XBiotech Signs Agreement With Megapharm To Market Xilonix™ In Israel
AUSTIN, Texas, 2016-06-28 14:46 CEST (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).
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.
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.
[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.
Media liaison U.S.
+1 917 242 1087
Media liaison ex-U.S.
+44 20 8618 2755
Mobile: +44 7725 925 841
Om NASDAQ OMX
NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra NASDAQ OMX
Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra NASDAQ OMX
Concurrent Achieves Sales Milestone for Zephyr Transcode19.10.2017 15:35 | Pressemelding
Concurrent Customers Now Transcoding on Three Continents ATLANTA, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Concurrent (NASDAQ:CCUR), a global leader in storage, protection, transformation, and delivery of visual media assets, announced today that Zephyr Transcode, which Concurrent launched last year as an integral part of its content delivery network (CDN) solutions, is now deployed with customers in Asia, Europe and North America. The deployments already support thousands of on-demand assets being transcoded to multiple formats and bit-rates to support any place, any device content availability. Zephyr Transcode supports multiple formats and quality levels including H.264 (MPEG-4) and H.265 (HEVC), strengthening Concurrent customers' capability to provide high-quality standards-based streams to any device their end-users desire. Zephyr Transcode is software-based and capable of running in traditional Central Processing Units (CPU) as well as Gra
German Armed Forces Renews Contract for Hexagon Geospatial Products19.10.2017 15:11 | Pressemelding
Defense agency will work closely with Hexagon Geospatial Premium Partner for next two years NORCROSS, Ga., Oct. 19, 2017 (GLOBE NEWSWIRE) -- At the HxGN LOCAL Defense Summit, a conference dedicated to defense and security in Western Europe, Hexagon Geospatial announced that the Bundeswehr Geoinformation Centre (BGIC) recently renewed a large software maintenance contract for Hexagon Geospatial products. The two-year renewal is for more than 100 licenses, mainly within the GeoMedia and ImageStation product families. The contract also includes consulting for workflow optimization. The contract was issued to Geosystems, a Hexagon Geospatial Premium Partner, which will work closely with the local subsidiary of Hexagon Safety & Infrastructure in Bonn and Munich to support BGIC. "The strong Hexagon Geospatial partner network allows our defense customers to benefit from a unique pool of expertise and tradecraft in the areas of remote sensing, GIS, and photog
Novel Preclinical Research Tools Provide Humanized Immune Response to Advance Immunotherapeutic Development, Live Webinar Hosted by Crown Bioscience19.10.2017 14:00 | Pressemelding
SANTA CLARA, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announces a live webinar to be presented by Dr. Michelle Mack, Director of Global Scientific Engagement, entitled "Beyond Syngeneics - Novel Tools for Addressing Human Specificity in Immuno-Oncology." Checkpoint inhibitors like anti-PD-1, anti-PD-L1, and anti-CTLA-4 have revolutionized cancer treatment and have recently gained approval in several cancer types. Despite their potential, immunotherapies face significant development challenges due to the specificity and complexity of the human immune system upon which they act. Crown Bioscience has generated innovative research models to address these obstacles early during preclinical drug development.
Perfectus Aluminum Inc. Responds to Trade Group19.10.2017 13:00 | Pressemelding
ONTARIO, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) -- Perfectus Aluminum Inc. has issued the following: On October 12, 2017 the Aluminum Extruders Council (AEC), an industry group representing largely American aluminum extruders, posted to its blog a false narrative regarding a suit to which Perfectus Aluminum Inc. is a related party. The government is not "seeking unpaid duties from Perfectus for goods brought into the country." Rather, the government is attempting to use a 2017 Department of Commerce determination to assess retroactive antidumping duties on goods imported as early as 2011. It is discouraging that AEC would tout such an obviously egregious government overstep as a "victory" to their members and the industry: were it one of AEC's own members facing such an obvious violation of fair play and due process, it would rightfully argue that government overreach is a threat to manufacturers everywhere. In addition to the hypocrisy of the AEC's promotion of this case, its s
Payvision's annual report reveals cross-border ecommerce trends in 201719.10.2017 09:00 | Pressemelding
With online marketplaces and consumer technology leading the way for growth AMSTERDAM, The Netherlands, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Payvision, global acquirer and data-driven omnichannel solutions provider, has published the findings of its fifth annual cross-border ecommerce research report, in collaboration with Juniper Research. The paper includes the results of a global survey of various industry players regarding the game-changers, the biggest challenges, the best practices for going cross-border, and much more. When compared to last year's findings, the report reveals a new and exciting context for global cross-border trade. The compound annual growth rate predicted for the next three years for cross-border ecommerce is now 17%, whereas it stands at just 12% for ecommerce overall. Also, over the past 12 months, merchants' attitudes towards cross-border ecommerce have become more positive, with 50% of respondents agreeing and 31% strongly
High Seizure Frequency in Children with Dravet Syndrome Negatively Impacts Quality of Life, New International Caregiver Survey Finds19.10.2017 08:00 | Pressemelding
Global survey of 584 caregivers of children, young adults and adults with Dravet illustrates the detrimental effect of debilitating, frequent seizures on quality of life and co-morbidities Results suggest a need for more effective antiepileptic treatments EMERYVILLE, Calif. and BREST, France, Oct. 19, 2017 (GLOBE NEWSWIRE) -- The Dravet Syndrome European Federation and Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, announced today the publication of the initial results from a landmark survey into the clinical, social and economic consequences of Dravet syndrome on children, young adults and their families in Developmental Medicine & Child Neurology [doi:10.1111/dmcn.13591]. This study was led by Lieven Lagae, M.D., Ph.D., Professor at the University of Leuven, Belgium, Head of the Pediatric Neurology Department and Director of the Childhood Epilepsy
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom