Botanix resubmission of NDA for Sofdra™ completed

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.

Successful completion of human factors validation study assessing revised Instructions for Use for Sofdra™

Botanix Pharmaceuticals has announced that the Company has successfully completed the planned human factors validation study assessing revised Instructions for Use (IFU) for Sofdra™.

All HF Study participants successfully prepared and applied Sofdra in accordance with the revised IFU, and both users and caregivers successfully completed the use-related tasks.

Botanix CEO, Dr Howie McKibbon, said:

“We are very pleased with the outcome of the HF Study for Sofdra and the performance of the revised IFU in guiding patients to the safe and successful use of the product.

“The team will continue working over the holiday break to expeditiously assemble materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra approval.”

Botanix will now prepare to resubmit the Sofdra new drug application to FDA in 1Q CY2024, targeting FDA approval in mid-CY2024.

Click here to read the ASX release.

FDA confirms approach to Sofdra™ NDA resubmission

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.

$13.5M institutional placement

Botanix has today announced it has received firm commitments for $13.5m via an institutional placement, with proceeds to support preparation for commercial launch activities for Sofdra™.

The Company has welcomed support from a significant number of new and existing institutional and sophisticated investors.

Proceeds from the Placement will support preparation for commercial launch activities of Sofdra in the United States, as well as general working capital purposes and costs of the Placement. 

Botanix Executive Chairman, Vince Ippolito, said:

“We are extremely pleased to announce this Placement to institutional investors, with the resubmission to FDA pending and approval planned for mid-2024.

“There are a number of initiatives that need to be completed to ensure a successful launch of Sofdra and subsequent revenue growth, and this new capital enables those initiatives to be accelerated.”

Click here to read today’s ASX release.

Research note | Continued Strong Sales from Japanese Partner

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®

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

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

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

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

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.