Positive EU Opinion for AZN Drug - Analyst Blog

AstraZeneca (AZN) recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Brilique (ticagrelor). The company is seeking approval in the EU for the use of Brilique in the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (ACS).

The positive recommendation was based on data submitted by the company on Brilique including data from the PLATO study. A final decision from the European marketing approval authority should be out within a few months.

US Decision Expected in December

The candidate is currently under regulatory review in twelve regions, including the US, where AstraZeneca intends to market it under the trade name Brilinta. With the US Food and Drug Administration (FDA) recently extending its review period for Brilinta by three months, a decision on its approvability in the US should be out by December 16, 2010.

In addition to receiving a positive opinion from the CHMP, we note that the FDA's Cardiovascular and Renal Drugs Advisory Committee also recommended the approval of the candidate earlier this year in July.

Brilinta/Brilique's approval for ACS will be a major boost for AstraZeneca, given the fact that the company's major products Toprol XL, Casodex, Plumicort, Nexium, Atacand and Arimidex are either already facing generic competition or will face generic risk in the 2010 to 2013 time frame. Once launched, Brilinta/Brilique will compete with Sanofi-Aventis' (SNY) Plavix.

Our Recommendation

We currently have a Zacks #2 Rank (short-term Buy rating) on AstraZeneca, given the June 29, 2010, favorable court ruling on Crestor's US patent, which was upheld and validated until 2016 and proved to be a major win for the company, as well as the FDA Advisory Committee's positive recommendation for the approval of Brilinta.