- Eli Lilly hopes to launch 20 new drugs in the ten years between 2014 and 2023, the company announced Tuesday, setting an ambitious R&D goal after a lean 2015 which saw only one new drug approved in the U.S.
- Patent expiries have hurt Lilly's sales, particularly in the U.S., and the pharma giant has had mixed results in its efforts to replace that lost revenue. Global revenue was 13.5% lower than five years ago, despite heavy R&D investment in new products.
- In addition to the sweeping commitment to 20 new drug launches, Lilly also said it could win an average of two expanded indications or line extensions for already-approved products per year.
Lilly's goal is a little less impressive when accounting for the six products already approved in 2014, 2015, and the first few months of 2016. Achieving 20 new drug launches over ten years is no small feat, however, and would represent a substantial return on Lilly's investment if accomplished.
"There are no guarantees given the nature of science and of our business; 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," said Lilly CEO John Lechleiter.
Lilly said it will focus on five therapeutic areas: the core units of diabetes, oncology, immunology, and neurodegeneration, in addition to an emerging segment in pain.
In oncology, Cyramza and Portrazza both received FDA approval over the past two years, and Lilly hopes its treatment for soft-tissue sarcoma olartumab can clear regulatory review later this year. The breast caner drug abemaciclib headlines Lilly's near-term pipeline potential.
But Lilly also believes it will have five differentiated immuno-oncology molecules in clinical testing by year-end 2016, and 11 by year-end 2018. Targeting PD-L1 pathways is a key part of that strategy, both through combination therapies with products from other companies and through internal R&D.
Diabetes, on the other hand, has long been a mainstay unit for Lilly, and the company has invested heavily in establishing the cardiovascular benefit of Jardiance, a type 2 diabetes drug approved in 2014.
But there have been struggles elsewhere. Lilly scrapped the development of peglispro, a long-acting insulin, late last year.And a major phase 3 trial for the cholesterol drug evacetrapib was halted in October 2015 after showing no clinical benefit in reducing rates of heart attack, stroke, or cardiovascular disease.
Evacetrapib was part of a class known as CTEP inhibitors, which were once seen as as promising alternative to statins. Lilly had originally hoped the drug might reach blockbuster status.
Still, Lilly has continued to spend significant cash on drug development, investing 24% of revenues to R&D in 2015 - the third highest mark in the industry, according to EP Vantage. Jan Lundberg, head of Lilly Research Laboratories, claims the company has improved pipeline productivity by increasing focus, quality, and speed.
"These improvements have led to the potential for unprecedented R&D output," Lundberg said. Lilly will need such output if it hopes to significantly grow revenue in the years to come.