FDA confirmation Sofpironium Bromide NDA is formally under review

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Botanix has today announced that it has received formal written communication from the FDA, confirming that the New Drug Application (NDA) for Sofpironium Bromide is suitable for substantive review, and that no issues have been identified.

With the NDA now formally under review, and a standard review period confirmed, Sofpironium Bromide remains on track for approval in 3Q, 2023.

Botanix President and Executive Chair, Vince Ippolito, said:

“We are very pleased that the NDA for Sofprionium Bromide has been accepted for substantive review by the FDA. Our team has worked diligently to file a comprehensive application and we look forward to the anticipated mid-cycle review in 1Q 2023 and the ultimate approval of Sofprionium Bromide.”

Click here to view ASX release.

SPP Now Open

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Botanix’s recently announced Share Purchase Plan (SPP) to raise up to A$3 million is now open for eligible AU/NZ shareholders.

The SPP opens today, 9 November 2022 and will remain open until 8:00pm AEDT on Wednesday, 23 November 2022 (unless extended or withdrawn). 

As the SPP is only open for two weeks, eligible shareholders are encouraged to apply for new shares as soon as possible.

Click here to read today’s ASX release.

A$5 million strategic Placement + Share Purchase Plan

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Botanix (ASX:BOT) has today lifted its trading halt, sharing news that it has secured a commitment of A$5.0million from a highly respected institutional investor, Antares Capital. The Company will also offer a limited Share Purchase Plan (SPP) for eligible AU and NZ shareholders to raise up to A$3 million.

Click here to read today’s ASX release.

Significant R&D Tax Incentive Refund

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Botanix has today announced it has received a Research and Development (R&D) Tax Incentive Refund of A$3,669,439 for the 2021/2022 financial year.

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Promotion of Dr Howie McKibbon to Chief Operating Officer

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Botanix has announced the promotion of Dr Howie McKibbon to the role of Chief Operating Officer, from his current position as Chief Commercial Officer.

Howie has more than 20 years of leadership experience in the pharmaceutical industry. He has launched 15 products including 11 in dermatology, and managed over 30 dermatology products. Importantly too, he played a significant role in two of the world’s largest dermatology acquisitions with combined valuations of $7.8 billion. 

Howie’s role will be expanded to include responsibility for all commercial, manufacturing, medical affairs and regulatory activities. We believe the breadth and depth of his experience will be invaluable as the Company prepares for FDA mid-cycle review of our lead asset, Sofpironium Bromide in late Q1 2023.  

Click here to read today’s ASX release.

Positive BTX 1702 Phase 1b/2 Clinical Study for Rosacea

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Botanix has released positive data from its BTX1702 rosacea clinical study. 

The Phase 1b/2 randomised, double-blind vehicle-controlled study examined the effects Botanix’s CBD formulation BTX 1702 in adults with moderate to severe papulopustular rosacea over an 8-week treatment period. The study tested two different concentrations of BTX 1702 topical gel – 10% and 20% – alongside a control arm. 

Pleasingly, both the 10% and 20% doses showed clinically meaningful results, with the 10% concentration showing statistically significant reduction in inflammatory lesions – an FDA-designated endpoint for the study. A review of the photo evidence from the study also demonstrated visibly reduced redness in target patients. 

Both doses were found to be very safe and well tolerated when compared to the control gel. 

Botanix medical advisor, Dr Ira Lawrence commented:

“To achieve this level of inflammatory lesion reduction and improvement in both IGA and CEA within 8 weeks is very exciting, particularly with such an excellent safety profile.”

Rosacea affects more than 430 million people worldwide, and the market for treatments is expected to reach US$2.6 billion by 2025. 

Click here to read today’s ASX release

Botanix submits NDA for FDA approval of Sofpironium Bromide

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Botanix has today announced the submission of a New Drug Application to the FDA for approval of Sofpironium Bromide for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating).

Phase 3 studies of Sofpironium Bromide showed very high statistical significance for the treatment of primary axillary hyperhidrosis. In the US alone, there are approximately 7.3 million people who suffer from this disorder, with more than half of them actively seeking treatment.

Botanix President and Executive Chair, Vince Ippolito, said:

“We are delighted with the achievement of this submission milestone, and are targeting FDA approval in the US for 4Q CY2023 (following the usual 12-month FDA assessment and review period) to enable the commencement of sales in the US market.”

Click here to view ASX release

Capital Raise Update

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Botanix has announced it has now closed the first tranche of its anticipated $7.5 million placement to new and existing institutional and sophisticated investors.

The second tranche of the Placement is an issue of New Shares to Botanix directors, who have  committed to subscribe for a total of $0.5 million of New Shares, which is subject to shareholder approval.  

Click here to view ASX release

$7.5m Capital Raise

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Botanix has today announced it has received strong commitments to raise $7.5m through a placement to Australian and international institutions and sophisticated investors.

Funds will support the development of the Company’s lead asset – Sofpironium Bromide (SB) – a novel dermatology asset with positive Phase 3 data to treat primary axillary hyperhidrosis, a medical condition which results in excessive underarm sweating.

This will include support for the FDA approval process and preparation for commercial launch. The New Drug Approval (NDA) filing with the FDA remains on track for submission this quarter with a 12-month review process.

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NDA filing accelerated and trials fully enrolled

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Botanix has today announced the New Drug Approval (NDA) submission to the FDA for our recently acquired dermatology asset, Sofpironium Bromide for the treatment of excessive underarm sweating, will now be ready to file in Q3 2022.

The Company also provided an update on its pipeline clinical studies. Both the rosacea (BTX1702) Phase 1/2 clinical study and the canine dermatitis (BTX 1204A) pilot study have reached target enrolment numbers, and subjects will be completing their treatments over the coming weeks. Outcomes for these two studies are expected later in the year.

Click here to view ASX release and presentation.