NEW YORK – Bristol Myers Squibb on Thursday entered into an exclusive global strategic collaboration agreement with Eisai to codevelop and commercialize MORAb-202, Eisai's anti-folate receptor alpha (FRα) antibody.
BMS will pay $650 million upfront in the agreement, $200 million of which will go toward Eisai's research and development costs. Eisai will also be eligible for $2.45 billion in potential future development, regulatory, and commercial milestones.
The companies will jointly develop and commercialize MORAb-202 in Japan, China, South Korea, Taiwan, Hong Kong, Macau, the Philippines, Vietnam, Lao People's Democratic Republic, Thailand, Cambodia, Malaysia, Singapore, Indonesia, India, Australia, New Zealand, the US, Canada, the EU, the UK, and Russia. BMS will develop the drug in other regions and Eisai will be responsible for manufacturing and supply globally.
BMS and Eisai will share profits, as well as R&D and commercialization costs for MORAb-202. BMS will pay Eisai royalties on sales in regions outside of the collaboration countries. Eisai is expected to book sales of MORAb-202 in Japan, China, countries in the Asia-Pacific region, Europe, and Russia, while BMS is expected to book sales of MORAb-202 in the US and Canada.
MORAb-202 is the first antibody drug conjugate that Eisai has developed. The company is investigating the drug in two studies of FRα-positive solid tumors, including endometrial, ovarian, lung, and breast cancers. One is a Phase I clinical study in Japan and the other is a Phase I/II clinical study in the US.
"MORAb-202 combines Eisai's in-house-discovered antibody and payload using the company's advanced chemistry capabilities," Eisai CEO Haruo Naito said in a statement. "It is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma. Our collaboration with Bristol Myers Squibb will accelerate the development of MORAb-202 with the goal of bringing a potentially impactful treatment option to patients globally."
In Phase I study data presented in 2019, MORAb-202 demonstrated a manageable safety profile. The small study also showed an objective response rate of 37.5 percent, with one complete response in a patient with FRα-positive ovarian cancer. The disease control rate in this study was 75 percent.
Both the US and Japan trials are dose-escalation studies. The US trial began last year and will enroll up to 196 patients. The Japanese study began in 2017 and included up to 120 participants. The companies are planning to move MORAb-202 into the registrational stage of development as early as next year.
Eisai's stock jumped 4 percent on the news and was trading at $108.47 on Friday morning. BMS's stock price fell slightly and was trading at $66.15 on Friday morning.