Botanix Pharmaceuticals Ltd (ASX: BOT) to Launch Sofdra for Excessive Sweating in the US

Botanix Pharmaceuticals Ltd (ASX:BOT) has announced an upcoming launch of its approved product, Sofdra, for treating primary axillary hyperhidrosis (PAH), a condition causing excessive sweating. The product is expected to hit the US market in the March quarter of next year, targeting an estimated 10 million individuals affected by this condition.

Key Product Details

Sofdra, a topical gel recently approved by the US Food & Drug Administration (FDA), offers a novel solution for managing PAH, which is characterized by excessive sweating that goes beyond what is necessary to regulate body temperatureThis condition affects millions and ranks as the third most common dermatological condition, following acne and dermatitis.

Botanix Pharmaceuticals has recruited 500 patients through the International Hyperhidrosis Society for initial trials, with plans to involve an additional 18,000 patientsThe company has also expanded its sales team, hiring 27 sales representatives to boost market presence and is engaging with the approximately 4,500 physicians who prescribe PAH treatments.

The market potential is significant, with seven million diagnosed PAH patients and three million undiagnosed in the US, representing an incidence rate of around 3% of the populationSofdra will be available with reimbursement options, minimizing out-of-pocket costs for most patients.

Historical Development and FDA Approval

Initially, Botanix Pharmaceuticals focused on synthetic cannabinoid treatments for various skin conditionsAfter mixed results, the company acquired the rights to sofpironium bromide, now branded as Sofdra, in May 2021Sofdra works by inhibiting M3 muscarinic receptors in eccrine glands, which are responsible for sweating and other bodily responses.

The FDA had previously rejected Sofdra due to concerns with packaging instructions, but these issues have been resolvedThe March 2025 launch date represents a delay from the originally planned mid-2024 timeframe.

Following FDA approval, Botanix raised $70 million through an institutional placement, positioning itself well to launch Sofdra in the USBotanix shares closed at 42 cents, reflecting a market capitalization of $770 million.

Pacific Smiles Ltd (ASX:PSQ) 

In the ongoing takeover saga for dental chain Pacific Smiles Ltd, Genesis Capital has presented an improved offer of $1.90 per share, valuing the company at around $300 millionThis offer follows the rejection of a $2.05 per share proposal from Crescent Capital in August, influenced by Genesis's significant 19.9% stake and opposition from co-founder Alex Abrahams.

Genesis's revised offer includes options for cash, partial scrip, or all scrip, representing an 8% premium over the previous closing price and a 59% premium over the price from DecemberPacific Smiles operates approximately 120 clinics across Australia, including those under health insurer brands nib and HBF.

The company has advised shareholders to await further information in its target statementIf Genesis's offer is successful, it would result in the elimination of ASX-listed dental chains from the sector.

Bubs Australia Ltd (ASX:BUB) 

Infant milk supplier Bubs Australia Ltd has successfully recruited its 400th and final infant for its US clinical trial, aiming for FDA approvalDespite challenges in the Chinese market, Bubs seeks to solidify its presence in the US, having previously addressed a supply gap in 2022.

The clinical trial focuses on growth rates and tolerance levels rather than taste preferencesBubs plans to submit trial documentation to the FDA in early 2025, with regulatory approval anticipated in October 2025Bubs shares, which have experienced a 90% decline in value over the past five years, were unchanged at 12 cents this morning.

These updates reflect significant developments for Botanix Pharmaceuticals, Pacific Smiles, and Bubs Australia, indicating noteworthy movements in their respective sectors.