Am­gen start­ed off the new year with a bang, join­ing forces with ADC play­er Synaf­fix and agree­ing to dole out as high as $2 bil­lion in Synaf­fix’s largest ADC li­cens­ing deal to date.

The Dutch biotech — run­ning in the same cir­cles as ADC Ther­a­peu­tics, Seagen, Macro­Gen­ics and Emer­gence Ther­a­peu­tics — said Thurs­day that it se­cured a li­cens­ing deal with Am­gen to de­vel­op new AD­Cs. As part of the deal, the Big Phar­ma gets ac­cess to Synaf­fix’s ADC plat­forms and tech­nol­o­gy, start­ing out with one ADC pro­gram. Am­gen re­tains an op­tion to ex­clu­sive­ly li­cense four more pro­grams at a lat­er date, but what those pro­grams could be re­mains un­der wraps.

Am­gen is shelling out $2 bil­lion to get its hands on the tech­nol­o­gy, and those pay­ments span pro­gram nom­i­na­tion and mile­stone pay­ments, plus tiered roy­al­ties on com­mer­cial sales. A Synaf­fix spokesper­son tells End­points News that there is an up­front pay­ment, but that amount re­mains undis­closed.

Am­gen will be do­ing all the R&D, man­u­fac­tur­ing and com­mer­cial­iza­tion of the AD­Cs, leav­ing Synaf­fix to on­ly be re­spon­si­ble for man­u­fac­tur­ing of com­po­nents specif­i­cal­ly re­lat­ed to its in-house tech­nolo­gies.

Am­gen de­clined to com­ment out­side of Synaf­fix’s an­nounce­ment.

This new deal comes right af­ter Synaf­fix an­nounced an­oth­er li­cens­ing agree­ment with Sin­ga­pore biotech Hum­ming­bird Bio­science, where Hum­ming­bird will be pay­ing out $150 mil­lion in up­front and mile­stone pay­ments, plus roy­al­ties on net sales.

The deal with Am­gen marks the biotech’s 12th col­lab­o­ra­tion and it now has close to two dozen pro­grams in de­vel­op­ment. Synaf­fix will in­vest in man­u­fac­tur­ing to de­liv­er cer­tain tech­no­log­i­cal com­po­nents in a bid to short­en can­di­date time to the clin­ic. The biotech is al­so branch­ing out in­to tar­get­ed gene ther­a­py and im­mune cell en­gagers, with a spokesper­son say­ing that the biotech will be shar­ing da­ta in those fields lat­er in the year to sup­port BD ac­tiv­i­ty.

The biotech cur­rent­ly has part­nered pro­grams with com­pa­nies like In­novent and Gen­mab, with Janssen as its oth­er Big Phar­ma part­ner in mul­ti­ple undis­closed pro­grams.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.