BRILINTA (ticagrelor) Launches “Complete the Course” — a Creative Education Program for Patients With ACS, Including “Access My BRILINTA” Support Service Focused on Continuity of Care

National Survey Shows Patients with Acute Coronary Syndrome Value Robust, Multi-Channel Communication about their Medication

WILMINGTON, Del.--()--AstraZeneca (NYSE: AZN) today introduced Complete the Course, a creative education program to support patients taking BRILINTA® (ticagrelor). Patients who enroll in the Complete the Course program receive support services across multiple channels to help them stay on their full course of BRILINTA therapy. One important support resource now available is Access My BRILINTA, which provides time-saving prescription access and affordability information to patients and healthcare providers.

Complete the Course was created specifically to address patient preference for how they receive information about their medication as they transition from hospital to home. A recent nationwide patient survey showed that patients with ACS value robust, multi-channel communication to learn more about the medication prescribed. The survey was sponsored by AstraZeneca and conducted by Ipsos Public Affairs.

“Cardiologists have a tremendous responsibility to not only provide the best possible care for their patients, but also to ensure that their patients receive complete information about their diagnosis and the importance of adherence to treatment,” stated James Ferguson, MD, Executive Director, Medical Affairs and Strategic Development, and Vice President for Global Medical Affairs. “With the combination of the BRILINTA Complete the Course program along with Access My BRILINTA, we are now able to provide a variety of resources to patients with ACS and healthcare providers to help ensure continuity and optimal delivery of care throughout the course of treatment.”

A nationwide patient survey was conducted in 201 patients with ACS. The patients with ACS were adults aged 60 years and older who have suffered a heart attack or have been diagnosed with ACS (including heart attack and chest pain), and have been prescribed some form of medication for treatment of their heart attack.

Key findings from the survey to support more multi-channel methods of communication indicate that:*

  • Fifty-nine percent of respondents have never researched the medication they were prescribed for the treatment of their heart attack on the Internet. While 41 percent of respondents have used the Internet to research their medication.
  • Fifty-one percent of respondents indicated they are likely to answer phone-call reminders about prescription refills from the prescription drug manufacturer, while only 34 percent reported they are likely to read emails about their prescription and heart attack treatment from the prescription drug manufacturer.
  • Sixty-nine percent of respondents reported they are likely to read the inserts that come with their prescription from the pharmacy.

*Based on a survey conducted both online and via telephone among a nationwide cross-section of 201 U.S. adults aged 60 years and older conducted from February 29 – March 9, 2012. The survey respondents were 57.2% male. The percent of responders across age groups was: 51% 60–69 years, 32% 70–79 years, and 17% 80+ years. The overall margin of error was ± 6.9% points at a 95% confidence interval.

“With over one million people diagnosed with ACS each year, there is an ever increasing need for additional tools and resources that can help patients and their caregivers learn about and understand ACS. These materials may help patients maintain their medication regimen,” said Dr. Ferguson.

In addition to the right types of communication, the timing is equally important. Certain moments in time after a cardiovascular event help define a patient’s continuum of informational needs. These include hospital discharge, when patients are first Learning about BRILINTA, a couple months later when Reinforcement is necessary and further down the road when Re-education may be important. While any patient can choose to receive any offering any time, Complete the Course will call their attention to those that will be most applicable based on their course of therapy.

Patients enrolled in Complete the Course will receive information about heart attacks, preventing a second heart attack, tips on preparing for doctor’s visits, and reminders about doctor appointments, daily dosing and refills. The material also outlines the benefits and side effects of therapy with BRILINTA and why it is important to continue taking medication, as prescribed. The program includes a patient pull-out tool that illustrates how BRILINTA helps stop platelets from sticking together and forming a clot in an artery.

Access My BRILINTA provides time-saving prescription access and affordability support. It will be available online and by telephone. The program will help ensure patients have access to their therapy with BRILINTA as prescribed, including benefit verification, copay and coverage information, and information on prior authorization. This service will be available for patients, caregivers, physicians, nurses, discharge planners, pharmacists and other health care providers. Access My BRILINTA is available by calling 1-888-512-7454 (888-51-BRILINTA) or visit BRILINTA.com.

BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS: unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis.

BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA

WARNING: BLEEDING RISK

  • BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding
  • Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
  • Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA
  • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

  • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75 mg - 100 mg per day

CONTRAINDICATIONS

BRILINTA is contraindicated in patients with a history of intracranial hemorrhage and active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with severe hepatic impairment because of a probable increase in exposure; it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins

WARNINGS AND PRECAUTIONS

  • Moderate Hepatic Impairment: Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor
  • Premature discontinuation increases the risk of MI, stent thrombosis, and death
  • Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea resulting from BRILINTA is self-limiting. Rule out other causes
  • BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers. Avoid simvastatin and lovastatin doses >40 mg
  • Monitor digoxin levels with initiation of, or any change in, BRILINTA therapy

ADVERSE REACTIONS

  • The most commonly observed adverse reactions associated with the use of BRILINTA vs clopidogrel were Total Major Bleeding (11.6% vs 11.2%) and dyspnea (14% vs 8%)
  • In clinical studies, BRILINTA has been shown to increase the occurrence of Holter-detected bradyarrhythmias. PLATO excluded patients at increased risk of bradycardic events. Consider the risks and benefits of treatment

Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

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 patients that require BRILINTA beyond their hospital stay, a savings card program is available based on eligibility. Commercially insured and cash-paying patients may be eligible for one free 30-day prescription and can save up to $825 per year on their next 11 refills. For each refill (a 30-day supply of up to 60 tablets), savings may apply after the first $18 spent by a patient, up to a $75 savings limit. Patients covered through Medicare, Medicaid or a resident of Massachusetts may be eligible for one month free prescription. Patients can find out more at www.BRILINTAtouchpoints.com or by calling 1-888-412-7454.

AstraZeneca also offers a U.S. patient assistance program for BRILINTA through its AZ&MeTM Prescription Savings Program. To determine eligibility, patients can visit www.AZandMe.com or call 1-800-AZandMe (292-6363).

– ENDS –

NOTES TO EDITOR

About BRILINTA® (ticagrelor) tablets

BRILINTA is an oral antiplatelet treatment for ACS. BRILINTA is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with ACS.

BRILINTA is available in 90-mg tablets to be administered with a single 180-mg oral loading dose (two 90-mg tablets) followed by a twice daily, 90-mg maintenance dose. Following an initial loading dose of aspirin, BRILINTA should be used with a maintenance dose of 75 mg - 100 mg aspirin once daily, 81-mg aspirin dose in the US.

BRILINTA is a registered trademark of the AstraZeneca group of companies.

About Acute Coronary Syndrome (ACS)

ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions range from unstable angina (UA), non–ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI).

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the U.S. or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

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Contacts

AstraZeneca
Media Inquiries US
Stephanie Jacobson, +1 302-885-5924 mob: +1 302-379-0443
Julia Walker, +1 302-885-5172 mob: +1 610-350-8240
or
Investor Inquiries US
Ed Seage, +1 302-886-4065 mob: +1 302-373-1361
Jorgen Winroth, +1 212-579-0506 mob: +1 917-612-4043

Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide. Additional information can be found at www.brilintatouchpoints.com. (Photo: AstraZeneca)

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Contacts

AstraZeneca
Media Inquiries US
Stephanie Jacobson, +1 302-885-5924 mob: +1 302-379-0443
Julia Walker, +1 302-885-5172 mob: +1 610-350-8240
or
Investor Inquiries US
Ed Seage, +1 302-886-4065 mob: +1 302-373-1361
Jorgen Winroth, +1 212-579-0506 mob: +1 917-612-4043