Botanix Pharmaceuticals (ASX: BOT) has acquired novel dermatology asset Sofpironium Bromide gel 15% for the treatment of primary axillary (underarm) hyperhidrosis, a medical condition which results in excessive underarm sweating.
The acquisition has been agreed with US publicly-listed company Brickell Biotech Inc which developed the gel on the back of phase 3 pivotal studies including a 48-week safety study late last year.
Under the terms of the agreement, Botanix’s US subsidiary Botanix SB Inc will purchase all of Brickell’s interests in Sofpironium Bromide and receive services from Brickell to assist in a new drug application (NDA) filing and approval of the asset.
Botanix will make an upfront cash payment of approximately US$3 million (A$4.22 million) to Brickell and will pay another US$2 million (A$2.81 million) if a positive response is received from the US Food and Drug Administration (FDA) after the NDA filing.
If FDA approval is received before 30 September 2023, Botanix will pay Brickell another US$4 million (A$5.63 million), which will reduced to zero if the NDA is approved after 17 February 2024.
Botanix will also make a milestone payment of US$4 million (A$5.63 million) if marketing approval is received from an international regulatory authority in the European Union or United Kingdom; and the same amount again if approval is received for a new indication from US, EU or UK authorities.
A one-time milestone payment will be made once net sales of Sofpironium Bromide exceed US$75 million (A$105 million) for the first time in a year.
In addition, Botanix will reimburse Brickell for limited expenses related to the development of Sofpironium Bromide incurred in recent months.
Commercial dermatology space
Botanix executive chairman Vince Ippolito said the acquisition of Sofpironium Bromide would facilitate Botanix’s strategy of becoming a leading commercial dermatology company.
More than 15 million patients suffer from hyperhidrosis in the US alone [and] existing therapies either lack efficacy, have unfavourable side effects, or involve invasive procedures or surgery.
Sofpironium Bromide will be positioned at the front of the company’s growing pipeline, with the assets also complementing the company’s others under development.
“Having demonstrated statistically significant efficacy and favourable safety in pivotal studies, we are well-advanced in preparing Sofpironium Bromide for FDA approval in the second half of this year and look forward to accelerating Botanix into a commercial dermatology company much sooner than we originally expected,” Mr Ippolito added.
Sofpironium Bromide has been developed as a “best-in-class”, topically-administered therapy for the treatment of primary axillary hyperhidrosis.
As an anticholinergic/antimuscarinic drug delivered to the underarms in a gel formulation, it blocks sweating at the gland by binding to the body’s receptor and stopping the sweat signal.
It uses a patent-pending applicator which allows a patient to avoid direct contact with the drug.
“The data demonstrates that one-daily topical Sofpironium Bromide achieved early, sustained, and significant improvements in primary axillary hyperhidrosis signs and symptoms consistent across all efficacy measures and was generally well-tolerated over six weeks of treatment,” Botanix chief medical adviser Dr Patricia Walker noted.
More than 700 patients were enrolled in two phase 3 studies using Sofpironium Bromide and approximately 300 patients participated in a 48-week safety study.
Approximately 85% of patients from the phase 3 trials were reported to have experienced a “clinically meaningful” improvement in their condition.
Additionally, there were no treatment-related serious adverse events in any of the studies.
World first entity
Sofpironium Bromide is believed to be the world’s first and only new chemical entity to treat axillary hyperhidrosis, where excessive sweating occurs beyond what is needed to maintain normal body temperature.
The condition results from a physiological (not psychological) overstimulation of the nervous system and 80% of patients report its occurrence on more than one part of their body.
Approximately 77% of patients with hyperhidrosis report it has a negative impact on their lives, while the vast majority go undiagnosed or untreated.
Existing treatment options including topical anti-perspirants, systemic oral drugs, Botox injections and surgery have proven a lack of efficacy with poor side effect profiles.
The market for hyperhidrosis treatment currently exceeds US$1.6 billion (A$2.25) billion per annum and is projected to grow to US$2.8 billion (A$3.94 billion) by 2030.