MISSISSAUGA, Ontario,
Jan. 11, 2017 /PRNewswire/
-- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX:
ARZ), a global specialty pharmaceutical company, today announced
that the United States Patent and Trademark Office (USPTO) has
issued a patent entitled "Compositions and Methods for Delivery of
Omeprazole Plus Acetylsalicylic Acid" that covers
Yosprala™ (aspirin and omeprazole), the only
prescription fixed-dose combination of an anti-platelet agent,
aspirin, and the proton pump inhibitor, omeprazole, in the U.S.
The USPTO issued U.S. Patent number 9,539,214 on January
10, 2017, which will expire in late 2032 with possible patent term
adjustment into early 2033. Aralez plans to list this patent
in the FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations, also known as the Orange Book. Once
listed there will be a total of four patents in the Orange Book for
Yosprala.
About Aralez Pharmaceuticals Inc.
Aralez
Pharmaceuticals Inc. (NASDAQ: ARLZ and TSX: ARZ) is a global
specialty pharmaceutical company focused on delivering meaningful
products to improve patients' lives while creating shareholder
value by acquiring, developing and commercializing products
primarily in cardiovascular, pain and other specialty areas.
Aralez's Global Headquarters is in Mississauga, Ontario, Canada, its U.S.
Headquarters is in Princeton, NJ
and the Ireland Headquarters is in Dublin, Ireland. More information about Aralez
can be found at www.aralez.com.
Cautionary Language Concerning Forward-Looking
Statements
This press release includes certain statements
that constitute "forward-looking statements" within the meaning of
applicable securities laws. Forward-looking statements include, but
are not limited to, statements regarding an additional U.S. patent
for Yosprala which will expire in late 2032 with possible patent
term adjustment into early 2033, plans to list this patent in the
FDA's Orange Book, that once listed there will be four patents
in the Orange Book for Yosprala, and other statements that are not
historical facts, and such statements are typically identified by
use of terms such as "may," "will," "would," "should," "could,"
"expect," "plan," "intend," "anticipate," "believe," "estimate,"
"predict," "likely," "potential," "continue" or the negative or
similar words, variations of these words or other comparable words
or phrases, although some forward-looking statements are expressed
differently.
You should be aware that the forward-looking statements included
herein represent management's current judgment and expectations,
and are based on current estimates and assumptions made by
management in light of its experience and perception of historical
trends, current conditions and expected future developments, as
well as other factors that it believes are appropriate and
reasonable under the circumstances, but there can be no assurance
that such estimates and assumptions will prove to be correct and,
as a result, the forward-looking statements based on those
assumptions could prove to be incorrect. Accordingly, actual
results, level of activity, performance or achievements or future
events or developments could differ materially from those expressed
or implied in the forward-looking statements. Our operations
involve risks and uncertainties, many of which are outside of our
control, and any one or any combination of these risks and
uncertainties could also affect whether the forward-looking
statements ultimately prove to be correct and could cause our
actual results, level of activity, performance or achievements or
future events or developments to differ materially from those
expressed or implied by the forward-looking statements. These risks
and uncertainties include, without limitation, our inability to
build, acquire or contract with a sales force of sufficient scale
for the commercialization of our products in a timely and
cost-effective manner; our failure to successfully commercialize
our products and product candidates; competition, including
increased generic competition; costs and delays in the development
and/or approval of our product candidates, including as a result of
the need to conduct additional studies or due to issues with
third-party API or finished product manufacturers, or the failure
to obtain such approval of our product candidates for all expected
indications, including as a result of changes in regulatory
standards or the regulatory environment during the development
period of any of our product candidates; with respect to certain
products, dependence on reimbursement from third-party payors and
the possibility of a failure to obtain coverage or reduction in the
extent of reimbursement; the inability to maintain or enter into,
and the risks resulting from our dependence upon, collaboration or
contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution
of any products, including our dependence on AstraZeneca AB and
Horizon Pharma USA, Inc. for the
sales and marketing of VIMOVO®, our dependence on Patheon
Pharmaceuticals Inc. for the manufacture of Yosprala, our
dependence on Schering-Plough (Ireland) Company for the supply of ZONTIVITY®
and our dependence on AstraZeneca AB for the manufacture and supply
of Toprol-XL® and its currently marked authorized generic (AG); our
ability to protect our intellectual property and defend our
patents; regulatory obligations and oversight; failure to
successfully identify, execute, integrate, maintain and realize
expected benefits from new acquisitions, such as the acquisitions
of Tribute Pharmaceuticals Canada Inc., ZONTIVITY and Toprol-XL and
its AG; fluctuations in the value of certain foreign currencies,
including the Canadian dollar, in relation to the U.S. dollar, and
other world currencies; changes in government regulations,
including tax laws and unanticipated tax liabilities and
regulations regarding the pricing of pharmaceutical products; risks
related to our financing; general adverse economic, market and
business conditions; and those risks detailed from time-to-time
under the caption "Risk Factors" and elsewhere in the Company's
Securities and Exchange Commission (SEC) filings and reports and
Canadian securities law filings, including in our Annual Report on
Form 10-K for the year ended December 31,
2015 and our Quarterly Report on Form 10-Q for the quarterly
period ended September 30, 2016,
which are available on EDGAR at www.sec.gov, on SEDAR at
www.sedar.com, and on the Company's website at www.aralez.com, and
those described from time to time in our future reports filed with
the SEC and applicable securities regulatory authorities in
Canada. You should not place undue
importance on forward-looking statements and should not rely upon
this information as of any other date. We undertake no obligation
to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
unless required by law.
Contact Information:
Aralez Pharmaceuticals US Inc.
Nichol Ochsner
Executive Director,
Investor Relations & Corporate Communications
732.754.2545
nochsner@aralez.com
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SOURCE Aralez Pharmaceuticals Inc.