Scoop: No­var­tis’ re­treat on CAR-T in­cludes ax­ing most of its se­nior ex­ecs on the team

Us­man “Oz” Azam

No­var­tis’ plan to pull back on CAR-T in­cludes purg­ing most of the se­nior ex­ecs in­volved in the project, sig­nal­ing the phar­ma gi­ant’s R&D re­treat is more ex­ten­sive than the com­pa­ny has want­ed to ad­mit so far.

End­points News, which broke the sto­ry on No­var­tis’ sur­pris­ing R&D move, ini­tial­ly ob­tained the top frag­ment of an in­ter­nal cor­po­rate memo au­thored by Us­man “Oz” Azam at No­var­tis spelling out that the com­pa­ny is dis­solv­ing its cell and gene ther­a­py unit re­spon­si­ble for its pi­o­neer­ing work on CAR-T. Now we have the rest of it, and it in­cludes this on the team ex­ecs:

Un­for­tu­nate­ly a num­ber of col­leagues will be im­pact­ed by this change as many po­si­tions are be­ing elim­i­nat­ed. Im­pact­ed US-based as­so­ciates are be­ing no­ti­fied in meet­ings to­day. As­so­ci­ates based in Basel will learn more about their in­di­vid­ual cir­cum­stances on Thurs­day. The ma­jor­i­ty of the CG­TU Lead­er­ship Team mem­bers, who are among the best I have worked with, are al­so im­pact­ed.

Ear­li­er in the week, No­var­tis por­trayed the de­ci­sion to in­te­grate the unit in­to its on­col­o­gy di­vi­sion as an ef­fi­cien­cy move, some­thing No­var­tis does on a reg­u­lar ba­sis. The com­pa­ny, a spokesper­son not­ed, would con­tin­ue to work in the field and “with a new in­te­grat­ed de­vel­op­ment mod­el, we can ef­fi­cient­ly ad­vance our work on CART as part of our fo­cus in im­muno-on­col­o­gy by rein­te­grat­ing the func­tions.”

Elim­i­nat­ing the ex­ec­u­tive team un­der­scores con­cerns that No­var­tis, one of the three key lead­ers in CAR-T, along with Kite and Juno, is step­ping away just as the first CAR-T ther­a­pies are near­ing ap­proval. And No­var­tis has said that it will con­tin­ue to push its lead pro­gram CTL019 in pe­di­atric r/r ALL to the FDA in ear­ly 2017 and the EMA lat­er in 2017.

Just two years ago, in a Forbes cov­er sto­ry, No­var­tis CEO Joe Jimenez vowed to pur­sue CAR-T with a no-ex­pens­es-spared ap­proach to cur­ing can­cer. But how se­ri­ous can it be about CAR-T when the se­nior team lead­ers are be­ing axed as part of a move to elim­i­nate 120 jobs out of the 400 af­fect­ed?

I asked No­var­tis rep­re­sen­ta­tives that ques­tion ear­ly Fri­day, but have yet to hear back. (Up­date: Here’s their re­sponse.)

Azam goes on at one point to as­sure the 400-mem­ber group, many of whom were about to be axed, that “We have led the in­dus­try in trans­form­ing the prac­tice of med­i­cine with CART ther­a­py…the clin­i­cal and reg­u­la­to­ry teams will move to Glob­al Drug De­vel­op­ment and specif­i­cal­ly On­col­o­gy Glob­al De­vel­op­ment, and our col­leagues who are sup­port­ing com­mer­cial readi­ness will move to the On­col­o­gy or­ga­ni­za­tion.”

Here is the en­tire memo ob­tained by End­points:

Dear Col­leagues,

I still vivid­ly re­mem­ber the mo­ment that David Ep­stein in­vit­ed me to lead a new Unit ded­i­cat­ed to Cell & Gene Ther­a­pies. It was a mix­ture of ex­cite­ment and fear – a feel­ing that fu­els my en­tre­pre­neur­ial spir­it, and one that so many of you share. The risk of em­bark­ing on a new ad­ven­ture in un­chart­ed ter­ri­to­ry is that things don’t al­ways work out how you en­vi­sioned. To­day, I have the un­for­tu­nate task of an­nounc­ing that we are dis­solv­ing the Cell & Gene Ther­a­pies Unit. The ad­ven­ture start­ed years ago with the ini­ti­a­tion of the Penn col­lab­o­ra­tion. Af­ter rec­og­niz­ing the unique­ness of this ther­a­py, the or­ga­ni­za­tion im­ple­ment­ed our CG­TU de­sign struc­ture to bring to­geth­er bright minds in dis­parate func­tions from across No­var­tis to act as a SWAT team and fig­ure out how to make this a suc­cess. And we did. In the space of two years we com­plet­ed an un­prece­dent­ed tech trans­fer of CAR tech­nol­o­gy to a com­mer­cial-grade, GMP qual­i­ty, scal­able man­u­fac­tur­ing site in Mor­ris Plains, gained clar­i­ty on the in­di­ca­tions with the great­est ben­e­fit/risk pro­file, ini­ti­at­ed and ful­ly en­rolled two glob­al mul­ti-site clin­i­cal tri­als in two dif­fer­ent in­di­ca­tions, and laid the ground­work for the evo­lu­tion of fu­ture cell pro­cess­ing. But most im­por­tant­ly, as Kathy says, we saved the lives of sev­er­al kinder­garten class­es and dozens of par­ents and grand­par­ents.

We have led the in­dus­try in trans­form­ing the prac­tice of med­i­cine with CART ther­a­py.

While we were fo­cused on cell and gene ther­a­pies, the larg­er No­var­tis or­ga­ni­za­tion con­tin­ued to evolve. We el­e­vat­ed the role of On­col­o­gy, we have in­te­grat­ed our glob­al de­vel­op­ment func­tion, and we are op­er­at­ing, more than ever, as one No­var­tis. This is the time to re-in­te­grate the Unit back to the func­tions. We have grown, the or­ga­ni­za­tion has grown, and it’s time to come back to­geth­er. An in­te­grat­ed Mor­ris Plains foot­print in­clud­ing Tech Ops, Qual­i­ty and IT process de­vel­op­ment will move un­der BT­DM, the clin­i­cal and reg­u­la­to­ry teams will move to Glob­al Drug De­vel­op­ment and specif­i­cal­ly On­col­o­gy Glob­al De­vel­op­ment, and our col­leagues who are sup­port­ing com­mer­cial readi­ness will move to the On­col­o­gy or­ga­ni­za­tion.

Un­for­tu­nate­ly a num­ber of col­leagues will be im­pact­ed by this change as many po­si­tions are be­ing elim­i­nat­ed. Im­pact­ed US-based as­so­ciates are be­ing no­ti­fied in meet­ings to­day. As­so­ci­ates based in Basel will learn more about their in­di­vid­ual cir­cum­stances on Thurs­day. The ma­jor­i­ty of the CG­TU Lead­er­ship Team mem­bers, who are among the best I have worked with, are al­so im­pact­ed.

I know this news may be dif­fi­cult, and I know you have ques­tions. I would like to elab­o­rate on what I have shared here in a Town Hall this af­ter­noon at 15:00 CET/3:00 PM EDT. I know this is short no­tice, so we have arranged many ways for you to con­nect from mul­ti­ple time zones. We have booked rooms in East Hanover, Mor­ris Plains (where I will be) and Cam­bridge, or you can di­al in via We­b­cast or tele­con­fer­ence if you would like to hear more. A meet­ing in­vi­ta­tion will fol­low.

Scott Gottlieb, AP Images

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