TWi Biotechnology, Inc., a leading clinical stage biopharmaceutical company, has received Notice of Allowance for AC-201, TWi Biotechnology’s lead drug candidate, from The State Intellectual Property Office in China for patent application numbered 201180018154.8.  This patent includes AC-201 or its pharmaceutically acceptable salts, active metabolite for treatment of type II diabetes.  The patent also covers the methods of treatment using AC-201 for type II diabetes, and provides a protection period up to year 2030.  This patent adds to TWi Biotechnology’s broad intellectual property portfolio for AC-201.

"We are very pleased with the allowance of patent application in China for AC-201, after the issuance of two patents from the USPTO (US Patent & Trademark Office) in June this year.  These new patents combined will provide TWi Biotechnology intellectual property protection for AC-201 in addressing unmet medical needs as an effective treatment for type II diabetes and hyperuricemia." said Dr. Calvin C. Chen, President of TWi Biotechnology.  “Currently, China ranks first as the country with the most people with diabetes, estimated at a total of 98 million patients in the country in 2013.  We hope the drug candidate AC-201 will develop well in China and will bring benefits to the vast number of diabetes patients in China after it obtains drug approval.”

AC-201 is a first-in-class, small molecule which has shown the ability to inhibit the production and activity of caspase-1 and the 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 such as Spain and Italy since the mid-1990s.

TWi Biotechnology holds two US 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 for up to 6 months treatment period.

Diabetes is one of the most common metabolic diseases worldwide. The World Health Organization (WHO) has defined type II diabetes as a result of the body’s ineffective use of insulin. Type II diabetes comprises 90% of people with 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, 371 million people live with diabetes worldwide (8% of the world population), which is expected to affect 592 million by 2035. In China and the US, respectively the number 1 and 3 countries for most people with diabetes, 98 and 24 million people were estimated to have diabetes in 2013, which is expected to increase to 143 and 30 million by 2035, with total cost associated with diabetes in 2013 of USD 38 billion and 239 billion, respectively.

TWi Biotechnology, Inc., a fully owned subsidiary of TWi Pharmaceuticals, Inc., is a leading clinical stage biopharmaceutical company based in Taipei, Taiwan, specializing in the development of innovative new drugs for unmet medical needs, especially in diseases associated with innate immunity.