Basilea Pharmaceutica's (SIX:BSLN) long struggle to generate significant income from the U.S. may be nearing its end. After years of setbacks for the antibiotic ceftobiprole, antifungal isavuconazole is now on the cusp of winning FDA approval. And Basilea thinks it and partner Astellas Pharma have a potential blockbuster on their hands.
|Basilea CEO Ronald Scott|
A FDA advisory panel backed isavuconazole as a treatment for aspergillosis and mucormycosis, setting Basel, Switzerland-based Basilea and Astellas on the path to a positive final decision in March. Astellas has full rights to the antifungal in the U.S.--Basilea gave up its co-promotion option for total control outside North America last year--but a FDA approval still has significant implications for the Swiss biopharma.
Basilea is in line to receive up to CHF 374 million ($425 million) in regulatory approval milestones and sales royalties. And CEO Ronald Scott told Bloomberg sales could be big. Scott sees Pfizer's ($PFE) antifungal voriconazole--which racked up sales of $775 million in 2013--as a benchmark that isavuconazole could surpass. "Certainly it has the potential for Basilea to become a significant asset," Scott said.
The royalties could set Basilea on its way to becoming profitable in 2016. By then, isavuconazole may also have won approval in Europe, where Basilea has full rights and a strategy to promote the antifungal alongside its antibiotic ceftobiprole.
- read Bloomberg's article and FierceBiotech's coverage
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