Sunday, October 17, 2021

JPM: Bristol’s M&A shopping list, BioNTech’s 2B-dose rampup, Vertex’s beyond-CF ambitions

Boot up your computers and get those meeting room links ready: This year’s virtual J.P. Morgan Healthcare Conference has officially kicked off. Several players in the COVID-19 fight have already sketched out and updated their battle plans for the pandemic’s second year, as other Big Pharmas eye M&A in the months to come. 

Here’s your need-to-know, from Bristol Myers Squibb’s dealmaking cash flow to Vertex’s beyond-CF work to BioNTech’s new-and-much-bigger vaccine production plans—and more. 

Fierce Pharma will be covering the day’s biggest news at it happens. Check back here for updates. 

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UPDATED: Monday, Jan. 11 at 11:52 a.m. ET

Biogen and its investors have a lot riding on the company’s FDA application for Alzheimer’s candidate aducanumab, and now the fateful decision is less than 2 months away. At Monday’s JPM presentation, CEO Michel Vounatsos said 2021 could be a “transformative year” for the company as it awaits an FDA decision on the candidate—expected by March 7—and as it delivers new data on a series of pipeline programs.

Independent experts convened by the FDA in November voted against recommending approval for aducanumab, but Biogen R&D chief Al Sandrock said Monday the vote was “nonbinding” and that there’s precedent for the FDA to go against panel recommendations. As the aducanumab situation plays out, Vounatsos said Biogen presents a “balanced” risk reward profile for investors due to its marketed meds, its growing biosimilar business and its pipeline. The company could see “multiple blockbuster launches” in the coming years, he added.

UPDATED: Monday, Jan. 11 at 10:00 a.m. ET

Even after shelling out $74 billion for Celgene and $13.1 billion for MyoKardia, Bristol Myers Squibb still has “significant financial flexibility” to pull off deals, Bristol Myers CEO Giovanni Caforio said. Specifically, the company’s constantly exploring “midsize bolt-on deals” like that of MyoKardia, he added. The company expects to have $45 billion to $50 billion in free cash flow around 2021 to 2023. Story

One month back, the FDA told Regeneron to pump the brakes on its experimental blood cancer drug trial, citing safety concerns. After looking to “fulfill their need” to lift the hold, the company has done its part, and the ball is now in the FDA’s court, CSO George Yancopoulos, M.D., Ph.D., said. Regeneron has since paused enrollment on the study—while treatment continues for consenting patients—and sent off a new protocol amendment to the FDA, with the “goal of resuming patient enrollment in the first quarter of 2021.” Story

BioNTech says it’s gunning to produce 2 billion doses of its Pfizer-partnered vaccine—now dubbed Comirnaty—in 2021, up from its previous goal of 1.3 billion doses. And that’s not all BioNTech has in store for year two of the pandemic; the company is looking to boost capacity by rolling out a six-dose vial; plus, it’s continuing to expand with new sites, suppliers and CMOs. A Comirnaty manufacturing site with annual capacity for 750 million doses is pegged to come online by the end of February, for instance. Beyond distribution, the company is also eyeing label expansions in children, pregnant women and other sub-populations. 

After years of focusing on cystic fibrosis, Vertex Pharmaceuticals is advancing pipeline candidates and eyeing deals in other disease areas. Amid its worldwide rollout for triple combo CF therapy Trikafta, the company has new “firepower” to scout for mid- and late-stage drug programs, CEO Reshma Kewalramani said Monday.

Reshma Kewalramani
(Vertex Pharmaceuticals)

The drugmaker is scouting for candidates that complement its pipeline, or new “tools and technology” to grow Vertex’s toolkit, she added. Within its own pipeline, the company is enthusiastic about gene-editing therapy CTX001 in sickle cell disease and beta-thalassemia, Kewalramani said. Meanwhile, the company is focused on growing Trikafta in new patient groups and launching in countries where it’s not yet available.

While Novavax wasn’t a first-to-market COVID-19 vaccine player, the Maryland biotech has big goals for 2021. The company plans to report interim phase 3 data for its vaccine, NVX-CoV-2373, sometime during the first quarter, and it’s already stockpiling vaccine doses in case the program wins regulatory green lights. Since the start of last year, Novavax has established a worldwide manufacturing network able to produce 2 billion vaccine doses per year, CEO Stan Erck said during Monday’s presentation. Novavax expects to deliver 110 million doses to the U.S. in the second quarter of 2021. While the duration of protection from the vaccine remains uncertain—as does overall efficacy—R&D head Gregory Glenn said the biotech is exploring the potential for a booster dose.

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