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Deals

Lilly’s global deal for Innovent PD-1 could lead to U.S. approval, adds more cash for biotech’s R&D

August 18, 2020 11:09 PM UTC

An expanded deal with Innovent giving Lilly global rights to PD-1 inhibitor Tyvyt could position the pharma to gain U.S. approval of the cancer drug quickly and compete with other checkpoint inhibitors on price. For the Chinese biotech, the deal further strengthens a balance sheet that sports more than $1 billion in cash for pipeline development.

Eli Lilly and Co. (NYSE:LLY) paid Innovent Biologics Inc. (HKEX:1801) $200 million up front for ex-China rights to Tyvyt sintilimab; the biotech is eligible for $825 million in milestones, plus double-digit royalties. Lilly and Innovent already shared Tyvyt’s rights in China under a 2015 deal.

Last year, FDA’s Richard Pazdur urged Chinese companies to bring PD-1/PD-L1 inhibitors to the U.S. market and undercut the prices of other therapies in the class. Pazdur, director of FDA’s Oncology Center of Excellence, said the agency would accept regulatory applications for therapies that included data only from Chinese trials, provided the data were of high quality (see “Encouraging Chinese Companies to Bring Low-Cost PD-1s to the U.S.”).

Lilly spokesperson Mark Taylor told BioCentury that the company hopes to work with FDA “on the most expeditious path to filing in the U.S., leveraging existing data where possible,” and is expecting a launch within two to three years. He said the company hopes to market Tyvyt globally, but declined to name any specific geographies beyond the U.S. as top priorities; Lilly will continue to study the drug across various tumor types and in combinations.

Taylor and Innovent CEO Michael Yu declined to discuss Lilly’s pricing strategy for Tyvyt, which would compete with several approved anti-PD-1 and anti-PD-L1 drugs in the West, including Keytruda pembrolizumab from Merck & Co Inc. (NYSE:MRK), Opdivo nivolumab from Bristol Myers Squibb Co. (NYSE:BMY), and Tecentriq atezolizumab from Roche (SIX:ROG; OTCQX:RHHBY).

Tyvyt effectively does compete on price in China. The drug, approved in that country to treat classical Hodgkin lymphoma, is the sole PD-1 inhibitor on the 2020 National Reimbursement Drug List, and is priced at a 64% discount to its pre-reimbursement price. Innovent raised HK$2.4 billion ($303 million) in February to boost manufacturing capacity and meet increased demand (see “Tyvyt Edges Out PD-1s”; “Raising Cash for Tyvyt Rollout”).

Yu told BioCentury the partners’ original 2015 deal included Tyvyt’s ex-China rights, but Lilly out-licensed those territorial rights back to Innovent in 2017 while retaining some downstream economics. The partners continued to collaborate on Tyvyt’s development in China following that revision.

Tuesday’s deal closely follows news that could lead to a label expansion for Tyvyt. Last week, Lilly and Innovent said China’s National Medical Products Administration accepted for review an sNDA for the drug to treat first-line squamous non-small cell lung cancer (NSCLC); NMPA is already reviewing Tyvyt for first-line non-squamous NSCLC. 

The deal adds to Innovent’s 10-figure cash position, and Yu said it represents the first step in bringing the company’s innovative pipeline to the global market.

Among the pipeline’s 23 assets, 19 therapies have reached the clinic. Yu said the list includes five programs cleared for study in the U.S., including Tyvyt. Among the others are IBI188, a mAb targeting CD47; IBI322, a bispecific antibody targeting CD47 and PD-1; and IBI939, which targets TIGIT.

In May, Lilly partnered with another Chinese biotech, Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877), taking ex-China rights to mAbs against COVID-19 including clinical candidate JS016 (see “China’s First COVID mAb in Clinic”).

TARGETS
PD-1 (PDCD1, CD279) - Programmed cell death 1

PD-L1 (B7-H1, CD274) - Programmed cell death 1 ligand 1

TIGIT - T cell immunoreceptor with Ig and ITIM domains