Sucampo Announces Resolution of Par Pharmaceutical's ANDA for RESCULA(R)
February 11 2015 - 4:02PM
Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global
biopharmaceutical company, today announced that Sucampo and R-Tech
Ueno, Ltd. (RTU), have entered into a stipulation and license
agreement with Par Pharmaceutical, Inc. (Par). The agreement states
that in limited circumstances, Sucampo or RTU would grant Par a
license for a generic version of the RESCULA® (unoprostone
isopropyl ophthalmic solution) 0.15% product approved for the
lowering of intraocular pressure in patients with open-angle
glaucoma or ocular hypertension prior to the latest expiration date
of the patents, which is July 2021. Par had previously submitted an
Abbreviated New Drug Application to the U.S. Food and Drug
Administration requesting approval to market, sell, and use a
generic version of RESCULA.
Under such license, Par will split with Sucampo the gross
profits of the generic or authorized generic version sold during
the term of the agreement, which continues until the last of
Sucampo patents relating to RESCULA have expired. In the event Par
elects to launch an authorized generic, Sucampo will supply Par
under the terms of a manufacturing and supply agreement at a
negotiated price.
"We previously announced our exit from commercialization
activities for RESCULA as we focus on the growth of AMITIZA sales
with our partners and the expansion and advancement of our
pipeline," said Peter Greenleaf, Chief Executive Officer of
Sucampo. "However, we still remain committed to enforcing our
intellectual property for RESCULA and believe the terms of this
agreement are favorable to Sucampo."
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the development and
commercialization of medicines that meet major unmet medical needs
of patients worldwide. Sucampo has one marketed product – AMITIZA®
– and a pipeline of drug candidates in clinical development. A
global company, Sucampo is headquartered in Bethesda, Maryland, and
has operations in Japan, Switzerland and the United Kingdom. For
more information, please visit www.sucampo.com.
The Sucampo logo is the registered trademark and the tagline,
The Science of Innovation, is a registered trademark of Sucampo
AG. AMITIZA is a registered trademark of Sucampo AG.
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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; the ability of Sucampo to develop and
commercialize existing and pipeline products; 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 U.S. and internationally; the effects of
competitive products on Sucampo's products; 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
10-K as filed with the Securities and Exchange Commission on March
12, 2014 as well as its filings with the Securities and Exchange
Commission on Form 10-Q and 8-K, which Sucampo incorporates by
reference.
CONTACT: Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations
and Corporate Communications
1-240-223-3718
staylor@sucampo.com
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