Stef­fen Lang

No­var­tis has of­fered to buy a cell and gene ther­a­py man­u­fac­tur­er in an on­go­ing ef­fort to un­clog a com­mer­cial roll­out for its pi­o­neer­ing CAR-T ther­a­py Kym­ri­ah that’s been slowed down by man­u­fac­tur­ing woes.

Set to be­come a whol­ly owned No­var­tis fa­cil­i­ty, Cell­for­Cure first signed an agree­ment to pro­duce Kym­ri­ah in Ju­ly 2018. With the tech trans­fer com­plete, the clin­i­cal sup­ply pro­duc­tion is ex­pect­ed to be­gin by mid-2019 — when the deal is ex­pect­ed to close.

The CD­MO is based in Les Ulis near Paris, op­er­at­ing what it de­scribes as one of the first and largest plat­forms in Eu­rope for cell and gene ther­a­py.

Vari­abil­i­ty in prod­uct spec­i­fi­ca­tions has ham­pered No­var­tis’ abil­i­ty to meet de­mand for an in­cred­i­bly com­plex treat­ment — which in­volves ex­tract­ing T cells from pa­tients, mod­i­fy­ing them and then in­fus­ing pa­tients with a ther­a­peu­tic punch — and a re­volv­ing door at the cell man­u­fac­tur­ing chief’s of­fice didn’t help.

In Au­gust, when No­var­tis scored a key mar­ket­ing ap­proval from the Eu­ro­pean Com­mis­sion, it al­so un­veiled plans to in­vest €78.8 mil­lion in­to their cell and gene ther­a­py man­u­fac­tur­ing op­er­a­tions in Switzer­land. It al­so has an al­liance in place with the Fraun­hofer In­sti­tute in Ger­many to sup­port clin­i­cal tri­als and post-ap­proval man­u­fac­tur­ing.

Liz Bar­rett

Liz Bar­rett, who’s step­ping down as on­col­o­gy chief, pre­vi­ous­ly al­so told Pharmapho­rum that No­var­tis was look­ing to move man­u­fac­tur­ing fa­cil­i­ties clos­er to the clin­ics where pa­tients are treat­ed to speed up the process.

It’s all part of a toe-to-toe fight with Gilead and Kite Phar­ma, which have a be­spoke man­u­fac­tur­ing site for Yescar­ta.

“If com­plet­ed, this ac­qui­si­tion al­so would po­ten­tial­ly in­crease man­u­fac­tur­ing ca­pac­i­ty for oth­er cell and gene ther­a­pies in the No­var­tis pipeline,” Stef­fen Lang, No­var­tis’ glob­al head of tech­ni­cal op­er­a­tions, added in a state­ment.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.