FDA opts for standard review on bone cancer drug from Ariad, Merck

Much as was expected, the FDA accepted the NDA from Ariad Pharmaceuticals and Merck on their closely watched cancer drug ridaforolimus. But there was more than one eyebrow raised by the agency's decision to assign a standard 10-month review period for the treatment.

Just weeks ago the EMA accepted the developers' application for ridaforolimus--a bone cancer drug which blocks the mTOR protein, which is linked to cell growth--triggering a $25 million milestone payment to Ariad ($ARIA) from Merck ($MRK). Merck has global commercialization rights, but Ariad decided last May to take an option on 25% co-promotion rights for the U.S. market. Progress in Europe was seen as a big step for the biotech, but this morning its shares sagged slightly as some wondered why the FDA would be averse to a faster priority review, a common approach to highly anticipated cancer treatments.

At the beginning of this year Ariad was on a roll, cheering on its share price as investors reacted with glee to the Phase III sarcoma data, which demonstrated a 28% reduction in the risk of disease progression compared to a placebo. Investigators also reported a 21% increase in median progression-free survival--adding 3.1 weeks for patients. Merck will owe Ariad an additional $10 million milestone for a European approval and a $25 million payday if the FDA pushes ahead with an approval of their own.

Just a few days ago Ariad reported that it had begun dosing patients in a small study of AP26113, its third cancer drug, which blocks the overexpression of ALK and EGFR. Those two targets are also in the sights of Pfizer's ($PFE) newly approved crizotinib and Tarceva and the biotech has high hopes for forging ahead to first-in-class status. 

- here's the press release

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