JERUSALEM & WOODCLIFF LAKE, N.J.—Pharmaceutical giant Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals Inc. have initiated an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride (HCl) rapid infusion product for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). Per the terms of the agreement, Teva will assume responsibility for all U.S. commercial activities for the product, which includes promotion and distribution. Eagle will be responsible for obtaining all regulatory approvals for EP-3102, conducting any necessary post-approval clinical studies and initially supplying the drug product to Teva.
Teva will pay Eagle $30 million in an upfront cash payment, and the latter is also eligible to receive up to $90 million in additional milestone payments. Eagle stands to receive double-digit royalties on net sales of the product as well. The agreement also stipulates that Teva will waive its orphan drug exclusivities for the NHL and CLL indications with respect to EP-3102, which should enable the product to reach the market sooner.
“We are very pleased to partner with Teva for the commercialization of our rapid infusion bendamustine product,” Scott Tarriff, president and CEO of Eagle Pharmaceuticals, commented in a statement. “Given their strong presence and unsurpassed knowledge of this market, we believe there is no better company than Teva to optimize the market potential of this product.”
Eagle has submitted a New Drug Application (NDA) 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. The company has also requested priority review of its NDA from the U.S. Food and Drug Administration. The product candidate has already been granted Orphan Drug Designations for both the CLL and indolent B-cell NHL indications.
“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.”
In other product news for Teva, the company simultaneously announced the launch of its generic equivalent of Lovenox (enoxaparin sodium injection) in seven dosage strengths in the United States. Enoxaparin Sodium Injection, USP is indicated for the prophylaxis of deep vein thrombosis in patients undergoing abdominal surgery, hip or knee replacement surgery; for patients with severely restricted mobility during acute illness; and for the treatment of acute deep vein thrombosis. Teva also recently launched the generic version of Zyvox (linezolid) Injection for the treatment of infections caused by Gram-positive bacteria.