RXDX-106

March 18, 2015 By Riley McDermid , BioSpace.com Breaking News Sr. Editor Israeli company Teva Pharmaceutical Industries Ltd. is once again rearranging its oncology portfolio, saying late Tuesday that it will sell four of its cancer assets to Ignyta in a deal valued at $41.6 million. As part of the switch, Ignyta will now own four of Teva ’s oncology assets: CEP-32496 (RXDX-105)--a Phase 1/2 small molecule inhibitor of BRAF, EGFR and RET; CEP-40783 (RXDX-106)--a preclinical pseudo-irreversible inhibitor of AXL and cMET; CEP-40125 (RXDX-107)--a preclinical nanoformulation of modified bendamustine and TEV-44229 (RXDX-108)--a preclinical selective inhibitor of the atypical kinase RKCiota plus next generation PKCiota inhibitors. “Acquiring these four development stage programs from Teva is truly transformational for Ignyta and well aligned with our strategic focus on developing first-in-class and best-in-class precision medicines to help cancer patients with unmet needs,” said Ignyta Chairman and Chief Executive Officer Jonathan Lim . Ignyta will pay for the group via a stock purchase agreement, which has Teva buying an additional 1.5 million shares of Ignyta at $10 per share. Other investors will buy an additional 2.7 million RXDX shares also at $10, valuing the total offering at $41.6 million. “These oncology programs add critical mass to our pipeline and further enable us to leverage our precision oncology platform, including our proprietary multiplex diagnostic assays and our CLIA certified, QSR compliant diagnostic laboratory,” said Lim. “Furthermore, these new assets complement our entrectinib development program and extend our ability to target the majority of known oncogenic drivers across multiple solid tumor indications,” he said. “For example, in non-small cell lung cancer alone, we believe that our product candidates have potential activity against many of the most frequent oncogenic drivers in this disease, and we plan to explore these opportunities through innovative clinical trial designs such as master protocols.” This is the second time this year Teva has switched around its cancer assets. On Feb. 17 Teva announced it has entered into a $120 million licensing agreement that will allow it to distribute and promote a competitor to its own cancer drug, Eagle Pharmaceuticals ‘s EP-3102. The news pushed Eagle ’s stock up over 13.8 percent in morning trading Tuesday. Eagle ’s non-Hodgkin’s lymphoma drug EP-3102 competes directly with Teva ’s Treanda, because both drugs target chronic lymphocytic leukemia. However, because EP-3102 is delivered via infusion, it is easier and faster to administer. The two companies said they will now settle a patent infringement lawsuit that had been brewing between them in U.S. District Court for the District of Delaware . Under the terms of the deal, Teva will shell out $30 million in cash, which will be followed by $90 million in additional milestone payments and double- digit royalties on sales. Teva will handle all regulatory approvals and both the costs and logistics associated with running clinical trials. “With a substantially shorter infusion time [than Treanda], Eagle ‘s rapid infusion bendamustine HCl represents an important and improved benefit to both patients and healthcare providers,” said Paul Rittman , vice president of oncology, in a statement. Teva also said Tuesday it will now waive its orphan-drug exclusivities for two diseases that EP-3102 also targets, a move which will put it in front of consumers much more quickly. Eagle already has submitted a new drug application for EP-3102, a 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, to the U.S. Food and Drug Administration (FDA) . Because of its efficacy in clinical trials, it had requested priority review, a nice boost for a product which has already received orphan-drug designation the seven years of patent exclusivity that go with that demarcation. Separately, the companies said they will settle a pending patent-infringement action between them in the U.S. District Court for the District of Delaware . “We are very pleased to partner with Teva for the commercialization of our rapid infusion bendamustine product,” said Scott Tarriff , president and CEO 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.” BioSpace Temperature Poll After Amgen Inc. said last week that it will close its South San Francisco facility acquired during its $10 billion buyout of Onyx Pharmaceuticals and will lay off 300 of Oynx ’s 750 workers, BioSpace is wondering—will the number of mergers and acquisitions completed in 2014 mean a “streamlining” of biotech jobs in the Bay Area? 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