Herald Sun + Daily Telegraph | Sofpironium Bromide Story

🗞 MAKING HEADLINES

Herald Sun Reporter, Owen Leonard, met with Botanix executives while they were in Australia this week and has published a story about the Company’s recent acquisition of Sofpironium Bromide.

This novel potential treatment for primary axillary hyperhidrosis, a medical condition that results in excessive underarm sweat, is bringing new hope for sufferers.

Botanix Executive Director, Matthew Callahan, explained why it could fill a market gap:

“At the moment, to treat it, you’ve got a couple of options. You’ve got antiperspirants – covers up the smell but does nothing to actually have an effect on the excessive sweating – and at the other extreme, you’ve got surgery, where they’ll actually go in and cut the nerve to stop the signals getting to the sweat gland to stop you sweating excessively.

“In between, there’s been a lot of drugs that have been around for decades that don’t work very well and have all sorts of nasty side effects.”

Click here to read the story.

Euroz Hartleys Report | ‘Transformational Acquisition’

Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the Company’s recent acquisition of Sofpironium Bromide.

The deal has been called a “transformational acquisition”.

Click here to view the report.

Investor Webinar | May 2022

Botanix Pharmaceuticals (ASX: BOT) hosted an investor update webinar following the announcement of its acquisition of Sofpironium Bromide, the first and only novel treatment for primary axillary hyperhidrosis. Present on the call was President and Executive Chairman, Vince Ippolito; Executive Director, Matt Callahan; Chief Medical Adviser, Dr Patricia Walker; and Chief Commercial Officer, Howie McKibbon. 

Video Interview | Vince Ippolito

Botanix President and Executive Chairman, Vince Ippolito, is a world-leading dermatology executive.

In this video, he explains why today’s announcement of our acquisition of Sofpironium Bromide is such a promising commercial opportunity for Botanix – as the first and only new chemical entity developed for the treatment of primary axillary hyperhidrosis.

Small Caps Interview | Vince Ippolito

Botanix Pharmaceuticals (ASX: BOT) executive chairman Vince Ippolito joins Kerry Stevenson on Small Caps to discuss the company’s acquisition of novel dermatology asset Sofpironium Bromide gel.

New dermatology asset acquisition

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.

Quarterly Activities Report and 4C Quarterly Cash Flow Report

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:

  • Strategic appointments to Botanix’s executive leadership team,including Dr Patty Walker as Chief Medical Officer and Mr Howie McKibbon as Chief Commercial Officer
  • Danny Sharp also joins as Non-Executive Director bringing 30+ years capital markets experience and an extensive network of institutional investors
  • Completion of pre-clinical work to support initiation of Phase 2 BTX 1801 antimicrobial study
  • Advancement of clinical programs, with the completion of recruitment for both the Phase 2 BTX 1702 rosacea study and BTX 1204 canine atopic dermatitis study, both of which are on track for 2Q 2022
  • Significant progress on broadening and maturing the Botanix pipeline with a number of new opportunities in late-stage assessment

Botanix maintains a strong cash position, with approximately $16.4 million in cash at closing of Q1 2022.

Read today’s ASX release here.

FDA grants new QIDP Designation Status for BTX 1801

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

Presentation at Health Economics Conference | ISPOR 2022

Botanix Pharmaceuticals (ASX:BOT) is pleased to share news of an upcoming poster presentation at the Professional Society for Health Economics and Outcomes Research Annual Meeting (ISPOR 2022) on 15-18 May 2022.

ISPOR is renowned for attracting leaders from the global healthcare and outcome research community for discussion and dissemination of the latest trends in healthcare.

The abstract, to be presented by lead author, Professor Tom Lodise of Albany College of Pharmacy and Health Sciences, models the annual costs associated with central venous catheter-related S. aureus bloodstream infections in hemodialysis patients.

Based on a 7.5% annual rate of infections in this vulnerable population, it is projected that attributable costs will exceed US$360 million annually. 

Dr Jamie P. Dwyer, MD, Professor of Medicine, University of Utah Clinical and Translational Sciences Institute, Co-founder of Innovative Renal Care, remarked in relation to the Abstract:

“It is widely known that S. aureus nasal carriers have a markedly higher risk of bacteremia vs non-carriers 1. There is a need for novel agents for intranasal decolonisation of S. aureus to reduce the risk of S. aureus bloodstream infections among this high risk, hemodialysis patient population.”

Click here to read today’s ASX release.

Data Presentations | ECCMID 2022

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.