Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Corporate Update (September 2023)
10 slides from Botanix Pharmaceuticals's corporate update, Sep 26, 2023
Slide 1: Update regarding NDA filing for Sofpironium Bromide
Update regarding NDA filing for Sofpironium Bromide 26 September 2023 www.botanixpharma.com
Slide 2: Presenters
Presenters VINCE IPPOLITO HOWIE MCKIBBON Mr Clissold has broad-based experience advising pharmaceutical, Executive Chairman Chief Executive Officer biotechnology, medical device, food, and dietary supplement clients on regulatory and legislative matters at HPM. HPM is the largest • COO of Anacor and
Slide 3: Announcement today
Announcement today Botanix receives Letter from FDA identifying one area for clarification relating to patient use instructions ❖ The only area listed in the Letter was related to the how the patient is instructed to use the product, including the printed Instructions for Use document ❖ No clinical
Slide 4: 'Complete Response Letter' and 'End of Review' meeting
‘Complete Response Letter’ and ‘End of Review’ meeting ❖ A Complete Response Letter communicates to a sponsor that the FDA cannot approve the application in its present form and describes any areas that must be addressed before the application can be approved1 ❖ The sponsor is not provided with a pr
Slide 5: Issues that could be raised in a Complete Response Letter
Issues that could be raised in a Complete Response Letter No safety, efficacy, pharmacology, non-clinical or manufacturing issues were raised in the letter for Sofpironium Bromide Safety and Clinical Efficacy Issues Pharmacology and Non-clinical Issues Decreasing risk or challenge to overcome issues
Slide 6: Instructions for Use – why are they needed?
Instructions for Use – why are they needed? ❖ Sofpironium Bromide gel, 15% is a ”combination product” in that it combines a drug (Sofpironium Bromide), with a dispenser pump and applicator, that is used to apply the drug ❖ Instructions For Use generally contain step-by-step written and visual instru
Slide 7: What does FDA want now?
What does FDA want now? Applicator 1. Label gel applicator with “applicator” 2. Reformat the Instructions For Use so that it does not fold and “revise” the Instructions to further simplify the guidance for application 3. Place the statement “wash hands with soap and water immediately after use” on t
Slide 8: How long will this take - planned timeline
How long will this take - planned timeline Rapid engagement with FDA, followed by short human factors validation study and resubmission - with a 6-month review clock Originally planned Revised planned launch launch Resubmission indicative timeline (CY) 4Q 2018 2023 1Q 1Q2019 2024 2Q 2024 End of Revi
Slide 9: Impact on the commercial opportunity for Sofpironium Bromide?
Impact on the commercial opportunity for Sofpironium Bromide? Minimal delay in commercialisation and no impact on market opportunity ❖ Given commercialization was planned to commence in 1Q CY2024, the delay caused by the resubmission is likely to be only 3-6 months ❖ No clinical efficacy, safety, ph
Slide 10: Important Notice & Disclaimer
Important Notice & Disclaimer 1. Summary information This presentation has been prepared by Botanix Pharmaceuticals Ltd (“Botanix”) and contains summary information about Botanix and the business conducted by it which is current as at the date of this presentation (“Presentation”) (unless otherwise
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