HIV approval thrusts Theratechnologies into the limelight

While Glaxosmithkline and Gilead fight for domination of the HIV treatment market a virtually unknown company yesterday emerged as a contender lower down the pecking order.

That company is Canada’s Theratechnologies, which thanks to US approval of Trogarzo looks set to become the world’s fifth-biggest HIV player. True, it will not come close to competing with the big beasts in this surprisingly resurgent sector, but its transformation from being a niche marketer of a growth hormone will be no less impressive.

The growth hormone drug, Egrifta, is approved in the US and Canada for reducing excess abdominal visceral adipose tissue, a complication of HIV. While this generated just $33m of sales last year it is relevant for Theratechnologies in that its HIV sales force will have been primed to hit the ground running with Trogarzo.

No further options

The new drug was yesterday given the all-clear by the US FDA for use in heavily pretreated HIV patients who have no further options.

In this late-line setting sellside consensus has it generating $401m of revenue in 2022, according to EvaluatePharma, and after yesterday’s 28% surge Theratechnologies has a market cap of $540m. Whether further upgrades are warranted will clearly depend on making Trogarzo profitable.

This brings into play drug pricing – a sensitive area in HIV. On Theratechnologies’ fourth-quarter analyst call the group said it was planning to price Trogarzo “definitely over” Fuzeon’s $50,000 per patient per year, but “under the average price of orphan drugs in the US, which is $140,000”.

Roche’s Fuzeon makes for an apt comparison for several reasons. The drug had been launched in 2003 with great fanfare, but a botched pricing scheme combined with cumbersome dosing relegated it to the salvage setting, where it sold just $21m last year.

This is clearly the same segment Theratechnologies will be targeting. Fuzeon is delivered by daily subcutaneous injection while Trogarzo, previously known as ibalizumab, has an IV route of administration every two weeks.

The Roche drug works by preventing the entry of HIV into its target CD4+ T cells by displacing components of the HIV-1 fusion machinery. Trogarzo also prevents HIV entry, in its case by binding to CD4; it is a non-immunosuppressive MAb, so it exerts no immune function, merely physically blocking the primary receptor for HIV.

First in 10 years

It is fair to say that Theratechnologies will not trouble the sector leaders. Gilead, Glaxo and Johnson & Johnson are battling over blockbuster sales of ever more complex drug combinations in settings such as first line, switching and pre-exposure prophylaxis (Glaxo scores HIV double, but bigger tests loom, November 23, 2017).

But Trogarzo should not be underestimated; it represents the first HIV treatment with a novel mechanism of action to be approved for 10 years. And, while Fuzeon prescriptions might present an obvious initial switching opportunity, the company dismisses this, estimating that there are only about 400 patients on the Roche drug, and “we can’t really find them”.

Assuming that there are plenty more salvage HIV patients who decline Fuzeon, and that Theratechnologies can avoid Roche’s mistakes, the Canadian group could have a blank canvas to work with.

To contact the writer of this story email Jacob Plieth in London at [email protected] or follow @JacobPlieth on Twitter

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