Research note | Continued Strong Sales from Japanese Partner

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Euroz Hartleys has published a research note on the performance of Kaken Pharmaceuticals, our Japanese pharmaceutical partner, which may provide insight into rapid growth potential for Sofpironium Bromide in the US.

Analyst Seth Lizee wrote:

“Sales of Sofpironium Bromide (branded as “Ecclock”) grew 71% pcp to ¥700 million in Q2 2023. Moreover, Kaken upgraded its 2023 full year sales target to ¥2.1 billion (from ¥1.9 billion), implying +67% YoY growth.

“These figures provide insight into the potential future sales of Sofpironium Bromide in the United States, underscoring the considerable market opportunity at hand.”

Click here to read the full report

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.

Investor Webinar Replay | 26 September 2023

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Botanix (ASX: BOT) has received a communication from FDA in relation to its NDA submission for Sofpironium Bromide gel, 15% (SB) for the treatment of primary axillary hyperhidrosis.

Encouragingly, no clinical efficacy, safety or manufacturing issues were raised and no additional clinical studies are required by the FDA to support approval. We will be revising the printed Instructions for Use document proposed for inclusion with the product and our team is now focused on working with the FDA to address the points raised, with plans to resubmit the NDA for SB by 1Q CY24 and targeting approval for mid-CY24.

Earlier today Botanix hosted an investor webinar outlining details of the Response Letter from the FDA – and next steps for approval. The team was joined by Mr Dave Clissold, Director of Hyman, Phelps & McNamara – the largest dedicated FDA law firm in the United States advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory matters.

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.

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.

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.

Video | Investor Webinar

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Botanix (ASX: BOT) hosted a webinar recently to update investors on the Company’s progress during the FDA review period for its lead product, Sofpironium Bromide.

The webinar was hosted by Executive Director, Matt Callahan and Chief Operating Officer, Howie McKibbon.

Take a look.

Investor Webinar Invitation

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Botanix (ASX: BOT) is preparing to host an upcoming investor webinar on Wednesday 07/06/23, 10:30am AEST | 8:30am AWST.

On this call, you will hear from Executive Director, Matt Callahan and Chief Operating Officer, Howie McKibbon. Together, they will be sharing an update on our progress during the current FDA-review stage for our lead product Sofpironium Bromide.

Click here to pre-register now to secure your place.