On November 10, 2014 Eagle Pharmaceuticals reported positive results from a recently-conducted clinical trial of its bendamustine hydrochloride ("HCl") product, in which the dose was delivered in a 50mL admixture in ten minutes (the "rapidly infused product") versus a 500mL admixture in the 60-minute infusion required for Treanda (bendamustine HCl) (Press release Eagle Pharmaceuticals, NOV 10, 2014, View Source [SID:1234500946]).
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In this study, Eagle’s rapidly infused product was found to be bioequivalent to Treanda, which was the primary endpoint of the study. The incidence and profile of adverse events, both infusion-related and general, for the rapidly infused product was comparable to Treanda. This is particularly important because the rapidly infused product delivers the same amount of active ingredient as Treanda but with a lower admixture volume, which enables the Eagle product to be administered more quickly.
Eagle received tentative approval for this formulation in July 2014. The positive data supports that the product can be delivered in this new low-volume infusion.
Eagle received orphan drug designation for its rapidly infused product for chronic lymphocytic leukemia ("CLL") and indolent B-cell non-Hodgkin’s lymphoma ("NHL") on July 2, 2014.
"We are very excited about these results, and intend to file these data with the FDA as soon as possible," said Scott Tarriff, President and Chief Executive Officer. "We look forward to our pre-NDA meeting with the FDA in mid-December.
"We believe the shorter infusion time afforded by the 50mL admixture will greatly benefit cancer patients and healthcare providers alike, and our goal is to bring our rapidly infused product to market as soon as possible," Tarriff concluded.
This open-label, randomized, crossover, Phase I clinical trial was designed to compare bioequivalence of Eagle’s rapidly infused product and Treanda, and to assess the safety and tolerability of the rapidly infused product. The study evaluated 81 patients with a histologically-confirmed diagnosis of solid tumors and hematologic malignancies for which no curative or standard therapy is appropriate.
The treatment phase, pharmacokinetic assessments, infusion-related safety assessments and bioequivalence evaluation are complete in all 81 patients. The overall safety assessment is complete in over 80% of subjects and will conclude on November 17th.
On September 16, 2014, Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries, Ltd., filed a motion to dismiss all claims against Eagle concerning alleged infringement of U.S. Patent No. 8,445,524. Cephalon recently filed a second lawsuit in the District of Delaware alleging that Eagle’s bendamustine product infringes Cephalon’s newly-issued U.S. Patent No. 8,791,270. That case remains pending.
Eagle also confirmed that the U.S. Patent and Trademark Office ("USPTO") has allowed a patent covering administration of its bendamustine HCl product candidate in a low volume admixture with a shorter infusion time. This is the second patent allowed for this product. Eagle continues to execute its strategy to further strengthen its intellectual property surrounding this and its other products and product candidates.