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Biopharma Launches COVID Vaccine Program in South Africa & Mexico
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Oramed Pharmaceuticals' oral vaccine offers "convenience and safety advantages as well as coverage of emergent variant strains," noted a Nov. 29, 2021 H.C. Wainwright & Co. report.

New developments regarding Oramed Pharmaceuticals Inc.'s (ORMP:NASDAQ) COVID-19 vaccine are advancing the program outside the U.S., and the company continues making strides in testing its insulin product in types 1 and 2 diabetes, reported H.C. Wainwright & Co. analyst Ram Selvaraju in a Nov. 29 research note.

Also, H.C. Wainwright raised its 12-month price target on Israel-based Oramed to $32 per share from $17 after revising its model assumptions pertaining to the biopharma's lead drug candidates, ORMD-0801 and ORMD-0901.

Regarding its COVID-19 vaccine, Selvaraju reported that Oramed's subsidiary, Oravax Medical Inc., is preparing to begin a Phase 1 trial of its oral, virus-like particle vaccine technology in South Africa after recently receiving approval to proceed.

The vaccine "targets three SARS-CoV-2 coronavirus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially more effective against current and future variants of the COVID-19 virus," Selvaraju pointed out.

In addition, Oravax recently formed a 50/50 joint venture with Genomma Lab to develop and commercialize Oravax's COVID-19 vaccine candidate in Mexico. Based there, Genomma is a pharmaceutical and personal care products firm.

"We believe that there remains ample room for additional vaccine approaches, particularly those that offer both convenience and safety advantages as well as coverage of emergent variant strains, as could be achieved with Oravax," Selvaraju commented. "The total COVID-19 vaccine market could approach $100 billion in 2022, in our view."

As for Oramed's flagship product, an oral insulin capsule, ORMD-0801, the biopharma "continues to achieve key milestones," Selvaraju reported.

Specifically, the company has enrolled and randomized more than three-quarters of the 675 patients to be included in its most advanced trial, the Phase 3 ORA-D-013-1. The study will continue evaluating ORMD-0801 in type 2 diabetes.

The ORMD-0801 trial consists of two components. One, ORA-D-013-1, taking place at 75 U.S. locations, will test the insulin product in patients who are taking two or three oral glucose-lowering agents.

The second component, ORA-013-2, will test ORMD-0801 in 450 patients, in the U.S., Europe and Israel, who have subpar glycemic control and are either are on a modified diet but no medication or are on Metformin as sole treatment.

As far as a timeline to market for ORMD-0801, Selvaraju outlined that commercial launch could occur in the U.S. and Europe in 2024. Leading up to that, completion of enrollment and data readout should occur for both Phase 3 studies next year. Oramed could apply for a biologics license application for the insulin product in 2023, and the U.S. Food and Drug Administration could approve it in 2024.

Also, Selvaraju noted, H.C. Wainwright expects Oramed to partner on commercialization of ORMD-0801 outside of China.

"Revenue to Oramed derived from sales of ORMD-0801 could thus drive meaningful upside to our forecasts," he added.

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This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. 
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