Botanix Pharmaceuticals is committed to the development and commercialisation of novel treatments for common skin diseases and infections. The company was created to address common skin conditions, they are focusing on synthetic cannabinoids thanks to their antimicrobial and anti-inflammatory benefits and are now working towards commercializing dermatological applications with the help of CBD. More specifically, they are working on treating atopic dermatitits, rosacea and plaque psoriasis.
Clinical trials – Yes.
NEWS & PARTNERSHIPS:
2017
The company announced an expansion of its licensing of Permetrex to now include all drugs for skin diseases and not just cannabinoids, as was the earlier agreement.
The company filed 5 patents covering products made with Permetrex.
2018
The company joined forces with The University of Queensland for the acceleration and development of BTX 1801 and was awarded the Innovation Connections Grant from the Australian Government. The research collaboration will further explore the antimicrobial activity of cannabidiol and Permetrex skin delivery technology.
The company received a 1.6 million AUD R&D tax incentive refund.
The company received a 4.6 million AUD R&D tax incentive refund.
2019
The company announced a CBD supply agreement with Purisys involving synthetic CBD.
The company released a presentation from Tioga Research saying that Botanix’s BTX 1503 delivered over 5 times as much CBD to the epidermis and over 3 times as much CBD to the dermis relative to the closest comparative CBD topical product and significantly better than other CBD topical creams and gels. Results also showed that BTX 1503 delivered more CBD than the compared to products’ continent in their entire packages.
The company received a 7.6 million AUD R&D tax incentive refund.
The company received a 6.87 million AUD R&D tax incentive refund.
The company received a 2.75 million AUD R&D tax incentive refund.
The company received a 3.7 million AUD R&D tax incentive refund.
The company received another Innovation Connections Grant from the Australian government for the acceleration of its medicinal chemistry program focused on the creation of new synthetic analogs of CBD and for further investigation into how CBD works.
The company’s human clinical study showed that their synthetic CBD BTX 1801 antimicrobial formula eradicates Staphylococcus Aureus.
2022
Botanix was granted a new Qualificed Infectious Disease Product designation by the FDA in the US for BTX1801 which is their investigational antibacterial product treating golden staph. This gives the product an additional five years of FDA exclusivity and in turn makes it eligible for fast-track status as well as priority FDA review.
The company acquired all assets primarily relating to sofpironium bromide from Fresh Tracks Therapeutics.
The company acquired all assets primarily relating to 15% Sofpironium Bromide gel, developed for the treatment of primary axillary hyperhidrosis.
2023
The company signed an exclusive agreement with UpScriptHealth for them to provide its digital platform and telehealth services for the launch of the company’s Sofdra gel (sofpironium bromide) 15% in the US.
The company’s partner Kaken Pharmaceutical Co secured a sublicense and distribution agreement where Dong Wha Pharmaceuticals will commercialize Sofpironium Bromide in Korea. The company and Kaken will receive a share of upfront payments, milestones and royalties based on net sales of the product.
2024
The FDA approved Sofdra in its topical gel 12.45% form for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older.
The 2nd largest payer organization in the US started covering Sofdra topical gel 12.45%.