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12 July 2022
Updated Investor Presentation
Key highlights
- Release of updated corporate presentation to be used in a number of non-deal investor meetings scheduled this week
- The presentation includes:
- an update on the accelerated FDA submission timetable of the New Drug Approval (NDA) for Sofpironium Bromide which is now planned for this quarter;
- further insights into the market opportunity for Sofpironium Bromide; and
- updated timetable for completion of rosacea (BTX 1702) Phase 1/2 clinical study and the canine dermatitis pilot study (BTX 1204A), which are now both fully enrolled and on target for completion in Q3 CY2022
Philadelphia PA and Phoenix USA, 12 July 2022: Clinical dermatology company, Botanix
Pharmaceuticals Limited (ASX: BOT, "Botanix" or "the Company"), is pleased to release an updated corporate presentation being used for a number of investor meetings scheduled this week.
The presentation includes an update on the FDA filing timetable for Sofpironium Bromide which has been accelerated and is now planned for this quarter, further insights into the market opportunity for Sofpironium Bromide, as well as an update on the Company's BTX 1702 Phase 1b/2 rosacea study and the BTX 1204A Phase 1b canine dermatitis study, which are on target for completion in Q3 CY2022.
Release authorised by
Vince Ippolito
President and Executive Chairman
About Botanix Pharmaceuticals
Botanix Pharmaceuticals Limited (ASX:BOT) is a dermatology company based in Philadelphia and Phoenix (USA) which is committed to the development of novel treatments for a range of common skin diseases. The Company has a mature dermatology pipeline with its first product, Sofpironium Bromide, for the treatment of primary axillary hyperhidrosis, planned to be filed for FDA in Q3 CY2022. The Company also has a pipeline of other products in late-stage clinical studies for the treatment of moderate to severe rosacea, dermatitis and acne respectively. Botanix is also developing a topical antimicrobial product for the eradication of bacteria on the skin surface, initially in patients who are undergoing hemodialysis.
For personal use only
Botanix leverages its proprietary drug delivery system (PermetrexTM) for direct skin delivery of active pharmaceuticals in all skin diseases, which is utilised in its existing development programs and is being explored with a view to being utilized in a number of other product opportunities. To learn more please visit: http://www.botanixpharma.com/
For more information, please contact:
General enquiries | Investor enquiries | Media enquiries |
Corporate Communications | Hannah Howlett | Haley Chartres |
Botanix Pharmaceuticals | WE Communications | H^CK |
P: +61 8 6555 2945 | P: +61 450 648 064 | P: +61 423 139 163 |
investors@botanixpharma.com | hhowlett@we-worldwide.com | haley@hck.digital |
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, the expected timing and/or results of regulatory approvals and prospects of commercialising product candidates or research collaborations with its partners, including in Japan, the outcome and effects of Sofpironium Bromide and the market for Sofpironium Bromide and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company's or its partners' ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company's or its partners' ability to obtain marketing approvals for is product candidates. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
For personal use only
Investor Update
July 2022
Preparing to file first dermatology product for FDA approval in Q3 2022
1
onlyuse
personalBotanix:a leaderin topical drug development
For
Preparing to file for FDAapproval offirst productin $1.6 billion market
Pharmaceutical focus
New treatments for common skin diseases - such as excessive sweating (hyperhidrosis), rosacea and acne - as well as life- threatening bacterial infections
Topically driven
Targeting key indications with topical treatments that are safe, well tolerated and validated with clinical efficacy
World class team
US based team that have been responsible for more than 30 dermatology drug developments and launches
Sofpironium Bromide
First and only new drug for "primary axillary hyperhidrosis" (medical condition which results in excessive underarm sweating) already approved in Japan with partner1
Near-term catalysts
Upcoming filing for FDA approval for Sofpironium Bromide and data readouts from other pipeline products in 3Q CY2022
Source 1 : ASX release May 4 2022 | 2 |
For personal use only
World class board and | Developed, secured approval |
for and commercialised over 30 | |
management team | dermatology products |
VINCE IPPOLITO | HOWIE MCKIBBON | DR PATRICIA WALKER | MATT CALLAHAN | DR BILL BOSCH |
President and Executive Chairman | Chief Commercial Officer | Chief Medical Adviser | Board Executive Director | Board Executive Director |
• COO of Anacor and Medicis; former President | • Former SVP Commercial of Dermavant, Anacor | • Former President and head R&D | • Serial founder and ex-investment director | • 30+ years experience in pharma industry |
Dermavant; more than 17 years at Novartis. | and Medicis | Brickell Biotech | of two venture capital firms in life sciences | • Co-inventor of SoluMatrix™ drug delivery |
• More than 35 years experience in pharma with | • 20+ years working in dermatology - launched | • Former CMO/CSO at Kythera, Inamed and | • Developed four products through FDA | technology and NanoCrystal® Technology |
20+ years within dermatology | more than 15 brands and managed over 35 | Allergan Medical responsible for multiple | approval and launch | |
dermatology products | products including Botox and Tazorac |
ANTHONY ROBINSON | DR JACK HOBLITZELL |
VP of Development | SVP Pharmaceutical Development |
• Recently Vice President R&D at Advicenne | • 30+ years leading world-class technical |
• Senior leadership roles at Aquestive Therapeutics, | operations |
Intrommune and Shire Pharmaceuticals | • Senior leadership roles at Assertio Therapeutics, |
Pfizer, King, Ivax and Teva |
DR IRA LAWRENCE | DR CLARENCE YOUNG | LYNDA BYRNE |
Clinical and Regulatory Adviser | Chief Medical Adviser, Antimicrobials | Commercial Adviser, Antimicrobials |
• 30+ years of senior level leadership experience | • Recently Chief Medical Officer at | • Managing Partner BAL Pharma Consulting |
within the global pharmaceutical and medical | Velicept Therapeutics | • Senior leadership roles at Motif Biosciences, |
device industries | • Senior leadership roles at Iroko Pharmaceuticals, | Nabriva Therapeutics, Shire Abbot and BMS |
• Former SVP R&D Medicis, Astellas and Fujisawa | Novartis, Protez and GlaxoSmithKline | 3 |
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Botanix Pharmaceuticals Ltd. published this content on 11 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 July 2022 23:33:02 UTC.