Botanix Pharmaceuticals FDA Approval Announcement

Botanix Pharmaceuticals Ltd (ASX: $BOT) has received FDA approval for Sofdra™ (sofpironium) gel, 12.45%, marking a significant milestone in the treatment of primary axillary hyperhidrosis. Sofdra is the first new chemical entity approved by the FDA for this condition, offering a safe and effective solution for patients suffering from excessive underarm sweating.

Executive Commentary on Sofdra Approval

Botanix Chief Executive Officer, Dr Howie McKibbon, expressed his pleasure at the FDA approval, acknowledging the dedicated team, dermatologist partners, patients, and shareholders for their contributions. Dr McKibbon highlighted this approval as a transformative event for Botanix, signifying the company's transition to a revenue-generating dermatology company. The approval was also praised by leading expert on hyperhidrosis, Dr David Pariser, who emphasized the significance of Sofdra as a new, convenient, and effective treatment alternative for patients and physicians.

Summary of FDA Approval and Outlook

The FDA's approval of Sofdra gel, supported by pivotal Phase 3 studies, marks a significant advancement in addressing the unmet medical needs of approximately 10 million patients with primary axillary hyperhidrosis in the US. Botanix plans to launch a patient experience program in Q3 CY2024, with the expectation of generating first revenues from Sofdra in early Q4 CY2024. The Company's Executive Chairman, Mr Vince Ippolito, expressed excitement about providing a new option for patients and highlighted Sofdra's potential as a new therapeutic approach for dermatologists. The Company's outlook includes a potential capital raising, with further updates expected by the opening of trading on Friday, 21 June 2024.