TAIPEI, July 28, 2015 /PRNewswire/ -- TWi Pharmaceuticals, Inc. today announced that it launched its generic version of Par Pharmaceutical's MEGACE ES® (megestrol acetate oral suspension) 625mg/5ml after the United States District Court for the District of Maryland reinstated its finding that United States Patent No. 7,101,576 (the '576 Patent) is invalid.
"We are very pleased to see the court reinstating its original ruling in favor of TWi and to launch the generic Megace ES today," said Tina Guilder, President and CEO of TWi. "This favorable decision not only validates TWi's capability in successful patent challenges but more importantly, allows TWi to fulfill its commitment to bring high-quality affordable pharmaceutical products to the patients."
TWi's Abbreviated New Drug Application ("ANDA") for its generic version of MEGACE ES® was approved by US FDA on August 27, 2014. As the first applicant to file an ANDA for MEGACE ES®, TWi has been deemed eligible for 180-day generic market exclusivity by US FDA.
MEGACE ES® is indicated for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients. According to IMS Health, a market research firm, the total annual sales of Megace ES® in the U.S. were approximately US$44 million for the year ended in May 2015.
About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier generic prescription products ranging from oral controlled release dosage form 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 Paragraph IV first-to-file or first-to-market opportunities in the United States. For more information of TWi Pharmaceuticals, please visit www.twipharma.com.
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may," "will," "should," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "potential," or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency/severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganisation, including related integration issues.
The company assumes no obligation to update any information contained herein.
Tel: +886-2-2657-3350 #407
SOURCE TWi Pharmaceuticals, Inc.