Investigations related to products or pipeline candidates by
regulatory authorities are a major overhang for companies and
create uncertainty until the issue is resolved. Earlier this week,
) received some encouraging news when the U.S. Department of
Justice confirmed that it is closing its investigation on the PLATO
trial, on the basis of which blood-thinner Brilinta was approved.
The government does not plan to take any further action.
We remind investors that on Oct 21, 2013, AstraZeneca had received
a civil investigative demand from the Department of Justice looking
for documents and information related to the PLATO study.
AstraZeneca's Brilinta is available for reducing cardiovascular
death and heart attack in patients suffering from acute coronary
syndrome (ACS) since it was approved in the U.S. in 2011. The FDA
had cleared the drug on the basis of the PLATO study which compared
Brilinta to Sanofi's (
) Plavix in 18,624 patients suffering from ACS.
AstraZeneca is looking to broaden Brilinta's label. Several studies
on Brilinta are ongoing including SOCRATES (acute ischemic stroke
or transient ischemic attack), THEMIS (type II diabetes and
coronary atherosclerosis), EUCLID (peripheral artery disease) and
PEGASUS (secondary prevention in patients with previous myocardial
infarction - headline results expected in the first quarter of
2015). The company has completed enrollment for EUCLID and PEGASUS.
We note that all four studies are part of the PARTHENON program on
We are pleased with the favorable conclusion of the PLATO study
investigation. Brilinta is one of the key new products at the
company. In the first half of 2014, the product generated revenues
of approximately $216 million, up 84% year over year. The company
is working on driving Brilinta sales.
AstraZeneca presently carries a Zacks Rank #2 (Buy). Some
better-ranked stocks in the health care sector include Endo
) and Allergan (
). Both are Zacks Rank #1 (Strong Buy) stocks.
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