New U.S. patent issued for Limbrel in osteoarthritis

May 27 2009

Primus Pharmaceuticals, Inc. has announced the issuance of a new composition of matter patent for Limbrel, the first prescription medical food product to safely meet the distinctive nutritional requirements of patients with osteoarthritis (OA). U.S. Patent #7,514,469 was recently issued by the U.S. Patent and Trademark Office.

Limbrel contains flavocoxid, a proprietary composition of natural flavonoid ingredients from the plant sources of Scutellaria baicalensis and Acacia catechu that meet the FDA strict safety standard of Generally Recognized As Safe (GRAS). Under this new composition patent, allowable claims for Limbrel include “…improving mobility, range of motion, flexibility and physical function comprising… a mixture of an extract derived from Scutellaria enriched for Free-B-ring flavonoids containing baicalin and an extract derived from Acacia enriched for flavans containing catechin or epicatechin…”

“This new patent validates the uniqueness of Limbrel’s proprietary combination of ingredients which was designed for osteoarthritis patients,” said J.D. Weir, CEO of Primus. “This patent provides an additional layer of protection beyond the existing patents on the individual components. Now no other product can contain Limbrel’s pharmaceutical grade ingredients, particularly at such a high purity and concentration. We are especially proud to have a strong licensing partner with a track record for developing and aggressively defending this kind of robust intellectual property.”

Osteoarthritis is a disease that is caused, in part, by the metabolism of fatty acids, such as arachidonic acid through metabolic inflammatory processes involving cyclooxygenase (COX-1 and COX-2) and 5-lipoxygenase (5-LOX) enzymes. The pathology and metabolic aspects of OA involving these enzymatic processes were published in the Journal of Knee Surgery, “Metabolic Pathogenesis of Osteoarthritis” (2006; 19(3):191-197).

Flavocoxid’s composition is responsible for Limbrel’s clinical efficacy through the metabolic dietary management of arachidonic acid enzymatic and oxidative pathways of osteoarthritis (OA). Over 100,000 patients have used Limbrel under the care of Rheumatologists, Orthopedic Surgeons and Pain Management physicians. Limbrel is only available by prescription and is dispensed at retail pharmacies nationwide.