MISSISSAUGA, Ontario,
Jan. 9, 2017 /CNW/ -- Aralez
Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez"
or the "Company") today announced that it has submitted
a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) for its investigational candidate, PA10040,
for the secondary prevention of cardiovascular disease in patients
at risk for aspirin-induced gastric ulcers.
"As we seek to maximize the opportunity for Yosprala on a
worldwide basis, we plan to engage in early discussions with
potential partners for territories outside of the United States and Canada," said Adrian
Adams, Chief Executive Officer of Aralez. "At the same time,
we are making significant progress with our commercial efforts in
the United States."
Aspirin and omeprazole is currently marketed in a tablet form
under the brand name Yosprala™ in the
United States and indicated for patients who require aspirin
for secondary prevention of CV and cerebrovascular events and who
are at risk of developing aspirin-associated gastric ulcers.
The MAA is based on the results from two randomized,
double-blind controlled clinical trials in which patients were
randomly assigned to receive either Yosprala 325 mg/40 mg (n=524)
or 325 mg of enteric-coated aspirin (n=525) as well as
bioavailability studies which evaluated the Yosprala 100 mg/40 mg
dose. (The 100 mg aspirin dose is the most common in the European
Union (EU) for secondary prevention of cardiovascular and
cerebrovascular events.) In the Phase 3 efficacy studies with the
325 mg/40 mg dose, each study achieved its individual primary
endpoint with patients in the Yosprala arm experiencing
significantly fewer endoscopic gastric ulcers compared to those
taking enteric-coated aspirin (325 mg) alone. In addition,
significantly fewer patients treated with Yosprala discontinued
therapy because of prespecified upper gastrointestinal adverse
events compared to patients in the enteric-coated aspirin (325 mg)
arm.i The most common adverse reactions reported in
adults (incidence ≥ 2% and greater than 325 mg EC aspirin) during
the studies were gastritis, nausea, diarrhea, gastric polyps and
non-cardiac chest pain.
About Yosprala™ in the EU
Yosprala for use in
the EU is a combination of enteric-aspirin (100 mg), an
anti-platelet agent, surrounded by immediate-release omeprazole (40
mg), a proton pump inhibitor. Aralez is seeking EU approval for
patients who require aspirin for secondary prevention of CV and
cerebrovascular events and who are at risk of developing
aspirin-associated gastric ulcers.
The aspirin component of Yosprala, if approved in the EU, would
be indicated for reducing the combined risk of death and nonfatal
stroke in patients who have had ischemic stroke or transient
ischemia of the brain due to fibrin platelet emboli; reducing the
combined risk of death and nonfatal myocardial infarction (MI) in
patients with a previous MI or unstable angina pectoris; and
reducing the combined risk of MI and sudden death in patients with
chronic stable angina pectoris. It is also indicated for use in
patients who have undergone revascularization procedures − coronary
artery bypass graft or percutaneous transluminal coronary
angioplasty − when there is a pre-existing condition for which
aspirin is already indicated.
The omeprazole component of Yosprala, if approved in the EU,
would be indicated for decreasing the risk of developing aspirin
associated gastric ulcers in patients at risk for developing
aspirin-associated gastric ulcers due to age (≥ 55) or documented
history of gastric ulcers.
Yosprala, if approved in the EU, would not be for use as the
initial dose of aspirin therapy during onset of acute coronary
syndrome, acute MI or before percutaneous coronary intervention.
Yosprala was evaluated in clinical studies for the reduction of
gastric ulcers. It was not evaluated for the reduction of GI
bleeding and therefore has not been shown to reduce the risk of
gastrointestinal bleeding due to aspirin. Yosprala would not be
interchangeable with the individual components of aspirin and
omeprazole.
Important Safety Information
You should take
Yosprala (aspirin and omeprazole) exactly as prescribed, at the
lowest dose possible and for the shortest time needed. Do
not stop taking Yosprala without talking with your doctor. Stopping
Yosprala suddenly could increase your risk of having a heart attack
or stroke.
Do not take Yosprala if you are allergic to aspirin, omeprazole,
or any of the ingredients in Yosprala. Do not take Yosprala if you
have a medical condition with severe shortness of breath, chest
tightness or pain, coughing or wheezing (asthma), sneezing, runny
nose or itchy nose (rhinitis), and growths inside of your nose or
sinuses (nasal polyps). Do not take Yosprala if you are allergic to
any non-steroidal anti-inflammatory drug.
Do not take Yosprala if you are taking a medicine that contains
rilpivirine such as EDURANT®, COMPLERA®, or
ODEFSEY®.
Yosprala should not be used in children.
Tell your doctor if you have unexpected bleeding, if you bleed
more than usual, or if your bleeding lasts longer than is normal
for you, such as increased bruising or more frequent nose bleeds
after taking Yosprala.
Tell your doctor if you have stomach problems while taking or
after you stop taking Yosprala. Stop taking Yosprala and call your
doctor right away if you have any of the following signs or
symptoms: black, bloody, or tarry stools, coughing up blood or
vomit that looks like coffee grounds, or severe nausea, vomiting,
or stomach pain.
Avoid heavy alcohol use (3 or more drinks daily) during
treatment with Yosprala.
Yosprala contains aspirin and omeprazole. Before taking
Yosprala, tell your doctor if you take:
- aspirin, or any prescription or over-the-counter medicines
containing aspirin or other NSAIDs (non-steroidal anti-inflammatory
drugs)
- clopidogrel bisulphate (PLAVIX®). You should not
take clopidogrel bisulphate (PLAVIX®) if you take
Yosprala.
- ticagrelor (BRILINTA®). If your doctor prescribes
Yosprala for you, you should not take Yosprala that contains the
325/40 mg strength dose.
Kidney problems may happen at any time during treatment with
Yosprala. Call your doctor if you have a decrease in the amount
that you urinate, have blood in your urine, changes in urination,
swelling, skin rash or itching, or your breath smells like
ammonia.
Yosprala can cause diarrhea caused by an infection
(Clostridium difficile) in your intestines. Call your doctor
if you have watery stools or stomach pain that does not go away.
You may or may not have a fever.
Bone fractures (hip, wrist, or spine) in people who take
multiple daily doses of proton pump inhibitor (PPI)-containing
medicines like Yosprala for a long period of time (a year or
longer) may occur.
Certain types of lupus erythematosus may happen or get worse in
people who already have lupus and who take PPI medicines, including
Yosprala. Call your doctor right away if you have joint pain or a
rash on your cheeks or arms that gets worse in the sun.
Liver problems may happen during treatment with Yosprala. Tell
your doctor if you have signs or symptoms of liver problems,
including: yellowing of your skin or your eyes, stomach-area
(abdominal) pain and swelling, itchy skin, and dark (tea-colored)
urine.
Low vitamin B12 levels in your body can happen in people who
have taken a PPI medicine, such as omeprazole, for a long time
(more than 3 years). Tell your doctor if you have symptoms of low
vitamin B12 levels, including: shortness of breath,
lightheadedness, irregular heartbeat, muscle weakness, pale skin,
feeling tired, mood changes, and tingling or numbness.
Low magnesium levels in your body can happen in people who have
taken Yosprala for at least 3 months. Tell your doctor if you have
symptoms of low magnesium levels, including: seizures, dizziness,
irregular heartbeat, jitteriness, muscle aches or weakness, and
spasms of hands, feet or voice.
If you are pregnant, planning to become pregnant, or nursing,
talk to your doctor before taking Yosprala. Breastfeeding is not
recommended during treatment with Yosprala.
Tell your doctor about all the medicines you take, including
prescription and non-prescription drugs, anti-cancer drugs,
vitamins, and herbal supplements. Yosprala may affect how other
medicines work, and other medicines may affect how Yosprala works.
This can cause serious side effects.
Especially tell your doctor if you are taking:
- a medicine that contains rilpivirine (EDURANT®,
COMPLERA®, ODEFSEY®)
- clopidogrel bisulphate (PLAVIX®)
- ticagrelor (BRILINTA®)
- St. John's Wort (Hypericum perforatum)
- rifampin (RIMACTANE®, RIFATER®,
RIFAMATE®, RIFADIN®)
- methotrexate (OTREXUP®, RASUVO®,
TREXALL®)
Yosprala is not interchangeable with the individual components
of aspirin and omeprazole.
The most common side effects of Yosprala include: indigestion or
heartburn and stomach-area pain, nausea, diarrhea, growths (polyps)
in your stomach, and chest pain behind the breastbone, for example,
with eating.
The risk information provided here is not comprehensive. To
learn more, talk about Yosprala with your pharmacist or other
health care providers. The product information can be found
at www.Yosprala.com or 1-866-207-6592.
Call your doctor for medical advice about side
effects. You are encouraged to report negative side effects
of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
For full prescribing information and additional important safety
information, please visit: www.Yosprala.com.
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 Note Regarding 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 seeking to maximize the
opportunity for Yosprala on a worldwide basis, the Company's plans
to engage in early discussions with potential partners for Yosprala
for territories outside of the United
States and Canada, making
significant progress with our commercial efforts for Yosprala in
the United States, seeking EU
approval for Yosprala, including the proposed indications for
Yosprala and its components in the EU, the the benefits and risks
of 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 Yosprala in
the EU), 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.
Aralez Pharmaceuticals US Inc. Contact:
Nichol L. Ochsner
Executive Director, Investor Relations & Corporate
Communications
732-754-2545
nochsner@aralez.com
i Whellan D, et al. Am Heart J. 2014
Oct;168(4):495-502.
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SOURCE Aralez Pharmaceuticals Inc.