TWi Biotechnology gets European, Russian patents for drug candidate AC-201 to treat type I and II diabetes

( – TWi Biotechnology, Inc., a subsidiary of TWi Pharmaceuticals, Inc, and a leading clinical stage biopharmaceutical company, has received notices of allowance for its lead drug candidate, AC-201 from the European Patent Office and the Patent Office of the Russian Federation for patent applications numbered 11766702.2-1460 and 2012147449, respectively.

This patent includes AC-201, or its pharmaceutically acceptable salts or active metabolites, for treatment of both type I and type II diabetes. This patent adds to TWi Biotechnology’s broad intellectual property portfolio for AC-201. The patent provides a protection period up to year 2030, and has been previously allowed in US, Mexico, New Zealand and China.

“We are very pleased with the allowance of patent covering the use of AC-201 in treating diabetes in both Europe and Russia. Given the unique modes of action of AC-201, if successful, AC-201 will not only be able to help diabetic patients in controlling blood sugar, but also protect vital organs from the damage caused by the chronic inflammation associated with diabetes and obesity,” said Dr. Calvin C. Chen, chief executive officer of TWi Biotechnology.

“It is estimated Europe and Russia have a total of 80.1 million patients in 2013. We have conducted multiple clinical trials for AC-201 in the US and Asia with positive results, and hope to develop AC-201 soon in European countries, with the goal of bringing benefits to the vast number of diabetes patients in Europe after it obtains drug approval.”

TWi Biotechnology holds two US Investigational New Drug Application (INDs) for AC-201 — one for controlling blood glucose in patients with type II diabetes and the other for treating gout in patients undertaking urate-lowering therapy. In addition to the good safety record of its active ingredient used in treating another chronic disease, AC-201 has demonstrated safety in multiple human clinical trials including 3 phase II trials with treatment periods up to 6 months in duration.

AC-201 is a first-in-class small molecule which has shown the ability to inhibit the production and activity of the caspase-1 and cytokine interleukin-1beta (IL-1beta), and to down-regulate IL-1beta receptors. Inhibition of IL-1beta signaling has been demonstrated to be effective in treating a variety of diseases including arthritis, gout, and diabetes mellitus (DM). The active ingredient of AC-201 has been approved for treating patients with chronic rheumatic diseases in France and subsequently in other EU and Middle Eastern countries since the mid-1990s.

Diabetes is one of the most common metabolic diseases worldwide. The World Health Organisation (WHO) has defined type II diabetes as a result of the body’s ineffective use of insulin. Type II diabetes comprises 90 per cent of cases of diabetes around the world, and is largely caused by excess body weight and physical inactivity. According to The 6th Edition of the International Diabetes Federation (IDF) Diabetes Atlas, 382 million people live with diabetes worldwide (8 per cent of the world population), which is expected to affect 592 million by 2035. In Russia and Europe, 10.9 and 56.3 million people were estimated to have diabetes in 2013, which is expected to increase to 11.2 and 68.9 million by 2035, with total cost associated with diabetes in 2013 and 2035 of USD 147.2 billion and 158.6 billion, respectively.

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