Botanix Pharmaceuticals Limited announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Sofpironium Bromide for patients with severe primary axillary hyperhidrosis. The submission follows the successful results from the Cardigan (Phase 3 clinical trials), which demonstrated highly statistically significant clinical efficacy and excellent safety. Sofpironium Bromide is a topically applied gel which has successfully completed Phase 3 studies with very high statistical significance for the treatment of primary axillary hyperhidrosis (a medical condition which causes excessive underarm sweating).

Positive results from the Phase 3 Cardigan I and II clinical studies demonstrated very high statistical significance on both co-primary and all key secondary endpoints. More than 700 patients were enrolled in the two Phase 3 studies and approximately 300 patients participated in a separate 48-week safety study of Sofpironium Bromide. There were no treatment related serious adverse events in any of the studies and adverse events were transient and mild to moderate in nature.

Based on these studies, the Company believes that Sofpironium Bromide has the potential to be the best-in-class treatment for axillary hyperhidrosis. In the US alone, there are approximately 7.3 million subjects who suffer from severe primary axillary hyperhidrosis, which is the patient population in which the successful Phase 3 studies were conducted. Of those subjects, approximately 3.7 million subjects are actively seeking treatment.

With the FDA filing of the Sofpironium Bromide NDA, Botanix is accelerating its transition to a commercial dermatology company that can be revenue generating following FDA approval, which is expected to be received 12 months after filing. Botanix has begun building its commercial capability and will be preparing for the important mid-cycle review from FDA which occurs 6 months after filing of the NDA. The Company will continue to look for other opportunities to bolster its pipeline with additional late stage or revenue producing dermatology products, that can be acquired for modest cost and which contribute to profitability and value.