Vontobel AG, told BioWorld International. "There's still a question outstanding in Europe," he said.

The company may opt to wait until results from a Phase III clinical trial of ceftobiprole in hospital-acquired pneumonia are in before filing for approval in cSSSI as well, since otherwise the company would have to wait to gain approval in the first indication before being permitted to file for the second. "The regulatory process works differently in Europe," he said.

The company's filing strategy is likely to be influenced by the rate of recruitment onto the Phase III clinical trial in hospital-acquired pneumonia, which began in April 2005. A Phase III study in community-acquired pneumonia began 12 months ago. The company will update the market on its filing strategy in the second half of this year.

Basilea originally entered an agreement worth up to CHF370 million with J&J to co-develop ceftobiprole in February 2005, and since then it has taken advantage of options to co-promote the product in the U.S. and in major European countries.

The company will be able to promote alitretinoin via the same sales force. "Marketing costs should be relatively low, so the profitability for Basilea should be high," said Metzger, who recently raised his peak sales forecast for the product from CHF300 million to about $350 million following positive data from retreatment studies. These indicate that patients who relapse do respond to subsequent treatment. Although 70 percent of patients receiving alitretinoin remained relapse-free for six months after treatment, some 80 percent of those who did relapse exhibited a response to a 30 mg dose of the drug.

The data support the development of treatment protocols that would incorporate drug holidays, Metzger said. That would be important for women of child-bearing age, because of the teratogenic effect of the drug.

Basilea aims to complete its European and Canadian filings before entering dialog with the FDA on a U.S. regulatory submission. It may be able to obtain U.S. approval on the basis of its existing Phase III package plus a post-marketing surveillance study, or it may need to conduct an additional trial in the U.S.

"With the EU/Canadian study program, we have generated a significant ICH-compliant safety and efficacy database that would play an important role in supporting the U.S. NDA," the spokesman said.

The anti-fungal drug is ravuconazole, which is undergoing two Phase III clinical studies in Aspergillus and in Candida infections, and also could be commercialized via Basilea's sales force. "If they go for nail indications they would have to partner because they would have to go to GPs then," Metzger said.

"That's one opportunity which may arise later, but at the moment we're focused on hospital indications," the Basilea spokesman said. The company is not excluding an agreement within the hospital market opportunity, but "it would have to be a very attractive offer," he said.

Basilea's shares were trading at CHF277.75 by late Tuesday afternoon, down Monday's close at CHF280.25 but still ahead of last week's opening price of CHF260.

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