If you opened any financial newspaper or site today, you couldn't have missed it: AstraZeneca (AZN) announced that its experimental heart drug Brilinta was more effective than Sanofi-Aventis (SNY) and Bristol-Myers Squibb Co's (BMY) blockbuster Plavix in the prevention of cardiovascular events, such as heart attacks, in patients with acute coronary syndromes.
Both drugs are antiplatelet treatment, meaning they stop the platelets from clumping together and forming life-threatening clots in arteries. The Phase III clinical trial, involving 18,624 patients in 43 countries with acute coronary syndrome, showed that Brilinta worked better than Plavix in protecting high risk patients from heart attacks, strokes, and CV death.
AstraZeneca said it remained on schedule to submit the drug for regulatory approval in the fourth quarter of 2009, stirring high hopes with investors and analysts. Plavix was the second-biggest-selling drug in the world last year, with global revenue of $8.6 billion. Competitors -- and better competitors at that if AZN's claims regarding Brilinta pan out -- have a shot at a big piece of the pie, a potential multibillion-dollar-a-year seller. Some analysts peg that number at $3 billion, considerably adding to AZN's current earnings forecast -- 15 percent.
However, despite the "statistically significant" results of the huge trial, there are concerns, which may not be answered until the study is presented in full in August. One particular concern is regarding side effects, even though the overall safety profile for Brilinta in the study was in line with the safety data observed in the phase II studies, the company said.
Other competitive problems could involve generics and other branded products. Already some generics have hit Europe and are expected in the U.S. in 2011, while Eli Lilly (LLY) and Still, the early tests of Brilinta have given it another advantage over Plavix as its anticlotting effects are more quickly reversed when a patient stops taking the pill -- important for those needing emergency surgery.
AstraZeneca has not been very successful in recent years in bringing new products to market. No doubt, it's hoping Brilinta could break that dry spell, especially in the face of looming patents expiry, and help change investor sentiment toward the company. Other drugs in its pipeline could also help AZN with investors.
Investors seem to have bought the story, and while SNY and BMY stocks declined today, AZN closed up 5.6 percent.
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