2017.06
TWi Confirms Patent Challenge Relating to Its Paragraph IV ANDA Filing for a Generic Equivalent to Tecfidera

June 29, 2017. TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) confirmed today that it has filed an Abbreviated New Drug Application (“ANDA”) containing a Paragraph IV certification with US FDA seeking approval to market a generic version of Tecfidera, which the patents are owned by Biogen. The ANDA holder and the owner of the patents filed suit against TWi on June 29th, 2017 (US time) in the US seeking to prevent TWi from commercializing its ANDA product prior to the expiration of their patents. The lawsuit was initiated under the Hatch-Waxman Act.

TWi officially received the acceptance letter from US FDA on May 23th, 2017 for its paragraph IV ANDA submission of generic equivalent to Tecfidera. Pursuant to the rules under the Hatch-Waxman Act, the patent owner has the right to file suit within 45 days from the date of being notified by ANDA applicant of the patent challenge. Such a patent litigation is a general practice for a paragraph IV ANDA filing in the US. Given the fact that TWi has not yet launched the product, no indemnification is expected.

Tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis. According to IMS Health data, the total sales of Tecfidera in the US were approximately US$3.6 billion for the 12 months ended March 2017. In addition to the originator, There is currently no other listed competitor to our best knowledge.

About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high-entry-barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and 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.

Contact:
Angela Luan
Investor Relations
Tel: +886-2-2657-3350 ext. 241
Email: angela.luan@twipharma.com

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