XTL signs agreement with Yeda to amend development milestones for lupus treatment

Oct 13 2015

XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTL) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of unmet clinical needs with a focus on treatments for autoimmune diseases, today announced that it has reached agreement with Yeda Research and Development Company Ltd. ("Yeda") to amend the development milestones in the License Agreement signed between the parties in January 2014 for the development of hCDR1 for the treatment of systemic lupus erythematosus (SLE).

The amended agreement extends the time for achievement of key development milestones by approximately five additional months including delivery to Yeda of a full protocol for an upcoming clinical trial on hCDR1, raising an aggregate of US$5 million (of which US$4 million was raised in April 2015), and commencing a clinical trial on hCDR1 by January 2017.

Josh Levine, Chief Executive Officer of XTL, commented, "We are pleased with Yeda's affirmation of their support and confidence in our ability to develop hCDR1 for the treatment of SLE. The amended agreement recognizes XTL's efforts to date to advance hCDR1 to a clinical trial including: assembling a world-class Clinical Advisory Board with leading names in SLE, strengthening the Company's Board with Directors with drug development and financial market experience, transferring the IND relating to hCDR1 from Teva Pharmaceutical Industries Limited to the Company, manufacturing the drug substance for the upcoming trial, engaging in ongoing discussions with the FDA to seek opportunities to strengthen hCDR1 intellectual property and optimize the regulatory pathway, and raising US $4 million out of the aggregate amount of US $5 million as required by the License Agreement."

"We believe the amended agreement provides XTL with the time needed to properly develop our hCDR1 program and bring the product to an advanced clinical trial in the near future. We believe our operational plan and activities over the last several months should allow us to achieve the amended development milestones well within the revised timeline. The recent publication of the encouraging results of a previous Phase 2b trial (the PRELUDE trial) on hCDR1 in a peer reviewed article in the Lupus Science and Medicine journal (full article), showing favorable safety and efficacy data on over 300 patients, further strengthens our commitment to advance the development of hCDR1 as soon as possible."

Amir Naiberg, Chief Executive Officer of Yeda commented: "We are encouraged by the progress that XTL has made to date with hCDR1. We look forward to XTL's continued development of the drug for the treatment of SLE."

SOURCE XTL Biopharmaceuticals Ltd