XTL Biopharmaceuticals' Lupus Drug hCDR1 Granted Patent for Pharmaceutical Composition & Manufacturing Processes
Lead asset addresses unmet need in market projected to reach $4 billion
RAANANA, ISRAEL / CRWEPRESSRELEASE / February 10, 2016 - XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, today announced that its lead drug candidate hCDR1 has been granted a patent by the Israel Patent Office. The patent, titled "Pharmaceutical Compositions Comprising a Peptide and a Substituted ß Cyclodextrin for use in Treating Systemic Lupus Erythematosus and Processes for their Manufacture," addresses the pharmaceutical composition of hCDR1 and its manufacturing processes. The compound hCDR1 and its formulations have been previously granted patents in numerous key jurisdictions including the U.S., Europe, Israel, Japan, China, India, Russia, Australia and Canada.
"As we head into our Phase 2 trial of hCDR1 in the U.S., Europe and Israel, we are pleased to see a fortification of our lead compound's intellectual property rights. Because systemic lupus erythematosus (SLE) is an indication in dire need of an effective treatment, a drug that shows promise of efficacy is of high interest to large pharma partners, making the IP surrounding the technology very valuable," stated Josh Levine, Chief Executive Officer of XTL.
XTL expects to initiate a Phase 2 trial of hCDR1 in the treatment of SLE in 2016.
The market for SLE drugs was $900 million in 2012 and is expected to grow to $4 billion by 2022 in the U.S., France, Germany, Italy, Spain, UK, and Japan according to Decision Resources.
hCDR1 is a novel compound with a unique mechanism of action and with clinical data on over 400 patients in three clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one and possibly more clinically meaningful endpoints. For more information please see a peer reviewed article in Lupus Science and Medicine journal (full article).
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic autoimmune disease involving many systems in the human body, including joints, kidneys, central nervous system, heart, hematological system and others. The biologic basis of the disease is a defect in the immune (defense) system, leading to production of self (auto) antibodies, attacking the normal organs and causing irreversible damage. According to the Lupus Foundation of America, at least 1.5 million Americans have the disease (more than 5 million worldwide) with more than 16,000 new cases diagnosed each year. The majority of patients are women of childbearing years. There has been only one drug approved by the FDA in the last over 50 years and recently two of the few drugs in advanced development did not meet their primary endpoints in Phase 3 trials.
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases including lupus. The Company's lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of systemic lupus erythematosus (SLE). There currently is no effective treatment on the market for SLE. hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer reviewed scientific journals. Based on safety and efficacy data shown in a completed Phase 2 study, the Company expects to initiate a Phase 2 trial in 2016.
XTL is traded on the Nasdaq Capital Market (XTLB) and the Tel Aviv Stock Exchange (XTLB.TA). XTL shares are included in the following indices: Tel-Aviv Biomed, Tel-Aviv MidCap, and Tel-Aviv Tech Index.
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Source: XTL Biopharmaceuticals Ltd.