Aralez finally scores FDA approval for Yosprala, but the combo med could be a hard sell

FDA sign

Just weeks after Aralez’s purchase of Merck's abandoned CV drug Zontivity, the Canada-based pharma won FDA approval for its new drug Yosprala, a fixed-dose combination of aspirin and the generic stomach remedy omeprazole.

As a branded combination of two cheap generics, Yosprala will have a tough job gaining traction, particularly with increasingly skeptical payers. But Aralez believes that combining the two meds in one pill will help patients stick to their meds. The company says Yosprala can cut noncompliance--which can be risky for heart patients--by 24% to 26% compared with separate pills.

Aspirin has long been used in patients to prevent second heart attacks and strokes, but it increases the risk of stomach problems, including gastric ulcers. Gastrointestinal symptoms are often cited as the reason patients discontinue the daily therapy. The omeprazole component--a proton pump inhibitor--is added to help reduce that risk.

Aralez expects to win mid-single-digit market share among patients prescribed aspirin after a heart attack or stroke. That's a population Aralez estimates at 26 million, CEO Adrian Adams said. Around 6 million patients take both aspirin and a proton pump inhibitor every year, the company figures.

“We remain confident that Yosprala, a product that is specifically designed to reduce aspirin intolerance and therefore potentially improved compliance to therapy, has the promise to resonate well with healthcare practitioners, payers and in particular patients,” Adams said during a media conference about the approval.

The company has decided on a wholesale acquisition cost, or WAC, of $150 per 30-count bottle. That adds up to about $1,800 per year--about four-tenths of the WAC for Novartis' heart failure drug Entresto, which costs about $4,600 a year. The company is aiming for a daily copay of about $1 for most patients. If Aralez can keep that promise, the number is competitive to the aggregate cost of the two individual over-the-counter components. Now, a 40-mg dose of omeprazole costs slightly less than $1, the company said.

Aralez expects to launch Yosprala in the first week of October in two doses: 81 mg or 325 mg of delayed-release, enteric aspirin combined with 40 mg of immediate-release omeprazole.

Earlier this month, Aralez purchased Zontivity--a clot-fighting drug designed to be used alongside aspirin--from Merck & Co. for more than $25 million. As Aralez--a product of a merger between Tribute Pharmaceuticals and Pozen--strives to become a major player in cardiovascular-related specialty drug manufacture, it sees Yosprala as “an excellent strategic fit” with Zontivity and intends to relaunch the latter in 2017.

Now that Yosprala has been approved in the U.S., Aralez is planning to submit for its approval in Europe in the fourth quarter of this year and in Canada in the first half of next year.

Related Articles:
With $25M-plus Aralez deal, Merck finds a buyer for abandoned clot-fighter Zontivity
Merck cuts 148 jobs after giving up on ex-blockbuster hopeful Zontivity
Is Pozen prepping to sell? Sudden CEO exit, new Irish subsidiary hint yes
Pozen has a new CEO to deal with the FDA's API concerns
Pozen gets another FDA cold shoulder for its cardio drugs