Oramed Pharmaceuticals Lands Vietnamese Distribution Agreement, Key European Patent Grant, & Oral Vaccine to be developed in Mexico

Distribution Agreement with Vietnam

Jerusalem’s Oramed Pharmaceuticals (ORMP.O) Oravax Medical unit signed a deal with Vietnam’s
Tan Thanh Holdings for the pre-order of 10 million doses of its oral COVID-19 vaccine that is in clinical trials. The agreement also gives Tan Thanh, a drug distributor, the right to sell Oravax’s oral vaccine in development throughout the Association of Southeast Asian Nations (ASEAN), which includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam, Oramed said.

“The parties have agreed to negotiate follow-on orders potentially worth hundreds of millions of dollars,” it said, adding the ASEAN region has a prospective patient population of about 660 million.

Nadav Kidron, chief executive of Oramed, said its oral COVID vaccine is undergoing Phase I clinical trials, and results should be available early this year. The vaccine has been shown to work in animal tests, he said.

As a Communist country, Kidron said, Vietnam could decide on a short Phase II trial and then give emergency authorization. “Potentially, marketing could be very fast.” As long as Phase I results are as expected, Kidron believes more countries will be interested since the new technology is not likely to require as many boosters as current vaccines. “The idea is that you take it and that’s going to be your dosing and you’re done,” he said.

“Countries like the U.S. and Israel (which uses the Pfizer vaccine) …may end up being behind because if developing countries step up their game they may be having the newest technologies available to them before the Western world,” Kidron added.

In December 2021, Nikki Fried, Florida’s Agriculture Commissioner, said that given the rapid spread of the Omicron variant, she was pushing the U.S. Food and Drug Administration (FDA) to accelerate the review of oral vaccines as alternatives to injections.

Oravax Medical Inc. is a joint venture between Oramed Pharmaceuticals with Premas Biotech, an Indian biotechnology firm to develop and bring to market novel oral COVID-19 vaccine candidates. Oramed Pharmaceuticals specializes in making oral drug delivery systems. Premas has a technology platform called D-Crypt that is used to make a variety of “difficult to express” proteins in sizeable quantities efficiently. The oral Covid-19 Oravax is a vaccine candidate that harnesses and combines the true potential of the two unique platforms.

Grant of Key European Patent

The European Patent Office has granted Oramed a patent titled “Protease inhibitor-containing Compositions, Compositions Comprising Same, and Methods for Producing and Using Same.” Oramed has already been granted this patent in the United States and Japan. Protease inhibitor is a key component of Oramed’s PODTM technology that protects therapeutic proteins in the digestive system.

The patent supports Oramed’s oral protein delivery platform technology which underlies its lead drug candidate ORMD-0801 now in pivotal Phase 3 studies and positioned to potentially be the first oral insulin capsule on the market. The granted patent covers a unique method for the purification of raw protease-inhibiting materials which are a key component of the platform technology that protects therapeutic proteins in the digestive system.

“With this newly granted patent, we now have 88 patents granted and 35 more pending, further fortifying Oramed’s leading position with respect to intellectual property assets addressing the oral delivery of therapeutic proteins currently only available via injection,” stated Oramed CEO Nadav Kidron.

Oral Vaccine to be Developed in Mexico

Oramed has announced a partnership with Mexico’s Genomma Lab Internacional to help fast track a Phase II clinical trial and gain emergency use authorization in the Latin American Country.

The companies have entered a 50/50 joint venture, including a $20 million share swap. Genomma Lab is expected to spearhead clinical, regulatory, and commercial activities for the vaccine in Mexico. Genomma also committed to participate in future investment in Oravax.

“Our goal is to try to get emergency use approval ASAP.” said Nadav Kidron, “The company’s strategy is to start with developing countries where we believe we have a good chance to get relatively accelerated marketing approval. We believe that Mexico is one of these ideal places.”

Kidron said that Oravax would supply Genomma Lab with the oral vaccine and that the company has already hired people to assist in running through a Phase II trial beginning sometime in early 2022. They will also work with the authorities and fund the costs related to achieving regulatory approval.

Only about 58% of Mexico’s population has received at least one dose of a coronavirus vaccine. The country averaged around 4500 new cases a day in November.

“We are thrilled to be forming this strategic alliance with Oramed to bring Oravax ’s next generation oral vaccine and booster candidate, once developed and authorized, to Mexico and potentially throughout Latin America to protect our populations from the COVID-19 virus,” said Rodrigo Herrera, chairman of Genomma Lab. “Based on our initial discussion with the authorities, we are already beginning to prepare for a Phase II trial immediately upon successful completion of the Phase II trial of the oral vaccine in South Africa.”

The Oravax oral vaccine is based on Oramed’s “POD” oral delivery technology and Premas’s vaccine technology. Oramed’s technology can be used to orally administer a number of protein-based therapies, which would otherwise be delivered by injection. Premas has been working on developing a vaccine against the novel coronavirus since March 2021.

The vaccine candidate targets three structural proteins of the novel coronavirus, as opposed to the single spike protein targeted by the current Moderna and Pfizer vaccines, Kidron said. “This vaccine should be much more resistant to COVID-19 variants,” he said. Even if the virus gets through one line, there is a second line, and if through the second line, there is a third.”

If approved, the vaccine would be used either as a standalone or as a booster for previously vaccinated individuals.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals (Nasdaq/TASE:ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (PODTM) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule (ORMD-0901).

For more information please visit www.oramed.com

Company contact:   Zach Herschfus 1-844-9 ORAMED   Zach AT oramed.com

Source: www.oramed.com

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