Alive and Kicking: No sweat as Botanix readies for US launch of its hyperhidrosis treatment

Botanix is targeting a US market of 10 million patients with its anti-sweating drug.

Pic via Getty Images

• Botanix plans a US launch of its anti-sweating treatment in the March 2025 quarter

• Pacific Smiles shareholders have a new offer to get their teeth into

• Bubs Australia enrols its 400th and final infant for US clinical trial

Alive and Kicking is renowned biotech journo Tim Boreham’s new daily wrap covering morning movers and shakers of note in the ASX Healthcare sector, Monday through Thursday.

---

Botanix Pharmaceuticals (ASX:BOT) says it will launch its approved product for excessive sweating in the US in the March quarter of next year, targeting 10 million sufferers of the common but little-known primary axillary hyperhidrosis (PAH).

In June the US Food & Drug Administration green-lighted its topical gel Sofdra, a “novel, safe and effective solution for patients who have lacked treatment options for this socially embarrassing medical condition.”

PAH is sweating over and above what is required to regulate the body’s temperature. We’re talking about shirt-drenching sweat, not something that can be ameliorated with an extra spray of Brut 33.

It’s the third-biggest dermatological condition behind acne and dermatitis.

At an investor update on Tuesday morning, the company said it had recruited 500 patients via the International Hyperhidrosis Society – yes, there is such a thing – with 18,000 to follow.

Meanwhile, the company has hired 27 sales reps across three regions to kick-start the sales and is wooing the small number of physicians – 4500 or so – who prescribe PAH treatments.

The company says seven million PAH patients have been diagnosed over the past 10 years, while three million remain undiagnosed. Given the US population of 336 million, that’s an incidence rate of a not insignificant 3%.

The company stresses that Sofdra will be eligible for reimbursement, with no out-of-pocket costs for most patients.

Initially, Botanix focused on developing synthetic cannabinoid treatments for skin diseases including acne, atopic dermatitis and psoriasis.

But results were patchy and in May 2021 the company obtained the rights to the sofpironium bromide (renamed Sofdra).

Unlike antiperspirants, Sofdra addresses the underlying problem by suppressing underarm receptors. Technically, Sofdra works by inhibiting M3 muscarinic receptors in eccrine glands at the application site. 

Found throughout the body, these receptors induce a ‘fight or flight’ response, including sweating and salivating, lactation and even urination. 

The excessive sweating comes in three iterations: primary axillary (under the arms), cranio-facial (head and face), palmar (hands and palms) and plantar (feet). The company has FDA approval for the first. 

Initially, the FDA rebuffed the company because of concerns about the wording of instructions in the Sofdra packaging, but these issues proved surmountable. 

However the March 2025 timeline is a slippage from the originally envisaged mid-2024 launch.

Immediately after approval, Botanix raised $70 million in an institutional placement, so it is well placed to lob its first US underarm delivery.

Botanix shares closed one cent higher at 42 cents, ascribing a meaty $770 million market capitalisation.

Pacific Smiles takeover saga takes a new turn

Don’t hold us to it, but the protracted takeover tussle for dental chain Pacific Smiles (ASX:PSQ) looks to have reached its denouement after original bidder Genesis Capital on Tuesday returned with an improved $1.90 per share, circa $300 million offer.

Shareholders in early August  knocked back a $2.05 per share scheme of arrangement from Crescent Capital, which was kind of inevitable given Genesis holds a 19.9% blocking stake and co-founder and 9.65% shareholder Alex Abrahams voted against the offer.

Crescent owns the private National Dental Care network.

Genesis originally bid $1.40 per share back in December, before revising its offer to $1.75 in March and then $1.90 in late July.

The new off-market offer Genesis associates Beam Dental Bidco gives shareholders the choice of cash, partial scrip or all scrip.

The offer is pitched at an 8% premium to yesterday’s closing price of $1.75 and a 59% premium to the ‘undisturbed’ price back in December.

Pacific Smiles operates around 120 clinics nationally, some of them under the banners of health insurers nib and 10% shareholder HBF.

Genesis argues the offer will provide certainty to shareholders, especially after the recent resignation of CEO Andrew Vidler and CFO Matthew Cordingley.

The company advises shareholders to chill out and wait for its target statement.

If Genesis succeeds, there will be no more ASX-listed dental chains in what was once a well-populated sector.

Pacific Smiles listed ten years ago at $1.40 per share and for investors the experience has been more painful than a root canal treatment.

Oh baby! Bubs recruits its 400th infant for US clinical trial

In clinical trials of a different sort, infant cow and goat milk supplier Bubs Australia (ASX:BUB) has rounded up its 400th and final infant in the US to press its case for US Food & Drug Administration approval.

Having struck a Great Wall of trouble in the Chinese market, Bubs is seeking permanent access to the US, having filled a supply gap emergency in 2022 at the bequest of President Biden himself.

The study doesn’t appraise whether the rug rats like the stuff or not, but measures factors such as growth rates and tolerance levels.

Bubs intends formally to submit the clinical trial documentation to the FDA early in 2025 with regulatory approval expected in October 2025. 

A year ago, Bubs founder and CEO Kristy Carr was ousted amid an acrimonious board tiff, centred on  the performance of Bubs’ now former China distributor.

Bubs shares have lost 90% of their value over the past five years and were unchanged at 12 cents on Tuesday morning.

Originally published as Alive and Kicking: No sweat as Botanix readies for US launch of its hyperhidrosis treatment