Botanix to Present at Euroz Hartleys Institutional Conference

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Botanix Pharmaceuticals (ASX:BOT) announced that Botanix CEO Dr Howie McKibbon will be among the featured presenters tomorrow at the annual Euroz Hartleys Institutional Conference being held March 12–14 on Rottnest Island. Also participating from Botanix is Executive Chairman Vince Ippolito who will take part in a panel discussion with Australia-based life science companies.

The Conference brings together institutional and sophisticated investors from around Australia and internationally to showcase small to mid-cap companies with a Western Australian focus. Botanix will provide an update on progress towards commercialisation of Sofdra™, which remains on track for FDA approval in late June 2024, as launch readiness activities accelerate.

Click here to read today’s ASX release.

Euroz Hartleys Healthcare Forum Presentation

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Botanix Pharmaceuticals (ASX:BOT) announced that Botanix CEO, Dr Howie McKibbon, is presenting at the Euroz Hartleys Healthcare Forum being held today in Perth, Western Australia.

The Conference brings together some of Australia’s leading listed and private healthcare companies, as well as institutional investors from around Australia and the region. Botanix will be outlining the significant commercial potential of Sofdra and sharing some of the launch preparation activities that are currently scaling up in anticipation of FDA approval which is targeted for late June 2024. 

Click here to read today’s ASX release.

Botanix resubmission of NDA for Sofdra™ completed

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Botanix Pharmaceuticals has announced that the Company has successfully completed resubmission of the new drug application (NDA) for Sofdra™.  FDA approval for Sofdra is now targeted for late 2Q 2024.

The NDA resubmission follows successful completion of the human factors validation study that assessed revised Instructions for Use (IFU) for Sofdra.

Botanix CEO, Dr Howie McKibbon, said:

“We are pleased to advise that the resubmission of the Sofdra NDA has been completed well ahead of schedule, and I am very appreciative of the effort the Botanix team has exerted over the last few months to achieve this earlier than expected filing.

“Our focus now is firmly on preparation for commercialisation as we work with FDA towards Sofdra approval by midyear.”

Click here to read the ASX release.

FDA confirms approach to Sofdra™ NDA resubmission

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Botanix Pharmaceuticals has announced that the Company has received feedback from FDA following its “end of review” Type A meeting request in respect to the Sofdra™ new drug application review that was completed in September 2023. 

FDA confirmed that the planned content of materials proposed by Botanix would be acceptable for the resubmission of the Sofdra NDA package.

Botanix CEO, Dr Howie McKibbon said: 

“We are thankful to the Division for confirming the approach and materials proposed to be included in the resubmission of the NDA for Sofdra which we are on track to file in early 1Q CY2024. 

“The team will be working over the holiday break to ensure we complete the human factors study and assemble the materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra approval.” 

Click here to read the ASX release.

Botanix Pharmaceuticals signs exclusive agreement with leading telehealth provider UpScriptHealth®

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Botanix Pharmaceuticals (ASX:BOT) has signed an exclusive agreement with UpScriptHealth® to provide the digital platform and telehealth services for the commercial launch of Sofdra™ (sofpironium bromide) gel, 15%. The agreement with UpScriptHealth is an important step towards building the commercial infrastructure for the successful launch of Sofdra following approval.

UpScriptHealth was the first company to deliver prescriptions online. With more than 1 million patients served, UpScript is the leading digital platform for pharmaceutical companies to offer medications and other therapeutics direct to consumers.

The UpScript website will be the first point of entry for the majority of patients seeking a prescription for Sofdra gel. Patients will be matched with UpScript’s nationwide network of licensed U.S. physicians for online consultations. If a physician finds that a patient is an appropriate candidate, an electronic prescription will be issued and forwarded to a pharmacy that fills it and then ships it to the customer’s home or office.

For patients who are actively seeking support and solutions online, UpScript provides a fast, convenient, clickable option.

Botanix CEO, Dr Howie McKibbon said:
“Our exclusive agreement with UpScriptHealth® forms a cornerstone of the commercial infrastructure required for the successful launch of Sofdra™ (sofpironium bromide) gel, 15%. UpScriptHealth’s proven digital platform and telehealth services are expected to greatly facilitate Sofdra prescriptions.

“UpScript will provide a fast, convenient, clickable option for patients seeking hyperhidrosis solutions online. Botanix and our patients will benefit from the enhanced patient access offered by UpScript’s digital hub.”

Click here to read the ASX release.

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.

The West Australian | Botanix Pharmaceuticals secures $12.5m via an institutional placement

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Botanix has been featured in an article by Cheyanne Enciso in The West Australian newspaper, reporting on its A$12.5 million raise via an institutional placement.

Read the article here.

Investor Webinar | March 2023

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Botanix (ASX: BOT) hosted a webinar to update shareholders on the Company’s preparations for the FDA mid-cycle review of Sofpironium Bromide in Q1 2023.

The webinar was hosted by Gautam Aggarwal, a Partner with Triangle Insights Group, who has conducted insightful market research in relation to the Sofpironium Bromide.

Other presenters included Botanix Executive Director, Matt Callahan and Botanix Chief Operating Officer, Dr Howie McKibbon.

Special Report | Stockhead

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Botanix has today appeared in Stockhead in an article titled, ‘As it awaits crucial FDA approval Botanix reckons Aussies have a penchant for backing high-risk companies.’

This special report explores the appetite for Australian investors to back companies with a high risk to reward ratio, and why Botanix stands out as a stock to watch as we move towards the mid cycle review milestone with the Food and Drug Administration (FDA) for our lead product, Sofpironium Bromide.

Botanix COO, Dr Howie McKibbon, has extensive experience at this stage of the biotech race and is quoted in the article:

“The drug has already been launched by our partner in Japan in 2020 and the reaction there has been great, so we are now very busy implementing a full-scale commercialisation

strategy, pending a final FDA approval in Q3 this year.’’

Click here to read the article.