Can Eli Lilly’s R&D game plan deliver a bottom-line rebound?

Lechleiter
Breaking

Eli Lilly’s management has weathered a long, brutal slide in income by promising investors that its pipeline would pay off in a big way--big enough to begin to offset the loss of franchise therapies. And today it’s extending that promise to reach out to 2023, saying it’s potentially on track to gain approvals on an additional 14 new product launches through 2023.

"There are no guarantees given the nature of science and of our business,” noted CEO John Lechleiter in a statement; “however, in looking at our recent launches and current pipeline, we believe we are in the midst of the most prolific period of new launches in our company's 140-year history.”

To make that argument stick, Lechleiter has to successfully navigate the embedded disclaimer in his remark and do something about the company’s swooning income. Even in the first quarter of the year, the pharma giant saw another decline in income--down 17%--after a single-digit bump in revenue. 

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Lilly counts four core R&D focuses--diabetes, oncology, immunology and neurodegeneration--with pain added to the mix as the company pursues a late-stage study of tanezumab as well as a program for galcanezumab, a CGRP migraine drug.

To be sure, there has been progress at Lilly. A recent round of approvals includes a potential blockbuster nod for ixekizumab, sold as Taltz. Fairly soon we should learn more about its promising late-stage CDK 4/6 cancer drug abemaciclib.

Just about all of its most promising late-stage pipeline players, though, are attached to a familiar set of asterisks; most either face considerable risk in surviving pivotal studies or some major league competition that got a big head start. 

Taltz was recently approved with a blockbuster peak sales forecast for psoriasis, but it arrived in the wake of Novartis’s Cosentyx, with J&J and Merck in hot pursuit. Baricitinib is also attached to some lofty expectations for the hotly competitive rheumatoid arthritis market, and may do well after setbacks for Pfizer’s Xeljanz.

If abemaciclib makes the cut in cancer, it will have to distinguish itself against Pfizer’s CDK 4/6 pioneer Ibrance and a rival drug from Novartis that’s ready for regulatory filing. Lilly has made a lot of progress differentiating Jardiance, but diabetes is a heavyweight category that attracts competition from a slate of big players. And CGRP inhibition is another crowded field, with Amgen, Teva and Alder in hot pursuit.

The big gamble remains in Alzheimer’s, where Lilly is nearing the end of a second pivotal program for solanezumab. Lilly, though, essentially signaled that sola will miss one of two required primary endpoints with a last-minute trial design change. There’s also a BACE inhibitor--AZD3293, brought in from AstraZeneca--that just passed a safety review and entered its pivotal phase of development. After many setbacks in the field, few analysts give either drug a high chance of success.

Even an ugly win on partial success, though, would be a big deal in Alzheimer’s. After more than a decade of chronic failure in the field, millions of patients with no effective drugs to pick from now would be ready to try just about anything to slow the disease. 

Ultimately, patient desperation may be Lilly’s best hope for achieving its long-sought rebound on the bottom line. Lilly is focused on the right fields; what it needs to do now is show it can develop game-changing drugs that earn billions. 

- here's the release

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