Novartis’s triple push has an unusual target

In the highly competitive respiratory medicines world two companies, GlaxoSmithKline and AstraZeneca, had been pioneering development of a triple combination. Today they were joined by a third: Novartis.

But the big surprise about Novartis’s entry, QVM149, is that it is not being targeted at chronic obstructive pulmonary disease, but rather at asthma. This might be a reflection of cost pressures that are just hitting COPD; asthma has already suffered its big pricing blow, and there are recent signs that the regulatory stance towards combination therapies is softening.

This is not to say that Novartis will have it easy. QVM149, a fixed-dose combo of the LABA indacaterol, Vectura’s LAMA glycopyrronium and the steroid mometasone, will likely need to show a major advance over existing therapies to have a chance of commanding any kind of a price premium.

However, what has changed recently is the view of the FDA. The US regulator, having implemented a stringent safety clampdown on asthma combination drugs five years ago, recently approved Glaxo’s Breo Ellipta, the first LABA/steroid combo since Merck & Co’s Dulera in 2010 (Breo’s watershed moment unlikely to rescue Glaxo, May 1, 2015).

Triple action

The handful of big pharma players competing in respiratory therapeutics have different strategies as regards follow-on drugs.

As well as developing triple combinations, Glaxo and Astra also have MABA (dual-acting muscarinic antagonist/beta agonist) projects that can be combined with a steroid to get a similar triple effect, and indeed via Almirall and Pearl Therapeutics Astra has two of these. Chiesi has both a triple and a MABA, but is focused on Europe.

On the other hand Boehringer Ingelheim has consistently rejected the value of both triples and MABAs, but has developed a combo of Spiriva with the steroid olodaterol. Of course all the above relate to COPD and not asthma.

The inhaled triple combination players
Project Company Status Indication Trial ID Enrolment Completion
FF/UMEC/VI GlaxoSmithKline Phase III COPD NCT02164513 (Impact) 10,000 Jul 2017
Phase III COPD NCT02345161 (Fulfil) 1,800 Mar 2016
LAICS Chiesi  Phase III COPD NCT01917331 (ex-US) 1,863 Jan 2016
Phase III COPD NCT01911364 (ex-US) 3,686 Feb 2016
PT010 AstraZeneca  Phase III COPD NCT02465567 8,000 Dec 2018
QVM149 Novartis Phase II asthma PhIII starting 2015

For its part Novartis had kept its cards close to its chest, in February saying only that it regularly reviewed the possibility of triple combinations. Today this became reality with the revelation at the group’s investor day that QVM149 would start pivotal trials for asthma this year, with a filing scheduled for 2018.

Novartis will target the triple at patients who are uncontrolled on a LABA/steroid combo like Glaxo’s Advair or Astra’s Symbicort; the Swiss group has its own dual asthma combo, QMF149 (indacaterol plus mometasone), in phase II, though this has taken a back seat. In COPD it already markets Ultibro, a glycopyrronium/indacaterol combo, as well as its respective single ingredients as Seebri and Onbrez.

Beyond the obvious novelty of triple combinations it is also worth noting that such a combo would introduce a novel component – the LAMA – to asthma patients.

Boehringer’s standalone LAMA Spiriva was only recently approved additionally for asthma in Europe, with a US decision due this year. Conversely, in COPD dual LABA/steroid combos are available, in addition to mainstay standalone LAMA treatment, so perhaps combining the three might get an easier ride in this indication.

Either way, it will be interesting to see whether Novartis’s move back into asthma triggers the likes of Glaxo and Astra to follow suit with their respective triple combinations. One thing is for sure: the big rebate war might already have shaken up the market, but pricing asthma drugs is not about to get easy.

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

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