Back in May, the pharmaceutical company 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. However, as I mentioned at the time, concerns about side effect remained.
On Sunday, AstraZeneca published the full results of the study in the New England Journal of Medicine and quieted all concerns. The drug was more effective, yet didn't increase the risk of bleeding; in fact, it prevented 16 percent more heart attacks, strokes and deaths than standard therapy with Plavix, while -- unexpectedly -- reducing the overall risk of early death from any cause by 22 percent.
Since Plavix is the world's second-best selling medicine with almost $10 billion in annual revenue, it seems like a good time for AstraZeneca to perform a little dance of joy. Indeed, shares of AZN were up 1.5 percent by midday trading, while shares of SNY were down about as much, and shares of BMY dropped 0.6 percent.
Given that other treatments, such as Eli Lilly (LLY) and Efient (or Effient in the U.S.), can cause more severe bleeding episodes than Brilinta, it seems like the drug could find itself in a much better competitive position than anticipated.
The PLATO study included 18,624 patients in 43 countries and showed that 9.8 percent of patients taking Brilinta for a year after being treated for a heart attack or worsening chest pain suffered another heart attack or stroke, or died from vascular disease, compared with 11.7 percent of those given Plavix. Overall, 4.5 percent of Brilinta patients died from any cause, significantly fewer than the 5.9 percent of Plavix patients who died. The rates of major bleeding were similar between the two groups
Interestingly, those in North America may have done worse on Brilinta, a finding that researchers couldn't explain. This might affect future sales in the U.S., even if it passes the regulatory hurdle that it might cause. AstraZeneca hopes to file for approval of Brilinta in the fourth quarter in Europe and the U.S.
AstraZeneca, like most pharmaceuticals, is facing a patent cliff by 2014, at which time it willl face increased competition from lower-priced generics on products that generate 62 percent of sales. It counts on Brilinta to help offset the lost revenue. Currently, however, the general consensus pegs sales of Brilinta at $1 billion a year. That may not be enough.
While this study was definitely one of the most anticipated at Saturday's European Society of Cardiology meeting in Barcelona, was not the only one. Boehringer Ingelheim GmbH also released results on its Pradaxa drug, saying it may be a safe, effective and easier-to-use alternative to the generic blood thinner warfarin (Coumadin), that has been given to patients with erratic heart rates for over 50 years now.
According to the results of a trial known as RE-LY, Pradaxa prevented more strokes and damaging clots than warfarin without increasing the risk of major bleeding when given at a high dose. A lower dose of the experimental drug was as effective as warfarin with less bleeding, causing some to call it a "game changer" and a "real breakthrough." Still, questions remained about Boehringer's study design and a minor heart attack signal with the drug.
While hurdles remain to both, it seems these new blood thinners could be alternatives to current long-time heavyweights.