Astellas bags FDA approval for a new anti-infective

Japanese pharma giant Astellas won FDA approval for an antifungal treatment targeting two rare but dangerous infections, the latest drugmaker to take advantage of new incentives for anti-infective products.

Astellas' treatment, to be sold as Cresemba, is an oral and injected solution for invasive aspergillosis and mucormycosis, two infections that commonly afflict patients undergoing chemotherapy or who have received organ transplants. Left untreated, the fungal infections can lead to acute renal failure and death, according to Astellas.

The company bought into Cresemba's promise back in 2010, signing a deal with Switzerland's Basilea Pharmaceutica in which it paid $86 million up front and promised about $550 million more if the drug comes through on its development and sales goals. Beyond aspergillosis and mucormycosis, the partners are in the midst of Phase III trials against invasive candidiasis, a lethal infection caused by Candida yeasts.

The approval marks the 6th drug cleared under the FDA's Qualified Infectious Disease Product (QIDP) program, which bestows an additional 5 years of market exclusivity on products that target life-threatening infections.

The Japanese company's embrace of antibiotics follows a trend among the world's largest drugmakers, whose history of inattention to R&D in the field is in part responsible for the current increase in demand--and market opportunity--for anti-infectives. Now, buoyed by government incentives like QIDP, Big Pharma is creeping back into the space, with Merck ($MRK) trading $9.5 billion for specialist Cubist Pharmaceuticals late last year and well-funded players including Roche ($RHHBY) and Actavis ($ACT) spending big to beef up their antibiotic pipelines.

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