Think back to this time last year. Remember the uncertainty the COVID-19 pandemic posed?
Well, thanks to omicron, here we are again, asking many of the same questions and with renewed anxiety about the future.
At least now we know the drill. “I see COVID continuing to have new variants and coming back each season,” Cantor Fitzgerald’s Grace Chen told Fierce Pharma.
We also know what questions to ask. Is omicron more contagious? Will vaccines and treatments be effective? Are we destined for a return of restrictions and lockdowns? And, after omicron, what’s next? Are we simply on a coronavirus hamster wheel, with many more variants yet to contend with?
As the pharmaceutical industry approaches 2022, there is some comfort knowing that ablueprint is in place to respond to the pandemic–and one that will allow business to continue. But what about those best-laid plans based on the belief that the pandemic would transition into an endemic in 2022?
“If we look at the global situation, I think it’s fair to say that we are still in very challenging times,” Rasmus Bech Hansen, CEO of Airfinity, a life sciences analytics company, said during a recent press briefing. “Cases globally are rising quite significantly. We are sadly not far from the biggest peak we had in 2021.”
Vaccine makers respond to omicron
For pharma companies, the scramble is back on to find drugs that can prevent and treat omicron. COVID-19 vaccine producers such as Pfizer-BioNTech and Moderna have ramped up their efforts to create an omicron-tailored shot. And they are in an optimal position to do so quickly and efficiently, as they have the mRNA expertise.
“We continue with high speed with the development of a potential omicron vaccine to be ready if one is needed,” BioNTech CEO Ugur Sahin, said earlier this month in a press conference.
The companies have said it would be possible to have an omicron-adapted vaccine ready by February or March. Airfinity estimates that it would take until September for a different company with a new omicron-adapted vaccine to receive approval.
“This is the highest level of alert we’ve ever been on, by far,” Moderna President Stephen Hoge, M.D., told The Washington Post.
If an omicron-adapted vaccine is required, scaling up to manufacture it will slow the pace of production. Airfinity’s current projection for 2022 global vaccine production is 8.7 billion doses. But if a new shot is needed, the analytics group figures only 5 billion doses will be manufactured, with some producers leaving the market entirely as demand for their shots disappears.
“We are already freeing up capacity for plasmid production,” Sierk Poetting, BioNTech’s chief operating officer, said in the press conference. “The production process itself, once you have the plasmid, is exactly the same.”
The emergence of omicron will keep many more companies busy than the handful that have developed successful vaccines and antibodies. There are 358 COVID-19 vaccines in preclinical development around the world, says Airfinity. And of the 175 candidates in clinical development, 41 are in phase 3.
Among those in development are combination vaccines that would inoculate against COVID-19, the flu and other respiratory diseases. Also in the works are different forms of vaccines that might gain acceptance with those who are hesitant.
“There’s no doubt that needle injections are keeping some people from being vaccinated, so we are seeing intranasal, we’re seeing oral, we’re seeing needle-free injection,” Bech Hansen said in the press briefing. “Looking into 2022, we can expect significant innovations and scientific progress as we have already witnessed in 2021.”
The emergence of omicron has been a wake-up call that COVID-19 will remain a major threat for a while. For example, it recently compelled analysts at Cantor Fitzgerald to increase their projection of 2027 sales for the Pfizer vaccine, Comirnaty, from $10 billion to $25 billion.
But while omicron presents a new challenge, it’s not as though vaccine makers are starting at square one. Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization, remembers the “daunting” feeling the pandemic brought a year and a half ago.
“We set out to decouple infection from death and disability, and we are starting to see quite a bit of that decoupling, and that is incredibly promising,” McMurry-Heath said. “In the U.S. alone, mRNA vaccines have saved more than a million lives in this last year. Can you think of another medical innovation that within its first year of use saved a million lives? It’s absolutely miraculous.”
Other COVID-19 treatments
With omicron’s emergence, the scramble also is on to uncover drugs to treat those who are infected with COVID-19. In lab studies, the most commonly used treatments, antibodies by Regeneron and Eli Lilly, show little effectiveness against omicron.
Another approved antibody treatment, produced by GlaxoSmithKline and Vir Biotechnology, is the best available option against omicron, but supply is quickly becoming strained.
Meanwhile, Regeneron and Lilly are busily developing treatments to address the new variant. Regeneron CEO Len Schleifer, M.D., Ph.D., said the company could be ready with their adjusted version in the first quarter of 2022, and it will be effective against multiple variants.
“We need to figure out a way to get this to patients on a large scale before the next variant shows up. We don’t want to be chasing our tail here,” Schleifer told CNBC.
“We have a whole host of new antibodies which can work against both omicron and delta.”
Another option coming is Pfizer’s oral antiviral Paxlovid, which had yet to be approved as of Dec. 21. Considering that a trial has shown Paxlovid cuts the risk of hospitalization and death by 89% and the demand it is likely to generate, it could also face supply problems initially.
Merck and Ridgeback’s oral antiviral molnupiravir hasn’t fared as well in testing. After an interim trial result showed it cut the risk of hospitalization and death by 50%, more complete data later showed a risk reduction of 30%.
While the biopharma–and virtually every other–industry initially recoiled with the market uncertainty and restrictions brought on by the pandemic, those factors receded through 2021. Will the emergence omicron bring a return to those factors?
Glenn Hunzinger, leader of the U.S. pharma and life science segment at business consulting firm PwC, doesn’t think so.
“We believe that we’re past the concerns of COVID stopping the business environment,” Hunzinger told Fierce Pharma. “Ultimately people have figured out a way to do business. I think this is just the new norm of how the world will operate.”
Original Post: fiercepharma.com
You Say Trintellix, I Say Brintellix: Why a Drug Name in the US Won’t Always Translate Across the Pond Feedzy
As a British citizen living in England but writing on American drug names, I’m in a perfect position to know that many drugs approved in Europe and the U.K. can have very different names from those in the U.S.
Why is that? Well, to find out, Fierce Pharma Marketing sat down with Scott Piergrossi, president of creative at the Brand Institute, a company that has helped name some of the world’s biggest drugs. He’s not explaining the reasoning behind any drug name changes mentioned in this piece, but offering up insight into why different regions may need tweaks–or complete rethinks–in branding for the same drug.
Often, the change in name can be very minor. Let’s take Amgen’s new non-small cell lung cancer drug as an example: In the U.S., the FDA approved the drug as Lumakras, but in in Europe, its counterparts at the European Medicines Agency approved the med as Lumykras earlier this month.
You’ll see this U.S.-Europe divide a lot with drug names–but why? Piergrossi explains that changing a single letter can often provide enough differentiation to satisfy regulatory requirements, which can be different in the U.S. and Europe, “such as changing a vowel to a y, or adding/removing a letter or two.” Just as we see with Lumakras/Lumykras.
Another key reason an agency might reject a name is if they think the name is overly promotional–what the FDA refers to as “misbranding,” such as making misrepresentations about safety or efficacy. Hence, you don’t have antivirals called KillsCOVIDNoSideEffects.
Some examples can seem obvious, but Piergrossi explains there can be more subtle and subjective naming differences that create misleading suggestions in a name.
Take the FDA-approved osteoporosis drug Boniva. In Europe and elsewhere, the drug is sold under the brand name Bonviva. “The latter perhaps suggesting ‘good life’ more so than the former,” Piergrossi says, though he adds that extracting meaning from an invented name, in his experience, is “highly subjective.”
There’s also the rare example of a change mandated after the agency has approved a drug and its name. We saw this with Trintellix, an antidepressant from Takeda and Lundbeck. That’s its newer name: Originally approved as Brintellix, the drug had to change–per the FDA–given that name’s similarity to AstraZeneca’s anti-blood-clotting therapy, Brilinta. Prescribers were actually confusing the two brands, triggering medication errors. Brintellix still bears that name in Europe and elsewhere.
Sometimes, it just comes down to regional preferences at a company. Global pharmas have global teams working on product marketing and name development. “A regional team might prefer one spelling versus another, assuming they are given the latitude to make those decisions, so the name is modified accordingly,” said Piergrossi.
Original Article: fiercepharma.com
GlaxoSmithKline Rushes to Accelerate COVID-19 Antibody Output Amid Omicron-driven Demand Feedzy
GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they’re the only companies with an antibody that appears to be truly effective against omicron.
The FDA on Dec. 30 cleared a Samsung Biologics site as a second manufacturing facility to make GSK and Vir’s Xevudy (sotrovimab), a GSK spokesperson told Fierce Pharma.
Along with adding the new facility, GSK and Vir worked with external partners to secure additional batches of drug substance to support supply this year, the spokesperson said via email.
GSK had been planning to commission a new production facility to scale up production and establish a second manufacturing site amid pandemic uncertainty, the spokesperson said. But omicron’s emergence suddenly pushed the acceleration button.
GSK and Vir recently found that sotrovimab retains its strength against omicron in cell cultures, while lab data showed that Eli Lilly’s antibody combo of bamlanivimab and etesevimab and Regeneron’s REGEN-COV cocktail are unlikely to be able to tackle the new variant.
That means, among the three FDA-authorized antibody drugs to treat infected patients, only sotrovimab is still powerful enough to fight omicron. AstraZeneca’s Evusheld is authorized as a prevention method for immuno-compromised people.
After those lab tests, the U.S. government in December temporarily halted distribution of Lilly’s and Regeneron’s offerings. Although the two products are now shipping again, their ability to fight the now-dominant omicron remains questionable.
Demand naturally started to shift to Xevudy. Last week, the Biden administration signed a deal to buy 600,000 additional doses for distribution this quarter.
“We were on the phone with the U.S. government immediately, sharing the data, discussing what was possible from a supply perspective,” said Bart Murray, who leads GSK’s COVID operation in the U.S., as quoted by The Wall Street Journal.
Other countries have also been snagging supplies of Xevudy. A few days ago, Canada signed on for 20,000 doses. GSK also has agreements with Japan, U.K., Singapore, Australia and others. All told,
GSK and Vir have said they expect to manufacture about 2 million doses globally in the first half of 2022.
Before the new deal, GSK had delivered the 440,000 doses it agreed to supply to the U.S. in 2021. The government is still allocating that supply to healthcare facilities. The company now expects to start shipping the 600,000 doses in February and March, the spokesperson said.
Both Regeneron and Eli Lilly have started developing new antibody treatments that could neutralize omicron.
Meanwhile, China’s Brii Biosciences is seeking an FDA green light for its antibody combo of amubarvimab and romlusevimab, which won Chinese approval in December. The company recently said its cocktail also held up against omicron. The U.S. doesn’t yet have any supply agreement with Brii.
Fierce JPM Week: Bristol Myers’ Next-gen Autoimmune Med Not Just Another JAK Drug, Exec Says Feedzy
After a high-profile study turned up safety risks for Pfizer’s JAK inhibitor Xeljanz last year, the FDA put the entire class under a microscope–and it only recently went back to granting new approvals in that class. Bristol Myers Squibb, meanwhile, has a new candidate that the company’s chief medical officer says is safer than the other JAKs.
Speaking during the Fierce JPM Week virtual conference, Bristol’s CMO, Samit Hirawat, said the company’s deucravacitinib is a novel TYK2 inhibitor “with a very specific downstream effect of integrating IL-12, IL-23 and interferon and sparing other cytokines and sparing JAK 1, 2 and 3.”
While Bristol aims to highlight its med’s differences from drugs in the JAK class, TYK2 is known colloquially as JAK4 and is part of the Janus kinase family. That has some industry watchers worried that the FDA may take a tough stance on the candidate amid safety concerns for the larger drug class.
After an FDA submission last year, deucravacitinib is under review to treat moderate to severe plaque psoriasis. The agency’s decision deadline is set for Sept. 10, 2022.
So far in deucravacitinib’s studies, BMS doesn’t “see the hematologic impact that JAK inhibitors do show [and] we don’t see the dysfunction in the liver enzymes that is seen with JAK inhibitors,” Hirawat said during Fierce JPM Week.
Further, “we don’t see dyslipidemia that is shown by JAK inhibitors,” Hirawat added.
Since Xeljanz post-marketing study showed heightened risks of cardiovascular problems and cancer, the FDA has put the entire JAK inhibitor class in a protracted safety review. That process triggered missed approval deadlines for new drug candidates and delayed label expansions for existing meds.
More recently, the FDA started giving new blessings for JAK drugs–but under the condition that they’re used behind old-school TNF inhibitors such as Humira. Pfizer’s new Cibinqo and AbbVie’s Rinvoq recently won eczema approvals, for instance.
As for deucravacitinib, Hirawat said the Poetyk PSO-1 and Poetyk PSO-2 studies–plus trials in Japan and China–show that the med is a “first-in-class” medicine, apparently hoping to differentiate the drug from existing meds at the center of the FDA safety review.
When Bristol bought Celgene for $74 billion back in early 2019, the company had to sell the lucrative psoriasis drug Otezla to score antitrust approval for the deal. The company opted to stick with deucravacitinib, which later beat Otezla in the Poetyk studies by helping more patients achieve 75% skin clearance.
These days, Amgen markets Otezla and is generating blockbuster sales from the psoriasis medicine. For its part, Bristol figures deucravacitinib can generate $4 billion at peak.
And deucravacitinib has some other new indications in the works. BMS is “looking forward to seeing the data imminently” for a phase 2 trial in systemic lupus erythematosus, Hirawat said. If that result is “supportive,” BMS will launch a phase 3 program, he said.
Meanwhile, the drug didn’t meet proof of concept criteria in inflammatory bowel disease last October, but Hirawat said the company is running two studies with higher doses and is “absolutely” committed in that disease. With those results, the company expects to have more information about potential indications to “pursue in the future,” Hirawat said.
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