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 Xarelto, from Bayer AG and Johnson & Johnson, and Eliquis, sold by
Bristol-Myers Squibb and Pfizer, were approved as safer and more
convenient alternatives for preventing blood clots and strokes than
warfarin.
But there was one hitch: there was no way to quickly restore normal
clotting for patients in need of emergency surgery or to stop a
major bleeding episode, leading many doctors to hold off on
prescribing the drugs.
"It may be uncommon, but they're memorable when they happen," Dr.
Charles Pollack, an emergency physician at Thomas Jefferson
University Hospital in Philadelphia, said of major bleeding events.
"We didn't have a specific reversal strategy for these drugs, and I
think that left people feeling a bit insecure," added Pollack, who
has done clinical work on a recently approved antidote to Boehringer
Ingelheim's rival blood clot preventer Pradaxa.
That is about to change.
Small drugmaker Portola Pharmaceuticals this month applied for U.S.
approval of a drug called andexanet alfa that rapidly reverses the
effect of Xarelto and Eliquis. It is expected to enter the market in
2016.
"It will make a big difference," said Dr. Mariell Jessup, a
cardiologist at the University of Pennsylvania Medical Center. "I
have many physicians, particularly surgeons, who hate these drugs.
They're frightened of them because they've had to deal with the
consequences of somebody coming in with trauma," while using the new
blood thinners.
The new drugs cause fewer major bleeding episodes than warfarin and
do not require dietary restrictions or constant monitoring as with
the decades-old medicine. But major bleeding remains the most
worrisome risk of all anti-coagulant therapy as it can be fatal or
cause debilitating, long-term problems.
Bristol-Myers reported $466 million in global third-quarter sales of
Eliquis, which won U.S. approval at the end of 2012, about 18 months
after Xarelto. J&J posted U.S. Xarelto sales of $461 million in the
quarter, while Bayer reported about $509 million in international
sales.
There is still a lot of room to grow as warfarin, also prescribed
under the brand name Coumadin, commands some 60 percent of the blood
thinner market. Morningstar expects annual sales for Xarelto and
Eliquis could reach $8 billion for each.
PAYERS SEE VALUE
The treatments are about 70 times more expensive than pennies-a-day
warfarin, according to Express Scripts Holding Co, the largest U.S.
pharmacy benefits manager. But given the superior safety and
convenience, Express Scripts said in a statement that "the overall
value is likely justified."
Health insurer Aetna Inc expects approval of the Portola drug to
gradually increase use of Xarelto and Eliquis, said Edmund Pezalla,
Aetna's national medical director for pharmaceutical policy and
strategy.
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Xarelto and Eliquis are approved to treat patients with a type of
irregular heartbeat called atrial fibrillation that significantly
increases stroke risk, as well as to prevent blood clots following
hip or knee replacement, and to treat deep vein thrombosis and
pulmonary embolism.
Paul Burton, vice president of medical affairs for Johnson &
Johnson's Janssen unit, stressed Xarelto's safety but said
availability of Portola's drug would enhance doctor comfort levels.
The Xarelto partnership is seeking additional approved uses, with
trials underway in patients with acute coronary syndrome, and for
reduction of major adverse cardiovascular events in patients with
heart failure or peripheral artery disease.
Bristol and Pfizer have a direct-to-consumer television ad campaign
to increase Eliquis awareness.
"We believe that a reversal agent could be an important
consideration for physicians when initiating Eliquis and switching
appropriate patients from warfarin to Eliquis," Bristol and Pfizer
said in a joint statement.
Portola’s reversal drug "will certainly help sales. Anybody who was
waiting on the sidelines will not be fence-sitting anymore," said
Les Funtleyder, healthcare portfolio manager for E Squared Capital
Management, which holds Pfizer shares.
The drug would become Portola’s first product on the market.
Cowen and Co forecast $355 million in sales by 2020 for the
antidote. Portola is also developing a drug to rival Xarelto and
Eliquis.
Duke University's Dr. Jerrold Levy predicted that all hospitals will
stock the Portola antidote.
"It increases the safety margin," Levy said.
(Reporting by Bill Berkrot; Editing by Michele Gershberg and Will
Dunham)
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