XBiotech Signs Exclusive Licensing Agreement With Megapharm

XBiotech Inc., developer of next-generation True Human antibody therapies, recently 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 US 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,” added 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. We are prepared to launch Xilonix as soon as possible,” added Drucker.

Unlike previous generations of antibody therapies, XBiotech’s True Human antibodies are 100% 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 US 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).

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, TX, 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.

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, www.megapharm.co.il.