Zeftera problems weigh down Basilea
pharmafile | February 5, 2010 | News story | Sales and Marketing | 2009 financials, Basilea, Zeftera
Specialist Swiss pharma company Basilea has announced a doubling of its revenues in 2009, thanks to the launch of its new eczema treatment Toctino.
Revenues and other income rose to CHF 26.8 million compared to CHF 12.0 million in 2008. Toctino was launched in Germany, the UK, France and Denmark last year, and total revenues for the product rose to CHF 17.3 million (from just CHF 1.9 million in 2008).
But investors are concerned about the fate of new antibiotic product Zeftera (ceftobiprole) which is being held up by regulatory problems in the US and Europe.
In late 2009 the company announced that Zeftera, an anti-MRSA broad-spectrum antibiotic, was delayed following an FDA request for a new phase III study for complicated skin and skin structure infections (cSSSI) from Basilea’s US partner Johnson & Johnson.
The FDA had concluded that data from the studies could not be relied upon because inspections and audits of around a third of the clinical trial sites found much of the data to be unreliable or unverifiable.
The FDA said this raised concerns about the overall data integrity for both studies.
In Europe, things had been more encouraging following a positive opinion from the CHMP in November 2008, but the EMEA then followed the US regulator in requesting Good Clinical Practice (GCP) inspections at investigator sites to be completed.
Basilea responded by submitting a ‘Request for Arbitration’ over the delays relating to what it says are ‘substantial damages’ suffered by the business, caused by the delayed approval as well as delay in milestone payments.
Further troubles hit later on in the year when patient recruitment in a phase III programme of antifungal drug isavuconazole was interrupted due to manufacturing issues. These have now been addressed, and patient recruitment is expected to resume in the first half of 2010.
The company’s chief executive Dr Anthony Man addressed the year’s mixed news.
“Basilea experienced successes as well as setbacks in 2009. We are very proud of the successful commercialisation of Toctino in first key markets in the past year reflecting the innovation and pharmacoeconomic value of Toctino. We are, however, clearly disappointed with the delays following the review of the market applications for ceftobiprole,” he said.
The first clinical results from the phase III study of alitretinoin and further efforts to resolve the ceftobiprole will be key milestones for the year ahead.
Ron Scott, chief financial officer, said: “We are pleased to see first full year product sales for Toctino with major contributions from the German market and additional sales from Denmark and the UK. We also achieved first sales in France, a major European market, where the product was launched recently.
“During 2010 we expect enhanced sales uptake of Toctino following further national approvals and launches. We are committed going forward to take advantage of the strategic flexibility that our rich and competitive product portfolio provides.”
The company’s early-stage programme includes – BAL30072, a novel antibiotic against the most difficult-to-treat multi-drug-resistant Gram-negative bacteria. Another is BAL27862, a cancer treatment with activity against a broad range of tumour types – including those unresponsive to standard therapeutics.
Both are currently undergoing pre-IND (Investigational New Drug) studies. The company anticipates successful completion of pre-IND studies, which would then lead to the initiation of phase I clinical trials in the second half of 2010.
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