--Eliquis seen generating multibillion-dollar annual sales
--Drug approved in December by FDA to reduce risk of stroke in people with irregular heartbeat
--Eliquis to enter competitive market against other new anticlotting drugs
(Adds comment from Boehringer Ingelheim spokeswoman in 13th paragraph.)
By Peter Loftus
Bristol-Myers Squibb Co. (>> Bristol Myers Squibb Co.) and Pfizer Inc. (>> Pfizer Inc.) plan to launch the anticlotting drug Eliquis in the U.S. next week, kicking off a marketing campaign that could eventually generate billions of dollars in sales.
The U.S. Food and Drug Administration approved Eliquis in late December to be used to reduce the risk of stroke and certain blood clots in people with an irregular heartbeat known as atrial fibrillation. Some analysts think the drug's annual sales could eventually top $4 billion.
Eliquis is one of a new crop of blood thinners known as anticoagulants that aim to replace--in some medical situations--an older drug, warfarin, which has been the standard of care for decades but which can be cumbersome to administer. Eliquis will compete with Xarelto, co-marketed by Johnson & Johnson (>> Johnson & Johnson) and Bayer AG (BAYN.XE, BAYRY), as well as Pradaxa from Boehringer Ingelheim GmbH, both of which are already on the market.
Bristol-Myers and Pfizer plan to launch Eliquis in the U.S. next week, and the companies are making similar plans in other countries, Bristol-Myers Chief Executive Lamberto Andreotti said on a conference call with analysts Thursday morning.
"Our teams have been working together, planning for this day, preparing for our launch," he said. The companies initially hoped to begin selling Eliquis in the U.S. last year, but the FDA extended its review after asking for more information about the drug.
Bristol-Myers spokeswoman Laura Hortas said the drug has already been shipped and is expected to be available in pharmacies soon, with full promotional activities beginning in early February. The drug has a wholesale acquisition cost of $8.35 per day.
The companies are working with health insurers and payers to secure reimbursement and patient access to the drug, said Giovanni Caforio, president of Bristol-Myers' U.S. pharmaceuticals unit. The companies also are planning a program to assist with out-of-pocket costs for the drug, he said.
Pfizer and Bristol-Myers believe Eliquis will have an edge over competing drugs because it demonstrated superiority versus warfarin in clinical trials in reducing risk of three key outcomes: stroke and systemic embolism, major bleeding and all-cause mortality.
"This unique and differentiated profile of Eliquis will resonate and will position us well against warfarin and against all other anticoagulants," Mr. Andreotti said.
Analysts have said the relatively strong clinical data for Eliquis could eventually make it the preferred choice among doctors. But a challenge for Pfizer and Bristol-Myers is to overcome "third-to-market status and general market inertia with warfarin," Leerink Swann analyst Seamus Fernandez said in a recent note. This could make for slow sales early on, picking up over time, he said.
The prescribing label for Eliquis also carries a prominent warning that discontinuing the drug could increase risk of clots and strokes, as does Xarelto's label.
William Foster, spokesman for J&J's Janssen unit, said Xarelto has the broadest profile of any of the new oral anticoagulants on the U.S. market, with six distinct uses approved by FDA. He said more than one million Xarelto prescriptions were written last year.
Boehringer Ingelheim spokeswoman Mary Lewis said Pradaxa reduced the risk of ischemic stroke and hemorrhagic stroke versus warfarin in atrial-fibrillation patients in clinical testing. "We are confident that Pradaxa will continue to be a dominant player" in the market for oral anticoagulants, she said.
Bristol-Myers discovered Eliquis and formed a partnership with Pfizer in 2007 to co-develop and co-commercialize the drug. The companies share commercialization expenses and profits equally on a global basis. The drug's U.S. patent is due to expire in 2023, according to a Bristol-Myers regulatory filing.
Write to Peter Loftus at firstname.lastname@example.org
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