TWi Pharmaceuticals has leveraged its proprietary strengths to focus on the research and development of drug delivery systems, avoiding the highly competitive generics market in the United States. Continuous R&D efforts and technology transfer to its parent company - Anchen Pharmaceuticals - has not only enhanced drug performance, but also created growing value-added products for the parent company, making hundreds of millions of US dollars in 2007. In April 2010, TWi Pharmaceuticals was spun-off from Anchen Pharmaceuticals as an independent company in Taiwan. Since then, TWi has determined to become the leading Taiwan pharmaceutical companies exporting finished products to the US market, taking advantage of its R&D and manufacturing capabilities for high-tech barriersgenerics. According to current planning, the company plans to go public in Taiwan within the next two to three years. In addition to independent development of high-tech barriersgenerics, the company plans to establish partnerships with other domestic pharmaceutical companies to further develop Taiwan's biopharmaceutical industry, attracting more attentions from global big pharma and biotech companies.
While Dr. Chih-Ming Chen, founder of TWi Pharmaceuticals may not be a household name to the public, he is widely known as one of the successful entrepreneurs among the US biopharmaceutical industry. In 1993, Dr. Chen founded Andrx Inc., the 4th largest generic pharmaceuticals firm in the US. In 2006, Andrx was acquired for NT$60 billion by world-renowned Watson Pharmaceuticals. As the acting President of TWi Pharmaceuticals, Dr. Calvin Chen noted, ""As a result, ever since TWi's 2010 spin-off from Anchen Pharmaceuticals, the company has never faced any financial issues.""
Establishing a Strong Technology Foothold, Completing the Plan One Step at Time
It's widely known that biopharmaceutical development requires tremendous capital investment and, without sufficient capital, even the best technology and products cannot sustain the growth of a biopharmaceutical company. However, upon h is ret u r n to Taiwan to push Taiwan's biopharmaceutical industry onto the world stage, Dr. Chih-Ming Chen had already been recognized by the media as one of the top four most influential figures of the biopharmaceutical industry in Taiwan.
Following his retirement from Andrx in 2001, a strong desire t o contribute to his homeland prompt e d Dr. Chen to encourage entrepreneurship in Taiwan's still immature biopharmaceutical industry. In 2002, he founded Anchen Pharmaceuticals in the US first, but hoped the company's R&D efforts could be centered in Taiwan. In 2004, he returned to Taiwan to establish TWi Pharmaceuticals as the R&D center for Anchen. The company purchased it s Chungli commercial facility from Parke-Davis and, in 2010, the company spun off from Anchen as a completely independent company re -named TWi Pharmaceuticals, Inc. I n August of the fol lowing year , Anchen was sold to ParPharmaceuticals in the US as part of Dr. Chen's step by step blueprint for the development of TWi as a world class biopharmaceutical enterprise.
Dr. Calvin Chen stressed that, ""Dr. Chih-Ming Chen's experience in the US generics industry has allowed TWi to smoothly sink roots in the US market and secure an advantageous position in the center of the global biopharmaceutical industry.""
TWi's primary objective is to establish a strong foundation in the high-tech barrier US generic pharmaceuticals market, led by Dr. Chih- Ming Chen. The company's management team has developed multiple sustained-release drug systems and technology platforms, producing more than 50 relevant international patents and 20 plus ANDA (Abbreviated New Dr ug Application) apporved by US FDA, including generic versions of Cardizem CD, Dilacor XR, Prilosec, Wellbutrin SR, Glucotrol XL, Procardia X Land Tiazac . These striking results have created a buzz in the US biopharmaceuticals industry and laid a good foundation for TWi's stable development in Taiwan.
Using International Experience to Establish Roots in Taiwan
In 2010, TWi formally started applying for ANDA in the US, which is definitely a major milestone for the company's development.
""In fact, initially we'd hoped to move our US team to Taiwan,"" said Dr. Calvin Chen. ""But, due to the scale of the undertaking, including human resources and regulations, we finally had to spin off TWi Pharmaceuticals from Anchen."" Given government policy incentives, especially a reduction in business taxes to 17% (as opposed to over 40% in the US), plus lower costs for APIs and manufacturing, it made sense for the company to return to its roots, keeping TWi's entire R&D in Taiwan with Dr. Chih-Ming Chen.
However, according to Dr. Calvin Chen, ""the most important factor was the call of home, especially to use our R&D expertise in the US to help promote Taiwan's domestic biopharmaceutical industry - everyone working together to develop the US market and make our mark on the international biopharmaceutical stage."" Taiwan's biopharmaceutical industry had always been small in scale and domestically-oriented. Breaking out into global regulated markets has been very difficult given the competitions form global big pharm and biotech with unimaginable financial resources international regulatory hurdles.
Cooperation with Major International Pharmaceutical Firms to Invigorate the Development of Taiwan's Biopharmaceutical Industry
Through the use of continuous technology improvement, TWi is actively entering the market for high-tech barrier generic drugs. Under the Drug Price and Patent Restoration Act of 1984 (also known as the Hatch- Waxman Act), securing first-to-file without infringing the premise of the originator's patents gives the applicant(s) 180day market exclusivity in the US. Thus TWi has submitted ANDAs for a number of high-tech barriers generic pharmaceuticals. These ANDAs are expected to be approved within one to two years, giving TWi authorization to market many high-tech barrier generics in the US.
""We do not exclude collaborations with big pharma or biotech companies,"" commented Dr. Calvin Chen. ""The marketing and sales of pharmaceutical products is very complicated."" TWi has already signed supply and license agreements with the world's largest generic pharmaceutical firms to assist in sales and marketing in the US. In addition to sales alliances with major international manufacturers, TWi has started off its strategic alliance with many domestic pharmaceutical companies, combining efforts in product development and manufacturing in order to leap onto the international stage. Putting these measures in place is the key focus of TWi's future efforts.
Linking Existing Resources, Forging New Opportunities
The US generic drug market is growing increasingly competitive, especially after many Indian manufacturers enteried the market with extensive human and financial resources. This has heated up the competition for applications of 180-day exclusive marketing rights, thus raising a significant barriers to entry. TWi accordingly established TWi Biotechnology, Inc., committing themselves to the new drug development, which typically takes ten to fifteen years from drug discovery to product launch. Burning millions of US dollars a year for global pharmaceutical companies to conduct human trials on a new drug is very common only if this new drug can be launched successfully, which can lead to substantial future profits.
Currently, TWi has six new drugs under development, most of which were jointly developed with domestic research and/or academic institutions. For example, working with the Industrial Technology Research Institute's Institute of Biomedical Materials, the company has in-licensed the right toITRI-260, a targeted therapy drug for acute myeloid leukemia patients. TWi team has extensive clinical development experience in the US, which is being put to use in applications for preclinical studies and clinical trials, with the expectation that the applications will be fast tracked as ""orphan drugs"". In addition, working jointly with the Institute for Biotechnology and Medicine Industry and the National Health Research Institutes, the company is developing RSV vaccines which, once they have completed cGMP production and safety tests, will be submitted for IND (Investigational New Drug) application in the US.
TWi focuses primarily on the US market for generic drugs with high-tech barriers, supplemented by the development of high value-added new drugs, with the expectation of becoming the largest pharmaceutical company with global visions in the greater China region.
Source： Department of Investment Promotion, MOEA
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