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Teva Pharmaceutical Industries Ltd. (TEVA) and Eagle Pharmaceuticals, Inc. (EGRX) have entered into 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). 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. 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. 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 U.S. Patent No. 8,791,270. Teva will be responsible for all U.S. 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 U.S. 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 commercialization 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 optimize the market potential of this product.” Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2014 amounted to $20.3 billion. Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy is to utilize the FDA’s 505(b)(2) regulatory pathway. Eagle currently markets RYANODEX (dantrolene sodium) in the U.S. for the treatment of malignant hyperthermia.]]>