Sucampo Files Patent Infringement Lawsuit Against Anchen Pharmaceuticals and Par Pharmaceuticals
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it,
its affiliate Sucampo AG, R-Tech Ueno, Ltd., Takeda Pharmaceutical
Company Limited (Takeda), and certain affiliates of Takeda have filed a
patent infringement lawsuit in the United States District Court for the
District of Delaware against Anchen Pharmaceuticals, Inc., Par
Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc.
(collectively, Anchen) related to an Abbreviated New Drug Application
(ANDA) that Anchen filed with the U.S. Food and Drug Administration
(FDA) to market a generic version of AMITIZA® (lubiprostone)
oral capsules, 8 mcg and 24 mcg. The lawsuit claims infringement of six
patents that are listed in the FDA’s Orange Book and that are scheduled
to expire between 2020 and 2027.
Sucampo commenced the lawsuit within 45 days from the receipt of a
Notice letter sent by Anchen, dated December 26, 2012, regarding its
filing of its ANDA. Under the Hatch-Waxman Act, as a result of the
patent infringement lawsuit, final FDA approval of Anchen’s ANDA will be
stayed up to 30 months from the January 2, 2013 date of receipt of the
Notice letter.
“Sucampo’s patent estate for AMITIZA® is strong, and the
company intends to vigorously defend our intellectual property. We
believe that the AMITIZA® patents, granted by the US Patent &
Trademark Office, are valid, enforceable, and infringed by Anchen’s
proposed lubiprostone products,” said Thomas J. Knapp, Executive Vice
President, Chief Legal Officer, and Corporate Secretary of Sucampo.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused
on innovative research, discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of
prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D.,
Sucampo’s Chairman, Chief Executive Officer, Chief Scientific Officer,
and co-founder. Prostones, naturally occurring fatty acid metabolites
that have emerged as promising compounds with unique physiological
activities, can be targeted for the treatment of unmet or underserved
medical needs. For more information, please visit www.sucampo.com.
Sucampo Forward-Looking Statement
This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve
risks and uncertainties, which may cause results to differ materially
from those set forth in the statements. The forward-looking statements
may include statements regarding product development, product potential,
future financial and operating results, and other statements that are
not historical facts. The following factors, among others, could cause
actual results to differ from those set forth in the forward-looking
statements: the impact of pharmaceutical industry regulation and health
care legislation; Sucampo's ability to accurately predict future market
conditions; dependence on the effectiveness of Sucampo's patents and
other protections for innovative products; the risk of new and changing
regulation and health policies in the US and internationally and the
exposure to litigation and/or regulatory actions. No forward-looking
statement can be guaranteed and actual results may differ materially
from those projected. Sucampo undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events, or otherwise. Forward-looking statements in
this presentation should be evaluated together with the many
uncertainties that affect Sucampo's business, particularly those
mentioned in the risk factors and cautionary statements in Sucampo's
most recent Form 8-K and 10-K, which the Company incorporates by
reference.
