Botanix

Advancing new treatments for skin disease and infections

Dermatology company leveraging the unique properties of synthetic cannabinoids with its Permetrex™ technology

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

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

A leader in topical drug development

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

Botanix’s lead program is a recently acquired 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 being readied for US regulatory approval and subsequent launch in key global healthcare markets.

Botanix’s broader clinical pipeline leverages the unique anti-inflammatory and antimicrobial properties of synthetic cannabidiol (CBD) and utilises its proprietary drug delivery system, Permetrex™️. The 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).

Check out our latest news

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New Drug Application (NDA) Ready Product

In May 2022, Botanix acquired the rights for a novel dermatology product called Sofpironium Bromide – a drug being developed to treat primary axillary hyperhidrosis, a medical condition where excessive sweating occurs beyond what is needed to maintain normal body temperature.

Sofpironium Bromide is now the most advanced product in our pipeline, with near term potential 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%).

Sofpironium Bromide is a new chemical entity for which Botanix is preparing to submit a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA) 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.

The NDA filing for Sofpironium Bromide Gel (15%) is planned for 2H 2022. We expect a 12-month review cycle and the first commercial launch in the US after FDA approval. Supported by our team of world-leading dermatology and commercialisation experts, Botanix is well-positioned to penetrate large and underserved global markets for this product.

Invest in innovation

Botanix Pharmaceuticals offers a compelling opportunity for investors who are interested in capitalising on the significant market for dermatology products. Our novel Permetrex™ delivery technology combined with drugs (including cannabidiol or CBD) that exhibit novel mechanisms of action, create promising new product opportunities in dermatology. Our clinical trials to date have highlighted the unique mechanism of action which drives synthetic cannabidiol to produce anti-inflammatory and antimicrobial effects. We are leveraging this evidence to inform the development of new pharmaceutical products, targeting some of the most underserved and lucrative segments of the global healthcare market. Already, we have one of the most advanced clinical pipelines for synthetic cannabinoids in the world.

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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