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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.”
https://botanixpharma.com/wp-content/uploads/BOT-QDIP-Website-TIle-1.png321845Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2022-04-28 00:29:002023-03-13 21:16:03FDA grants new QIDP Designation Status for BTX 1801
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.”
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).”
Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the release of the Company’s announcement that it had appointed executives, Howie McKibbon, Chief Commercial Officer (CCO) and Dr Patricia Walker, Chief Medical Officer (CMO).
Botanix has today welcomed two highly experienced US-based dermatology executives to the team:
Chief Medical Adviser, Dr Patricia Walker
Chief Commercial Officer, Mr Howie McKibbon
Dr Walker is a board-certified dermatologist specialising in medical and aesthetic dermatology. She is an industry expert and has served in various leadership roles, including President and head of R&D for Brickell Biotech; Chief Medical Officer for Kythera Biopharmaceuticals, Inc.; Executive Vice President and Chief Scientific Officer for Allergan Medical Aesthetics; and Vice President and Dermatology Therapeutic Area Head at Allergan.
Howie has more than 20 years of leadership experience in the pharmaceutical industry, including working directly as part of my team as Senior-Vice President, Sales and Marketing at Anacor Pharmaceuticals; Senior Vice-President, Worldwide Commercial Operations at Dermavant Science; and Vice-President, Dermatology and Immunology at Medicis Pharmaceuticals. Howie has launched 15 products including 11 in dermatology, and managed over 30 dermatology products. Importantly too, he played a significant role in two of the world’s largest dermatology acquisitions with combined valuations of $7.8 billion.
These new executives contribute valuable dermatology and commercial leadership credentials to our team, as Botanix prepares to move from clinical development towards focused commercialisation of our product portfolio.
https://botanixpharma.com/wp-content/uploads/Copy-of-BOT-Danny-Sharp-website-image.png321845Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2022-03-31 22:28:172023-03-13 21:16:03Botanix further expands executive team
Botanix (ASX:BOT) is pleased to share a Quick Comment research report from leading stockbroking firm, Euroz Hartleys, following the Company’s announcement that it had received an R&D tax incentive refund of $2.75m.
FDA grants new QIDP Designation Status for BTX 1801
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix 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
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix 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
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix 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.
Euroz Hartleys Report | 1 April 2022
/in Featured, Latest News, News /by Haley ChartresBotanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the release of the Company’s announcement that it had appointed executives, Howie McKibbon, Chief Commercial Officer (CCO) and Dr Patricia Walker, Chief Medical Officer (CMO).
Click here to view the report.
Botanix further expands executive team
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix has today welcomed two highly experienced US-based dermatology executives to the team:
Dr Walker is a board-certified dermatologist specialising in medical and aesthetic dermatology. She is an industry expert and has served in various leadership roles, including President and head of R&D for Brickell Biotech; Chief Medical Officer for Kythera Biopharmaceuticals, Inc.; Executive Vice President and Chief Scientific Officer for Allergan Medical Aesthetics; and Vice President and Dermatology Therapeutic Area Head at Allergan.
Howie has more than 20 years of leadership experience in the pharmaceutical industry, including working directly as part of my team as Senior-Vice President, Sales and Marketing at Anacor Pharmaceuticals; Senior Vice-President, Worldwide Commercial Operations at Dermavant Science; and Vice-President, Dermatology and Immunology at Medicis Pharmaceuticals. Howie has launched 15 products including 11 in dermatology, and managed over 30 dermatology products. Importantly too, he played a significant role in two of the world’s largest dermatology acquisitions with combined valuations of $7.8 billion.
These new executives contribute valuable dermatology and commercial leadership credentials to our team, as Botanix prepares to move from clinical development towards focused commercialisation of our product portfolio.
Click here to read today’s ASX release.
Euroz Hartleys Report | 28 March 2022
/in Featured, Latest News, News /by Haley ChartresBotanix (ASX:BOT) is pleased to share a Quick Comment research report from leading stockbroking firm, Euroz Hartleys, following the Company’s announcement that it had received an R&D tax incentive refund of $2.75m.
Click here to view the report.