Botanix News Hub
Welcome to our home for news – the latest headlines, all in one place. Click through to view a selection of our media coverage, industry news, videos and more.
Botanix (ASX:BOT) is pleased to advise that leading adviser @Euroz Hartleys has released an analysis outlining the strong market opportunities for our most recent asset acquisition, Sofpironium Bromide.
Within the report, analyst Seth Lizee commented:
“Sofpironium Bromide’s target patient population is estimated to be ~3.7 million people in the United States, equal to the estimated number of patients with severe axillary hyperhidrosis seeking treatment…Even modest market penetration can translate into significant revenues.”
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.”
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.”
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).”