2014.06
TWi Biotechnology Receives Notice of Patent Allowance for Its Lead Drug Candidate AC-201 in United States.

TWi Biotechnology, Inc., today announced that it has received Notice of Allowance for AC-201, TWi Biotechnology's lead drug candidate, from United States Patent& Trademark Office (USPTO) for patent application U.S. 13/533,271 entitled, “Methods of decreasing glycosylated hemoglobin in patients with dyslipidemia” and U.S. 13/414,264 entitled, “Methods and compositions for treating hyperuricemia and metabolic disorders associated with hyperuricemia”.These two patents broadly cover methods and uses for AC-201as monotherapy or in combination with other lipid lower agents to treat patients with type II diabetes and dyslipidemiaor patients with hyperuricemia, respectively. These patentsare parts of TWi Biotechnology's broad intellectual property portfolio for AC-201.

 

"We are very pleased with the issuance of these patents inUnited Statesfor AC-201. These new issuancesprovide TWi Biotechnology the intellectual property protection for AC-201addressingunmet medical needs as an effective treatment for type II diabetes and hyperuricemia." saidDr. Calvin C. Chen, President of TWi Biotechnology. Currently, type IIdiabetic patients with dyslipidemia are mostly recommended to manage their lipid profile with HMG-CoA reductase inhibitors (statins). However, labels on statins for dyslipidemia treatment in the United States now includeinformation concerning glycemic effects, including diabetesand increases in hemoglobin A1c (HbA1c) or fasting plasma glucose (FPG).“This new issuance of patent application U.S. 13/533,271provides TWi Biotechnology the intellectual property protection for AC-201address anunderserved withan effective treatment for patients who have both type IIdiabetesand dyslipidemia”said Dr. Chen. AC-201 has demonstrated its efficacy of reducing HbA1c levels in type II diabetic patients in two phase II clinical trials. TWi Biotechnology last yearpresented the results of a 259-patient multinational phase IIb study atthe American Diabetes Association 73rd Scientific Sections in Chicago, USA. 
 

Added Dr. Chen:“The other new issuance of patent applicationU.S. 13/414,264is an important addition to our existing patent portfolio and strengthens our ability to protect our proprietary method of use of AC-201 for hyperuricemia and gout treatment.We continue to work towards a planned phase IItrial of AC-201 for gout treatment in Q3 2014.
 

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 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 beenapprovedfor treating patients with chronic rheumatic diseases inFrance and subsequently in other EU and Middle Eastern countries such as Spainand Italy since mid-1990.


TWi Biotechnology holds two US INDsfor AC-201–one for controlling blood glucose in patients with type IIdiabetes and the other fortreating gout in patients under taking urate-lowering therapy. In addition to the good safety record of its active ingredient used in treating another chronic disease, AC-201 has undergone testing in several human clinical trials including 3 phase II trials with up to 6 months treatment periodwith a satisfactorysafety profile demonstrated.


About Type IIDiabetes

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 millionpeople were estimated to have diabetes in 2013, whichis expected to increase to143 and 30millionby 2035,with total cost associated with diabetesin 2013 of USD 38 billion and 239 billion, respectively.


About Hyperuricemia and Gout

Gout is a medical condition usually characterized by recurrent attacks of acute inflammatory arthritis—a red, tender, warm, swollen jointcaused by an inflammatory response to uric acid crystals deposited in joints and soft tissues as a result of elevated levels of uric acid in the blood (hyperuricemia). Urate crystals in joints can trigger acute arthritic flares, chronic destructive arthropathy, and formation of tophi. According to the U.S.National Health and Nutrition Examination Survey (NHANES) study, the prevalence of gout among US adults in 2007-2008 was 3.9% (8.3 million individuals).


About TWi Biotechnology, Inc.

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 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 includesthree drug candidates for treatingtype II diabetes, retinopathy,arthritis, and immunodermatology diseases.


Contact :
Liru Yeh 
Tel: +886-2-2657-3350#367
email: liru.yeh@twipharma.com

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