FDA approves Teva and Eagle's Bendeka

Shares of Eagle Pharmaceuticals (Nasdaq: EGRX) leapt 14.4% to $93.70, after it was revealed that the US Food and Drug Administration had approved Bendeka (bendamustine hydrochloride) injection, a liquid, low-volume (50mL) and short-time 10-minute infusion formulation of bendamustine.

Bendeka, which has been developed in collaboration with Israel’s Teva Pharmaceutical Industries (NYSE: TEVA), is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

Under the February 2015 exclusive license agreement for Bendeka, Teva is responsible for all US commercial activities for the product including promotion and distribution. Teva expects to make Bendeka commercially available to prescribers during the first quarter of 2016.