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Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) is a pioneering pharmaceutical company focused on the development and commercialization of innovative oral drug delivery systems. Headquartered in the United States and Israel, Oramed aims to revolutionize the treatment of various diseases by transforming injectable therapies into oral formulations.
Oramed's flagship product, an orally ingestible insulin capsule known as ORMD-0801, is currently in Phase 2 clinical trials under the supervision of the U.S. Food and Drug Administration (FDA). This product holds significant promise for improving the quality of life for diabetes patients by eliminating the need for daily insulin injections.
The company’s proprietary Protein Oral Delivery (POD™) technology is designed to protect therapeutic proteins like insulin from the harsh conditions of the gastrointestinal tract, ensuring their effective delivery and absorption in the body. This platform technology opens up possibilities for the oral administration of a wide range of therapeutic proteins and peptides.
Oramed recently announced a strategic partnership with Hefei Tianhui Biotech Co., Ltd. (HTIT) to establish a joint venture aimed at the global commercialization of Oramed's oral insulin and POD™ pipeline. This collaboration leverages HTIT's advanced manufacturing capabilities, which include a state-of-the-art facility in Hefei, China. The initial phase of the partnership includes a $70 million investment from HTIT and a $20 million investment from Oramed, the latter consisting of both cash and shares of common stock.
Additionally, Oramed has entered a securities agreement with Scilex Holding Company, securing an 18-month Senior Secured Promissory Note valued at approximately $101.9 million. This agreement includes an interest rate of SOFR plus 8.5% and offers Oramed new warrants for up to 13 million shares of Scilex common stock.
Oramed is also branching into topical treatments through its acquisition of PeriTech Pharma Ltd.’s innovative film-forming technology. This includes over-the-counter treatments for hemorrhoids and other dermatological conditions. Oramed has secured an exclusive licensing agreement with an international consumer and pharmaceutical group, promising future royalties based on net sales.
With a robust pipeline and strategic partnerships, Oramed is well-positioned to advance its mission of improving patient care and increasing shareholder value through groundbreaking oral drug delivery solutions.
Oramed Pharmaceuticals has completed enrollment for its Phase 3 ORA-D-013-1 study of the oral insulin capsule, ORMD-0801, with 710 patients, exceeding the initial goal of 675. This study focuses on type 2 diabetes patients with inadequate glycemic control, aiming for efficacy results in January 2023. The oral insulin could significantly improve patient experience and outcomes compared to injectable insulin, potentially becoming the first FDA-approved oral insulin.
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) has received a patent from the European Patent Office for its innovative methods to treat non-alcoholic fatty liver disease (NAFLD) and hepatic steatosis. This patent complements a previously granted U.S. patent and is pending approval in various key markets. Additionally, Oramed has successfully completed 100% enrollment in its Phase 2 trial for oral insulin ORMD-0801, targeting type 2 diabetes patients with non-alcoholic steatohepatitis (NASH). The NASH drug market is projected to reach $84 billion by 2029.
Oramed Pharmaceuticals (Nasdaq: ORMP) will host a webinar on March 30, 2022, at 12:00 p.m. ET, featuring experts discussing the need for oral insulin in type 2 diabetes. Presenters include Dr. Anne Peters from USC and Dr. Alexander Fleming, formerly with the FDA. They will address the treatment landscape and the potential of Oramed's oral insulin candidate, ORMD-0801, currently in Phase 3 trials. A live Q&A session will follow. For registration, visit here.
Oramed Pharmaceuticals (Nasdaq: ORMP) has successfully completed patient enrollment for its Phase 2 trial of the oral insulin capsule ORMD-0801, targeting non-alcoholic steatohepatitis (NASH) in Type 2 diabetes patients. NASH affects 4 to 17 million adults in the U.S., with no approved treatments currently available. The trial, conducted in the U.S. and Israel, will evaluate ORMD-0801's safety and efficacy after 12 weeks of dosing. The global NASH drug market is projected to reach $84 billion by 2029. Oramed anticipates reporting topline results that support previous efficacy findings.
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) announced that CEO Nadav Kidron will present at the Barclays Global Healthcare Conference in Miami, Florida, from March 15-17, 2022. Kidron's presentation is scheduled for Tuesday, March 15, 2022, at 3:50 p.m. Eastern time. The event will be webcasted and available for view for 90 days. Oramed is a pioneer in oral drug delivery systems, particularly targeting diabetes treatment with its lead oral insulin candidate, ORMD-0801, currently in pivotal Phase 3 studies.
Oramed Pharmaceuticals (NASDAQ: ORMP) provided a shareholder update highlighting significant advancements in 2021. The company is advancing its oral insulin and COVID-19 vaccine candidates through pivotal trials, expecting topline results in H2 2022. ORMP has achieved over 75% enrollment in its Phase 3 oral insulin trial and is progressing with its oral COVID-19 vaccine in South Africa. With approximately $174 million in cash as of December 2021, Oramed is well-positioned for upcoming milestones, including key clinical results and potential emergency use authorization for its vaccine.
Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) announced that the European Patent Office has granted it a patent for its oral protein delivery platform technology, supporting its lead drug candidate ORMD-0801, which is undergoing pivotal Phase 3 studies. This patent involves a novel method for purifying protease inhibitors, vital for protecting therapeutic proteins during digestion. With this patent, Oramed now holds 88 patents and 35 pending, enhancing its intellectual property position in the oral delivery market for therapeutics, specifically for diabetes treatment.
MyMD Pharmaceuticals has announced that its investment company, Oravax Medical, signed a Cooperation and Purchase Agreement with Vietnam's Tan Thanh Holdings for an initial pre-order of 10 million doses of an oral COVID-19 vaccine currently under development. The deal also allows for significant follow-on orders. Oravax's vaccine targets less mutable proteins and has benefits in logistics due to simplified storage requirements. MyMD holds a 13% stake in Oravax, along with a 2.5% royalty on future net sales. This agreement may boost revenue potential for both companies in the ASEAN region.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced that its subsidiary, Oravax Medical, has signed a Cooperation and Purchase Agreement with Vietnam's Tan Thanh Holdings. This agreement involves an initial pre-order of 10 million doses of an oral COVID-19 vaccine currently in development, with potential follow-on orders worth hundreds of millions. Tan Thanh will fund advanced clinical trials and regulatory approval, targeting the ASEAN market. Oravax's vaccine aims to combat COVID-19 variants and offers logistical advantages. The ASEAN pharmaceutical market is valued at $25 billion and is growing rapidly.
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