Oramed files provisional patent application with USPTO for combination diabetes therapy

Oramed Pharmaceuticals Inc. (OTCBB:ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has filed a provisional patent application with the United States Patent and Trademark Office for a combination therapy of its lead compound, ORMD-0801 in combination with its oral exenatide formulation, ORMD-0901. There is no such approved combination product available on the market today.

The complexity of the development and progression of diabetes often requires concomitant treatments, designed to simultaneously target the numerous underlying pathological triggers. The combined use of these two drugs has recently been evaluated in animals and showed improved blood glucose regulation when compared to the administration of each drug separately.

These formulations have been designed to allow for oral delivery of drugs currently only available in injectable forms.  Both drugs are currently being independently assessed in human clinical trials.  An oral delivery system may substantially increase patient compliance, especially at the earliest of stages of treatment, which would have a meaningful outcome on quality of life and workplace productivity.

According to a report by Medtech Insight, diabetes affects nearly 24 million people in the U.S. and an estimated 246 million adults worldwide. Being one of the most expensive diseases, it costs the US healthcare system more than $130 billion per year and the market for direct pharmaceutical care is close to $15 billion.

"This intriguing development is part of the company's strategy to further expand our pipeline in a very focused manner. Expansion of Oramed Pharmaceuticals' intellectual property portfolio and related programs will further enhance our ability to offer a higher return on investment to our shareholders as we continue pioneering advances in drug delivery options," stated Oramed  Pharmaceuticals' CEO, Mr. Nadav Kidron.

Each of the formulations alone is currently patent pending in the US and other key markets around the world. ORMD-0801 is an orally ingestible insulin capsule and has recently demonstrated a favorable effect when evaluated in Phase II clinical trials for its effectiveness in treating Type II diabetes. ORMD-0901 is a glucagon-like peptide-1 analog, a gastrointestinal hormone that stimulates the secretion of insulin from the pancreas. Oramed commenced human clinical trials for ORMD-0901 following successful pre-clinical results.