Sanofi CEO Paul Hudson has a message: He’s not concerned about meeting an optimistic 18-month timeline for developing an effective COVID-19 vaccine. He's worried whether enough doses will be available.
And for that, he figures Sanofi and its collaborator GlaxoSmithKline probably have the world’s best chance at meeting demand.
“We know that there are over 76 different vaccines in play at the moment, but let’s be honest, to make them at scale, rather than just a few million doses, is really where the complexity will be,” Hudson said during a conference call with reporters Friday.
While a mass vaccination campaign will eventually require everybody to pitch in to make enough doses, “there’s only really us, perhaps in partnership with GSK, that can operate at scale” to make a significant contribution, Hudson said.
Sanofi and GSK are indeed two of the world’s largest vaccine manufacturers. A few days ago, they joined forces to work on a recombinant vaccine that uses GSK’s AS03 adjuvant.
In 2009, GSK used the vaccine booster in its Pandemrix vaccine against a pandemic H1N1 strain. Sanofi’s recombinant platform is also the foundation of its Flublok influenza vaccine, which the company acquired through its buyout of Protein Sciences.
The two companies aim to start enrollment in a clinical trial in the fourth quarter of 2020 and hope for an approval—probably under an emergency use protocol—by second-half 2021 the earliest.
Getting a vaccine approval within 18 months is quite bullish, some industry watchers figure. In a recent note to investors, SVB Leerink analyst Geoffrey Porges suggested Porges suggested a timeframe for approval and deployment of about two to three years and likened the current expectation to hitting a bullseye from “the equivalent of standing 24 feet … from a dartboard.” He noted that many recent pivotal vaccine trials themselves have taken over 3.5 years to complete.
Sanofi Pasteur currently produces about a billion doses of vaccines each year. “It takes us about 10,000 people to make that happen, and that’s an important context for you because whilst the pursuit of vaccine to protect everybody to get life back to normal is a worthy pursuit, there are very few companies that can … manufacture at this scale,” Hudson said.
For now, the company has the capacity to make about 100 million to 600 million doses, Hudson said, and it has a plan in place to expand to 1 billion doses in a year for the COVID-19 candidate.
Besides the recombinant approach, Sanofi has also formed an alliance with Translate Bio to develop an mRNA shot.
Multiple mRNA programs are already in development, including Moderna’s mRNA-1273 shot that’s advanced furthest in the clinic and BioNTech’s BNT162 that’s moving ahead in partnership with Pfizer and China’s Fosun Pharma. But Sanofi believes Translate Bio is the only mRNA player that can manufacture at scale, Hudson said, with a capacity for about 90 million to 360 million doses by the first half of 2021.
Outside of all the vaccine work, Hudson said Sanofi has 100% of its manufacturing sites worldwide operating to “almost perfect capacity” to make drugs for patients, COVID-19 or not.
Biopharma is one of few industries that has shown resilience during the COVID-19 pandemic. That holds true for Sanofi—for now.
In the first quarter, sales at Sanofi increased 6.6% at constant currencies to reach €8.97 billion ($9.65 billion), 4% ahead of industry watchers’ expectations. The French pharma attributed about half of that growth to distributors and patients stocking medicines amid the public health crisis.
The sudden burst of demand will wane moving into the second quarter as those inventories are consumed while patients avoid seeing doctors to get new scripts, Sanofi warned.
Regeneron-partnered dermatitis and asthma drug Dupixent delivered the lion’s share of growth, with sales that more than doubled to hit €776 million ($834 million) in the first quarter, beating the Street’s consensus by 8%.
Because Dupixent is not an immunosuppressant, it could be a safer option for patients during the pandemic; it wouldn't complicate their bodies' protection against COVID-19. As Hudson noted, Dupixent is the anti-inflammatory drug most prescribed via telemedicine, even though there's been a decrease in new patient starts during the pandemic.
For the second quarter, Sanofi expects sales to decline by a low single-digit percentage due to slower demand for innovative drugs, reduced sales of travel vaccines and lower pharmacy traffic for consumer products. The company maintains its 2020 earnings-per-share expectations at about 5% growth.