Health Check: Pfizer rises to the occasion with a ‘most favoured nation’ US drug pricing deal

• Pfizer has become the first Big Pharma company to sign a pricing deal with the Trump administration
• Bioxyne has the dope on likely US medical pot reforms
• Paradigm trial gets a knees-up with its first patient dosed

The Trump administration has signed its first agreement with Big Pharma over its ‘most favoured nation’ (MFN) drug pricing policy.

In what it dubs a “landmark voluntary agreement”, the New York-based Pfizer has agreed to bring its US drug prices in line with those paid by patients in other developed nations.

The select discounted drugs will be available on a new website – dubbed Trumprx, of course – to enable direct-to-consumer sales.

“The large majority of the company’s primary care treatments and some select specialty brands will be offered at savings that will range as high as 85% and on average 50%,” Pfizer says.

“Specific terms of the agreement remain confidential.”

Pfizer chief Albert Bourla describes the agreement as a “win for American patients, a win for American leadership, and a win for Pfizer.”

By agreeing to spend US$70 billion on new facilities in the US, Pfizer has also won a three-year reprieve from Trump’s 100% tariff on imported drugs.

Pfizer is famed for its erectile dysfunction pill Viagra, but its other products include the antidepressants Zoloft and Xanax and the anticoagulant Eliquis.

Will the others duck Donald’s wrath?

Drug makers had until September 29 to respond to Trump’s MFN directive.

So far, the likes of Eli Lilly & Co and Novo Nordisk have not done so.

Previously, the Prez has railed against “foreign freeloading nations” supposedly responsible for the high drug prices paid by Americans.

If the other drug makers are not good boy scouts as well, they face the wrath of Donald who has said the administration will use “every tool in our arsenal” to punish drugmakers that don’t comply.

The Pfizer announcement did no harm to the sector, with Big Pharma shares climbing on the US bourse overnight. Pfizer shares climbed 6% on the New York exchange, while other Big Pharma shares rose between 3% and 5%.

A positive for CSL?

With the MFN policy crystallising, the local investor focus turns to CSL (ASX:CSL), which last year derived just under half of its sales from the US.

A CSL spokesman said the company awaited further details of the Pfizer deal, but would work with the White House “on win-win solutions to ensure access to CSL’s innovative medicines and vaccines”.

He adds: “We have already shared with the administration our continued plans for multi-billion dollar investment in US sites and operations”.

RBC Capital Markets says while investors will need to wait for the details, “we consider Pfizer’s agreement to be a positive for CSL, given it appears to limit MFN pricing to certain medications and patients”.

Due to their complexity, CSL’s therapies must be delivered by healthcare specialists. That could mean they are not suited to (discounted) direct patient programs.

Commentary on CSL has centred on the tariff threat, which the company is confident of avoiding given its large US manufacturing presence.

CSL shares edged up half a per cent this morning.

Bioxyne girds for expected US medical pot reforms

Expect White House drugs reforms on another front as well: the likely liberalisation of cannabis (and potentially psychedelics) usage.

Pot stock Bioxyne (ASX:BXN) notes the White House is, er, mulling whether to downschedule cannabis from being a top-level schedule I controlled substance, to schedule III status.

“This recognises medical use and carries lower regulatory barriers,” the company says.

Such reforms could “materially influence the global regulatory environment and investment climate for cannabinoid and psychedelic-derived therapeutics.”

Of course, many US states have legalised recreational pot.

Put it this way: rapper Snoop Dogg has no shortage of supply and he wouldn’t do anything illicit.

But the vaunted federal change could widen research access, ease banking and tax constraints and “unlock pathways for institutional investment in cannabinoid therapeutics”.

Via its subsidiary Breathe Life Sciences, Bioxyne makes and markets a variety of cannabis-based and psychedelic compounds.

The company currently focuses on the local and European markets.

While American stoners rejoice, the company stresses nothing is set in stone.

Bioxyne also reaffirmed current year guidance of revenue of $65-75 million and earnings before interest, tax, depreciation and amortisation of $11.5-13.5 million.

Both revenue and earnings projections are 130% higher at the midpoint.

Bioxyne shares were about 2% off the pace this morning, but they have gained 270% over the last 12 months.

Paradigm doses first dicky knee patients

Paradigm Biopharmaceuticals (ASX:PAR) is off and running with its long-awaited phase III knee osteoarthritis pain study, with the first patients dosed.

Enrolling 466 patients across 65 local and US sites, the blinded, placebo-controlled trial tests the safety and efficacy of Paradigm’s re-purposed compound, injected pentosan polysulphate sodium.

As Bell Potter notes, the trial invites nervous comparisons with Opthea’s failed eye disease program.

Paradigm also must carry out two phase III trials.

“However, [Paradigm] has taken a measured approach and will complete a futility study at 50% enrolment in this first trial,” the firm says.

“This is a far more conservative approach than running two large phase III programs in parallel.”

The control arm is also a saline, rather than an active drug used in the Opthea trials.

This will help mitigate the risk of outperformance by the control group – always an embarrassing outcome.

The firm adds that Paradigm’s shaped the study using “extensive data” collected from previous trials.

Given that, the trial size is likely to exceed the requirement of US (and European) regulators.

Paradigm expects to dose all patients in the first half of 2026. The company should release an interim analysis of the first 50% of subjects shortly thereafter.

Bell Potter has lowered its valuation of Paradigm shares from 73 cents to 65 cents, but that’s still double the current share price.