Aralez Announces National U.S. Commercial Launch Of Zontivity

-Zontivity® is the Only Approved Protease-Activated Receptor-1 (PAR-1) Inhibitor, a Receptor for Thrombin on the Platelet Considered to be a Potent Platelet Activator-

-75 Aralez Sales Representatives Now Targeting 12,000 Cardiologists, Primary Care Physicians and Vascular Surgeons-

MISSISSAUGA, Ontario, June 7, 2017 /PRNewswire/ -- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) (Aralez or the Company) today announced the national commercial launch of Zontivity® (vorapaxar) in the U.S. will commence this week. Zontivity is the only antiplatelet therapy that inhibits PAR-1-mediated platelet aggregation in response to thrombin. Zontivity is a once-daily agent indicated for the reduction of thrombotic CV events in patients with a history of myocardial infarction (MI) or in patients with peripheral arterial disease (PAD), and should be used in combination with daily aspirin and/or clopidogrel according to their indications or standard of care.

"We believe Zontivity is a differentiated product that represents a significant opportunity for Aralez as a cornerstone of our cardiovascular franchise," said Adrian Adams, Chief Executive Officer of Aralez. "We are pleased the initial phased launch team has demonstrated immediate results with an inflection in new prescriptions resulting in a doubling of growth with target physicians in only five weeks post launch, and are excited about the national roll-out this week. We are also pleased with encouraging early indicators for our bold and significant change to our pricing strategy for Yosprala® aimed at allowing all patients to access the product for only $10.00 per month. Zontivity and Yosprala, together with Fibricor®, fully leverage our sales force and positions us nicely for growth."

On April 24, 2017, the Company commenced its phased launch of Zontivity utilizing 15 sales representatives deployed to high volume physicians who treat post-MI and PAD patients. Aralez is positioning Zontivity for patients with PAD and/or patients with a history of MI without a history of stroke or transient ischemic attack (TIA), and intends to provide more focused targeting on persistent vascular risk within these specific populations, defined as patients with PAD, patients with diabetes and/or patients who are smokers. This focused positioning, which elicited a positive response from physicians in market research and during the initial phased launch, helps identify cardiovascular and cerebrovascular (such as a first stroke) outcome improvements possible in patients treated with Zontivity in addition to the standard of care. Zontivity will now be promoted by a full complement of 75 sales representatives in the U.S. that will initially be covering approximately 25 percent of the oral antiplatelet market, targeting 12,000 physicians, including cardiologists, primary care and vascular surgeons.

The Company has also advanced its goal of ensuring patient access to Zontivity with an out-of-pocket cost competitive to other branded anti-platelet agents. The Company has improved Zontivity's managed care position by having prior authorizations reduced to less than 15% of commercial covered lives, which is expected to drop to 7-8% in the near future. Currently, approximately 85 percent of commercial formulary lives will have Zontivity covered with further coverage improvements anticipated as the Company's managed care team continues to engage key accounts in discussions on a regular basis. 

The combined U.S. patient population with PAD and a history of MI without diagnosed PAD is approximately 14.2 millionⁱ. Among that group of patients is a sub-population of approximately 9 million people who are smokers or have diabetes and are therefore at persistent riskⁱⁱ. Smoking is the single most important etiological factor for the development and progression of atherosclerosis. 

Important Medical Need Persists in Patients with PAD, Patients with a history of MI
Despite advances in the standard of care with oral antiplatelet therapy, there remains an important medical need for patients with PAD and patients with a history of MI, and especially those who smoke or have diabetes.  PAD patients face a high burden of atherosclerotic risk, potentially resulting in cardiovascular death and disability. Yet, PAD is an underdiagnosed and undertreated conditionⁱⁱⁱ. Aralez believes that Zontivity advances antiplatelet therapy by filling a potential treatment gap, and makes a meaningful difference for these patients who are at increased vascular risk.

"Atherosclerosis is a chronic and progressive disease with a risk of sudden atherothrombotic events that persists despite standard preventive therapies. TRA 2°P-TIMI 50 showed that Vorapaxar, a first-in-class PAR-1 antagonist, significantly lowers that risk in patients with PAD or prior MI," said David A. Morrow, MD, MPH - Professor of Medicine, Harvard Medical School and Senior Investigator, TIMI Study Group, Brigham and Women's Hospital.

Data supporting the clinical benefit of Zontivity are from a > 20,000-patient pivotal trial known as TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events – Thrombolysis in Myocardial Infarction), a four-year, multinational, randomized, double-blind placebo-controlled trial.

In patients with a history of heart attack or PAD who had no history of stroke or transient ischemic attack (TIA), Zontivity added to aspirin and/or clopidogrel produced a significant 17 percent relative risk reduction (RRR) over three years for the composite primary endpoint of CV death, MI, stroke, and urgent coronary revascularization (UCR) (event rate 10.1 percent vs. 11.8 percent for placebo). These results were driven by a 14 percent RRR in cardiovascular death [2.4 percent vs. 2.8 percent for placebo], an 18 percent reduction in MI [5.4 percent vs. 6.4 percent for placebo], a 33 percent reduction in first stroke [1.2 percent vs. 1.6 percent for placebo] and a 12 percent reduction in UCR [2.8 percent vs. 3.0 percent for placebo].

Adding Zontivity to aspirin and/or clopidogrel was associated with an increased rate of Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) moderate or severe bleeding through three years (3.7%) compared to adding placebo (2.4%). GUSTO severe bleeding occurred at a rate of 1.3 percent for Zontivity versus 1.0 percent for placebo.

Bleeding events with Zontivity were managed in the same manner as for other antiplatelet agents.

About Heart Attack and PAD
Heart attacks are generally caused by atherosclerotic plaque disruption and thrombus (blood clot) formation in a coronary artery. Each year, about 750,000 Americans have a new or recurrent heart attack^iv. PAD is generally defined as obstruction of arteries supplying the lower or upper extremities, most commonly due to atherosclerosis and much more commonly involving the lower extremities.

About 8.5 million individuals in the U.S. have PAD, a narrowing of the arteries in the legs, stomach, arms and head, occurring most commonly in the leg arteries. Approximately 10 percent have classic claudication symptoms (i.e., calf muscle pain on exertion), and another 50 percent have other leg symptoms^v. People with PAD are 1.3 times more likely to have a heart attack, stroke or cardiovascular death than people with coronary artery disease (CAD)^vi. Additionally, patients with PAD and CAD are at nearly twice the risk of cardiovascular death, and at three times the risk of coronary revascularization, than patients with CAD alone.

About Zontivity®
Zontivity is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). Zontivity should not be used in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding.  Zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).

Important Safety Information

Zontivity (vorapaxar) is an anti-platelet prescription medicine used to treat people who have had a heart attack or reduced blood flow in their legs or other vessels in their body (peripheral arterial disease).

Zontivity is used with aspirin, with clopidogrel (Plavix®), or with aspirin and clopidogrel to lower your chance of having another serious problem with your heart or blood vessels, such as heart attack, stroke, or death but Zontivity (and similar drugs) can cause bleeding that can be serious and lead to death.

While you take Zontivity and for about 4 weeks after your treatment with Zontivity is stopped:

• you may bruise and bleed more easily (nose bleeds may be common)
• it will take longer than usual for any bleeding to stop.

Call your doctor right away if you have any of these signs or symptoms of bleeding while taking Zontivity:

• bleeding that is severe or that you cannot control
• pink, red, or brown urine
• vomiting blood or your vomit looks like "coffee grounds"
• red or black stools (looks like tar)
• coughing up blood or blood clots.

Do not take Zontivity if you:

• have had a stroke or "mini stroke" (also known as transient ischemic attack or TIA)
• have had bleeding in your brain
• currently have unusual bleeding, such as bleeding in your head, stomach or intestines (an ulcer).

If you have a stroke, TIA, or bleeding in your brain while taking Zontivity your doctor should stop your treatment with Zontivity. Follow your doctor's instructions about stopping Zontivity.

Take Zontivity exactly as prescribed by your doctor. Do not stop taking Zontivity without first talking to the doctor who prescribed it for you.

Before you take Zontivity, tell your doctor if you:

• have had bleeding problems or history of stomach ulcers
• have had a stroke or "mini-stroke" (also known as transient ischemic attack or TIA)
• have had bleeding (hemorrhage) in your brain
• have had any recent serious injury or surgery
• plan to have surgery or a dental procedure
• have kidney problems or severe liver problems
• are pregnant or plan to become pregnant. It is not known if Zontivity will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Zontivity passes into your breast milk. You and your doctor should decide if you will take Zontivity or breastfeed. You should not do both.

Tell all of your doctors and dentists that you are taking Zontivity with aspirin, with clopidogrel (Plavix®), or with aspirin and clopidogrel. They should talk to the doctor who prescribed Zontivity for you before you have any surgery or dental procedure.

The possible side effects of Zontivity include:

• Anemia (low level of red blood cells)
• Depression
• Rash

These are not all the possible side effects of Zontivity.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary or herbal supplements. Taking Zontivity with certain other medicines may increase your risk of bleeding and may affect how Zontivity works.

The risk information provided here is not comprehensive. To learn more, talk about Zontivity with your pharmacist or other health care providers. The product information can be found at www.zontivity.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

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, New Jersey 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 the national U.S. commercial launch of Zontivity, which will commence this week, including that the product will be promoted in the U.S. by 75 Aralez sales representatives covering approximately 25% of the oral antiplatelet market, targeting 12,000 physicians, including cardiologists, primary care physicians and vascular surgeons; the benefits of Zontivity, including as the only approved PAR-1 inhibitor, lowering the risk of thrombotic cardiovascular events in patients with PAD or prior MI, and as a differentiated product that represents a significant opportunity for Aralez as a cornerstone of its cardiovascular franchise; the inflection in new prescriptions resulting in a doubling of growth with target physicians in only five weeks post launch as a result of the initial phased launch of Zontivity; encouraging early indicators for the bold and significant change to the pricing strategy for Yosprala aimed at allowing all patients to access the product for only $10.00 per month; Zontivity and Yosprala, together with Fibricor, fully leveraging the Company's sales force and positioning Aralez nicely for growth; that Aralez is positioning Zontivity for patients with PAD and/or patients with a history of MI without a history of stroke or TIA, and intends to provide more focused targeting on persistent vascular risk within these specific populations, defined as patients with PAD, patients with diabetes and/or patients who are smokers, that this focused positioning, which elicited a positive response from physicians in market research and during the initial phased launch, helps identify cardiovascular and cerebrovascular outcome improvements possible in patients treated with Zontivity in addition to the standard of care; that the Company has advanced its goal of ensuring patient access to Zontivity with an out-of-pocket cost competitive with other branded anti-platelet agents, that the Company has improved Zontivity's managed care position by having prior authorizations reduced to less than 15% of commercial covered lives, which is expected to drop to 7-8% in the near future, that currently approximately 85% of commercial formulary lives will have Zontivity covered with further coverage improvements anticipated as the Company's managed care team continues to engage key accounts on a regular basis; that Aralez believes that Zontivity advances antiplatelet therapy by filling a potential treatment gap, and makes a meaningful difference for these patients who are at increased vascular risk; the risks of Zontivity; 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, 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 maintain 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 marketed authorized generic (AG); our dependence on maintaining and renewing contracts with customers, distributors and other counterparties (certain of which may be under negotiation from time to time), including our inability to renew existing contracts on favorable terms, and the risks that we may not be able to maintain our existing terms with certain customers, distributors and other counterparties; 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, Zontivity and Toprol-XL and its AG; failure to realize the expected benefits of our initiatives to reduce costs and improve profitability; 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 laws and regulations, including tax laws and unanticipated tax liabilities and regulations regarding the pricing of pharmaceutical products; risks related to our financing and liquidity; 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, 2016 and our 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 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
[email protected]

ⁱ Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and Stroke Statistics—2016 update; Bonaca et al., Ticagrelor for prevention of ischemic events after myocardial infarction in patients with peripheral artery disease, 2016; Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis, 2013; US Department of Health and Human Services, Facts about Peripheral Artery Disease, 2006; USPSTF: (PAD) and CVD in Adults: Risk Assessment with ABI, 2013.

ⁱⁱ Pande et al., Secondary Prevention and Mortality in Peripheral Artery Disease National Health and Nutrition Examination Study, 1999 to 2004, 2011; Heart Disease and Stroke Statistics—2016 Update

ⁱⁱⁱ Steg G, et al. REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA 2007;297:1197-1206.

^iv Mozaffarian D, et al. Heart Disease and Stroke Statistics – 2016 Update. Circulation 2016.

^v Mozaffarian D, et al. Heart Disease and Stroke Statistics – 2016 Update. Circulation 2016.

^vi Alberts MJ, Bhatt DL, Mas JL, et al; Reduction of Atherothrombosis for Continued Health Registry Investigators. Three-year follow-up and event rates in the international Reduction of Atherothrombosis for Continued Health Registry. Eur Heart J. 2009;30(19):2318-2326.

SOURCE Aralez Pharmaceuticals Inc.

Related Links

http://www.aralez.com