U.S. Court of Appeals for the Federal Circuit Affirms Merus' Inequitable Conduct Claim Against Regeneron
UTRECHT, The Netherlands, July 28, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the U.S. Court of Appeals for the Federal Circuit affirmed the trial court's conclusion that Regeneron Pharmaceuticals, Inc. engaged in inequitable conduct before the United States Patent and Trademark Office while prosecuting U.S. Patent No. 8,502,018 ('018 patent), entitled "Methods of Modifying Eukaryotic Cells."
In today's decision, the Federal Circuit ruled fully in favor of Merus, affirming that Regeneron's '018 patent is unenforceable, having been obtained by inequitable conduct. The Federal Circuit noted Regeneron made "false" assertions, relied on a "misleading presentation," and withheld material information from the United States Patent Office, and further, that Regeneron's "litigation misconduct" "obfuscated its prosecution misconduct."
"We are pleased by today's decision, which serves as the latest vindication for Merus in this case against Regeneron," said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. "With this decision, and based on the continued strength of our IP estate, Merus remains focused and believes it is well-positioned as an innovator in the development of full-length human bispecific antibody therapeutic candidates for serious diseases."
About Merus N.V.
Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have several of the same features of conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus' lead bispecific antibody candidate, MCLA-128, is expected to begin a Phase 2 clinical trial in the second half of 2017 in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in Europe in gastric, ovarian, endometrial and non-small cell lung cancers. Merus' second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as MCLA-145 designed to bind to PD-L1 and a non-disclosed second immunomodulatory target, which is being developed in collaboration with Incyte Corporation.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics® and bispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaboration with Incyte or Incyte may fail to perform adequately under our collaboration; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; our ability to protect our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in existing and potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on April 28, 2017, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
+1 973 361 1546
+1 646 368 8014
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Merus N.V. via Globenewswire
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
K2 Launches New Process Automation Platform Including New Cloud Service20.9.2017 18:00 | Pressemelding
K2's process automation platform allows businesses of all types around the globe to rapidly build and deploy automation across the business. BELLEVUE, Wash., Sept. 20, 2017 (GLOBE NEWSWIRE) -- K2 today announced the availability of its new low-code process automation platform - furthering innovation in the way organizations drive digital efficiencies. With a new managed cloud service, K2 Cloud, new on-premises version, K2 Five, and completely redesigned user interfaces and experiences, the platform helps businesses of all types around the globe rapidly deliver powerful process automation and realize business productivity gains. Automating business processes across an enterprise is crucial to the success of companies in the era of digital transformation. However, many initiatives are impacted by a lack of sufficient resources and the use of inefficient systems to manage processes. K2's low-code process automation platform solves these problems by enabling organ
8x8 and Aryaka Partner to Enhance Cloud Communications for Global Enterprises20.9.2017 16:43 | Pressemelding
Strategic Alliance will improve communications experience for business users worldwide SAN MATEO, Calif., Sept. 20, 2017 (GLOBE NEWSWIRE) -- Aryaka®, the leading global SD-WAN provider, and 8x8, Inc. (NASDAQ:EGHT), the world's first Communications Cloud provider, today announced that they are entering a strategic partnership that will improve the performance and reliability of business-critical cloud unified communications. This will enable global mid-market and enterprise companies to enhance business communications, collaboration and customer engagement for their employees, customers and partners around the world. Through this partnership, Aryaka's global SD-WAN solution will provide enterprise-grade private connectivity to further enhance the superior voice and video quality delivered by the 8x8 Communications Cloud(TM). When tested against several leading Unified Communications as a Service (UCaaS) providers, 8x8 was recently found by the Tolly Group to deliver the hi
NRT Technology Corp and Gaming Payments Innovator Sightline Payments Announce Merger20.9.2017 16:00 | Pressemelding
Combination Will Accelerate Innovation in Mobile, Data, Cashless Payments, and Provisional Credit Solutions to the Worldwide Integrated Resort Casino Industry LAS VEGAS, Sept. 20, 2017 (GLOBE NEWSWIRE) -- NRT Technology Corp. ("NRT") a leading provider of integrated ticket redemption and payment services to global casino operators, and Sightline Payments ("Sightline"), developers of the disruptive Play+ platform that's powering the next generation of cashless and mobile gaming payment solutions, announced today an agreement to merge. The company on closing will be named NRT Sightline and will form one of the largest pure play gaming payment technology companies in the world with an equity value of over $300 million. Following the closing of the transaction and subject to regulatory approvals, Sightline's CEO and Founder, Kirk Sanford, will assume the role of President and CEO of NRT Sightline. NRT's current Founder, P
BT and Hitachi Partner to Develop Industrial and Enterprise IOT Solutions20.9.2017 15:00 | Pressemelding
Initial Focus on Asset Intelligence and Predictive Maintenance Use Cases LAS VEGAS and LONDON, Sept. 20, 2017 (GLOBE NEWSWIRE) -- BT, one of the world's leading providers of communications services and solutions, and Hitachi Vantara, a wholly owned subsidiary of Hitachi Ltd. (TSE:6501) today announced a global partnership to co-create innovative solutions in the area of industrial and enterprise internet of things (IoT). The partnership aims to drive better business outcomes for global customers, including greater efficiency, productivity and cost savings. The companies will initially focus on exploring and designing asset intelligence and predictive maintenance solutions to deliver the desired outcomes for customers in industry sectors such as manufacturing and transportation. Announced at Hitachi's inaugural user conference, Hitachi NEXT 2017, in Las Vegas today, the partnership unites BT's global network infrastructure, cloud capabiliti
XBiotech Announces Agreement with Cedars-Sinai Medical Center to Evaluate MABp1 in Combination with Onivyde® and 5-fluorouracil/folinic acid for the Treatment of Pancreatic Cancer20.9.2017 14:00 | Pressemelding
AUSTIN, Texas, Sept. 20, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today its agreement with Cedars-Sinai Medical Center located in Los Angeles, California, whereby XBiotech will provide its interleukin-1 alpha antagonist, MABp1, for a Phase I single arm study evaluating the maximum tolerated dose of Onivyde® (Irinotecan liposome injection) and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia. The study will also assess efficacy using various secondary measures including changes in lean body mass, weight stability, IL-6 levels, overall and progression free survival as well as evaluation of the relationship between treatment tolerance and patient functional status. Andrew Hendifar, M.D., Medical Oncology lead for the Gastrointestinal Disease Research Group at Cedars-Sinai and Co-Director of Pancreas Oncology, will be leading the study which is planned to enroll a total of 16 pati
NTT Security lanserer sikkerhetstjenester for industrielle kontrollsystemer20.9.2017 10:00 | Pressemelding
Cyberforsvar for kritisk infrastruktur, inkludert fabrikker, anlegg, forsyningstjenester og sykehus Oslo, 20. sept. 2017 (GLOBE NEWSWIRE) - NTT Security Corporation (hovedkontor: Chiyoda-Ku, Tokyo; adm.dir.: Jun Sawada), det spesialiserte sikkerhetsselskapet til NTT Group, har lansert IT/OT Integrated Security Services. De nye tjenestene skal markedsføres globalt gjennom NTT Group-selskapene Dimension Data, NTT Communications og NTT DATA. De inngår i en pakke med integrerte tjenester som gjør det mulig for kundene å gjennomføre digitale transformasjonsinitiativ. Selskaper arbeider i økende grad med tilpasning av IT/OT (operativ teknologi). Når OT-systemer kobles til internett, kan de effektivisere forretningsvirksomheten gjennom avansert styring av forsyningskjeden, realisering av massetilpasning og forbedring av kundeopplevelsen, samt utvikle ny intelligens som benytter IoT (Internet of Things, tingenes internett) og stordataanalyse. Som et resultat av dette gjør IT/OT-k
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom