Antares, Lipocine expand testosterone therapy offerings with FDA nod for a new, oral med for hypogonadism

In 2018 with Xyosted, Antares brought to the market a user-friendly testosterone replacement therapy for hypogonadism, with the drug administered at home by weekly injection.

Less than four years later, Antares and development partner Lipocine have gained approval for an oral TRT treatment. On Tuesday, the FDA signed off on Tlando, a twice-daily alternative to Xyosted.

The big pluses for Tlando are that it doesn’t require titration—the constant monitoring of testosterone levels and the adjustment of dosage—and injection by a needle.

In anticipation of the approval, New Jersey-based Antares has expanded its sales force to 108 reps. The launch will begin in the second quarter of this year, CEO Robert Apple said in a release.

“We expect to leverage our relationships with urologists and endocrinologists to drive adoption of Tlando,” Apple said. “This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both Tlando and Xyosted and support our future growth with an expanded commercial portfolio.”

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Antares reported sales of $62.2 million last year for Xyosted, an increase of 34% from 2020.

In a note to investors, Cantor Fitzgerald called the nod a “significant milestone achievement for Lipocine,” and believes the company is optimally positioned with its commercial partner in the U.S. The analysts project peak sales at $175 million in 2030, with $52 million in royalties and milestones to Lipocine.

“Antares’ experience in the TRT space can enable a strong, successful U.S. launch,” wrote analyst Jennifer Kim. “With Tlando’s commercialization in the hands of Antares, we think Lipocine can continue to focus on R&D, its core competency. We think Lipocine has multiple shots on goal across its metabolic and endocrine disorders pipeline over the next 12–18 months.”

RELATED: AbbVie faces first of thousands of men suing over AndroGel testosterone drug

Lipocine, a 25-year-old company based in Salt Lake City, has three promising liver cirrhosis drugs in the pipeline, said Cantor Fitzgerald.

Antares warns that TRT therapies have been prone to abuse by those using them at higher than the recommended dosage. AbbVie has spent several years litigating cases brought by users of its TRT drug AndroGel.