UPM Pharmaceuticals is pleased to announce it has entered into a partnership with RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill”), whereby UPM will act as a U.S. contract manufacturer for opaganib, RedHill’s novel, first-in-class, orally administered Phase 3-stage drug candidate under development for severe COVID-19 pneumonia.
RedHill recently announced partnerships for large-scale manufacturing of opaganib, in preparation for potential emergency use applications for opaganib for COVID-19, which could come as early as Q1/2021. Opaganib is a novel, first-in-class, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity. Opaganib acts on both the cause and the effect of COVID-19 disease, targeting a host cell component involved in viral replication, potentially minimizing likelihood of resistance due to viral mutations. A U.S. Phase 2 study with opaganib in patients with severe COVID-19 pneumonia is fully enrolled, with top-line data expected in the coming weeks. A parallel global Phase 2/3 study with opaganib is more than 50% enrolled and is on track to deliver top-line data in Q1/2021.
“We are honored to have been selected by RedHill for the manufacturing of opaganib, in preparation for potential global emergency use applications as early as Q1/2021,” said John Gregory, Executive Chairman of Gregory Pharmaceutical Holdings, which is the parent company of UPM Pharmaceuticals. “UPM stands ready to mass produce this very important product for the U.S. should it be approved for emergency use by the FDA.”
Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “We are pleased to have UPM as a trusted U.S.-based partner for manufacturing of opaganib. This partnership, along with additional collaborations in Europe and Canada, better place RedHill to meet potential demand for opaganib, if approved. We look forward to top-line data from the U.S. Phase 2 study with opaganib in the coming weeks and continue to work diligently to advance the global Phase 2/3 study of opaganib towards top-line data in Q1/2021.
UPM Pharmaceuticals is an FDA approved development and manufacturing facility for both prescription and over-the-counter drugs. Headquartered in Bristol, Tennessee, UPM is an independent, family-owned organization with the commercial pedigree of 80 products brought to market, and longstanding experience as a Big Pharma supplier.
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, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers’ diarrhea 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 COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (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 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.