Health Check: Fantastico! Telix wins Brazilian assent for prostate cancer imaging agent

Brazil’s health regulators have approved Telix Pharmaceuticals’ nuclear imaging agent for prostate cancer, Illucix.

Brazil's regulators and Telix are dancing to the same rhythm. Pic via Getty Images

• Telix Pharmaceuticals’ Brazilian win marks its first foray into the South American market

• Orthocell gains approval to sell its dental guided bone regeneration product in Singapore

• Sigma Healthcare: great prospects, a pity about the valuation

• Syntara to spend $2 million on burns scarring trial

 

Telix Pharmaceuticals (ASX:TLX) has won marketing approval for its prostate cancer imaging agent in Brazil, marking the company’s first foray into the South American market.

The Brazilian Health Regulatory Agency has given the nod to Telix’s Illuccix, which uses a gallium-based isotope to detect the disease.

Illuccix is the country’s first and only fully-approved agent to diagnose prostate cancer, using positron emission tomography to target the telltale prostate-specific membrane antigen.

The approval applies to men with suspected metastasis who are candidates for definitive initial therapy (a prostatectomy).

But it takes two to samba in Brazil: Telix has granted local nuclear pharmacy and cyclotron network, Grupo GSh, an exclusive licence for the country.

Illucix is available in most key western jurisdictions – notably the US – but the Brazilian market is nothing to sneeze at.

There, prostate cancer is the most diagnosed male cancer, with an estimated 71,730 new cases in 2023.

The disease killed 20,000 Brazilians in 2022, with about 250,000 of them living with the disease.

“Over the next decade, the Brazilian radiopharmaceuticals market is  projected to reach US$330 million,” Telix says.

“This growth supported by rising investments in the healthcare industry, public health awareness and the introduction of new and advanced radiopharmaceuticals.”

In the year to December 2024 Telix generated revenue of $783 million, up 56%.

All this turnover derived from Illucix, with the US accounting for 97%.

Orthocell gains Singaporean approval

In other approval news, Orthocell (ASX:OCC) has got the Singaporean nod to sell its dental guided bone regeneration product, Striate, in the Lion City.

A resorbable collagen membrane, Striate already is approved in the US,  Europe and the UK, Canada, New Zealand and here.

But Singapore is a key regulatory hub and a gateway to other major ASEAN countries.

Orthocell shares bounced up to 12% on the news this morning.

Broker loves our pharmacy leader, but isn’t a buyer …

In an inaugural report on Sigma Healthcare (ASX:SIG) following its merger with Chemist Warehouse, broker Goldman Sachs can’t be more effusive.

The firm describes the engorged group as the “deeply vertically integrated leader” in the pharmacy sector.

Post merger, Sigma emerges with a 27% share of the local wholesale pharmacy (drug distribution) sector and 30% coverage of all chemists (as a wholesaler and franchisor).

The firm also notes Sigma’s network of 15 highly automated distribution centres.

Goldmans expects Sigma to achieve compound annual revenue growth of 9% over the next three and a half years, as well as 20% net earnings growth.

So, what’s not to like?

The answer – simply – is Sigma’s valuation, which puts the company on a current earnings multiple of more than 60 times, abating to a still heady 50 times in the 2025-26 year.

Plumping for a ‘neutral’ call, Goldmans values Sigma at $2.70 a share, 6% lower than Monday’s close of $2.88.

Defying the sceptics, the stock has edged up 7% since the February 12 merger implementation.

On Monday, the $4.9 billion market cap Sigma joins the rarefied ranks of the S&P/ASX50 index, along with imaging hero Pro Medicus.

… but Neurizon could be worth four times as much

In contrast, broker Morgans is ultra bullish about Neurizon Therapeutics (ASX:NUZ) as the company seeks to get its amyotrophic lateral sclerosis (ALS) clinical study back on track.

Neurizon is targeting ALS, a form of motor neurone disease, with a repurposed veterinary drug called monepantel.

In an “unexpected development” in mid-January, the US Food & Drug Administration (FDA) imposed a ‘clinical hold’ on the company’s human trial.

As it happened, the agency wanted more animal data to confirm safety.

In response, the company is undertaking two animal studies in coming weeks, with a duration of four months.

All, up the trials should cost $400,000 to $600,000.

Broker Morgans opines that Neurizon should be able to re-start its adaptive phase 2/3 human trial by the end of calendar 2025.

This is by way of participating in a broader platform called Healey, which road-tests several ALS drug candidates.

Allowing for the degree of risk, Morgans values Neurizon shares at 42 cents, compared with Monday’s close of 10 cents.

Syntara is burning to start Perth scarring trial

While inflammatory diseases specialist Syntara's (ASX:SNT) main game is its advanced myelofibrosis clinical program, the company is girding for two early-stage burns scarring trials.

The program is in collaboration with the University of Western Australia (UWA) and famed burns legend Professor Fiona Wood, inventor of the spray-on skin used to treat victims of the Bali terrorist bombings.

Syntara is all about amine oxidase chemistry, the basis of several enzymes involved in inflammation and fibrosis.

Starting in the June quarter, a phase 1a/b clinical trial will assess safety in healthy volunteers, but then study the appearance and physical properties of hypertrophic scars.

This Syntara-funded effort will cost $2 million, funded by the company’s cash reserves which were enlarged via a recent $15 million raise.

The company expects results in the first half of 2026.

The next step is an application to the FDA to carry out a further trial, hopefully paving the way for approval of the “first approved pharmacological treatment for skin scarring”.

The Fiona Wood Foundation and UWA will also conduct an exploratory clinical trial in keloid scarring, with Syntara providing financial and technical support.

Hypertrophic scars and keloids are both raised scars resulting from excessive collagen production during wound healing.

But keloid scars differ biologically from hypertrophic scars and “present unique challenges for patients".

At Stockhead, we tell it is as it is. While Neurizon and Orthocell are Stockhead clients, the companies did not sponsor this article