Taking aim at AbbVie's AndroGel, Antares scores FDA nod for testosterone drug Xyosted

FDA
Antares Pharma won FDA approval for its testosterone injection Xyosted after a rejection last year. (FDA)

Antares Pharma finally has its FDA approval for testosterone replacement therapy Xyosted—and now it's revving up to take on AbbVie's market-leading AndroGel at a 20% list-price discount.

With the FDA endorsement (PDF), Antares can start touting its once-weekly drug's ease of use—Xyosted is an at-home self-injection, while AndroGel is a daily rub-on product—but will also have to contend with a black-box warning detailing risks of blood pressure increases that can lead to serious cardiovascular problems. 

On the company’s second-quarter conference call this summer, CEO Bob Apple called the drug Antares’ “most important and exciting asset” in development and argued that Antares is launching with a “much better product” than those currently available. At least one analyst sees the med hitting $450 million in peak sales, a hefty haul for the small biopharma.

Antares plans to hire about 60 sales reps, Apple said, and the drugmaker plans to launch at a monthly list price of $450 to $500, a discount to AndroGel’s $625 list price per month.

By discounting to the leading brand, Apple said Antares is planning a “more effective pricing program" to ensure access for patients and to avoid paying big rebates. Antares plans to launch Xyosted by the end of the year.

In a note after the approval, Jefferies analyst Anthony Petrone wrote that he expects the drug to pull in about $450 million at peak. Ahead of the nod, the analyst’s team surveyed 25 doctors in the field and found that all plan to prescribe the drug. According to Symphony Health data, there are about 600,000 testosterone therapy replacement prescriptions per month, Petrone wrote. Based on the team’s discussions with doctors, he believes Xyosted can grab 20% of the market.

The path to approval hasn't been smooth, however. The FDA turned Xyosted back in a complete response letter last October, and Antares has since been working to address the agency's concerns about its clinical data.

RELATED: AbbVie strikes tentative deal to settle 4,000-plus AndroGel lawsuits

Antares is also launching into a field that’s been active with liability litigation in recent years as plaintiffs have filed thousands of lawsuits against AbbVie and other testosterone drugmakers. The plaintiffs say the companies overmarketed the drugs and downplayed risks, causing cardiovascular complications. The companies have moved to settle the lawsuits, most recently with AbbVie last month. AndroGel brought in $577 million in the U.S. last year.

Antares' share prices were up about 9% on Monday morning before the market opened.

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Editor's note: This story was updated with new information from Jefferies analyst Anthony Petrone.