Botanix Pharmaceuticals chief operating officer Dr Howie McKibbon believes Aussie Investors are comfortable backing early-stage, high-risk companies which is good for biotechs.

When pitching an investment opportunity focused on a new drug to effectively treat excess sweating for ASX-listed, US-based Botanix Pharmaceuticals (ASX:BOT) McKibbon has made an interesting observation.

“I’m told Aussies have experience investing in high-risk resources exploration companies, so they also lean towards early-stage drug development companies – so we really stand out with a product that is close to FDA approval and significant revenue generation,” said McKibbon.

On the cusp of US Food and Drug Administration approval and backed by excellent phase three clinical results, BOT’s lead dermatology product Sofpironium Bromide is a novel treatment for Primary Axillary Hyperhidrosis.

The medical condition is where excessive sweating occurs beyond what is needed to maintain body temperature.

Botanix asx BOT
Hyperhidrosis can be the cause of discomfort and embarrassment. You may have trouble working or enjoying recreational activities because of wet stains on clothes Image: Supplied

Crucial engine in drug pipeline

Only a handful of Australian pharmaceutical companies have managed to steer a new drug application through US regulatory approval.

The FDA is due to make a final decision on Sofpironium Bromide by Q3 of 2023, a new asset in the BOT drug pipeline having been purchased from Nasdaq-listed Brickell Biotech, which rebranded to Fresh Tracks Therapeutics (NASDAQ:FRTX).

Brickell spent more than $100 million developing the product before concluding that they didn’t have the experience and track record to launch the product.

“It is like we have this great engine at the front of the train that is going to carry along the rest of our drug pipeline carriages, but at this stage a lot of investors don’t realise how quickly it might pull into the station,’’ McKibbon said.


Chief Operating Officer at Botanix, Dr Howie McKibbon Image: supplied

“The drug has already been launched by our partner in Japan in 2020 and the reaction there has been great, so we are now very busy implementing a full-scale commercialisation strategy, pending a final FDA approval in Q3 this year.’’

Positive signs for FDA approval

Forecasting results of any regulatory process is perilous. However, that Sofpironium Bromide passed all its phase three primary and secondary efficacy and safety endpoints and no outstanding filing issues have been found before the mid-cycle review is completed this quarter is positive.

If the FDA doesn’t raise any significant issues at the mid-cycle review, that would dramatically improve the odds of a successful new drug application (NDA) approval later in the year.

Stats from the US industry organisation Bio indicate that the odds of obtaining FDA approval after filing are already 90%, so BOT appears to be on track to succeed.

Much needed treatment

McKibbon is now working on how to commercialise Sofpironium Bromide to treat Primary Axillary Hyperhidrosis, which is suffered by more than 16 million people in the US alone.

The US market for treatment is worth ~$2.2 billion annually and is forecast to grow to $3.9 billion by 2030, although the arrival of a new and effective drug could even increase these numbers.

Current treatments are not optimal for most patients – ranging from surgery, Botox injections, specialised deodorants, and some older prescription drugs.

It is a tricky disorder to treat because the body can adjust to treatments, allowing the symptoms to return, while existing treatments might also cause problems such as tiredness and dryness in the mouth and eyes.

A new class of drug, Sofpironium Bromide, mitigates these problems by binding to a receptor in the sweat gland to block the sweat signal before being quickly metabolised and excreted from the body.

A controlled dose applicator also directs the drug to the underarms, preventing contamination reaching the eyes or mouth.

Dermatological research found 54% of hyperhidrosis patients surveyed would “pay anything” for a treatment to improve their excessive sweating, showing the extent of social and psychological damage caused by the condition.

“There are many hyperhidrosis patients who have never even seen a doctor or dermatologist about their condition, which in many cases has a severe effect on their lifestyle,” McKibbon said.

“The challenge of reaching this group with a new drug that can change their lives is the sort of task that really gets you out of bed in the morning.

“Helping people to overcome significant medical problems is the reason that attracted many of us into drug development in the first place and clinical trials for this product to date show that this treatment could literally change the lives of millions of people around the world.’’

This article was developed in collaboration with Botanix Pharmaceuticals, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.