By M. Marin
READ THE FULL ORMP RESEARCH REPORT
Oral COVID vaccine pill moving forward in several key international markets…
Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) continues to advance its assets, and expand its management team and financial flexibility to support its growth initiatives. Oravax has secured pre-orders for Oravax's COVID-19 oral vaccine, strengthened its cash position and continues advancing its dual T2D and NASH studies forward. We also believe the COVID-19 vaccine initiative underscores the versatility - and economic potential - of the company's oral drug delivery technology.
… including Latin America…
Oravax's joint venture with Genomma Lab Internacional, a pharmaceutical company based in Mexico, to jointly develop and commercialize Oravax's oral COVID-19 vaccine is expected to facilitate the path to regulatory approval and commercialization for the COVID-19 vaccine pill in Mexico and potentially throughout Latin America. Oramed and Genomma Lab entered into a US$20 million share swap, underscoring their aligned interests and Genomma Lab also committed to invest in Oravax.
… the Association of Southeast Asian Nations (ASEAN)…
Oravax also signed a cooperation and purchase agreement with Vietnam-based Tan Thanh Holdings to pre-purchase Oravax's oral COVID-19 vaccine. The agreement grants Tan Thanh Holdings the right to sell Oravax's oral vaccine in development throughout the Association of Southeast Asian Nations (ASEAN), with an initial pre-order of 10 million doses and, in success, the potential for follow-on orders valued at hundreds of millions of dollars, according to ORMP.
…and South Africa
Oravax has screened and enrolled the first participant in a Phase 1 clinical trial of its oral virus-like particle (VLP) COVID-19 vaccine in Johannesburg, South Africa. The open-label trial anticipates enrolling 24 participants who have not received either a COVID-19 vaccine or contracted the virus.
While dual T2D studies and NASH trial are also advancing, with data expected later this year
In terms of its core ORMD-0801 asset, ORMP has enrolled and randomized over 75% of the 675 patients planned for the Phase 3 ORA-D-013-1 study. The company is nearing the end of enrollment and anticipates announcing efficacy data and results in 2022. Oramed anticipates announcing last patient in later in 2022 and having data from the study to share, as well.
The European Patent Office has granted a patent supporting Oramed's oral protein delivery platform technology which underlies its lead drug candidate ORMD-0801, bringing the patent portfolio to 88 patents granted and 35 additional patents pending.
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