On December 8, 2015 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported that it has achieved the milestone which entitles the Company to receive a $15 million payment from Teva Pharmaceuticals Industries Ltd. resulting from the U.S. Food and Drug Administration ("FDA") approval of BENDEKA, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine 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 (Press release, Eagle Pharmaceuticals, DEC 8, 2015, View Source [SID:1234508487]). Schedule your 30 min Free 1stOncology Demo! The Company will receive a 20% royalty on net sales of BENDEKA. In addition, Eagle may earn an incremental step-up royalty upon the achievement of future milestones.
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"We look forward to Teva’s successful commercialization of this new treatment option. We believe the $15 million milestone payment triggered by approval, coupled with future royalties of 20% on Teva’s net sales of BENDEKA, will expedite Eagle’s ability to deliver long-term, sustainable growth," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
BENDEKA was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.
Under the February 2015 exclusive license agreement for BENDEKA, Teva is responsible for all U.S. commercial activities for the product including promotion and distribution.