-Secures Formulary Status with CVS Caremark for YOSPRALA™
MISSISSAUGA, Ontario, Dec. 15, 2016 /PRNewswire/ -- Aralez
Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the "Company") today announced that it has
entered into a rebate agreement with CaremarkPCS Health (also known as CVS Caremark), which secures formulary status for
YOSPRALA™, the only prescription fixed-dose combination of an anti-platelet agent, aspirin, and a proton pump inhibitor,
omeprazole, in the United States. The rebate agreement with CVS Caremark is effective
immediately.
"At launch we had approximately 25% of lives covered, which increased to 50% in early November," said Adrian Adams, Chief Executive Officer of Aralez. "Through the successful implementation of our managed care
strategy, and with the addition of this rebate agreement with CVS Caremark, we now anticipate approximately 80% of lives will be
covered and not blocked. We are pleased with our managed care progress thus far as we continue to have ongoing discussions with
other pharmacy benefit managers and payors with the goal of further increasing patient access to YOSPRALA commencing in early
2017."
About YOSPRALA™
YOSPRALA is a combination of enteric-aspirin (81 mg or 325 mg), an anti-platelet agent, surrounded by
immediate-release omeprazole (40 mg), a proton pump inhibitor, 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 aspirin component of YOSPRALA is 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 is 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 is not 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 is not 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 planned to be 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 a rebate agreement with CVS
Caremark, which secures formulary status for YOSPRALA, the progress and successful implementation of our managed care strategy
with respect to YOSPRALA, including that, with the addition of the rebate agreement with CVS Caremark, we anticipate
approximately 80% of lives will be covered and not blocked and ongoing discussions with other pharmacy benefit managers and
payors with the goal of further increasing patient access to YOSPRALA commencing in early 2017, 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 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
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SOURCE Aralez Pharmaceuticals Inc.