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.
Contact :
Eric Lin
Tel: +886-2-2657-3350 #407
email: eric.lin@twipharma.com
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SOURCE TWi Pharmaceuticals, Inc.