MDRNA to receive European patent for its intranasal insulin formulation

MDRNA, Inc. (NASDAQ: MRNA), a leading RNAi-based drug discovery and development company, today announced that the European Patent Office intends to grant a patent for application EP06826368 covering formulations for the intranasal delivery of rapid acting insulin, and its use for the treatment of diabetes.

"While our focus remains the development of RNAi-based therapeutics, we believe that the intranasal assets from our predecessor company, Nastech Pharmaceuticals, have considerable value," said J. Michael French, President and CEO of MDRNA. "Specifically, we believe that our insulin intellectual property assets, with the positive results from the Phase II clinical trial completed in 2008, have out-licensing potential."

The intranasal formulation would help people with diabetes, for whom managing blood sugar levels within acceptable limits is a constant challenge. Post-meal glucose levels frequently "spike" requiring immediate insulin intervention. However, there is a risk that such interventions can lead to excess insulin in the blood stream resulting in post-meal hypoglycemia (or low blood sugar levels). Intranasal insulin taken after a meal reduces hypoglycemia significantly faster than injectable insulin.

The proprietary intranasal insulin formulation covered by EP06826368 provides for a rapid-acting therapy using non-modified forms of insulin. Phase II clinical studies have demonstrated that the intranasal insulin formulation was superior to oral anti-diabetic medications and non-inferior to injectable insulin for control of blood glucose immediately (60 and 90-minutes) after a meal. Intranasal insulin provided a significant reduction in hypoglycemia at 4 hours after a meal, as compared to injectable insulin. These attributes are expected to provide for improved glycemic control. Importantly, the nasal administration did not result in insulin entering the lungs, further improving the potential safety profile of this product. The nasal delivery device used in the trials is compact and easily stored for patient convenience.