AstraZeneca Pharma India Limited

HEALTH/PHARMA

AstraZeneca launches its patented life-saving heart drug BRILINTA^® (Ticagrelor) in India

BRILINTA works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce patient’s risk of another cardiovascular event (called atherothrombotic events) such as a heart attack or cardiovascular death. AstraZeneca Pharma India Limited (AZPIL) announced the launch of a new patented antiplatelet drug BRILINTA (Ticagrelor) in India. BRILINTA is an oral antiplatelet treatment for Acute Coronary Syndromes (ACS) in adult patients. BRILINTA is competitively priced to enable ACS patients benefit from having access to this medicine. BRILINTA® works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce patient’s risk of another cardiovascular event (called atherothrombotic events) such as a heart attack or cardiovascular death. The Drug Controller General of India (DCGI), based on the New Drug Advisory Committee’s (NDAC) recommendations granted its approval in May 2012 for marketing BRILINTA® (Ticagrelor) tablets in India. The DCGI approval is based upon the submission of data from the landmark PLATO (Platelet Inhibition and Patient Outcomes) trial, comparing treatment with BRILINTA® to Clopidogrel - the current standard of care, available in the market for over a decade. Dr. Paurus Irani, Vice President Medical & Regulatory Affairs of AstraZeneca Pharma India Limited said, “With over 40 lakh people affected by ACS in India each year, BRILINTA® gives cardiologists a new and effective treatment to help reduce the rate of heart attack and cardiovascular deaths in these patients. Such exciting medical breakthroughs don’t happen very often.” To date, BRILINTA has been approved in 83 countries and launched in 63 countries (including India now) under the trade name BRILINTA® and in the European Union under the trade name BRILIQUE™. About BRILINTA® (Ticagrelor) BRILINTA® is an oral antiplatelet treatment for acute coronary syndromes (ACS) in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce a patient’s risk of another cardiovascular event (called atherothrombotic events) such as a heart attack or cardiovascular death. BRILINTA will be 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 aspirin. BRILINTA® is a registered trademark of AstraZeneca in India and other countries. Like all medicines, BRILINTA may cause side effects, although not every patient will experience them. The most common side effects reported with BRILINTA were bleeding and shortness of breath. Bleeding occurs commonly with any potent platelet inhibitor. With BRILINTA, severe bleeding is uncommon, while less severe bleeds such as bruising and nosebleeds are common. Shortness of breath often resolved during BRILINTA treatment and led uncommonly to patients stopping BRILINTA in the PLATO study. Other uncommonly reported side effects include headache, dizziness, abdominal pain, diarrhea, rash, itching, and upset stomach. About Acute Coronary Syndromes (ACS) ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions range from unstable angina (unremitting chest pain that threatens a heart attack) to heart attack. About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical company with a primary focus on the discovery, development and commercialisation 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 please visit: www.astrazeneca.com. AstraZeneca in India has R&D, Manufacturing and Marketing entities in India. AstraZeneca Pharma India Limited (AZPIL) is involved in Manufacturing and Marketing, and AstraZeneca India Private Limited (AZIPL) is engaged in the R&D, PR&D and Branded Generics. AstraZeneca in India employs more than 1900 employees of which approximately 1450 are part of the commercial organization, 250 involved in manufacturing, 200 are in R&D including more than 90 scientists of international repute focused on TB research with the goal of discovering new and novel therapeutic agents. The rest are employed in the clinical trials and global external sourcing.