Eli Lilly enters strike mode ahead of pivotal Alzheimer’s, diabetes launches, CFO says – FiercePharma

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 …….

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.