TWi Biotechnology Receives Patent Allowance for Its Lead Drug Candidate AC-201 in the United States

TAIPEI, Sept. 10, 2013 /PRNewswire/ -- TWi Biotechnology, Inc., today announced that it has received an official notification of patent allowance for AC-201, TWi Biotechnology's lead drug candidate, from the United States Patent & Trademark Office. The granted patent, US patent number 8,536,152, covers AC-201's use as a combination therapy with other existing blood glucose lowering therapy agents to treat Type II diabetes. The patent is part of TWi Biotechnology's broad intellectual property portfolio for AC-201.

"We are very pleased with the issuance of this patent in United States for AC-201. This is the third patent TWi Biotechnology has received this year for our diabetes franchise," said Dr. Calvin C. Chen, President of TWi Biotechnology. "This new issuance provides TWi Biotechnology the intellectual property protection needed for AC-201 to address an unmet medical need for an effective treatment for chronic type II diabetes. Currently, the first line treatment for blood glucose therapy is metformin or sulfonylurea monotherapy. However, monotherapy with metformin or sulfonylurea still has limited benefit. Many patients fail to achieve the treatment goal after going through an extended treatment period. Our AC-201, in combination with existing blood glucose lowering therapy agents including metformin, has demonstrated its efficacy of reducing HbA1c levels in type 2 diabetic patients in two phase II clinical trials. TWi Biotechnology had presented the results of a 259-patient multinational phase IIb study in the American Diabetes Association 73rd Scientific Sections in Chicago, USA."

About AC-201

AC-201 is a first-in-class, orally available small molecule which has shown the ability to inhibit the production and activity of the cytokine IL-1Beta and to down-regulate the IL-1Beta receptors. Inhibition of IL-1Beta signaling has been demonstrated to be effective in treating a variety of diseases including arthritis and diabetic 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 mid-1990.

TWi Biotechnology holds two US INDs for AC-201 – one for controlling blood glucose in type 2 diabetic patients and the other for gout flare prevention in patients under urate-lowering therapy. In addition to the good safety record of its active ingredient used in treating another chronic disease, AC-201 has gone through several human clinical trials including two phase II trials with 6 month treatment periods with a satisfactory safety profile.

About Type 2 Diabetes

Diabetes is one of the most common metabolic diseases worldwide. According to a June 2011 Lancet publication by Danaei and colleagues, the number of adults diagnosed with diabetes worldwide in 2008 was a staggering 347 million and this number is expected to rise to 472 million by 2030. World Health Organization (WHO) has defined type 2 diabetes as the result 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. The American Diabetes Association estimated that in 2012, the total cost associated with diabetes in US was US$245 billion of which US$176 billion was direct medical cost while US$69 billion was loss due to reduced productivity.

About TWi Biotechnology, Inc.
TWi Biotechnology, Inc., a fully owned subsidiary of TWi Pharmaceuticals, Inc., is a leading clinical stages biopharmaceutical company based in Taipei, Taiwan, specializing in the development of innovative new drugs for unmet medical needs, especially in the diseases associated with innate immunity. The company is building its product pipeline through in-licensing and internal research. TWi Biotechnology's product development pipeline includes three drug candidates for treating Type II Diabetes, retinopathy, arthritis, and immunodermatology diseases.

Contact:
Michael L. Huang
Head of Investor Relations
Tel: +886-2-2657-3350
Email: michael.huang@twipharma.com

SOURCE TWi Pharmaceuticals, Inc.



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