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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 (Nasdaq: ORMP) announced that CEO Nadav Kidron will present at the virtual H.C. Wainwright BioConnect 2021 Conference from January 11-14, 2021. The presentation will be available on demand starting January 11. Oramed is focused on oral drug delivery systems and aims to revolutionize diabetes treatment with its lead candidate, ORMD-0801, potentially the first commercial oral insulin capsule. Established in 2006, Oramed has completed multiple Phase II clinical trials of ORMD-0801 under FDA regulations.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced positive results from a proof-of-concept study of its oral leptin drug candidate for type 1 diabetes, approved by Israel's Ministry of Health. In this study, ten patients participated, with those receiving the drug showing reduced glucose levels compared to the placebo group. These findings pave the way for a larger double-blind study involving 30 patients. The company aims to tackle rising diabetes rates with its oral leptin treatment, which aligns with the expanding obesity market, projected to reach $15.6 billion by 2024.
Oramed Pharmaceuticals (Nasdaq: ORMP) has initiated a global Phase 2 trial for its oral insulin capsule, ORMD-0801, targeting Nonalcoholic Steatohepatitis (NASH). The trial will include eight clinical sites across the U.S., EU, and Israel, focusing on efficacy measured via MRI-PDFF over a 12-week dosing period. Prior studies indicated a 30% reduction in liver fat with ORMD-0801, fueling optimism for this trial. CEO Nadav Kidron expressed excitement for the international trial and the potential to provide groundbreaking treatment for NASH.
Oramed Pharmaceuticals has initiated its global Phase 3 trials for the oral insulin capsule, ORMD-0801, aimed at treating type 2 diabetes (T2D). The screening of the first patients took place at U.S. sites in the ORA-D-013-1 trial, part of a broader two-trial program involving 1,125 patients over 6 to 12 months. The primary goal is to assess ORMD-0801's efficacy against a placebo in glycemic control. CEO Nadav Kidron highlighted the significance of this milestone as the first FDA Phase 3 oral insulin trial.
Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) announced a webinar on November 18, 2020, featuring Nobel Laureate Prof. Avram Hershko and Chief Scientific Officer Dr. Miriam Kidron. This session is part of a series focusing on the company's progress in oral drug delivery systems, especially its oral insulin candidate, ORMD-0801, which is entering Phase 3 trials in the U.S. Oramed aims to transform diabetes treatment with its proprietary Protein Oral Delivery (POD™) technology. Interested investors can register for the webinar via a provided link.
Oramed Pharmaceuticals (Nasdaq: ORMP) will have CEO Nadav Kidron present an overview at the H.C. Wainwright 6th Annual Israel Conference on November 12, 2020, at 11:30 AM ET. The company is focused on oral drug delivery systems, aiming to revolutionize diabetes treatment with its lead candidate, ORMD-0801, potentially the first oral insulin capsule. Oramed has completed multiple Phase II trials and is also developing ORMD-0901, an oral GLP-1 analog.
Oramed Pharmaceuticals announced its participation in the AAPS 2020 PharmSci 360 conference, presenting research on its oral insulin candidate, ORMD-0801, for Type 2 diabetes. The presentation, led by Dr. Miriam Kidron, focuses on the glycemic effects of bedtime oral insulin in uncontrolled diabetes patients. Oramed aims to innovate diabetes treatment through its proprietary Protein Oral Delivery (POD™) technology, with ORMD-0801 potentially being the first oral insulin capsule. The company has completed multiple Phase II clinical trials under FDA regulations.
Oramed Pharmaceuticals (NASDAQ: ORMP) announced a webinar titled "The Journey of Oral Insulin: Oramed Story," featuring CEO Nadav Kidron and Premas Biotech's Dr. Prabuddha Kundu on October 28, 2020, at 9:00 am ET. The session highlights the advancements in oral insulin delivery, focusing on Oramed's oral insulin capsule, ORMD-0801, which is entering pivotal Phase 3 trials in the U.S. Established in 2006, Oramed aims to revolutionize diabetes treatment with its oral drug delivery technology.
Oramed Pharmaceuticals has submitted protocols for pivotal Phase 3 studies of its oral insulin candidate, ORMD-0801, to the FDA following guidance from the agency. The two studies aim to evaluate the safety and efficacy of ORMD-0801 in approximately 1,125 patients with type 2 diabetes. The U.S. study, ORA-D-013-1, plans to recruit 675 patients across 75 sites, while ORA-D-013-2 will involve 450 patients across 61 sites. Patient enrollment is expected this quarter, with efficacy data anticipated after a 6-month treatment period.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced its participation in the EASD Annual Meeting, taking place virtually from September 21-25, 2020. Dr. Roy Eldor will present on September 22 at 3:45 p.m. CEST, discussing the glycaemic effects of oral insulin (ORMD-0801) in type 2 diabetes patients. Additionally, Dr. Miriam Kidron will showcase a poster on September 24 at 12:00 p.m. CEST, detailing oral insulin's impact on liver fat in T2DM patients with NASH. Oramed focuses on transforming diabetes treatment with its oral insulin capsule technology.
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