Botanix

World-class dermatology innovators - patient focused, market ready

Rapidly preparing for the approval and commercialisation of Sofpironium Bromide – new chemical entity for the treatment of primary axillary hyperhidrosis

Mature pipeline of dermatology and antimicrobial products – including a lead dermatology product, ready for market

World-class team with extensive dermatology drug development and commercialisation expertise

Final stage of FDA review for Sofpironium Bromide

Botanix is focused on the regulatory approval and commercialisation of its lead dermatology product, Sofpironium Bromide – a drug for the treatment of primary axillary hyperhidrosis, a medical condition where excessive sweating occurs.

We are now navigating the final stages of regulatory review for this product – with an FDA approval date expected in 3Q 2023.

Sofpironium Bromide is a new chemical entity for which Botanix has successfully submitted a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA), and is preparing for the FDA’s mid-cycle review in 1Q 2023 which will substantially de-risk the approval for the product

Supported by our team of world-leading dermatology and commercialisation experts, Botanix is ideally positioned to penetrate large and underserved global markets for this product, with scope for significant revenue generation.

The product has promising potential as a best-in-class solution, backed by positive results from a Phase 3 pivotal clinical program, and has already been approved in Japan and launched by Botanix’s partner, Kaken Pharmaceutical Co., Ltd. (Ecclock®️ Sofpironium Bromide 5%). as a self-administered, once-daily, topical gel therapy. 

Sofpironium Bromide is delivered via a metered-dose pump with an applicator that allows patients to avoid direct contact with the hands and other body parts. A point of difference that sets it apart from current products on market – for both patient use and drug efficacy. 

Expert Opinion: Sofpironium Bromide, a compelling opportunity

Watch this short video featuring one of the most highly experienced dermatology specialists in the world, and former head of the American Academy of Dermatology and Founding President of the International Hyperhidrosis Society, Prof. David Pariser MD; together with Triangle Insights Group Partner and respected pharmaceutical market research commentator, Gautam Aggarwal; and Botanix COO, Dr. Howie McKibbon (PharmD).

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

Innovators and commercial leaders in dermatology

Botanix is an ASX-listed dermatology company based in Philadelphia and Phoenix (USA), committed to the development and commercialisation of novel treatments for common skin diseases and infections.

Botanix’s lead program is a novel product for the treatment of primary axillary hyperhidrosis, a medical condition where excessive sweating occurs beyond what is needed to maintain body temperature, which impacts the lives of more than 15 million people in the US alone. This product is backed by successful Phase 3 clinical studies, is already approved in Japan, and is in the final stages of US regulatory approval and subsequent launch in key global healthcare markets.

Botanix’s broader clinical pipeline is targeting unmet needs in dermatology (including acne, rosacea and dermatitis) as well as infections, and are underpinned by well-controlled, randomised clinical trials.

Botanix has attracted a world-class team and significant capital to support the development and commercialisation of its products. We are moving quickly, but never at the expense of our rigorous commitment to ethical research and development, and the highest clinical standards mandated by the US Food and Drug Administration (FDA).

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Derisked, undervalued investment opportunity

Botanix is an ASX-listed company (ASX:BOT), in a prime position for growth and to return value for shareholders. With deep expertise in dermatology and pharmaceutical product commercialisation, together with a company structure that allows us to stay focused and flexible, we are on track to disrupt some of the most underserved and lucrative segments of the global healthcare market. 

We have the right experience and an FDA approval-ready product, in Sofpironium Bromide, to rapidly increase the value of our Company – right now.

New treatments, in demand

Botanix has generated strong scientific support for the anti-inflammatory and antimicrobial mechanisms of action of synthetic cannabinoids with application in the development of novel dermatology and bacteria fighting applications.

There have been no new chemical entities (NCE’s) in topical drugs approved for acne in more than two decades and resistance to available antibiotics remains a significant global issue, with no new classes of antibiotics approved in more than three decades. When bacteria survive exposure to antibiotics that would normally eliminate them, these surviving bacteria grow and spread resistance, leading to the emergence of ‘superbugs’. New treatments in dermatology and anti-microbials are needed now.

Botanix periodically runs clinical studies in Australia, New Zealand and the USA. Please share your details if you would like to learn more.

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