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Overview of Oramed Pharmaceuticals Inc.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) is a clinical-stage pharmaceutical company pioneering innovative solutions in the field of oral drug delivery. Leveraging its proprietary Protein Oral Delivery (POD™) technology, Oramed is addressing one of the most significant challenges in modern medicine: enabling the oral administration of therapeutic proteins and peptides that are traditionally delivered via injection. By focusing on this transformative approach, Oramed aims to enhance patient compliance and redefine treatment paradigms for chronic diseases such as diabetes.
Core Technology: Protein Oral Delivery (POD™)
At the heart of Oramed's innovation is its patented POD™ technology, a platform designed to protect the integrity of therapeutic proteins and peptides as they pass through the harsh environment of the gastrointestinal tract. This technology enhances drug absorption and bioavailability, offering a groundbreaking alternative to injectable therapies. The POD™ platform represents a significant advancement in pharmaceutical science, with the potential to broaden access to biologic treatments while improving patient convenience and adherence.
Product Pipeline and Focus Areas
Oramed's product pipeline is centered around its flagship candidate, ORMD-0801, an orally ingestible insulin capsule currently undergoing clinical trials. This product is designed to address a critical unmet need in diabetes management by providing a non-invasive alternative to injectable insulin. The pipeline also includes other innovative candidates, such as ORMD-0901, targeting additional therapeutic areas where oral delivery could offer significant benefits. These developments underscore Oramed's commitment to revolutionizing treatments for chronic conditions.
Strategic Initiatives and Partnerships
Oramed employs a strategic approach to accelerate the development and commercialization of its technologies. Notably, the company has formed a joint venture with Hefei Tianhui Biotech Co., Ltd. (HTIT), leveraging HTIT's advanced manufacturing capabilities to support clinical trials and future commercialization efforts. This partnership highlights Oramed's focus on building synergies to optimize resources and bring its products to market efficiently. Additionally, Oramed has announced plans to spin off its POD™ technology into a new entity, OraTech Pharmaceuticals Inc., to further streamline its operations and concentrate on advancing oral insulin and other pipeline assets.
Market Position and Competitive Landscape
Operating within the highly competitive pharmaceutical and biotechnology sectors, Oramed is uniquely positioned as a pioneer in oral biologics delivery. Its focus on diabetes management addresses a global health crisis, with millions of patients requiring innovative solutions for better disease control. While competitors may include companies developing alternative drug delivery systems or diabetes therapies, Oramed's proprietary POD™ technology and its emphasis on oral insulin provide a distinct competitive advantage. By addressing a significant unmet need and leveraging strategic collaborations, Oramed is carving out a niche in an evolving market.
Challenges and Opportunities
As a clinical-stage company, Oramed faces challenges typical of the pharmaceutical industry, including regulatory hurdles, the high cost of clinical trials, and the inherent risks of drug development. However, the company's innovative approach, strong intellectual property portfolio, and strategic partnerships position it well to navigate these challenges. The potential for its oral insulin to transform diabetes care represents a significant market opportunity, with implications for broader applications of its POD™ technology in other therapeutic areas.
Conclusion
Oramed Pharmaceuticals Inc. is at the forefront of a paradigm shift in drug delivery, leveraging its proprietary POD™ technology to develop oral alternatives to injectable therapies. With a robust product pipeline, strategic partnerships, and a focus on addressing critical unmet needs, Oramed is poised to make a lasting impact on the pharmaceutical industry. Its innovative approach not only enhances patient convenience and compliance but also has the potential to redefine treatment standards for chronic diseases, starting with diabetes.
Oramed Pharmaceuticals, a clinical-stage pharmaceutical company, has announced a registered direct offering of 2,000,000 shares of common stock priced at $25 per share, aiming to raise $50 million in gross proceeds. The offering is expected to close on or about November 5, 2021. The funds will be used for working capital and general corporate purposes. H.C. Wainwright & Co. serves as the exclusive placement agent. This follows a previous shelf registration statement filed on July 15, 2021, which was declared effective on July 26, 2021.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced that its subsidiary, Oravax Medical Inc., received clearance from the South African Health Products Regulatory Authority to initiate a Phase 1 clinical trial for its oral COVID-19 vaccine. This vaccine utilizes virus-like particle technology targeting three SARS-CoV-2 proteins, potentially enhancing efficacy against variants. The trial, which aims to simplify vaccine distribution by allowing self-administration, is set to begin shortly, with plans for a Phase 2/3 trial for emergency approval following successful results.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced that CEO Nadav Kidron will present a company overview at the Cantor Fitzgerald Global Healthcare Conference, occurring virtually from September 27-30, 2021. Kidron's presentation is scheduled for September 30, 2021, at 12:00 P.M. Eastern time. Oramed is focused on developing innovative oral drug delivery systems, notably for diabetes treatment, with their lead candidate ORMD-0801 under pivotal Phase 3 studies.
Oramed Pharmaceuticals (Nasdaq: ORMP) has achieved over 50% patient enrollment in its Phase 2 trial for ORMD-0801, an oral insulin capsule aimed at treating non-alcoholic steatohepatitis (NASH) in Type 2 diabetes patients. The trial will measure key efficacy endpoints like liver fat content and fibrosis after 12 weeks. NASH represents a significant unmet medical need, with no current approved treatments. The global NASH drug market is projected to reach $84 billion by 2029, highlighting the potential for ORMD-0801 to address this issue.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced that CEO Nadav Kidron will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021. This virtual event will start at 7:00 a.m. Eastern time and can be viewed online. Oramed is focused on oral drug delivery, particularly its lead candidate ORMD-0801, which aims to be the first commercial oral insulin capsule for diabetes treatment, currently in pivotal Phase 3 studies.
Oramed Pharmaceuticals has announced the enrollment of over 25% of its target of 450 patients in the Phase 3 ORA-D-013-2 trial for its oral insulin capsule, ORMD-0801, aimed at treating type 2 diabetes. This trial is one of two ongoing Phase 3 trials approved by the FDA. The study will assess the efficacy of ORMD-0801 in improving glycemic control compared to placebo over 26 weeks, with a secondary aim to maintain control over 52 weeks. Results from the concurrent ORA-D-013-1 trial, which enrolled nearly 65% of its 675 patients, are expected in 2022.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced the publication of a study in Diabetes, Obesity, and Metabolism evaluating the efficacy and safety of its oral insulin candidate ORMD-0801 for type 2 diabetes. The trial met its primary endpoint, demonstrating that ORMD-0801 effectively managed nighttime and 24-hour glycemia levels without increasing hypoglycemia risks compared to placebo. This study supports Oramed's efforts to develop the first commercial oral insulin capsule, as it undergoes two pivotal Phase 3 trials.
On August 9, 2021, Oramed Pharmaceuticals (Nasdaq: ORMP) announced that Chief Commercial Officer Michael Rabinowitz will present a company overview at the Canaccord Genuity's 41st Annual Growth Conference, taking place virtually from August 10-12, 2021. Rabinowitz's presentation is scheduled for August 12 at 11:30 a.m. Eastern and can be viewed online. Oramed is a clinical-stage pharmaceutical company specializing in oral drug delivery systems, focusing on its lead candidate ORMD-0801, aimed at transforming diabetes treatment.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced that its majority-owned company Oravax Medical will present its oral COVID-19 vaccine during a Keynote Talk at the Arena International Vaccines Virtual Conference on August 5, 2021. The presentation, led by Oramed CEO Nadav Kidron, will cover the development of the world's first triple antigen oral SARS-CoV-2 vaccine that targets three virus surface proteins. This innovative approach aims to enhance effectiveness against current and future COVID-19 variants.
Oramed Pharmaceuticals Inc. has appointed Michael Rabinowitz as the first Chief Commercial Officer to lead its commercial strategy starting August 1, 2021. This move comes as the company advances its Phase III trials for ORMD-0801, an innovative oral insulin candidate. Rabinowitz brings over 20 years of experience from Merck, where he successfully launched products globally. His appointment is seen as a strategic step towards enhancing Oramed's commercialization efforts.
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