Merck KGaA spinoff licenses IBD drug to Eisai joint venture

Fountain on Lake Geneva
Geneva, Switzerland

Merck KGaA spinoff Calypso Biotech has licensed its inflammatory bowel disease candidate to EA Pharma, a joint venture between Eisai and Ajinomoto. The agreement gives EA Pharma the global license to anti-MMP-9 monoclonal antibody CALY-001.

EA Pharma is paying an upfront fee and committing to milestones and royalties—the size of which haven’t been disclosed—to secure the exclusive global license to develop and commercialize the candidate. Calypso will continue to help out with the development of CALY-001, which it sees improving outcomes in IBD and other conditions by inhibiting the matrix metalloproteinase 9 class of enzymes.

CALY-001 is derived from research at Merck. When Merck decided to shutter its site in Geneva, Switzerland, Alain Vicari and Yolande Chvatchko saw enough potential in the program to seek to secure its future. That led to the creation of Calypso, the third biotech to emerge from the closure of the Geneva site. Calypso got started by snagging two preclinical programs from Merck and €2.5 million ($2.7 million) from the Big Pharma’s VC wing.

Geneva, Switzerland-based Calypso has kept a low profile since spinning out of Merck in 2013. And the biotech has progressed more slowly than initially expected. Having set out aiming to get its two candidates into the clinic in 2015 or 2016, Calypso pushed back its timeline to 2016 or 2017 two years ago. Calypso now says its two candidates—the other being refractory celiac disease asset CALY-002—need to undergo IND-enabling studies before they are ready for the clinic.

While that means Calypso’s original goal of getting into phase 2 this year is likely to prove overly ambitious, the biotech now has a partner with the resources to push the program forward faster.

Eisai and Ajinomoto set up EA Pharma as a 60-40 joint venture in 2015. The idea was to combine Eisai’s gastrointestinal unit with Ajinomoto Pharmaceuticals to create a company capable of taking a sizeable share of the market for drugs targeting conditions of the stomach and intestines in Japan and elsewhere. EA Pharma has 1,250 employees and a pipeline stocked with five clinical-phase assets.

By adding CALY-001 to its pipeline, EA Pharma has gained an asset aimed at the same target as Gilead’s GS-5745. Gilead scrapped a phase 2/3 trial of the GS-5745 antibody in patients with ulcerative colitis, a form of IBD, last year after an interim review of efficacy data from the first 150 patients in the planned 1,600-subject trial found the drug was unlikely to improve outcomes. Calypso claims its anti-MMP-9 antibody has a distinct mode of action from GS-5745.