Initial pre-purchase of 10 million doses of oral vaccines with a potential deal for further orders worth hundreds of millions of dollars
Prospective patient population of approximately 660 million throughout the Association of Southeast Asian Nations
NEW YORK, Dec. 29, 2021 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced that its subsidiary, Oravax Medical, has signed a Cooperation and Purchase Agreement with Vietnam-based Tan Thanh Holdings Investment Joint Stock Company to pre-purchase Oravax's oral COVID-19 vaccine, currently in development. The agreement grants Tan Thanh Holdings the right to sell Oravax's oral vaccine in development throughout the Association of Southeast Asian Nations (ASEAN) which includes Vietnam, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore and Thailand. The Agreement is for an initial pre-order of 10 million doses of oral COVID-19 vaccines from Oravax and is comprised of milestone payments. The parties have agreed to negotiate follow-on orders potentially worth hundreds of millions of dollars.
Tan Thanh Holdings, which operates one of the fastest growing pharmaceutical businesses in the ASEAN region, has received approval from Vietnam's Ministry of Health to conduct advanced stage clinical trials of Oravax's oral COVID-19 vaccine in development and will contribute to the funding and implementation of clinical development and regulatory approval. The ASEAN region spends close to 4% of GDP on healthcare and its pharmaceutical industry is valued at $25 billion and is expected to experience continued growth.
"This pre-purchase of our oral COVID-19 vaccine in development, represents a major milestone for Oravax Medical and another step forward in the implementation of our long-term strategy. With the dramatic increase in positive cases of the Omicron variant, the global need for an oral vaccine that protects against current and future variants is crucial. An oral COVID-19 vaccine would significantly improve vaccination logistics and reduce costs. We view Tan Thanh Holdings as an ideal partner to bring our vaccine to Vietnam and the ASEAN region," stated Oramed Chief Executive Officer and Oravax Chairman Nadav Kidron.
Oravax's oral VLP vaccine in development targets three SARS CoV-2 virus 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. Oravax's VLP vaccine technology is highly scalable for manufacturing and is easily transferable for logistical wide scale distribution as there is no need for subfreezing storage.
Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, and certain other shareholders, with a mission to bring an oral COVID-19 vaccine to the market. Oravax combines cutting-edge vaccine technology acquired from Premas Biotech and the proprietary POD™ oral delivery technology of Oramed Pharmaceuticals.
For more information, please visit www.ora-vax.com
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 (POD™) 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.
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential development and timing of an oral COVID-19 vaccine, the pace of studies and trials for such oral vaccine and the potential effectiveness, safety, scalability and other advantages of the vaccine, the value of potential future orders of such oral vaccine, the contribution of Tan Thanh Holdings to the clinical development and regulatory approval of such oral vaccine, the expected growth of the pharmaceutical industry in the ASEAN region or the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission.