December 27, 2016. TWi Pharmaceuticals, Inc. (“TWi”, Stock Ticker: 4180.TT) announced that TWi Biotechnology (“TWi Bio”), a subsidiary of 73.07% shares held by TWi, is officially listed on Emerging Market of Taipei Exchange and its stock ticker is 6610.
Established in July 2010, TWi Bio is dedicated to developing new drugs with a strategy of drug re-positioning to effectively and efficiently lower the research costs, shorten the development period, and minimize the risk. In addition, TWi Bio is mainly focused on unmet or niche medical needs, such as severe rare diseases without therapies, and proactively looks for external partnership with global leaders to further increase the success rate.
TWi Bio currently is working on 3 projects, including AC-201, AC-203, and AC-701. Among these, the main indication of AC-203 is for Epidermolysis Bullosa Simplex, or EBS, which is a very rare genetic connective tissue disorder causing the skin to be very fragile and to blister easily. Current treatments for EBS are primarily for relieving symptoms and wound care to prevent infection while the medical costs are high and frequent hospital visiting is required. As of today, AC-203 has obtained orphan drug designation in US, EU, and Taiwan, and TWi Bio has been collaborating with Castle Creek Pharmaceuticals (“CCP”), a US based orphan drug specialty pharma, by entering into a development and commercialization agreement and granting an exclusive license for worldwide territory ex-Asia. By leveraging CCP’s global networks and partners in EU, phase II clinical trials at multi-centers in multi-nations are completed with good efficacy and safety in patients. With the clinical data, US FDA has agreed TWi Bio and CCP to proceed with a global phase III pivotal trial and submit New Drug Application (“NDA”) with the trial results. The phase III trial is scheduled to be initiated in 2017. The current status of AC-201, potentially able for various indications due to its unique mechanism of action, and AC-701, mainly used to treat immune-related skin disorders, are both in phase II clinical trial stage.