Botanix to Present at Euroz Hartleys Institutional Conference

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

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™ accepted

Botanix Pharmaceuticals has today announced the Company’s resubmission of the new drug application (NDA) for Sofdra™ has been accepted as a complete response by FDA. FDA also confirmed that the resubmission of the Sofdra NDA is a Class 2 response (i.e., a 6-month review period from the resubmission in late December 2023), with the result that approval remains on target for late June 2024.

Botanix CEO, Dr Howie McKibbon, said:

“We are pleased that FDA has confirmed that the resubmission of the Sofdra NDA is acceptable as a complete response and that the anticipated approval date in late June 2024 remains on target.

“This clarity means that our commercialisation activities in preparation for launch can be appropriately designed to ensure a rapid launch of Sofdra, following successful approval from FDA.”

Click here to read the ASX release.

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.