Lilly and Innovent kick oncology R&D pact to next level

INDIANAPOLIS—The Chinese market has been a strong lure for many a pharma and biotech in recent years, and Eli Lilly and Co. is no exception, having seen potential in the market generally and in Shanghai-based Innovent Biologics Inc. in particular. March of this year saw the two companies forge a research and development deal and now fall has brought an upgrade to it.

On Oct. 11, the two companies announced 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.

As Zacks Investment Research wrote in a note about the deal, “Considering that the incidence of cancer in China is soaring with 2.2 million men and women dying each year of cancer, per information provided by the World Health Organization, we are positive on the deal. The deal would give Eli Lilly the opportunity to tap the Chinese oncology market.”

The work between Lilly and Innovent 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.

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.

Closer to Lilly’s own back yard, the company also forged a deal recently with Canadian specialty pharmaceutical company Locemia Solutions to acquire global rights to an intranasal glucagon that is in Phase 3 trials right now for the treatment of insulin-treated diabetics suffering from severe hypoglycemia. Noted Zacks: “We are positive on the deal, which is in line with Eli Lilly’s strategy of strengthening its diabetes portfolio. The company’s diabetes portfolio currently consists of Jardiance, Tradjenta and Trulicity among others.”

However, Lilly’s good news on the immuno-oncology and diabetes fronts was dampened by a hit to its pipeline and stock prices after it 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.”

Also 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.