Investor Webinar Replay | 26 September 2023

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Botanix (ASX: BOT) has received a communication from FDA in relation to its NDA submission for Sofpironium Bromide gel, 15% (SB) for the treatment of primary axillary hyperhidrosis.

Encouragingly, no clinical efficacy, safety or manufacturing issues were raised and no additional clinical studies are required by the FDA to support approval. We will be revising the printed Instructions for Use document proposed for inclusion with the product and our team is now focused on working with the FDA to address the points raised, with plans to resubmit the NDA for SB by 1Q CY24 and targeting approval for mid-CY24.

Earlier today Botanix hosted an investor webinar outlining details of the Response Letter from the FDA – and next steps for approval. The team was joined by Mr Dave Clissold, Director of Hyman, Phelps & McNamara – the largest dedicated FDA law firm in the United States advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory matters.

Video | Investor Webinar

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Botanix (ASX: BOT) hosted a webinar recently to update investors on the Company’s progress during the FDA review period for its lead product, Sofpironium Bromide.

The webinar was hosted by Executive Director, Matt Callahan and Chief Operating Officer, Howie McKibbon.

Take a look.

Investor Webinar | March 2023

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Botanix (ASX: BOT) hosted a webinar to update shareholders on the Company’s preparations for the FDA mid-cycle review of Sofpironium Bromide in Q1 2023.

The webinar was hosted by Gautam Aggarwal, a Partner with Triangle Insights Group, who has conducted insightful market research in relation to the Sofpironium Bromide.

Other presenters included Botanix Executive Director, Matt Callahan and Botanix Chief Operating Officer, Dr Howie McKibbon.

BOT Video | Not To Be Missed

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Botanix has united three experts to explain why its lead product, Sofpironium Bromide, is on track to define the success of Botanix this quarter.

Hear from one of the world’s most highly experienced dermatology specialists, former head of the American Academy of Dermatology and Founding President of the International Hyperhidrosis Society, Prof. David Pariser; together with Triangle Insights Group Partner and respected markets commentator, Gautam Aggarwal; and Botanix Chief Operating Officer, Dr. Howie McKibbon.

Together, they explain the scope of the market opportunity that Botanix is chasing for Sofpironium Bromide and how this product could positively impact peoples’ lives.

Video Interview | Howie McKibbon

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Botanix’s Chief Commercial Officer, Howie McKibbon, was interviewed on Ausbiz this week to discuss the positive results from our BTX 1702 Phase 1b/2 clinical trial for rosacea. 

Investor Webinar | May 2022

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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

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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

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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.

Conversation Series | Dr Clarence Young

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Meet Dr Clarence Young, Botanix’s Chief Medical Officer.

Dr Young has spent the past three decades dedicating his professional life to fighting infectious diseases and antimicrobial resistance (AMR), at the highest ranks of corporate advisory in big pharma, industry groups, and for the White House Working Group on Antimicrobial Resistance too.

In this short video, he explains why he is so motivated to reduce the risk of infection for haemodialysis patients, which is central to his role here at Botanix.

Tim Boreham Boardroom Interview

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Botanix Executive Director, Matt Callahan, visited Melbourne last week and took the time to participate in a boardroom interview with veteran business and biotech journalist, @Tim Boreham.

As part of this conversation, Matt Callahan explains the strategic importance of following the US Food and Drug Administration’s (FDA) clinical development blueprint, as we develop our dermatology and antimicrobial products, and reiterates the value of recruiting a highly experienced team at the helm. 

He also explains the meticulous methodology underpinning Botanix’s clinical trial process and how we are moving our late-stage products even closer to large underserved patient cohorts in the world’s largest healthcare markets.

Take a look: