RedHill Biopharma Ltd
22.7.2021 18:58:46 CEST | ACCESS Newswire | Press release
RedHill Biopharma Announces Settlement of Movantik® Patent Litigation with Apotex
TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / July 22, 2021 / RedHill Biopharma Ltd. (Nasdaq:RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP ('AstraZeneca') and Nektar Therapeutics have entered into a settlement and license agreement with Apotex, Inc. and Apotex Corp. ('Apotex') resolving their patent litigation in the U.S. in response to Apotex's Abbreviated New Drug Application ('ANDA') seeking approval by the US. Food and Drug Administration ('FDA') to market a generic version of Movantik® (naloxegol).
RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.
Under the terms of the settlement agreement, Apotex may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain circumstances.
The parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware which will conclude this litigation with respect to Apotex. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The settlement with Apotex does not end RedHill's ongoing litigation against the other one ANDA filer.
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib, a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.
This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 | Media contact (U.S.): Bryan Gibbs Vice President Finn Partners +1 212 529 2236 |
[1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
[2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
[3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word "Reach" in the source column of the News Explorer pages of London Stock Exchange's website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.
SOURCE: RedHill Biopharma Ltd.
View source version on accesswire.com:
https://www.accesswire.com/656647/RedHill-Settles-MovantikR-Apotex-Patent-Litigation
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
Chervon Names Devin Murray Director of Sales - Northern Division19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Devin Murray joins Chervon as Director of Sales - Northern Division, effective October 19, 2026, reporting to Thomas Kentouris, Vice President of Field Sales. Murray joins Chervon after completing a six-year fast track career in TTI sales and sales management. Most recently, he was a Key End User Account Manager for Milwaukee charged with growing the pro tool business with large end users. Murray's exceptional recruiting skills and leadership skills enabled him to build, manage and inspire highly effective sales teams at the store level. His account management prowess resulted in outstanding sales results and strong partnerships with multiple national accounts. "Early in his impressive career, Devin was identified as a high potential future superstar executive," said Thomas Kentouris. "His large end user pro tool experience is exactly what we need to help build our pro tool leadership position. His inspiring leadership skills combin
Chervon Names Krystle Adams Director of Sales Recruiting19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Krystle Adams joins Chervon as Director of Sales Recruiting, effective October 19, 2026, reporting to Matt DeFeo, SVP of Sales, Training and Recruiting. Over the past 9+ years, Adams has advanced through a series of increasingly responsible sales and recruiting positions at TTI. Earlier in her impressive career, Krystle distinguished herself as an outstanding sales representative and sales manager delivering consistently strong results. Most recently, she was a National Recruiting Operations Manager responsible for leading, coordinating, and implementing recruiting efforts across campuses nationwide. Krystle has demonstrated exceptional skills in developing and leading campus and field sales recruiting efforts. She also designed and executed a thriving national college internship program. "I feel incredibly fortunate to now have Krystle Adams in place to launch Chervon campus recruiting," said Matt DeFeo, SVP of Sales, Training and
Chervon Names Terry Lucero Director of National Accounts - Industrial19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Terry Lucero joins Chervon as Director of National Accounts - Industrial, effective October 19, 2026, reporting to Jeff Campbell, Senior Vice President of Industrial Commercial Sales. Lucero brings 25+ years of extensive experience in building professional tool businesses at national accounts, regional accounts, at the store level and at the end user level. Lucero started his career at Dewalt where he advanced through a series of sales, sales management and end user marketing positions over 5 years driving professional tool growth. Lucero went on to WW Grainger where he progressed through a series of business development and sales management positions. He was also a sales manager of professional equipment at United Rentals. Most recently, Lucero served as a director of sales at APEX Tool Group for the Americas. "Terry's impressive pro tool experience in industrial distribution, national account management and end user marketing make
Tenstorrent Announces a $1.5B Series E at a $6.2B Valuation19.10.2026 14:00:00 CEST | Press release
SANTA CLARA, CA / ACCESS Newswire / October 19, 2026 / Tenstorrent, the AI computing company, has closed $1.5B in Series E funding at a $6.2B post-money valuation. The round was led by Trace Capital and Innovation X, with participation from new and existing investors including Agostinelli Group, ARK Invest, Brett Barna, Cadence Ventures, Eclipse, Fidelity Management & Research Company, Maverick Silicon, Morgan Stanley, Protagonist, Sandisk, T. Rowe Price*, Tether Investments, Troluce Capital, Virtu Financial, and XTX Markets. Tenstorrent will use the capital to deploy Galaxy servers at scale, continuing to serve open-weight models across LLMs and video generation, and advance the AI and CPU IP it licenses to customers designing their own silicon. Tenstorrent sells AI compute at every level of the stack - from a single card or workstation to racks, superclusters, and custom IP. With an open-source software stack, developers can run frontier models locally and enterprises can deploy mode
OxyDew Analyzer: One Compact Instrument, Two Critical Gas Measurements19.10.2026 08:00:00 CEST | Press release
NAVAN, IE / ACCESS Newswire / October 19, 2026 / DwyerOmega introduces the new Ntron OxyDew Analyzer, a fully integrated solution that combines oxygen and moisture dew-point measurement in a single, compact wall-mountable analyzer. The result: fewer instruments to install, wire, and maintain, without sacrificing the accuracy and reliability that critical gas quality monitoring demands. By uniting two proven sensing technologies in one instrument, OxyDew cuts equipment costs, simplifies installation, and reduces ongoing maintenance, all without compromising performance. Operators monitor oxygen concentration and dew point simultaneously through a 3-inch color touchscreen, giving them a single point of control instead of two separate systems. OxyDew is available now throughout Europe and Asia Pacific. Integrated Dual Measurement for Reliable Process Monitoring At the heart of OxyDew is the integration of the proven Ntron SenzTx Oxygen Transmitter and Michell Easidew Dew-Point Transmitter
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom