Commercial Drug Manufacturing Status for COVID-19 Drug | RedHill Biopharma Partners with UPM for Opaganib Commercial-Scale Manufacturing | UPM Pharmaceuticals

UPM Pharmaceuticals has entered into a commercial drug manufacturing partnership with RedHill Biopharma Ltd. UPM will spearhead the US pharma commercial operations for opaganib, the novel, first-in-class, orally administered Phase 3-stage drug from RedHill that is under development for severely ill patients suffering from COVID-19 related pneumonia.

About RedHill Biopharma Ltd.

RedHill Pharma is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill's pipeline includes several drug candidates in advanced clinical development stages including drugs for nontuberculous mycobacteria, Crohn's disease, acute gastroenteritis and gastritis and cancer.

One of the most news-worthy products is opaganib, currently under development for the treatment of COVID-19.

What is Opaganib?

Opaganib (Yeliva®, ABC294640) is a first-in-class, proprietary drug produced by RedHill Biopharma. Testing has shown that it has anti-cancer, anti-inflammatory and anti-viral properties. Phase 2 Opaganib studies for prostate cancer and cholangiocarcinoma are ongoing.

Opaganib and COVID-19

Opaganib is a novel, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor that is effective in treating pneumonia and other inflammatory lung disorders. It inhibits the viral replication of SARS-CoV-2, the virus that causes COVID-19. This, paired with its ability to reduce the body's hyper-immune inflammatory response and diminish ARDS-related blood clots, means that it works to eliminate both the cause and effect of COVID-19. Opaganib safely and effectively helps get patients off oxygen and out of the hospital.

Opaganib works by targeting SK2, which is involved in viral replication inside the cell as well as in the downstream immune response, and it can potentially minimize the likelihood of resistance due to viral mutations. In trials, opaganib is showing promise in its ability to maintain its positive effect against variants and mutations in the SARS-CoV-2 spike protein. The drug's effectiveness against multiple viral strains and mutations is an important development and a clear advantage in treatment.

“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. UPM stands ready to mass-produce this very important product for the U.S. should it be approved for emergency use by the FDA.”

- John Gregory, Gregory Pharmaceutical Holdings, parent company of UPM Pharmaceuticals

The UPM & RedHill Pharma Partnership

RedHill Biopharma and UPM are partnering in the commercial-scale manufacturing of opaganib. This large-scale commercial drug manufacturing build-up is to prepare for potential emergency use applications for COVID-19.

“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.”

- Dror Ben-Asher, RedHill Biopharma Chief Executive Officer

About UPM

UPM Pharmaceuticals is an FDA-approved contract development and manufacturing organization (CDMO) for prescription, over-the-counter drugs and generic drugs located on seven acres in Bristol, Tennessee. We are a family-owned independent pharma commercial operation with years of experience in optimizing the commercial supply chain, manufacturing processes and Big Pharma commercial operations.

UPM's Award-Winning Commercial-Scale Manufacturing Capabilities

More than 80 compounds have been created at our nearly 500,000 square foot commercial drug manufacturing facility. From start to finish, we leverage our commercial supply chain capabilities for the manufacturing and packaging of the following types of pharmaceutical products: