Botanix is a medical dermatology company using a novel active and proven drug delivery technology to develop prescription treatments for serious skin diseases. Click on a section below for more information.
Argonaut Snapshot - Successful Acne Patient Study [PDF]
Argonaut At A Glance - First Patients Enrolled in BTX 1204 Dermatitis Study [PDF]
Argonaut Snapshot - Pipeline Starting to Flow [PDF]
Argonaut At A Glance - Approval to Commence Phase 1B Dermatitis Patient Study [PDF]
Argonaut At A Glance - FDA Clears Development Path for Lead Acne Product [PDF]
Argonaut At A Glance - Commencing BTX 1503 Acne Patient Study [PDF]
Argonaut Snapshot - Clearing Regulatory Hurdles [PDF]
Banyan Tree In-depth Research Note [PDF]
The Passionate Investor (refer to page 21) [PDF]
Under The Radar [PDF]
Argonaut - Initiation Coverage [PDF]
May 8, 2017
Video interview with Botanix Pharmaceuticals Executive Director Matt Callahan on the commencement of the first clinical study for BTX 1503 and upcoming milestones
March 14, 2017
Investor Update video with Botanix Pharmaceuticals Executive Director Matt Callahan
March 14, 2017
Video Interview with Botanix Pharmaceuticals COO Dr Michael Thurn on his experience in the medical dermatology sector
Non-Deal Roadshow Investor Presentation [PDF]
Botanix presents at Investor Seminar [PDF]
Capital Raising Presentation [PDF]
Botanix Corporate Presentation [PDF]
World first: Melbourne researchers work on gel to treat eczema
World-first cannabis cream to treat acne and other skin conditions
Botanix Commences BTX 1503 Acne Patient Study
Cannabis Hits the Spots
Biotech Dispatch: Oversubscribed Placement for Botanix
Botanix raise $7.4m to develop products
Biotech Botanix raises $7.4m in placement
Botanix raise $7.4m to develop skin products
Volatile Pot Stocks Arouse Strong Interest
The Potential of Transdermal Drug Delivery
BiotechDispatch: Botanix announces positive trial data
The Australian: Botanix happy with synthetic cannabidiol
The West Australian: Positive results for Botanix safety test
Business News Western Australia: Biggest Movers – Botanix attracts chairman’s investment
Botanix Pharmaceuticals attracts investment from its own chairman
Proactive Investors Australia: Botanix Pharmaceuticals Ltd to benefit from U.S. decision on cannabis
Business News Western Australia: Botanix makes ASX debut
Biotech Daily: Botanix $3.5m Takes Bone to Cannabinoid Dermatology [PDF]
Bone Medical Prospectus Offer Closes Oversubscribed; Relisting as Botanix Pharmaceuticals [PDF]
Media Release - Lodgement of Botanix Pharmaceuticals Inc Prospectus [PDF]
Pharmacy Daily: Perth firms buys Botanix [PDF]
Business News: Bone Medical in Dermatology move
Bone Medical Announces Acquisition of US-based Botanix Pharmaceuticals [PDF]
Q: Botanix Pharmaceuticals is studying cannabidiol for skin disease – is it a “medicinal cannabis company” or a “pharmaceutical company”?
A: Botanix is a pharmaceutical company. We are utilizing a synthetic form of cannabidiol which is not extracted from the cannabis plant and is a pure, pharmaceutical grade chemical that forms the basis of our drug product for clinical studies. In the same way as the active ingredient in the popular drug aspirin was originally sourced from the bark of the Willow tree, we wouldn’t think of using a natural extract of bark today, when we can synthetically manufacture the drug as a pure and commercial scale chemical. In the same way, we don’t refer to Bayer (the manufacturer of aspirin) as a “Willow tree company”.
Q: Is the difference between naturally extracted cannabidiol and synthetic cannabidiol that important?
A: Unlike cannabidiol sourced from natural extracts commonly used by ‘medicinal cannabis’ companies, synthetic cannabidiol which is manufactured to U.S. Food and Drug Administration (FDA) standards is 100% pure and similar to other drug substance that forms the basis of an approved drug product. Synthetic cannabidiol does not vary in strength or composition due to growing conditions, the genetics of the source plant, or the extraction and purification process that must be used to separate natural cannabidiol from the hundreds of other chemicals found in the cannabis plant.
As a result, synthetic cannabidiol provides an attractive alternative to existing cannabidiol therapies as it permits higher quality, more consistent manufacturing, greater scalability and more straightforward regulatory approval prospects over naturally extracted cannabidiol.
The company believes that using its proprietary source of synthetic cannabidiol substantially increases the likelihood that Botanix products can satisfy the stringent FDA requirements for purity and consistency, and avoid the risks associated with natural extract based products.
For more information on the additional hurdles that companies developing cannabidiol products from natural sources face, the FDA’s Guidance for Industry on Botanical Drug Products provides more details here.
Q: Why does Botanix Pharmaceuticals call itself a “medical dermatology” company not a “cosmetics” or “skin company”?
A: Botanix’s products will be topical treatments for serious skin diseases like acne, psoriasis and atopic dermatitis that will only be available with a prescription from a dermatologist or other medical specialists. We are following a prescription drug development process mandated by the FDA, which means that placebo controlled studies are required to demonstrate exactly what synthetic cannabidiol does and does not do – we are not relying on a general assertion that the multiple chemicals found in the cannabis plant have some “holistic” effect.
Cosmetic or skin companies which develop over-the-counter (OTC) products do not need to follow the FDA or equivalent regulatory processes, but in doing so, they are highly restricted in what they can do with their products in the market as a result. For instance, they cannot make any claims that their products treat a disease, they cannot be prescribed by dermatologists and specialists, they will not be reimbursed by insurance companies and they will face a competitive price point which is much lower than prescription products.
Botanix is focused on the multi-billion opportunity within the acne market where there have been no new medicines approved by the FDA to treat acne for more than 10 years. That’s why we are going to the regulatory process of developing BTX1503 and our pipeline products to be able to address these markets and unmet patient needs.