A cou­ple of years ago, Pfiz­er passed on an op­tion to buy out AM-Phar­ma and its re­com­bi­nant hu­man al­ka­line phos­phatase for kid­ney fail­ure on the heels of some mixed Phase II da­ta. Now, the pro­gram has at­tract­ed a new part­ner — and an ap­proval could mean a big pay­out for AM-Phar­ma.

Tokyo-based Ky­owa Kirin is putting down $23.6 mil­lion up­front for ex­clu­sive de­vel­op­ment and com­mer­cial­iza­tion rights to ilo­fo­tase al­fa in Japan. There’s an­oth­er $148 mil­lion in biobucks on the line, adding up to a $290 mil­lion deal with “tiered dou­ble-dig­it roy­al­ties” and a drug sup­ply fee.

AM-Phar­ma will be re­spon­si­ble for an on­go­ing Phase III study, which seeks to en­roll up to 1,600 pa­tients with sep­sis-as­so­ci­at­ed acute kid­ney in­jury and is ex­pect­ed to pro­duce da­ta in 2023. The com­pa­ny’s al­so on the hook for a Phase I PK, safe­ty and tol­er­a­bil­i­ty study in Japan. Af­ter that, Ky­owa Kirin will take the can­di­date to reg­u­la­tors.

Sep­sis is a life-threat­en­ing or­gan dys­func­tion that’s caused by an im­prop­er host re­sponse to in­fec­tion. The kid­ney is the most com­mon­ly af­fect­ed or­gan, re­sult­ing in AKI, which oc­curs in 40% to 60% of crit­i­cal-care ad­mis­sions, ac­cord­ing to the part­ners.

Ilo­fo­tase al­fa works by de­phos­pho­ry­lat­ing sub­stances that can trig­ger the im­mune sys­tem in­to dev­as­tat­ing the kid­ney, thus detox­i­fy­ing them and re­duc­ing the in­flam­ma­tion. In a Phase II tri­al, a 1.6 mg/kg dose showed a 46% rel­a­tive re­duc­tion in mor­tal­i­ty com­pared to the place­bo group (p=0.022). How­ev­er, the drug missed its pri­ma­ry end­point of im­prov­ing kid­ney func­tion in sev­en days.

“Short term kid­ney func­tion im­prove­ment was re­al­ly more a de­sign for the Phase II study to be able to pick the most op­ti­mal dose,” CEO Erik van den Berg told End­points News back in 2019. “It’s kind of a bio­mark­er if you like. For Phase III one has to choose hard clin­i­cal end­points, and the most pre­ferred end­point by the reg­u­la­tors is the mor­tal­i­ty in this set­ting.”

Pfiz­er had paid $87.5 mil­lion for a mi­nor­i­ty stake in AM-Phar­ma and an ex­clu­sive op­tion to buy out the rest of the com­pa­ny back in 2015. The phar­ma walked away from the deal fol­low­ing the Phase II read­out, cit­ing “in­ter­nal strate­gic rea­sons.” But AM-Phar­ma pushed on with a Phase III tri­al any­way, en­rolling the first pa­tient in its piv­otal RE­VIVAL study back in No­vem­ber. The tri­al was planned with the help of a small boost from Cowen Health­care In­vest­ments and a loan from the Eu­ro­pean In­vest­ment Bank last March.

“Based on the num­ber of suc­cess­ful in­ter­na­tion­al part­ner­ships they have, they are the ide­al part­ner to sup­port the com­mer­cial­iza­tion of ilo­fo­tase al­fa in Japan,” van den Berg said of Ky­owa Kirin in a state­ment.

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”