Before the sun has even risen on the first day of J.P. Morgan’s 2023 annual healthcare conference, two Eli Lilly execs already have their plates full, dubbing 2023 the year of new modalities and new medicines for the Big Pharma.
“It's an exciting time,” Patrik Jonsson, president of Lilly’s U.S. arm, EVP, president of immunology and chief customer officer, said early this morning, pointing to anticipated launches and the company’s next wave of innovation. “The impact we can make on patients has never been bigger than this right now. We just need to continue to get it right.”
“We're in this position of being really busy with five launches, and then the next five big molecules,” Dan Skovronsky, M.D., Ph.D, Lilly’s chief scientific officer and chief medical officer, told Fierce Biotech on the conference sidelines.
“It's daunting—we need to leave J.P. Morgan and get back to work,” Skovronsky continued with a laugh.
Top of mind following the FDA accelerated approval of Eisai and Biogen’s lecanemab, an Alzheimer’s disease drug now known as Leqembi that targets amyloid plaque, is Lilly’s donanemab. The investigational Alzheimer’s drug is also built around the amyloid plaque clearance theory and is currently being assessed in several trials, including a phase 3 set for a top-line readout this spring.
Lecanemab’s approval is a win-win, Skovronsky said, because it’s beneficial not only for the field but also patients with Alzheimer’s. If Eisai’s and Biogen’s phase 3 lecanemab trial had failed, it may have meant donanemab could prove less effective, since both monoclonal antibodies are based around amyloid clearance.
Lilly is applying for accelerated FDA approval for donanemab, but Skovronksy thinks the biggest opportunity to help patients will come with the full data and FDA approval package. With a potential full approval, the Big Pharma also intends to ask the Centers for Medicare & Medicaid Services (CMS) to reconsider its decision that only includes coverage for patients in clinical trials.
“It's an unfortunate situation for patients,” Skovronksy said. “We don't need CMS to provide coverage for randomized controlled trials—that's our business.”
Some of the other expected planned launches for 2023 are immunology drugs mirikizumab for ulcerative colitis and lebrikizumab for atopic dermatitis, which are both currently under FDA review. Lilly expects to make mirikizumab available in the U.S. in the first half of this year, Jonsson said, with rollouts expected later in Europe and Japan. As for lebrikizumab, if everything goes to plan, Lilly intends to launch the atopic dermatitis drug in late 2023, according to Jonsson.
The Big Pharma also anticipates market entry for pirtobrutinib, a small molecule next-gen BTK inhibitor for patients with relapsed/refractory mantle cell lymphoma who have received prior BTKi therapies. Finally, there’s tirzepatide¸ which is currently under phase 3 assessment but will be Lilly’s fifth and final 2023 launch The obesity drug, a dual GIP/GLP-1 receptor agonist, holds an FDA fast-track classification.
But even if those five launches go off without a hitch, Lilly won’t rest on its laurels. The Big Pharma will zoom in on its next five opportunities, which include a once weekly insulin; an oral SERD being studied in a phase 3 trial among patients with breast cancer; remternetug, a next-gen amyloid lowering drug for Alzheimer's; and two new phase 3 opportunities in obesity and diabetes tied to its oral GLP 104.
“We’ve never experienced a similar year and I think it’s actually quite unique for the industry,” Jonsson said, adding the biggest challenge he anticipates for this new year is being able to maintain focus and fully capitalize on each effort to maximize impact for patients.
“We've got a full plate,” Skovronsky said. “Of course, we always want to see what more we can do on behalf of patients. But if we can have success with these 10 things that I just mentioned, that’s a lot and positions us really well for not just the next thing, but the one after that too.”
As for JPM, it’s too soon to say how this year’s back in-person conference stacks up compared to other years, but Skovronsky said Lilly was meeting with more companies on the business development side this year compared to the last two virtual conferences.
“It’s been true for several years now that oncology and immunology is where we see the most biotech investment … so we have more meetings there,” Skovronsky said. “Of course, if there's any biotech company working in diabetes, obesity or Alzheimer's, we'd love to meet with them—and they love to meet with us.”