Teva Pharmaceutical Industries and Eagle Pharmaceuticals  have entered into an exclusive licence agreement for EP-3102, Eagle’s bendamustine hydrochloride (HCl) rapid infusion product for the treatment of chronic lymphocytic leukaemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). Teva will be responsible for all US commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.

Eagle has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle has requested Priority Review of the NDA; this product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from Eagle’s recently-completed clinical trials demonstrating that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture.

“Since 2008, Teva’s bendamustine HCl product, TREANDA, has played a valuable role in the treatment of patients with CLL or indolent B-cell NHL that has progressed,” stated Paul Rittman, vice president and general manager, Teva Oncology. “With a substantially shorter infusion time, Eagle’s rapid infusion bendamustine HCl represents an important and improved benefit to both patients and healthcare providers. By adding this product to Teva’s Oncology portfolio, we are furthering our commitment to enhancing treatment options for patients affected by cancer and executing on a business development strategy to pursue opportunities in therapeutic areas where we can apply our expertise, commercial infrastructure and experience.”

“We are very pleased to partner with Teva for the commercialisation of our rapid infusion bendamustine product,” said Scott Tarriff, President and chief executive officer of Eagle Pharmaceuticals. “Given their strong presence and unsurpassed knowledge of this market, we believe there is no better company than Teva to optimise the market potential of this product.”

As part of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which should allow the product to come to market more quickly. Under the terms of the exclusive license agreement, Eagle will receive an upfront cash payment of $30 million and is eligible to receive up to $90 million in additional milestone payments. In addition, Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval.

The companies will also settle the pending patent infringement action between them in the United States District Court for the District of Delaware involving Teva’s US Patent No. 8,791,270.