If cardiologists can’t make up their minds about which new anti-clotting drug is superior, imagine the difficulty facing investors.
The race to replace warfarin and aspirin as the standard treatments to prevent blood clots in patients with atrial fibrillation and blood clots following surgery has pitted some of the biggest names in the pharmaceutical industry against each other. The prize? A huge stake in a market that could eventually top $12 billion annually.
Vying for the top spot are Bristol-Myers Squibb (NSYE:BMY) and Pfizer (NYSE:PFE) and their entry Eliquis; Pradaxa, from Boehringer Ingelheim; and Xarelto, or rivaroxaban, a drug developed by Bayer (PINK:BAYRY) and Johnson & Johnson (NYSE:JNJ) that got FDA approval in early July. A fourth medicine called edoxaban from Daiichi Sankyo is on the horizon.
Pradaxa enjoys first-to-market advantage, but that edge may be mitigated by safety questions about the drug. The company recently agreed with European regulators to call for kidney-function testing in high-risk patients to make sure Pradaxa’s active ingredient is cleared from the blood stream at the correct rate to help avoid potentially dangerous bleeding.
While it has yet to be submitted for FDA approval, Eliquis got a big boost after a study presented in August found that the pill reduced deaths and bleeding rates more than warfarin. Last week, the drug won the recommendation of the U.K.’s health-cost agency, just six months after it was approved there to prevent clots after surgery.
But many cardiologists at the recent American Heart Association meeting remain undecided about whether any one drug is better for their patients, citing safety and cost concerns.
“I’m more confused than informed,” Dr Sanjay Kaul, a prominent heart doctor at Cedars-Sinai in Los Angeles, told Reuters after hearing presentations on the medicines at the meeting in Orlando
“The anti-thrombotic landscape has become more fuzzy for me, and it will continue to be fuzzy for the next few years until we make some sense out of the data,” he added.
Xarelto, meanwhile, made some impressive news at the recent American Heart Association meeting. Study data showed the drug succeeded where rivals failed in reducing deaths following a heart attack, cutting fatalities by more than 30% in patients with acute coronary syndrome.
Xarelto’s rivals failed in this patient group, giving Bayer and J&J a potentially distinct market, although stroke prevention in atrial fibrillation is seen as the most lucrative use for the new drugs.
Still, the market for ACS is estimated at more than $1 billion, and Bayer and J&J plan to seek FDA approval for this indication by the end of the year. If the OK is granted, Xarelto would enter a market that includes Brilinta from London-based AstraZeneca (NYSE:AZN), and Effient from Eli Lilly (NYSE:LLY). These drugs are used instead of the standard treatment, Plavix, a drug made by Bristol-Myers and Paris-based Sanofi (NYSE:SNY). Xarelto would likely be used in concert with Plavix.
“Xarelto appears to have hit the `sweet spot’ for efficacy with an acceptable safety profile,” wrote Seamus Fernandez, an analyst at Leerink Swann, in a research note, cited by Bloomberg. He predicted the low dose will be approved by the FDA for ACS and “can be a meaningful competitor in an increasingly crowded space that has been relatively slow to develop commercially.”
At the time of publication, Barry Cohen was long PFE, JNJ, AZN and BMY.
