Merck & Co. never got its clot-fighting drug Zontivity off the ground. Early estimates of up to $5 billion in sales proved far too optimistic, and last month, the company decided to stop promoting Zontivity in the U.S. altogether.
But there’s hope for Zontivity yet. A specialty drugmaker based in Canada, Aralez Pharmaceuticals, has snapped up U.S. and Canadian rights to the product, for $25 million up front, plus graduated royalties and sales-related milestones.
Aralez sees Zontivity, which is approved to reduce blood clots in patients with a history of heart attack or peripheral artery disease, as an “excellent strategic fit” with its drug candidate, Yosprala, which combines aspirin with stomach remedy omeprazole.
That’s because Zontivity (vorapaxar) is designed to be used alongside aspirin or another clot-fighter. If approved, Yosprala would be available in two strengths, allowing doctors to choose between regular-dose aspirin, or a lower dose, which some prefer. An FDA decision on the med is due on Wednesday.
Aralez CEO Adrian Adams said the company plans to promote the two meds, along with a sister drug, cholesterol remedy Fibricor, to “high-prescribing cardiologists.” Zontivity has plenty of patent life left, Adams noted in a statement; its patents and FDA-provided data exclusivity could give it solo access to the market until 2027.
Aralez itself is the product of a merger between Tribute Pharmaceuticals and Pozen, and now aims to be a cardiovascular-oriented specialty pharma, with some pain drugs along for support. When that merger closed last year, the company nabbed $150 million in financing from a group of healthcare investors, half of that in equity and the other in debt. Those investors also committed another $200 million to help fund acquisitions--such as this one.
“In the run-up to the launch of Yosprala, the company will focus its efforts on increasing sales of Fibricor in the U.S.,” Zacks Investment Management said in February, soon after the merger closed. Tribute had bought the drug from Sun, and Aralez planned to start promoting it in the second quarter.
Aralez could have some difficult work ahead. Zontivity failed to catch on, despite backing from a Big Pharma marketing machine. The active ingredient in Fibricor has a troubled history: It’s a formulation of fenofibric acid, once commonly prescribed alongside cholesterol-fighting statin meds, until clinical trials called its usefulness into question. The FDA revoked that combination approval last year.
Fenofibric acid is still marketed as a solo treatment for high triglycerides and out-of-balance cholesterol levels, but its former blockbuster glory is long gone. Though Abbott Labs made big money off its own fenofibric acid med, Trilipix, by the time the FDA made its move last year, sales had dropped to $179 million. And the drug’s market didn’t just shrink; generics are available, too, and they now have 80% of the market.
Plus, as a combination of two generic meds presumably more expensive than its constituent parts, Yosprala could find it tough to win over payers, which generally prefer that patients take the cheap route. Aralez knows all about that problem, too. Pozen developed Vimovo, a combination of naproxen and stomach drug esomeprazole, and its marketing partner Horizon Pharmaceuticals has had a tough time with formulary negotiations.
And that’s if Yosprala is approved. Pozen failed to get Yosprala through the FDA--twice--because of problems with its supplier. The company found a new one, of course.
Then again, specialty pharmas have succeeded at less likely pursuits. Aralez may believe that Zontivity was lost in the shuffle and underpromoted at Merck, given the company’s large portfolio of other products.
As for Yosprala, millions of heart attack patients take clot-busting drugs alongside aspirin; many of those also take a stomach acid-reducing drug in the same class as omeprazole. Aralez says it is already in talks with payers and has a strategy for pricing the drug in a way that will get it covered. And Zacks analysts expect Yosprala to ratchet up revenue to $100 million by 2018 and peak at $250 million in 2022. They are far less optimistic about Fibricor, however; from that drug, they expect a little more than $3 million.
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