FDA conditionally approves Sofdra™ as a trade name for sofpironium bromide

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Botanix (ASX: BOT) announced today that the U.S. Food and Drug Administration (FDA) has conditionally approved a trade name for sofpironium bromide gel, 15%. 

Pending final approval by the FDA, the once-daily topical gel for the treatment of primary axillary hyperhidrosis will be known as Sofdra™. 

Our team developed trade name options which would satisfy the FDA’s stringent requirements. Sofdra is easy to pronounce, achieved positive fit to concept, and generated strong recall scores among physicians and patients. Sofdra is one of few two-syllable names still available for use as a product trade name. Once approved, the new trade name will be used on the product packaging as well as marketing materials. 

Botanix CEO, Dr Howie McKibbon said: 

“We are very pleased to receive conditional approval for Sofdra™ as a trade name for sofpironium bromide, as we accelerate our commercial launch preparations for the product. Our team developed trade name options which would satisfy the FDA’s stringent requirements. Sofdra is easy to pronounce, achieved positive fit to concept, and generated strong recall scores among physicians and patients. Sofdra is one of few two-syllable names still available for use as a product trade name. Once approved, the new trade name will be used on the product packaging as well as marketing materials.”

Click here to read the ASX release.

Dr Howie McKibbon appointed Chief Executive Officer

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

Dr McKibbon was also previously Botanix’s Chief Commercial Officer, and brings over 25 years of experience in the pharmaceutical industry to the role. Over the course of his career Dr McKibbon has launched more than 15 branded products, managed over 30 dermatology products, and played a significant role in two of the largest dermatology acquisitions with combined valuations of US$7.8 billion.

Botanix Executive Chairman, Vince Ippolito said:

“I am very pleased to congratulate Howie on his promotion to CEO … His experience and proven track record of success is unsurpassed in medical dermatology and I look forward to working with him in his new role at Botanix.”

FDA review of Sofpironium Bromide remains on track, with approval targeted for the end of September 2023.

Click here to read today’s ASX release.

Bioshares Summit

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Botanix is joining the biotech investment community at the 17th Bioshares Biotech Summit in Hobart this week.

This year’s theme is ‘partnering and financing’, and Botanix Executive Director, Matt Callahan, will be sharing insights into the Company’s progress navigating towards FDA approval for Sofpironium Bromide.

Click here to review the presentation.

A$12.5 million institutional placement

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Botanix has announced it has secured firm commitments for A$12.5 million via an institutional placement.

Proceeds from this raise will be used to extinguish future milestone and royalty payments linked to Botanix’s lead product, Sofpironium Bromide (SB) – in a move that could save up to $160 million and prime the Company for potential M&A or partnership activity.

Click here to read ASX release.

New territory licensed for Sofpironium Bromide with partner Kaken

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Botanix has today announced that our partner Kaken Pharmaceutical Co Ltd, has secured a new sublicense and distribution agreement for Sofpironium Bromide in Korea.


The deal with Dong Wha Pharmaceuticals, Korea’s oldest pharmaceutical company, will see the expansion of Sofpironium Bromide into the Korean market. Sofpironium Bromide has been successfully marketed as ECCLOCK® by sublicensee Kaken in Japan since November 2020.


Under the terms of this agreement, Botanix will be entitled to a share of the upfront, milestone and royalty payments based on net sales of the products.


Botanix Executive Chairman, Vince Ippolito, said:
“We are very pleased with the progress being made by our partner Kaken in expanding the territories for Sofpironium Bromide commercialisation globally.

“Given the global incidence of primary axillary hyperhidrosis and the relative lack of effective solutions for patients, the opportunities for Sofpironium Bromide continue to expand beyond Botanix’s primary focus of the USA with our existing partner Kaken and new partners to come.”

Click here to view ASX release.

Botanix secures commitments for A $10 million via institutional placement

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Botanix lifted a trading halt this morning, sharing news that it has secured commitments of
A$10.0million via institutional investors to accelerate the marketing and launch activities for
Sofpironium Bromide.


Proceeds from the Placement will be used to progress Botanix’s lead development
program, Sofpironium Bromide gel (15%), including costs associated with completing
FDA review, manufacturing, satisfying milestone payments and preparing for commercial
launch in the United States, as well as general working capital purposes and costs of the offer.


Botanix Executive Chairman, Vince Ippolito, commented:
“We are very pleased to announce this placement to institutional investors who have
actively researched and engaged with Botanix and are prepared to invest at this pivotal point in
the Company’s development.

“We are particularly pleased by the support from new institutional investors as they take
the opportunity to join Botanix on its journey towards FDA approval and
commercialisation of our lead product, Sofpironium Bromide for primary axillary
hyperhidrosis.”


Click here to read today’s ASX release.

Mid-Cycle Review Complete + Capital Raise

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Botanix has today released an update regarding the progress of its lead product, Sofpironium Bromide, for the treatment of primary axillary hyperhidrosis – a medical condition where excessive sweating occurs beyond what is needed to maintain normal body temperature.

The U.S. Food and Drug Administration (FDA) has now conducted the mid-cycle review meeting for Sofpironium Bromide, and no significant issues have been identified, as a result of the review. This includes no major clinical safety issues, no risk management issues, or advisory board requirements.

The Company has also announced a capital raise to support the next stage of our New Drug Application (NDA) filing.

Click here to read ASX release.

Quarterly Activities Report and 4C Quarterly Cash Flow Report

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Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 December 2022.

Key highlights from this period include:

  • FDA accepted NDA filing for Sofpironium Bromide as sufficiently complete for a substantive review
  • FDA confirmed that a mid-cycle review of the NDA is planned for 1Q 2023
  • Independent market research project completed by Triangle Insights confirms significant revenue opportunity for Sofpironium Bromide and positive feedback from key physician, payer (insurance) and patient stakeholders, who were surveyed on a blinded basis
  • Successfully raised $5.96M via a placement to institutional shareholder Antares Capital and Shareholder Purchase Plan to existing holders
  • Successful Phase 1b/2 clinical study for BTX 1702 in rosacea completed
  • Cash position of $8.72 million at quarter end, with pivotal Sofpironium Bromide mid-cycle review meeting due this quarter

Click here to read today’s ASX release

JP Morgan Healthcare Conference Presentation

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Botanix will be attending the JP Morgan Healthcare Conference in San Francisco this week. The conference attracts more than 50,000 attendees from around the world, bringing together global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

As part of the conference, Botanix will be discussing the significant commercial potential of Sofpironium Bromide and sharing some of the independent market research recently completed by Triangle Insights.

With the formal filing of the Sofpironium Bromide NDA now accepted by FDA and a standard review period confirmed, we are pleased to report that the mid-cycle review remains on track for this quarter.

Click here to view the presentation.

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.