TOKYO
R-Tech Ueno (JASDAQ:4573):
Sucampo Pharmaceuticals, Inc. (“Sucampo”) announced that it, together with R-Tech Ueno, Ltd., Sucampo AG, and Takeda Pharmaceutical Company Limited (“Takeda”) and certain affiliates of Takeda, have filed a patent infringement lawsuit against Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy’s), which had filed Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) to market a generic version of the 8 mcg and 24 mcg AMITIZA® (lubiprostone) oral capsules. (For more details, please refer to Sucampo’s release dated November 12, 2014)
As a result of Sucampo’s filing of the said lawsuit, final FDA approval of Dr. Reddy’s’s ANDA will be stayed up to 30 months from October 3, 2014.
The said filing will have no impact on the forecast of business results for the fiscal year ending March 2015.
For full details of the press release, please visit:
http://www.rtechueno.com/en/investor/press/documents/141113_pr_en.pdf
CONTACT
R-Tech Ueno, Ltd.
Koji Nakamura, +81-3-3596-8011
Director
Business
Management Department
info@rtueno.co.jp