Botanix Pharmaceuticals (ASX: BOT) has responded to the recent announcement by President Trump regarding a proposed executive order focused on reducing pharmaceutical prices in the United States. The order aims to implement a ‘most favored nation’s policy,’ potentially pegging U.S. drug prices to the lowest prices paid globally. Botanix’s primary concern revolves around its FDA-approved product, Sofdra (sofpironium) topical gel, 12.45%, used for treating primary axillary hyperhidrosis.
Botanix clarifies that Sofdra is exclusively approved and marketed in the U.S. This distinction is crucial because the proposed executive order targets scenarios where the U.S. pays more for a drug than other nations. A similar product, Ecclock gel 5%, containing sofpironium bromide, is marketed in Japan by Botanix’s partner, Kaken Pharmaceutical Company. However, Ecclock has a different concentration and formulation than Sofdra, underwent separate clinical trials, and is not approved for sale in the U.S.
Given these factors, Botanix believes that the proposed executive order is unlikely to trigger price reductions for Sofdra based on sales outside the U.S., as there are no such sales. The company emphasizes it will thoroughly review the executive order once it is officially released to assess any potential impact further.
