Promotion of Dr Howie McKibbon to Chief Operating Officer

Botanix has announced the promotion of Dr Howie McKibbon to the role of Chief Operating Officer, from his current position as Chief Commercial Officer.

Howie has more than 20 years of leadership experience in the pharmaceutical industry. He 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. 

Howie’s role will be expanded to include responsibility for all commercial, manufacturing, medical affairs and regulatory activities. We believe the breadth and depth of his experience will be invaluable as the Company prepares for FDA mid-cycle review of our lead asset, Sofpironium Bromide in late Q1 2023.  

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Positive BTX 1702 Phase 1b/2 Clinical Study for Rosacea

Botanix has released positive data from its BTX1702 rosacea clinical study. 

The Phase 1b/2 randomised, double-blind vehicle-controlled study examined the effects Botanix’s CBD formulation BTX 1702 in adults with moderate to severe papulopustular rosacea over an 8-week treatment period. The study tested two different concentrations of BTX 1702 topical gel – 10% and 20% – alongside a control arm. 

Pleasingly, both the 10% and 20% doses showed clinically meaningful results, with the 10% concentration showing statistically significant reduction in inflammatory lesions – an FDA-designated endpoint for the study. A review of the photo evidence from the study also demonstrated visibly reduced redness in target patients. 

Both doses were found to be very safe and well tolerated when compared to the control gel. 

Botanix medical advisor, Dr Ira Lawrence commented:

“To achieve this level of inflammatory lesion reduction and improvement in both IGA and CEA within 8 weeks is very exciting, particularly with such an excellent safety profile.”

Rosacea affects more than 430 million people worldwide, and the market for treatments is expected to reach US$2.6 billion by 2025. 

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Botanix submits NDA for FDA approval of Sofpironium Bromide

Botanix has today announced the submission of a New Drug Application to the FDA for approval of Sofpironium Bromide for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating).

Phase 3 studies of Sofpironium Bromide showed very high statistical significance for the treatment of primary axillary hyperhidrosis. In the US alone, there are approximately 7.3 million people who suffer from this disorder, with more than half of them actively seeking treatment.

Botanix President and Executive Chair, Vince Ippolito, said:

“We are delighted with the achievement of this submission milestone, and are targeting FDA approval in the US for 4Q CY2023 (following the usual 12-month FDA assessment and review period) to enable the commencement of sales in the US market.”

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Capital Raise Update

Botanix has announced it has now closed the first tranche of its anticipated $7.5 million placement to new and existing institutional and sophisticated investors.

The second tranche of the Placement is an issue of New Shares to Botanix directors, who have  committed to subscribe for a total of $0.5 million of New Shares, which is subject to shareholder approval.  

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$7.5m Capital Raise

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.

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NDA filing accelerated and trials fully enrolled

Botanix has today announced the New Drug Approval (NDA) submission to the FDA for our recently acquired dermatology asset, Sofpironium Bromide for the treatment of excessive underarm sweating, will now be ready to file in Q3 2022.

The Company also provided an update on its pipeline clinical studies. Both the rosacea (BTX1702) Phase 1/2 clinical study and the canine dermatitis (BTX 1204A) pilot study have reached target enrolment numbers, and subjects will be completing their treatments over the coming weeks. Outcomes for these two studies are expected later in the year.

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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.

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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.”

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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.”

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