Biotech Values

[DewDiligence]

Brilinta Bests Plavix in Phase-3 ACS Study

[This PR has no data, but it confirms that the trial met its primary endpoint by showing a statsig reduction in the composite of CV death + non-fatal stroke/MI for Brilinta relative to Plavix. Brilinta, from AZN, is one of the “top 10” drug candidates in late-stage testing cited by the Business Week article in #msg-37566691. AZN is up about 3% in London on this news. The potential damage to SNY and BMY, the companies that market Plavix, is mitigated by the fact that Plavix goes off-patent in the next couple of years. Perhaps a bigger adverse impact will be felt by LLY and Daiichi Sankyo, the companies who will market Effient/Efficent.]

http://www.astrazeneca.com/media/latest-press-releases/brilinta-plato?itemId=5837126

›AstraZeneca Announces Top Line Results From Pivotal Phase III Study for BRILINTA

11-May-2009

AstraZeneca today announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus clopidogrel, in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death.

In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the phase II studies. Given the size of the PLATO trial, further analysis of the entire database, secondary variables, and subgroups is ongoing. AstraZeneca and the PLATO Executive Committee’s aim is to submit the PLATO data to a peer-reviewed medical journal and present at the European Society of Cardiology (ESC) annual meeting in August 2009.

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.

PLATO was a head-to-head outcomes study of BRILINTA versus clopidogrel to establish whether BRILINTA could achieve meaningful cardiovascular and safety endpoints in ACS patients. The study involved 18,624 ACS patients in 43 countries and was designed 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).

The submission of BRILINTA to regulatory authorities remains on schedule for the fourth quarter of 2009.

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.

AstraZeneca has proposed the name BRILINTA. If approved by the FDA and the EMEA, it will serve as the trade name for ticagrelor/AZD6140.

The study design of PLATO was published in the April 2009 edition of the American Heart Journal (James, S. et al. in Am. Heart J. 2009; 157: 599-605).

BRILINTA Phase II studies include DISPERSE and DISPERSE2. DISPERSE was published by Husted, S. et al. in Eur. Heart J. 2006; 27: 1038–1047. DISPERSE2 was published by Cannon, C.P. et al in J. Am Coll. Cardiol. 2007; 50: 1844-1851 and by Storey, R.F. et al in J. Am. Coll. Cardiol. 2007; 50: 1852-1856

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. 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. For more information about AstraZeneca, please visit: www.astrazeneca.com.‹