TWi's ANDA for Dimethyl Fumarate DR Capsules has been tentatively approved by US FDA

January 23, 2019. TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) today announced that the Company received tentative approval for its ANDA (“Abbreviated New Drug Application”) for Dimethyl Fumarate DR Capsules (generic version of Tecfidera®) from US FDA. The Company expects to prepare the product launch subject to the final result of the patent challenge litigation, which is still in the process as of the date.

Tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis. According to IQVIA data, the total sales of Tecfidera in the US were approximately US $3.56 billion for the 12 months ended November 2018.

About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier to entry generic prescription products ranging from oral controlled release dosage forms to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer unparalleled market opportunities in the United States. For more information on TWi Pharmaceuticals and its fully owned US subsidiary, TWi Pharmaceuticals USA, Inc., please visit www.twipharma.com

Contact :
Angela Luan
Finance/ Investor Relations
Email: angela.luan@twipharma.com