TWi Pharmaceuticals, Inc., has received an official notification of patent allowance for its metformin controlled release formulation from United States Patent & Trademark Office. The granted patent, US patent number 8,486,453, claims cover the controlled-release composition of TWi’s metformin product with reduced food effect.

The patent is part of TWi Pharmaceuticals’ broad intellectual property portfolio for building a franchise for treating type II diabetes and other metabolic disease.

"We are very pleased with the issuance of this patent in United States for our oral, controlled-release metformin formulation," said Dr Calvin C Chen, president of TWi Pharmaceuticals. "Metformin is the most prescribed oral drug to control blood glucose levels of type 2 diabetic patients. Due to its bioavailability is highly influenced by food intake, currently available controlled-release metformin formulations need to be taken with food that is inconvenient to patients. In addition, compliance of metformin products for diabetic patients, who usually have multiple illnesses and need to take several medicines daily, has sometime been poor because metformin administration time is always different than other medications. TWi’s proprietary formulation, on the other hand, may improve patient compliance and blood glucose control since this formulation has clinically proved to significantly reduce the variance of metformin concentration in blood when taken with or without food. By reducing the food effect, our formulation will be more feasible to combine with other medicines, which also can be taken once a day without restriction of food, to treat diabetes and other metabolic diseases. TWi intends to build a franchise of diabetes therapy with this new metformin formulation as standalone therapy or in combination with TWi’s own diabetes drug AC-201 or other metabolic disease drugs on the market.”

According to IMS Health, a market research firm, the total annual sales of the metformin products in US were approximately $2.1 billion in 2012.

Diabetes is one of the most common metabolic diseases worldwide. World Health Organization (WHO) has defined type 2 diabetes as results of the body’s ineffective use of insulin. Type 2 diabetes comprises 90% of people with diabetes around the world, and is largely caused by excess body weight and physical inactivity.

TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company focusing on the development of high barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems.