INDIANAPOLIS—Back in March, Eli Lilly and Co. placed a bet on the Chinese market with a collaboration deal between itself and Shanghai-based Innovent Biologics Inc., and now the fall brings with it a renewed and upgraded version of that springtime pact.
Specifically, Oct. 11 saw the two companies announce an expansion of their drug development collaboration, which they note was already one of the largest in China between a multinational and domestic biopharmaceutical company. Under the terms of the expanded agreement, Innovent could receive additional milestones totaling more than $1 billion if the products reach certain development, regulatory and sales milestones, both inside and outside of China. Sales royalties and other payments would occur on certain products if commercialized outside China. Further financial terms were not disclosed. The original deal to develop three cancer therapies had a potential value of around $500 million for Innovent
The work revolves around an increasingly busy area of exploration in immuno-oncology, in which the goal is to inhibit Programmed Death Ligand-1, or PD-L1, which is hypothesized would activate T cells to fight cancer. The companies will collaborate to support the development and potential commercialization of as many as three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
Under the previous agreement, Lilly will exercise its rights to develop, manufacture and commercialize these potential cancer treatments outside of China. Innovent will now have the rights to develop, manufacture and commercialize these potential cancer treatments for China, subject to a Lilly opt-in right for co-development and commercialization.
“We believe that combination therapy in immuno-oncology has the potential to transform the way cancer is treated,” said Dr. Greg Plowman, vice president of oncology research at Lilly. “We are pleased to be expanding our collaboration with Innovent to further the development of potential therapies for those fighting cancer in China and around the world.”
Dr. Michael Yu, co-founder, president and CEO of Innovent, added: “We are honored that Lilly is so quickly expanding our relationship and that Lilly is trusting Innovent to develop and manufacture their newly created bispecific antibodies for China. We are excited to be at the forefront of immuno-oncology drug development and to benefit from Lilly's deep experience in bispecific antibodies.”
Among the other players in the field are Genentech and Merck & Co.
Genentech investigational cancer drug atezolizumab reportedly is effective in shrinking tumors in people with locally advanced or metastatic non-small cell lung cancer whose disease expressed PD-L1. And trials of Merck’s Keytruda has been promising in treating three types of cancer: melanoma, non-small cell lung cancer and mesothelioma—also known as pembrolizumab, the drug is a humanized monoclonal antibody that blocks the interaction between the protein PD-1 and its ligands, PD-L1 and PD-L2.
However, Lilly’s potential good news on the immuno-oncology front was dampened by a hit to its stock prices—a dip of more than 10 percent in premarket trading Oct. 12 after the company announced it was discontinuing development of its late-stage cardiovascular drug evacetrapib due to insufficient efficacy.
An independent committee said there was a “low probability the study would achieve its primary endpoint based on results to date,” and Lilly has accepted the committee’s recommendation to terminate the Phase 3 Accelerate trial studying the efficacy of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease.
Lilly had been hoping to generate more than $630 million in annual sales of the drug; now, it will suffer an estimated cost of $90 million in pre-tax charges.
As reported at Biospace.com, “The failure of Evacetrapib is also serving as a warning to other drugmakers working on anti-cholesterol developers. In a Monday morning note, Joel Beatty, an investment analysts with Citi Group, said that Lilly’s decision could negatively impact Esperion Therapeutics’ development of ETC-1002. Beatty speculated Lilly’s decision could increase the likelihood the FDA will require outcomes trial results for LDL-lowering drugs before approval, In his note, Beatty said evacetrapib’s effectiveness at lowering LDL is at about the same rate as Esperion’s experimental drug.”
Another notable with regard to Lilly vacating this particular therapeutic space is that now Merck’s anacetrapib is the only CETP inhibitor in Phase 3 development.
Beatty speculated that, in light of these developments, Esperion’s ETC-1002 could be an attractive target for acquisition.
“This unfortunate outcome for evacetrapib does not change our ability to generate long-term growth,” according to Derica Rice, Lilly’s chief financial officer. “Our recent string of positive data readouts and our strong pipeline position us to grow revenue and expand margins through the remainder of this decade.”
