News

Botanix has today announced it has received strong commitments to raise $7.5m through a placement to Australian and international institutions and sophisticated investors.

Funds will support the development of the Company’s lead asset – Sofpironium Bromide (SB) – a novel dermatology asset with positive Phase 3 data to treat primary axillary hyperhidrosis, a medical condition which results in excessive underarm sweating.

This will include support for the FDA approval process and preparation for commercial launch. The New Drug Approval (NDA) filing with the FDA remains on track for submission this quarter with a 12-month review process.

Click here to view ASX release

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.

Click here to view ASX release and presentation.

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.”

Click here to read today’s ASX Release

Botanix Pharmaceuticals (ASX:BOT) is pleased to announce that data for our clinical stage antimicrobial asset, BTX 1801, will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2022) on 23–26 April 2022.

Results from our clinical program will form the basis of two abstract presentations.

The first abstract, titled ‘​​The Antimicrobial profile of BTX-1801: a new synthetic cannabidiol active against Gram-positive bacteria associated with serious infections’ will be presented by Professor Geoffrey Coombs from Murdoch University.

The second abstract, ‘The Bactericidal activity of BTX 1801: a synthetic cannabidiol with potent activity versus Staphylococcus aureus’ will be presented by Angela Kavanagh from the Centre for Superbug Solutions at The University of Queensland.

Botanix President and Executive Chairman, Vince Ippolito, said:

“The data to be presented at the upcoming ECCMID 2022 conference suggests the significant potential of BTX 1801 to prevent S. aureus bloodstream infections associated with considerable morbidity, mortality, and cost in haemodialysis patients who use Central Venous Catheters (CVC).”

Click here to read today’s ASX release.

Botanix has today announced the appointment of a new Australian-based Non-Executive Director to the Board, Danny Sharp.

Danny is a highly respected investment banker with more than 30 years’ experience and strong networks within global capital markets, institutional investment and private wealth too. Healthcare and technology are his speciality areas of expertise.

Most recently, Danny was Corporate Finance Executive Director of Canaccord Genuity, and he has previously spearheaded the Corporate Finance departments at both Shaw and Partners and Lodge Partners. 

Click here to read today’s ASX release.