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Bucking the trend, Antares gains FDA OK for testosterone injection on second try

A year after its testosterone replacement therapy was spurned at the FDA, Antares Pharma has snatched an OK from an agency that has made its dislike for such treatments well known.

Antares can now begin marketing three different doses of Xyosted, a subcutaneous auto-injector containing testosterone enanthate, though the approval does come with a boxed warning about blood pressure increases and subsequent elevated risk for cardiovascular problems.

Shares $ATRS briefly went up following Monday’s announcement before sliding, and rose again (2.15%) in pre-market trading Tuesday.

Robert Apple

“Published data from the Xyosted phase three studies have shown our product to be easy to use and virtually pain free while providing steady testosterone levels.” said president and CEO Robert Apple in a statement. “We will now begin the process of onboarding sales representatives and expect to make Xyosted available to patients before the end of this year.”

The approval marks an unusual turn for the FDA, which has demonstrated its skeptical attitude toward new testosterone replacement treatments by batting back a few applications from Lipocine and Clarus this year. Concerned about the side effects — especially given their popularity among a graying generation of men — regulators have significantly raised the bar, restricting their use to certain medical conditions as opposed to simply providing a boost for men.

In Antares’ case, their product is indicated for conditions associated with a deficiency or absence of endogenous testosterone.

AbbVie claims the most popular product in testosterone replacement field with AndroGel, accounting for around 60% of the market and booking $577 million in sales in 2017, according to a research note by Raymond James analyst Elliot Wilbur quoted in Reuters.

Apple, who has argued that Antares has a “much better product,” is also planning to launch the drug at a discount — $450 to $500 compared to AndroGel’s $625 list price per month — with the help of 60 sales reps.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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