Moderna builds commercial muscle as new launches loom

Moderna is hoping to launch three new vaccines in the next couple of years – including a flu shot that will come in front of an FDA advisory committee tomorrow – and has started building up its commercial operation in anticipation.

To support the potential launches of its mRNA-based seasonal flu, combined flu/COVID-19, and norovirus vaccines in 2027 and 2028, Moderna has hired ex-Novartis, Bristol Myers Squibb, and Zoetis executive Esther Banque as chief commercial officer and handed an expanded operational role to company president Stephen Hoge.

The appointments were announced as the FDA published a briefing document on the seasonal flu vaccine, mFlusiva (formerly mRNA-1010), which pointed to some gaps in the efficacy data submitted by the company, but – on the whole – is supportive and seems to signal a positive outcome at tomorrow's adcomm.

That assessment will come as a relief for Moderna, which was rocked earlier this year when the FDA refused to accept its marketing application for mFlusiva, only to change its mind after negotiations on a revised application. That was accompanied by a public falling out between the company and then FDA Commissioner Marty Makary, who has been critical of mRNA vaccines, and who has since departed the agency.

Assuming mFlusiva is approved, the rollout will now be the responsibility of Banque and Hoge, along with the mRNA-1083 combined flu/COVID jab – approved in Europe under the mCombriax brand name, but delayed by an FDA request for another clinical trial in the US – and norovirus candidate mRNA-1403, which is in the phase 3 NOVA 301 trial due to read out next year.

Moderna said that Hoge will now lead oversight of "operational and cross-functional leadership" across R&D, manufacturing, and commercial, while Banque will concentrate on building up its commercial operation around the world, including in new markets.

Along with mCombriax, Moderna is already selling COVID-19 vaccines (Spikevax and successor mNEXSPIKE) – which accounted for the bulk of its $389 million in revenues in the first quarter of the year – as well as respiratory syncytial virus (RSV) shot mResvia, which so far has failed to gain much traction in a competitive category.

The company's chief executive, Stéphane Bancel, said the new appointments are critical as Moderna faces the prospects of having three commercial franchises, spanning vaccines, cancer, and rare diseases.

Its lead cancer asset is MSD-partnered neoantigen therapy intismeran autogene for melanoma and non-small cell lung cancer (NSCLC), in late-stage clinical trials, while the rare disease franchise is headed by mRNA-3927 for inherited metabolic disorder propionic acidaemia (PA), which is in phase 1/2 testing.