RedHill Biopharma Ltd. , a specialty biopharmaceutical company primarily focused on the commercialization and development of proprietary drugs for the treatment of gastrointestinal (“GI”) diseases, announced that it is acquiring the global rights to Movantik® (naloxegol)1, excluding Europe, Canada and Israel, from AstraZeneca. The acquisition is expected to close in the first quarter of 2020, subject to customary closing conditions and regulatory clearances.
“The acquisition of Movantik® is a transformative event for RedHill. We would like to thank AstraZeneca for entrusting us with this important product,” said Dror Ben-Asher, RedHill’s Chief Executive Officer. “Along with the planned launch of Talicia® later this quarter and the ongoing promotion of Aemcolo® to gastroenterologists, primary care physicians and other specialists, the acquisition of Movantik® further positions RedHill as an emerging GI-focused leader.”
Movantik® is a peripherally acting mu-opioid receptor antagonist (PAMORA) indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent opioid dosage escalation. In 2019, Movantik® generated net sales of $96 million in the U.S. RedHill’s sales force is expected to increase to approximately 150 sales representatives and will promote Movantik® to gastroenterologists, primary care physicians, and additional specialists.
The acquisition of Movantik® will be financed by a non-dilutive, royalty-backed term loan from HealthCare Royalty Partners (HCR), as part of the previously announced $115 million non-dilutive financing by HCR to support RedHill’s U.S. commercial operations.
Under the terms of the license agreement, RedHill will make an upfront payment of $52.5 million to AstraZeneca upon closing and a further non-contingent payment of $15 million 18 months post-closing. RedHill will also assume financial responsibility for sales-based royalty and potential milestone payments that AstraZeneca is required to pay to Nektar Therapeutics, the originator of Movantik®. AstraZeneca will continue to manufacture and supply Movantik® to RedHill during a transition period. In 2015, AstraZeneca entered into a co-commercialization agreement with Daiichi Sankyo, Inc. (“Daiichi Sankyo”) for Movantik® in the U.S., which will be transferred to RedHill upon closing of the transaction. Following such transfer, RedHill expects to lead all U.S. commercialization activities for Movantik® and will continue to share costs and pay sales-related commissions to Daiichi Sankyo under that agreement.
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. It is the first oral PAMORA approved in the U.S. for the treatment of OIC and is recommended by the American Gastroenterological Association (AGA) guidelines 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 RedHill Biopharma Ltd.
RedHill Biopharma Ltd. is a specialty biopharmaceutical company, primarily focused on the commercialization and development of proprietary drugs for the treatment of gastrointestinal diseases. RedHill promotes the gastrointestinal drug Aemcolo® in the U.S. and is planning to launch Talicia® in the U.S. for the treatment of Helicobacter pylori (H. pylori) infection in adults. RedHill has entered into an agreement to acquire the rights to Movantik® for opioid-induced constipation. The acquisition remains subject to customary closing conditions and regulatory clearances. RedHill’s key clinical late-stage development programs include: (i) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (ii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iii) 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; (iv) ABC294640 (Yeliva®), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 2a study for cholangiocarcinoma; (v) RHB-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at www.redhillbio.com.
