-Patents Covering VIMOVO Infringed by Proposed
Generics Developed by Dr. Reddy's Laboratories, Mylan, and
Lupin-
MISSISSAUGA,
Ontario, June 27,
2017 /CNW/ -- Aralez
Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the
"Company") today announced that the United States District Court
for the District of New Jersey
upheld the validity of two patents owned by a subsidiary of Aralez
and licensed to Horizon Pharma plc ("Horizon") covering
VIMOVO® (naproxen/esomeprazole
magnesium), and that Dr. Reddy's Laboratories
Inc. and Dr. Reddy's Laboratories Ltd. ("Dr. Reddy's"), Mylan
Pharmaceuticals Inc., Mylan Laboratories Ltd., and Mylan Inc.
("Mylan"), and Lupin Ltd. and Lupin Pharmaceuticals Inc. ("Lupin")
would infringe at least one of the two patents with their proposed
generic naproxen/esomeprazole magnesium
products.
On April 21, 2011,
July 25, 2011, and June 28, 2013, an Aralez subsidiary filed patent
infringement lawsuits in District Court against Dr.
Reddy's, Lupin, and Mylan, respectively, related to Abbreviated New
Drug Applications filed with the U.S. Food and Drug
Administration to market generic versions of VIMOVO. The
lawsuits claim infringement of U.S. Patent Nos. 8,557,285 ('285
patent) and 6,926,907 ('907 patent) titled "Pharmaceutical
Compositions for the Coordinated Delivery of NSAIDs," which cover
VIMOVO. The District Court's decision was made based on the
validity of the '285 and '907 patents for VIMOVO and the Court's
judgment will prevent Dr. Reddy's, Mylan, and Lupin from launching
generic versions of VIMOVO in the United
States until at least the expiration of the relevant
patent.
"We are very pleased that the fair and appropriate ruling
regarding this litigation was rendered by the United
States District Court for the District of New Jersey," said
Adrian Adams, Chief Executive
Officer of Aralez. "This demonstrates the strength of
our intellectual property portfolio for VIMOVO and
Yosprala®. We remain committed to
aggressively defending our intellectual property."
VIMOVO has 14 Orange Book listed patents with terms that
extend to 2031. The '907 patent is also listed in the
Orange Book for Yosprala (aspirin/omeprazole) and has been asserted
against Teva Pharmaceuticals US Inc. in a separate patent
infringement case.
About VIMOVO
VIMOVO
(naproxen/esomeprazole magnesium) is a fixed-dose combination of
delayed-release enteric-coated naproxen, a non-steroidal
anti-inflammatory drug (NSAID), and immediate-release esomeprazole
magnesium, a stomach acid-reducing proton pump inhibitor (PPI),
approved for the relief of signs and symptoms of osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis and to decrease the
risk of developing gastric ulcers in patients at risk of developing
NSAID-associated gastric ulcers. VIMOVO is not
interchangeable with the individual components of naproxen and
esomeprazole magnesium.
VIMOVO is not recommended for use in children younger than
18 years of age. VIMOVO is not recommended for initial
treatment of acute pain because the absorption of naproxen is
delayed compared to absorption from other naproxen-containing
products. Controlled studies do not extend beyond six
months. VIMOVO should be used at the lowest dose and for the
shortest amount of time as directed by your health care
provider. For Full Prescribing Information please
see www.VIMOVO.com.
Important Safety Information
- Nonsteroidal anti-inflammatory drugs (NSAIDs),
including naproxen, a component of VIMOVO, may increase the chance
of a heart attack or stroke, which can be fatal. This chance
increases with longer use and in people who have heart disease or
risk factors for heart disease.
- VIMOVO should not be used before or after a type of
heart surgery called coronary artery bypass graft
(CABG).
- NSAID-containing medications like VIMOVO may increase
the chance of stomach and intestinal problems, such as bleeding or
an ulcer. These problems can happen without warning and can
lead to death. Older patients may have a greater chance of
developing these problems.
VIMOVO is not right for everyone, including patients who
have had an asthma attack, hives or other allergic reaction with
aspirin or any other NSAID medicine, patients who are allergic to
any of the ingredients in VIMOVO or women in late stages of
pregnancy.
Serious allergic reactions, including skin reactions, can
occur without warning and can be life-threatening; discontinue use
of VIMOVO at the first appearance of a skin rash or if you develop
sudden wheezing; swelling of the lips, tongue or throat; fainting
or problems swallowing.
VIMOVO should be used at the lowest dose and for the
shortest amount of time as directed by your health care
provider.
Tell your health care provider right away if you develop
signs of active bleeding from any source.
VIMOVO can lead to onset of new hypertension or worsening
of existing high blood pressure, either of which may contribute to
an increased risk of a heart attack or stroke.
Speak with your health care provider before starting
VIMOVO if you
- Have a history of ulcers or bleeding in the stomach or
intestines
- Have heart problems, high blood pressure, or are taking
high blood pressure medications
- Have kidney or liver problems
Tell your doctor about all of the medicines you take,
prescription and non-prescription drugs, including clopidogrel,
vitamins and herbal supplements. VIMOVO may affect how other
medicines work and other medicines may affect how VIMOVO
works.
VIMOVO may increase your risk of getting severe
diarrhea. Call your doctor right away if you have watery
stool, stomach pain and fever that does not go away.
Talk to your health care provider about your risk for bone
fractures and developing low levels of magnesium if you take VIMOVO
for a long period of time.
Talk to your health care provider about your risk for
developing low levels of magnesium if you take VIMOVO for a long
period of time.
The most common side effects of VIMOVO include:
inflammation of the lining of the stomach, indigestion,
diarrhea, stomach ulcers, abdominal pain and
nausea.
For more information on VIMOVO, please see
the Medication
Guide and Full
Prescribing Information.
About Aralez Pharmaceuticals
Inc.
Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ)
(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, New
Jersey and its Ireland Headquarters is in Dublin, Ireland. More information about Aralez
can be found at
www.aralez.com.
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 the impact of the District Court's
ruling on the '907 and '285 patents; patent protection with respect
to VIMOVO and Yosprala; the strength of the Company's intellectual
property portfolio for VIMOVO and
Yosprala; the Company's commitment to
aggressively defending its intellectual property; 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 estimates and 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.
In addition, the Company's operations involve risks and
uncertainties, many of which are outside of its 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 its 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, risks regarding appeal of the District Court's decision
and whether the decision is upheld on such an appeal 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 its Annual Report on Form 10-K for the year ended
December 31, 2016 and its Quarterly
Report on Form 10-Q for the quarterly period ended March 31, 2017, 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
the Company's 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. The Company undertakes 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.
Aralez Pharmaceuticals US Inc. Contact:
Nichol L.
Ochsner
Executive Director, Investor
Relations & Corporate
Communications
732-754-2545
nochsner@aralez.com
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SOURCE Aralez Pharmaceuticals Inc.