Brilinta (ticagrelor) better in reducing heart attacks and strokes than Plavix (clopidogrel), says AstraZeneca

Sun Pharma’s Clopilet and Ranbaxy’s Ceruvin are among the generic versions of Plavix.

AstraZeneca’s sees billion-dollar blockbuster potential in its new drug Brilinta (ticagrelor) as the drug showed an edge over Plavix (clopidogrel) in cutting down heart attacks and stroke in cardiac patients.

Brilinta(ticagrelor) is an investigational oral anti-platelet treatment for acute coronary syndromes (ACS). Brilinta is the first reversibly binding oral adenosine diphosphate (ADP) receptor antagonist and is chemically distinct from thienopyridines like clopidogrel. It selectively inhibits P2Y12, a key target receptor for ADP. ADP receptor blockade inhibits the action of platelets in the blood, reducing recurrent thrombotic events.

Brilinta has shown a statistically significant primary efficacy against the widely prescribed clopidogrel (Plavix) in the prevention of cardiovascular (CV) events including  myocardial infarction (heart attacks), stroke, and cardiovascular death in patients with ACS, AstraZeneca announced quoting figures from head-on study comparing Brilinta and Plavix.

The Phase III trial titled PLATO (A Study of Platelet Inhibition and Patient Outcomes), PLATO tried to compare Brilinta (ticagrelor) and Plavix (clopidogrel) to establish whether Brilinta could achieve meaningful cardiovascular and safety endpoints in ACS patients.

The study involved 18,624 patients with acute coronary syndromes in 43 countries. It also aimed to provide a comprehensive analysis of efficacy, safety and tolerability of Brilinta.

The PLATO study was led by the Executive Committee co-chairs, Professor Lars Wallentin, Sweden (Uppsala Clinical Research Center) and Professor Robert Harrington, USA (Duke Clinical Research Institute).

PLATO showed the overall safety profile for Brilinta was in line with the safety data observed in the phase II studies.

AstraZeneca plan to submit Brilinta to regulatory authorities during the fourth quarter of 2009.

The PLATO data will be submitted to a peer-reviewed medical journal and present at the European Society of Cardiology (ESC) annual meeting in August 2009.

Brilinta is one of three pipeline drugs that investors are watching closely at AstraZeneca. The company has already filed a new diabetes drug, Onglyza, for regulatory approval. AstraZeneca is expected to submit clinical data on cancer drug Zactima later this month.

Acute coronary syndrome (ACS) is serious heart ailment. It is estimated that one in three ACS patients will die, have a recurrent heart attack (also known as myocardial infarction), or be readmitted to hospital within six months of their first cardiovascular event so preventing reoccurrence is vital in ACS patient treatment.

Plavix contains clopidogrel sulphate, a pro-drug whose action may be related to adenosine diphosphate (ADP) receptor on platelet cell membranes. The specific subtype of ADP receptor that clopidogrel irreversibly inhibits is P2Y12 and is important in platelet aggregation and the cross-linking of platelets by fibrin. Plavix is proven to help keep platelets from sticking together and forming clots, which can help protect against a future heart attack or stroke.

Plavix is marketed by Bristol-Myers Squibb and Sanofi-Aventis in nearly 110 countries. Plavix, which recorded sales of US$5.9 billion in 2005, had been the 2nd top selling drug in the world for a few years till 2007. Generic version of Plavix are currently marketed by Sun Pharmaceuticals under the trade name Clopilet, by Ranbaxy Laboratories under the trade name Ceruvin.

Generic clopidogrel is also produced by several pharmaceutical companies in India at significantly lower retail prices, up to 1/30th of the price.

AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines.