Aralez Submits Marketing Authorization Application To The European Medicines Agency For PA10040

MISSISSAUGA, Ontario, Jan. 9, 2017 /PRNewswire/ -- 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.