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
On Sale Now! LiberNovo Maxis Big & Tall Ergonomic Chair Debuts, Unlocking a New Level of "Stability, Width, and Comfort" for Prolonged Sitting16.6.2026 18:00:00 CEST | Press release
The Maxis series is live today across the US, Canada, and Europe, starting at €829, with launch savings up to 48% off MSRP. HONG KONG, HK / ACCESS Newswire / June 16, 2026 / LiberNovo's Maxis series goes on sale today, the brand's first line built from the ground up for Big & Tall users rather than scaled up from a standard chair. It ships in three configurations, alongside two additions to the LiberNovo Omni family. Built for the body, not scaled up to fit Maxis targets the three things that fail a larger body in a standard seat: thighs left unsupported, a recline that sways under weight, and support that gives out by mid-afternoon. The 52 cm seat extends fully under the thigh. Multi-density foam holds its shape instead of bottoming out under load. A tall backrest and adjustable neck support hold the spine and neck, with the neck support sitting at the neck rather than behind the head. The frame is BIFMA-certified to 181 kg (399 lb) on a die-cast aluminum alloy base. Recline that hold
MicroVision Brought Onboard by Lake Fusion Technologies and Timberline Aerospace to Accelerate IRIS Sensor Package Deployment16.6.2026 15:20:00 CEST | Press release
Collaboration supports global deployment of advanced situational awareness solutions across commercial, critical infrastructure, security, and government applications REDMOND, WA / ACCESS Newswire / June 16, 2026 / MicroVision, Inc. (NASDAQ:MVIS), a leader in advanced perception solutions for industrial, automotive, security and defense applications, today announced recent shipments of its IRIS lidar sensors to Lake Fusion Technologies (LFT) LLC, as LFT and Timberline Aerospace welcome MicroVision onboard to further expand their collaboration and accelerate the deployment of advanced situational awareness solutions. MicroVision recently shipped IRIS sensors to LFT, marking an important milestone as LFT, together with Timberline Aerospace, brings MicroVision more fully into its ecosystem to broaden capabilities and expedite the development and delivery of integrated IRIS Sensor Packages. The deployment will support LFT's continued development and validation activities as it advances sol
Karbon-X Advances Large-Scale Senegal Blue Carbon Project as Second Globally Registered Under Verra's VM0033 Methodology16.6.2026 15:15:00 CEST | Press release
7,500-hectare Senegal blue carbon initiative achieves Verra registration, marking a significant project development milestone for Karbon-X CALGARY, AB / ACCESS Newswire / June 16, 2026 / Karbon-X Corp. (OTCQB:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions company operating across global carbon markets and climate infrastructure, today announced that its Senegal Blue Carbon Mangrove Project has achieved registration under Verra's Verified Carbon Standard (VCS) and Climate, Community & Biodiversity (CCB) Standards, becoming the second project globally to achieve registration under Verra's VM0033 methodology for tidal wetland and seagrass restoration. Located within Senegal's Sine Saloum Delta and Casamance Estuary regions, the approximately 7,500-hectare project is focused on restoring degraded mangrove ecosystems through reforestation and ecosystem recovery activities. Mangrove forests are among the world's most carbon-rich natural environments, capable o
Leggett Dynamics Launches Smart Brushless Motor & Advances Quiet, Software-Defined Comfort & Motion16.6.2026 13:00:00 CEST | Press release
Reduces Complexity & Cost, Improves Performance, Supports Next-Gen Architectures DETROIT, MI / ACCESS Newswire / June 16, 2026 / Leggett Dynamics today launched its Smart Brushless Motor, a next-generation motion system that simplifies design and vehicle integration, improves NVH and durability and supports evolving software architectures across seating and other motion-control applications. Less Complexity, More Capability Unlike conventional systems, Leggett Dynamics' Smart Brushless Motor can operate with or without a seat-level electronic control unit (ECU), enabling direct communication from the vehicle-level ECU to individual actuators. This streamlined approach supports the industry shift toward more centralized or zonal architectures and enables simplified, scalable integration across multiple seat configurations and trim levels with varying actuator counts. In addition, the motor's design reduces packaging size, weight, and wiring complexity while enhancing sound, durability,
Polaris Renewable Energy Reminds Shareholders to Vote Ahead of Annual Meeting16.6.2026 00:30:00 CEST | Press release
TORONTO, ON / ACCESS Newswire / June 15, 2026 / Polaris Renewable Energy Inc. (TSX:PIF) ("Polaris" or the "Company") today reminds shareholders to vote their common shares in advance of the Company's upcoming annual meeting of shareholders, which will be held virtually on June 18, 2026 at 9:00 a.m. Toronto time. Shareholders are encouraged to vote as soon as possible and prior to the proxy voting deadline of 9:00 a.m. Toronto time on June 16, 2026. Voting in advance helps ensure that shareholders' shares are represented at the meeting. At the meeting, shareholders will be asked to receive the consolidated financial statements of the Company for the year ended December 31, 2025, together with the report of the auditors thereon. Shareholders will also be asked to vote on the following matters: electing directors of the Company; and reappointing PricewaterhouseCoopers LLP, Chartered Accountants, as auditors of the Company and authorizing the directors of the Company to fix their remunerat
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