Sucampo Announces Settlement Agreement That Resolves Patent Litigation in U.S. Related to AMITIZA
Company Receives Additional Paragraph IV Notice
BETHESDA, Md., Oct. 9, 2014 (GLOBE NEWSWIRE) -- Sucampo
Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global
biopharmaceutical company, today announced that Sucampo, R-Tech Ueno,
Ltd. (RTU), Takeda Pharmaceutical Company Limited (Takeda) and certain
affiliates of Takeda have entered into a settlement and license
agreement with Anchen Pharmaceuticals, Inc., Par Pharmaceutical, Inc.,
and Par Pharmaceutical Companies, Inc., (collectively, Par) that
resolves patent litigation in the United States (U.S.) related to
Sucampo's AMITIZA(R) (lubiprostone) 8 mcg and 24 mcg soft gelatin
Under the terms of the settlement, Sucampo and RTU will grant Par a
non-exclusive license to market Par's generic version of lubiprostone 8
mcg soft gelatin capsule and 24 mcg soft gelatin capsule (licensed
products) in the U.S. for the indications approved for AMITIZA
beginning January 1, 2021, or earlier under certain circumstances.
Beginning on January 1, 2021, Par will split with Sucampo the gross
profits of the licensed products sold during the term of the agreement,
which continues until each of the Sucampo patents has 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. Additional details of the agreement remain
"This settlement agreement is an important step for Sucampo toward
securing our foundation and continuing to grow sales of AMITIZA," said
Peter Greenleaf, Chief Executive Officer of Sucampo. "We are on track
with the strategic imperatives I communicated in August that include a
sharp focus on our flagship product. This is not only beneficial to our
company and shareholders, it is important to prescribing physicians and
their patients who depend on AMITIZA for treatment."
Sucampo, RTU, Takeda and Par have agreed to dismiss with prejudice the
patent litigation filed in the U.S. District Court for the District of
Additionally, Sucampo said it has received a Paragraph IV certification
notice letter (Notice Letter) regarding an Abbreviated New Drug
Application (ANDA) submitted to the U.S. Food and Drug Administration
(FDA) by Dr. Reddy's Laboratories, Inc. (Dr. Reddy's), requesting
approval to market, sell and use a generic version of the 8 mcg and 24
mcg AMITIZA(R) (lubiprostone) soft gelatin capsule products.
Sucampo is currently reviewing the Notice Letter. By statute, if
Sucampo initiates a patent infringement lawsuit against Dr. Reddy's
within 45 days of the Notice Date, the FDA would automatically stay
approval of the Dr. Reddy's ANDA until the earlier of 30 months from
the notice date or entry of a district court decision finding the
patents invalid or not infringed. The product is currently protected by
15 issued patents that are listed in the FDA's Orange Book, with the
latest expiring in 2027.
"We will continue to vigorously enforce AMITIZA's intellectual property
rights," said Greenleaf. "Generic companies have made Paragraph IV
certifications a routine part of business. Sucampo is well prepared to
pursue all legal pathways in defense of AMITIZA."
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the development and
commercialization of medicines that meet unmet medical needs of
patients worldwide. Sucampo has two marketed products - AMITIZA(R) and
RESCULA(R) - and a pipeline of product 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 pending trademark of Sucampo AG. AMITIZA is
a registered trademark of Sucampo AG. RESCULA is a registered trademark
of R-Tech Ueno, Ltd, and has been licensed to 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; 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 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 Sucampo
incorporates by reference.
CONTACT: Sucampo Pharmaceuticals, Inc.
Senior Vice President, Investor Relations and