Oramed Pharmaceuticals (NASDAQCM:ORMP) was established in 2006, and is based on over 30 years of medical research at the world-renowned Hadassah University Medical Center in Jerusalem, Israel.
For over two decades, scientists at Hadassah Hospital's Diabetes Unit, led by Professor Hanoch Bar-On, worked to develop a technology designed to enable the oral administration of insulin to diabetics. A medical breakthrough in 2005 laid the foundation for the founding of Oramed Pharmaceuticals, of which Hadassah remains a part owner. Professor Bar-On helped found Oramed, together with Dr. Miriam Kidron, and served as a director until his untimely death in 2006.
From the time of the company’s inception, Oramed has successfully tested its technology via various animal and human studies on its two flagship products, an oral insulin capsule, ORMD-0801, and an oral exenatide (a GLP-1 Analog) capsule, ORMD-0901. Combination therapy (ORMD 0801+0901) showed promising results in pre-clinical trials, and clinical trials are expected to follow.
Oramed's unique oral delivery technology serves as a platform for other vaccines and medications currently available in injection form. The company is approached by pharmaceutical companies large and small looking to test compliance with Oramed’s technology on their product pipeline.
Oramed has garnered worldwide support of prominent scientists to its scientific advisory board, a testament to its sound technology: the former Senior VP of Pfizer, Dr. Michael Berelowitz; Prof. John Amatruda, former Senior VP of Merck and Co.; Prof. Ele Ferrannini, Past President of the EASD*; and Prof. Avram Hershko, 2004 Nobel Prize Laureate in Chemistry, and a leader in the field of drug delivery methods, among others. The office of the Chief Scientist of Israel has also shown its confidence in Oramed’s technology, having awarded Oramed its third consecutive grant to continue its research.
Recent and promising developments at Oramed also include 5 patent approvals for its technologies in the Israeli, Japanese, Australian, and New Zealand Patent Offices. Patent approval is particularly important as it validates Oramed’s technology, establishing an international stronghold for its oral protein delivery methods. Oramed has an additional 34 pending patents and expects to see more of them approved in the future.
Overview of Product Status:
- ORMD-0801: FDA clearance to proceed with Phase 2 trials in the US under IND (Investigational New Drug application) as of May 2013. Trial to commence shortly.
- ORMD-0901: Trials on healthy volunteers (Phase Ib) and type 2 diabetic patients (Phase IIa) currently underway after successful pre-clinical and Phase Ia results.
- Combination Therapy (ORMD-0801+0901): An abstract of pre-clinical results was presented at the 72nd Scientific Sessions of the American Diabetes Association (ADA) in June, 2012. Clinical trials expected to follow.
* European Association for the Study of Diabetes is the European equivalent of the American Diabetes Association (ADA)