Verastem has filed for FDA approval of duvelisib, a blood cancer drug the Needham, MA, company took a shot on in a 2016 bargain deal with Infinity Pharmaceuticals.
Verastem will seek approval of duvelisib as a treatment for patients who have one of three different blood cancers—chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or follicular lymphoma—and haven’t responded to other treatment. Verastem hopes to begin selling the drug next year.
If approved, duvelisib, a pill that blocks PI3 kinases, a well known cancer target, would be Verastem’s first marketed product—a twist of fate considering Verastem started out developing stem cell therapies for cancer and duvelisib has been in the hands of several other drugmakers over the years. Duvelisib was originally discovered by San Diego, CA-based Intellikline and licensed to Infinity (NASDAQ: INFI) in 2010. In September 2014, AbbVie paid Infinity $275 million up front to co-develop duvelisib, but the results in a non-Hodgkin lymphoma study weren’t as good as expected. Infinity later shuttered its research operations, cut jobs, and AbbVie terminated the partnership in June 2016. (Long-time Infinity R&D chief Julian Adams reflected on the situation in an interview with Xconomy last year.)
Just months later, Verastem, which was reeling from its own clinical setbacks, took a low-cost flier on duvelisib. The deal didn’t include an up front payment, just $6 million if the drug succeeded in a Phase 3 trial in CLL, another $22 million upon its first approval, and royalties on net sales. Verastem, whose shares closed at just $3.36 apiece on Tuesday, succeeded with that bet when duvelisib succeeded in a Phase 3 study last year. But it will face a tough commercial road ahead with duvelisib, as there are several drugs available or emerging for CLL.