AUSTIN, Texas, June 28, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), developer of next-generation True Human™ antibody therapies, today announced that it has entered into an exclusive licensing agreement with Megapharm Ltd., to commercialize Xilonix™ in Israel for the treatment of advanced colorectal cancer.
Xilonix is currently under accelerated review by the European Medicines Agency (EMA); a decision on approval could come as early as the fourth quarter of 2016. Xilonix also has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of colorectal cancer.
Under terms of the agreement, Megapharm will pay XBiotech an undisclosed upfront fee followed by payments upon the completion of certain commercial and regulatory milestones, including the approval of Xilonix for sale in Israel. In addition, upon this approval, Megapharm will purchase Xilonix from XBiotech at a supply price that is based on a percentage of net sales of the product.
“We are very pleased to partner with Megapharm to bring Xilonix to patients in this important market,” said XBiotech Founder, President and Chief Executive Officer John Simard. “Megapharm has a proven track record of commercial success working with some of the world’s leading biotech and pharmaceutical companies, and their deep experience in oncology makes them an ideal partner. This partnership is consistent with our plan to build marketing and distribution expertise in regional markets that will enable us to focus our internal commercialization efforts in Europe.”
“Xilonix meets a significant unmet need for the growing number of advanced colorectal cancer patients who seek an effective treatment option that is not encumbered by debilitating side effects,” said Megapharm Chief Executive Officer Miron Drucker. An estimated 3,500 people in Israel are diagnosed with colorectal cancer every year.
Founded in 1989 and headquartered in Ra’anana, Israel, Megapharm has partnered with international biotech and pharmaceutical companies to market medicines throughout Israel. “This agreement is an important step in our strategy to expand our oncology portfolio with a truly innovative therapy,” Drucker said. “We are prepared to launch Xilonix as soon as possible.”
About Colorectal Cancer
Colorectal cancer is the second leading cause of malignancy in the industrialized world.[i] Because the incidence of colorectal cancer increases with economic development and aging, incidence is rising worldwide.[ii] In Europe, approximately 470,000 patients will be diagnosed with colorectal cancer this year, and half will progress and ultimately succumb to the disease.[iii] Disease progression is associated with significant morbidity, functional impairment, and failure of multiple therapies often with substantial toxicities. Patients with advanced disease are thus symptomatic and intolerant to further treatment-related morbidity. New anti-cancer options are needed for patients suffering from advanced colorectal cancer.
About True Human™ Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech’s True Human antibodies are 100 percent human, derived from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
The first of these therapies, Xilonix, for advanced colorectal cancer, is in Phase III clinical trials in the United States with a Fast Track designation by the U.S. Food and Drug Administration (FDA). In Europe, Xilonix Phase III clinical trials have been completed, and the therapy is under accelerated review following the validation of its Market Authorization Application by the European Medicines Agency (EMA).
About XBiotech
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.
About Megapharm
Megapharm Ltd. is one of the leading private biotech, pharmaceutical and medical nutrition marketing companies in Israel with a strong biotech orientation, exclusively representing a number of major American and European pharmaceutical companies. Megapharm has demonstrated dynamic sales growth by developing a strong company presence and expertise in select therapeutic areas and diversified segments of the healthcare business. For more information see www.megapharm.co.il.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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[i] Lozano R, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380: 2095e128.
[ii] United European Gastroenterology (UEG). https://www.ueg.eu/press/releases/ueg-press-release/article/europe-is-falling-behind-america-in-the-fight-against-colorectal-cancer-due-to-low-screening-uptake/. Accessed April, 2016.
[iii] EuropaColon. http://www.europacolon.com/crcstatistics.php?Action=Crcstatistics. Accessed April, 2016.