Cassiopea gets U.S. FDA approval for acne treatment Winlevi

ZURICH (Reuters) - Swiss-listed drugmaker Cassiopea said on Thursday it won approval for its first medicine, an acne treatment, from the U.S. Food and Drug Administration, setting the stage for a likely capital increase to support its launch.

Winlevi, a twice-daily topical prescription medicine that targets hormones called androgens, won approval for males and females 12 years and older, Cassiopea said. Winlevi reduced acne in trials. The most frequent local reaction was skin redness, or erythema.

Historically, acne has been treated by drugs called retinoids that help unplug hair follicles, and antibiotics that kill excess skin bacteria.

The drug is expected to be available in the United States in early 2021 and Cassiopea plans to announce the price in the fourth quarter. It did not give sales expectations.

The company was spun off in 2015 by Cosmo Pharmaceuticals into a separate firm listed on the Swiss stock exchange. Cosmo still owns just under half of Cassiopea.

“We are excited to bring our first prescription drug to the market and have built a detailed strategic and tactical launch plan,” said Cassiopea Chief Executive Diana Harbort, adding Cosmo would support Cassiopea’s plan to raise more capital for the launch, but likely eventually monetize its investment.

The drug is also being studied against hair-loss causing alopecia.

Cassiopea shares are up about 10% this year.

Reporting by John Miller and Silke Koltrowitz; editing by Thomas Seythal and Shailesh Kuber