Io­vance won’t be able to file for its first-ever ap­proval by the end of this year af­ter all.

At is­sue is the po­ten­cy as­says Io­vance is us­ing to de­fine what would be the first-ever tu­mor-in­fil­trat­ing lym­pho­cyte (TIL) ther­a­py. Reg­u­la­tors want to have more da­ta on the cur­rent as­says, or po­ten­tial­ly see dif­fer­ent as­says in the BLA, the biotech sug­gest­ed.

Maria Fardis

All of that work would push the BLA sub­mis­sion in metasta­t­ic melanoma to 2021, when Io­vance has com­plet­ed the re­quired clin­i­cal fol­low-up and fin­ished re­fin­ing its as­says as well as de­vel­op­ing al­ter­na­tive ones. That means a launch won’t hap­pen un­til 2022 at the ear­li­est, with cer­vi­cal can­cer to fol­low in the same year.

Chem­istry, man­u­fac­tur­ing and con­trol is­sues have loomed large among late-stage de­vel­op­ers of cell ther­a­py since the FDA slammed Bris­tol My­ers and blue­bird with a sur­prise refuse-to-file let­ter cit­ing a faulty sec­tion on CMC. The com­pa­nies still man­aged to sort it out and se­cure pri­or­i­ty re­view for the BC­MA CAR-T, ide-cel, but not af­ter five months of Cel­gene in­vestors fret­ting about the fate of their $7 bil­lion CVR pay­out.

An­a­lysts sus­pect­ed it was al­so a key rea­son why J&J-part­nered Leg­end Biotech pushed back their EMA fil­ing — to pre­pare a strong CMC pack­age and stay on the safe side.

For Io­vance the de­lay trig­gered a steep drop in stock price, as in­vestors trad­ed shares $IO­VA down 20.46% to $25.50.

Most an­a­lysts, though, ap­pear to echo Chardan an­a­lyst Geu­lah Livshits’ as­sess­ment that “this is a solv­able (but not triv­ial) is­sue.”

“In our view, the key word is ‘re­fine,’ which does not sug­gest the re­quire­ment for ad­di­tion­al clin­i­cal stud­ies or sub­stan­tive work,” Mizuho an­a­lyst Mara Gold­stein wrote in a note. “How­ev­er, this does raise the un­cer­tain­ty pro­file as the ex­act point of con­cern is un­known to us.”

Un­like CAR-T, TILs are non-en­gi­neered and more het­ero­ge­neous; mea­sur­ing the po­ten­cy is thus more com­plex. Io­vance is al­so go­ing af­ter sol­id tu­mors with li­fileu­cel, CEO Maria Fardis not­ed in a state­ment.

Biren Amin of Jef­feries ex­pects a de­lay be­tween four and six months. While he pre­vi­ous­ly pre­dict­ed 2021 and 2022 sales of $61 mil­lion and $458 mil­lion, re­spec­tive­ly, he’s now di­al­ing down those es­ti­mates to $211 mil­lion for 2022.

So­cial: Shut­ter­stock

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

With its Allergan buyout now long in the books, AbbVie has been taking a hard look at its suddenly expansive global ops to find space for a deal. Now, working with a Chinese cell and gene therapy player hungry for more elbow room abroad, AbbVie has taken one UK facility off its books.

AbbVie has offloaded its Liverpool manufacturing site as part of a $118.7 million sale to Chinese cell and gene therapy player Pharmaron, which is pitching the purchase as the next step in its global expansion plans, the companies said last week.