RedHill Biopharma Ltd. (NASDAQ:RDHL) has announced a resolution to patent litigation in the US in response to a generic version of Movantik (naloxegol) which the company acquired the global rights to, excluding Europe and Canada, from AstraZeneca in April 2020.
In a statement, the company said RedHill Biopharma Inc., AstraZeneca AB and AstraZenca Pharmaceuticals LP and Nektar Therapeutics have entered into a settlement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. LTD. resolving the patent litigation in the US in response to MSN's Abbreviated New Drug Application (ANDA) seeking approval by the US Food and Drug Administration (FDA) to market the generic version of Movantik, a treament for opioid-induced constipation in adults.
Under the terms of the settlement agreement, MSN may not sell a generic version of Movantik in the US until October 1, 2030 (subject to US FDA approval) or earlier under certain circumstances.
RedHiill said the parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the US. District Court for the District of Delaware which will conclude this litigation with respect to MSN.
As required by law, the parties will submit the settlement agreement to the US Federal Trade Commission and the US Department of Justice for review.
The company added that the settlement with MSN does not end RedHill's ongoing litigation against the other two ANDA filers.
RedHill is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. Aside from Movantik, RedHill promotes the two other gastrointestinal drugs - Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults; and Aemcolo for the treatment of travellers' diarrhoea in adults.
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 (Yeliva), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for coronavirus (COVID-19) and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a US 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.
Contact the author at jon.hopkins@proactiveinvestors.com
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