TEL AVIV - RedHill Biopharma Ltd. (Nasdaq: RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that it has gained the rights to Movantik (naloxegol)1 in Israel from AstraZeneca.
RedHill now holds the worldwide rights to Movantik, excluding Europe and Canada.
Movantik is approved in Israel, under the brand name Moventig, for the treatment of opioid-induced constipation (OIC) but is not yet commercialized. RedHill is evaluating the potential for a local commercialization partnership for Movantik in order to bring this valuable OIC treatment to patients in Israel.
'Our commercial focus for Movantik remains firmly fixed on the U.S., where we have sole and exclusive commercialization rights. We have built a strong and expanding commercial team to support Movantik, which despite the challenging COVID-19 pandemic environment generated approximately $20 million in net revenue in the second quarter of 2020 - its first quarter as a RedHill product.' said Adi Frish, Senior Vice President Business Development and Licensing at RedHill. 'We would like to thank AstraZeneca for expanding our Movantik partnership and Knight Therapeutics, which previously held the rights for Moventig in Israel, for enabling the smooth transfer of this asset.'
In August this year, the Company also announced an amendment to the agreement with Daiichi Sankyo which enabled RedHill to exercise full control over brand strategy and commercialization activities for Movantik in the U.S., while also increasing margins.
About Movantik
Movantik is a proprietary once-daily oral PAMORA approved by the U.S. Food and Drug Administration for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation. Movantik is the first oral PAMORA approved in the U.S. for the treatment of OIC and is recommended by the American Gastroenterological Association (AGA) guidelines2 and the National Comprehensive Cancer Network (NCCN) guidelines. Movantik is part of the exclusive worldwide license agreement announced in 2009 between AstraZeneca and Nektar Therapeutics. It was developed using Nektar's oral small-molecule polymer conjugate technology. Movantik was first approved in 2014 and launched in the U.S. by AstraZeneca and Daiichi Sankyo in 2015.
About Opioid-Induced Constipation (OIC)
OIC is a condition caused by prescription opioid pain medicines. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC. OIC is the most prevalent and disabling adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy each year4.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Movantik for opioid-induced constipation in adults3, Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults4 and Aemcolo for the treatment of travelers' diarrhea in adults5. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and ongoing Phase 2 studies for prostate cancer and cholangiocarcinoma; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) 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; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation.
Contact:
Adi Frish
Tel: +972-54-6543-112
Email: adi@redhillbio.com
DAIICHI SANKYO CO., LTD. 
