NASDAQ OMX

Merus Announces Favorable Decisions in Europe and Japan for Patents Covering Genetically-Modified Mice for Common Light Chain Human Monoclonal Antibodies

15.11.2016 13:05 | NASDAQ OMX

Del

European Patent Office Dismisses Arguments by Regeneron

Favorable Rulings Further Strengthen IP Estate in Europe and Japan through 2029

UTRECHT, The Netherlands, 2016-11-14 18:13 CET (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced that it received two favorable rulings for its European patent EP 2147594 B1 (the “‘594 patent”) by the Opposition Division of the European Patent Office (the “EPO”) as well by the Trial Board of the Japanese Patent Office for its Japanese counterpart JP 5749161 (the “‘161 patent”). Both patents cover Merus’ genetically-modified mice and their use to produce common light chain human monoclonal antibodies.

“We are very pleased by these positive rulings for Merus’ common light chain mouse patents in Europe and Japan which we believe are a testament to the strength of our intellectual property estate and provide us with sufficient protection through 2029,” said Ton Logtenberg, PhD, Chief Executive Officer of Merus. “These favorable rulings reflect the unique attributes of our proprietary Biclonics® bispecific antibody technology platform that we believe has broad applicability in the development of novel therapeutics for the treatment of cancer and other serious medical conditions.”  

In Europe, the Opposition Division of the EPO upheld without amendment the ‘594 patent in oral proceedings held in The Hague on October 28, 2016. The claims of the ‘594 patent cover methods of obtaining common light chain human monoclonal antibodies from genetically-modified mice that comprise in their genome a human rearranged immunoglobulin light chain variable region. In Japan, the Trial Board of the Japanese Patent Office upheld the ‘161 patent with minimal amendments. The claims of the ‘161 patent are similar to those of the ‘594 patent.

Both the European Opposition Division and the Japanese Trial Board dismissed arguments brought by Regeneron (NASDAQ:REGN) that the patent lacked novelty and inventive step. In both territories, the decision is open to appeal.

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 being evaluated in a Phase 1/2 clinical trial in Europe as a potential treatment for HER2-expressing solid tumors. Merus' second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1/ 2 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, and Biclonics® designed to bind to various combinations of immunomodulatory molecules, including PD-1 and PD-L1.

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, including without limitation statements regarding the strength of our intellectual property estate, the sufficiency of our protection of our intellectual property estate, including when such protection will terminate, the broad applicability of Biclonic® bispecific antibodies to cancer and other medical conditions, and the treatment potential of our bispecific antibody candidates. 

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: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding, which may not be available and which may require us to restrict out operations or require us to relinquish rights to our technologies or bispecific antibody candidates; potential delays in regulatory approval, which would impact the ability to commercialize our product candidates and affect our ability to generate revenue; the unproven approach to therapeutic intervention of our Biclonics® technology; potential difficulties in validating and developing companion diagnostics, which could harm our development strategy; our limited operating history; economic, political, regulatory and other risks involved with international operations; exchange rate fluctuations or abandonment of the euro currency; 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 adverse public reaction to the use of cancer immunotherapies; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our potential exposure to costly and damaging liability claims; post-marketing restrictions or withdrawal from the market; failure to obtain marketing approval internationally; compliance with environmental, health, and safety laws and regulations; anti-kickback, fraud, abuse, and other healthcare laws and regulations exposing us to potential criminal sanctions; recently enacted or future legislation; failure to compete successfully against other drug companies; potential competition from other drug companies if we fail to obtain orphan drug designation or maintain orphan drug exclusivity for our products; the possibility that governmental authorities and health insurers may not establish adequate reimbursement levels and pricing policies to support our products; the potential failure of our product candidates to be accepted on the market by the medical community; our lack of experience selling, marketing and distributing products and our lack of internal capability to do so; potential competition from biosimilars; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents being found invalid or unenforceable; potential lawsuits for infringement of third-party intellectual property; adequate protection of our trademarks; our potential failure to obtain extensions of the terms of patents covering our products; potential difficulties protecting our intellectual property rights in certain jurisdictions; changes in United States patent law; protection of the confidentiality of our trade secrets; claims asserting that we or our employees misappropriated a third-party’s intellectual property or otherwise claiming ownership of what we regard as our intellectual property; compliance with patent regulations; potential system failures; our ability to attract and retain key personnel; managing our growth could result in difficulties; the price of our common stock may fluctuate substantially; certain of our shareholders and members of our management board own a majority of our outstanding shares and exercise significant control over us; a significant portion of our total outstanding shares are eligible to be sold into the market; provisions of our Articles of Association or Dutch corporate law might deter favorable acquisition bids for us or prevent a beneficial change of control; we may lose our foreign private issuer status and incur significant expenses as a result; and unfavorable or lacking analyst research or reports might cause the price of our common shares to decline.

These and other important factors discussed under the caption “Risk Factors” in our final prospectus filed with the Securities and Exchange Commission, or SEC, on May 20, 2016 relating to our Registration Statement on Form F-1, 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. 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.

         Contacts:
         Merus N.V.
         Shelley Margetson - s.margetson@merus.nl
         +31 (0)30 253 8800
         
         Argot Partners
         Kimberly Minarovich - kimberly@argotpartners.com
         1-212-600-1902

Om NASDAQ OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

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

Promethean Opens New Global Headquarters in Seattle18.8.2017 18:38Pressemelding

Seattle, Wash., Aug. 18, 2017 (GLOBE NEWSWIRE) -- PrometheanTM, a global education technology company, announced today the opening of its new global headquarters in Seattle, Wash. Promethean's office in Atlanta, Ga. will continue to serve as the hub for the Americas markets, and the Blackburn, U.K. office will continue to carry on as the hub for the EMEA markets and parts of Asia.  Promethean is one of the leading brands in the international education technology market with more than 20 years of experience in the K-12 classroom. Its solutions are in more than 50,000 schools and institutions in 154 countries. "As traditional pedagogy continues to move towards immersive learning, it's important for Promethean to lead innovation in education with the latest technology," said Vin Riera, CEO of Promethean. "Seattle is a global technology hub, and establishing Promethean's global headquarters there increases opportunities for new business models, concepts

Hminers Disrupts the Cryptocurrency Market with Powerful, Multi-Algorithm Mining Rigs18.8.2017 11:00Pressemelding

Hminers continues to hit the headlines in the rapidly expanding global market for cryptocurrency. The Miami-based company has recently introduced three extremely powerful, multi-algorithm mining rigs that have been designed to provide maximum hash rate with minimum power consumption. MIAMI, Aug. 18, 2017 (GLOBE NEWSWIRE) -- In their relentless efforts to deliver state-of-the-art products related to cryptocurrency, Hminers has recently launched three brilliantly designed bitcoin mining rigs. The unique features and capabilities of the company's new H2U Miner, H4U Miner, and Rack Equipped with 5 x H4U have already grabbed the attention of the cryptocurrency enthusiasts and experts around the world. An organization with a rich tradition, Hminers (www.hminers.com) is recognized in the industry as the creator of the first ever 10 nm ASIC Chip in the world. Cryptocurrency mining is the process of generating new cryptocurrency that requires a pot

Nasdaq Welcomes I-AM Capital Acquisition Company (Nasdaq: IAMXU) to The Nasdaq Stock Market17.8.2017 18:50Pressemelding

NEW YORK, Aug. 17, 2017 (GLOBE NEWSWIRE) -- I-AM Capital Acquisition Company (Nasdaq:IAMXU), a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses, celebrated its initial public offering (IPO) on The Nasdaq Stock Market.  I-AM Capital's founders, Chief Executive Officer F. Jacob Cherian and Chief Financial Officer Suhel Kanuga, have been focused on investing into India over the last decade, with the distinction of completing the first listed-SPAC investment in India. "Through our keen focus and unique accomplishments in India over the last decade, we have seen our investment thesis bear fruit: India's prominence and rise on the world stage, its distinction as being one of the fastest growing major economies of the world, and its strong vibrant consumer demographics. We believe these factors are aligning well now,

Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency17.8.2017 14:30Pressemelding

WATERTOWN, Mass., Aug. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug- resistant (MDR) infections, today announced that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA). Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit. "The MAA filing represents a significant milestone for Tetraphase as it is our

RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules17.8.2017 13:00Pressemelding

RedHill was granted the exclusive rights to promote Esomeprazole Strontium Delayed-Release (DR) Capsules to gastroenterologists in certain U.S. territories Esomeprazole Strontium DR Capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor (PPI), indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions   RedHill expects to initiate the U.S. promotion of Esomeprazole Strontium  DR Capsules 49.3 mg  in the coming weeks   Esomeprazole Strontium  DR Capsules 49.3 mg  will be the third commercial GI product to be promoted by RedHill in the U.S.    RedHill's GI-focused sales force currently promotes two GI s

Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40Pressemelding

Complementary core strengths provide broader range of services for customers KENNESAW, GA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Brand Industrial Services, known as BrandSafway, has signed an agreement to acquire Venko Groep BV, a portfolio company of Mentha Capital. Venko will become a part of the Brand Energy & Infrastructure Services (Brand) group. "We are very pleased to announce the agreement with Venko," said Bill Hayes, President and CEO of BrandSafway. "Our combined customers in Europe will benefit from a broader range of solutions and greater depth of expertise in access, insulation and coatings. Bringing Venko's highly specialized knowledge in coatings to BrandSafway will provide the expertise we need to expand our services in the offshore market worldwide." Based in the Netherlands, with a focus on operations in the North Sea area, Venko is a leading offshore and onshore coatings maintenance provid

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom