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Botanix has today announced acquisition of a novel dermatology asset known as Sofpironium Bromide, which has been developed to treat primary axillary hyperhidrosis – a medical condition which results in excessive underarm sweating.
Sofpironium Bromide is the first and only new chemical entity developed for primary axillary hyperhidrosis, and this product is primed for market following successful pivotal studies conducted in late 2021.
This is a defining deal for Botanix, cementing our credentials as a global leader in the development and commercialisation of novel dermatology products. Sofpironium Bromide complements our existing dermatology pipeline and will leverage the core skills of our newly-expanded management team, with an enviable track record of successfully launching products.
Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 March 2022
Key highlights from this period include:
Botanix maintains a strong cash position, with approximately $16.4 million in cash at closing of Q1 2022.
Botanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801.
This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central venous catheters for hemodialysis’, the lead indication for our novel intranasal gel. This represents the first such designation ever granted for a nasal decolonisation agent in this patient group.
In addition to the standard regulatory exclusivity that comes with FDA approval of a New Drug Application (NDA), QIDP offers an additional five years of regulatory exclusivity, as well as eligibility for NDA ‘priority review’ and ‘fast-track designation’ – both of which will be invaluable to Botanix’s antimicrobial development program.
Botanix President and Executive Chairman, Vince Ippolito commented:
“Botanix is very excited to receive QIDP status from the FDA. This designation is supported by our Phase 2 clinical study results and a recent health outcomes study that highlighted the impact of bloodstream infections in hemodialysis patients that use central venous catheters for access.
“These life-threatening infections in this vulnerable population are estimated to cost the health system more than $360 million annually in the US.”