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Eli Lilly Enters Strike Mode Ahead of Pivotal Alzheimer’s, Diabetes Launches, CFO Says Feedzy

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As Eli Lilly progresses on its quest to debut 20 new drugs in a decade, the company is anticipating two red-hot launches next year in Alzheimer’s disease and diabetes. Meanwhile, the company is charting some unexpected gains in 2021’s close thanks to the success of its COVID-19 antibody combination.

As Lilly prepares to turn the page on another year, it’s ready to rumble on several fronts, Chief Commercial Officer Anat Ashkenazi said last week during an interview at the company’s investor day in New York. The company is equipped if more COVID antibody orders come in, ready to go in diabetes thanks to its experience with Trulicity and Jardiance, and “rapidly” tuning its commercial pitch in neuroscience, she said.

Alongside its late-stage testing efforts in Alzheimer’s disease, Lilly is taking steps to ensure its investigational drug donanemab gets off to a smoother start than its would-be rival, Biogen’s Aduhelm. For one, the Indianapolis-based pharma is working to build out an infusion and diagnostic infrastructure to forge a more efficient “ecosystem” for patients, Ashkenazi said.

Importantly, Lilly has also thrown down the gauntlet with a head-to-head trial against Aduhelm, also known as aducanumab. Data from that study are expected by the middle of next year, Ashkenazi said.

Getting ready to launch in Alzheimer’s

In preparation for donanemab’s potential launch, Lilly has worked to build out its commercial capabilities in neuroscience, Ashkenazi noted. That effort comes in contrast to other drug launches for the company over the years, many of which came in familiar treatment areas such as diabetes.

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Lilly has submitted the drug for an accelerated approval and expects to complete its rolling submission by the end of next year’s first quarter, Ashkenazi said. If all goes to plan at the FDA, the company aims to launch donanemab toward the end of next year.

The company expects limited sales when the drug first hits the scene, but the arrival of phase 3 data in 2023 could serve as another “inflection point” for the drug, Ashkenazi said. By the middle of next year, Lilly expects to have data from its head-to-head trial against Aduhelm, as well.

The head-to-head study “demonstrates our confidence in the product and it will provide further insight for prescribers on how to look at these different drugs,” she said.

For its part, Biogen won accelerated approval from the FDA for Aduhelm in June, meaning the company is on the hook for a confirmatory trial to prove its drug works. Biogen is aiming to finish that trial by 2026.

Lilly’s next GLP-1 entrant

As far as Lilly’s GLP-1 drug candidate tirzepatide is concerned, the company already has a strong commercial backbone in diabetes thanks to its repertoire of insulins, plus GLP-1 and SGLT2 meds Trulicity and Jardiance, respectively.

Lilly is anticipating a Type 2 diabetes nod for tirzepatide first, though the company hopes to eventually gain a use in obesity. Surprisingly, the overlap between these two areas isn’t very big, Ashkenazi said. In turn, that weight loss nod could help tirzepatide unlock an entirely separate market beyond diabetes.

“There is a significant percent of patients who suffer from obesity who do not have diabetes, so it creates an opportunity for a new space for us,” Ashkenazi said.

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Meanwhile, the conversation around obesity is changing.

“It’s not a lifestyle choice, it is a disease,” Ashkenazi pointed out. She flagged the fact that the Centers for Disease Control and Prevention included obesity among the top complications that put people at higher risk of severe COVID-19. In a way, that inclusion advanced the conversation around obesity by acknowledging it as an actual disease, she said.

“That’s where we have to educate prescribers and patients on the fact that there is an opportunity here to change your trajectory for other cardio-metabolic diseases in the future,” Ashkenazi said.

Should the drug clinch a weight loss nod, it will be going up against Novo Nordisk’s new obesity blockbuster-in-waiting Wegovy.

The COVID fight continues

On the COVID-19 front, the government is still tapping Lilly for antibody supplies. Early last month, the U.S. government splashed out $1.3 billion for another 614,000 doses of Lilly’s antibody combo of bamlanivimab and etesevimab. Those sales will mostly be reflected in Lilly’s 2021’s revenues.

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The company expects to wrap up its delivery by the end of 2022’s first quarter, Ashkenazi said. This year, the company is reporting a total of $2.1 billion COVID-19 antibody sales. The only antibody revenue reflected in next year’s guidance is the “remaining portion” of Lilly’s latest order, which should amount to about $420 million to $450 million early next year.

Looking forward,”it’s very difficult to forecast the demand for the COVID antibodies,” Ashkenazi said. Still, Lilly is ready to roll if the government decides it wants more bamlanivimab and etesevimab, she added.

Meanwhile, the COVID fight continues to evolve. Lilly’s combo stacks up well against delta, which remains the predominant version of the virus in the U.S. but appears to lose some efficacy against omicron, Ashkenazi noted.

With that in mind, the company is working on a next-generation antibody it thinks should stand up to omicron, she said. Still, the introduction of oral antivirals such as Pfizer’s Paxlovid could displace some demand for infused antibodies, the CFO figures.

“I expect that overall, the demand for the antibodies could potentially go down if those orals are introduced into the marketplace,” Ashkenazi said.

Source Here: fiercepharma.com

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