No­var­tis’ CAR-T chief Azam is leav­ing, but phar­ma gi­ant de­nies any ‘re­treat’ is un­der­way


No­var­tis re­spond­ed to a re­port in End­points News this morn­ing which out­lines the com­pa­ny’s de­ci­sion to purge most of the ex­ec­u­tive team in­volved in its pi­o­neer­ing cell and gene ther­a­py unit. Ac­cord­ing to the com­pa­ny, the de­ci­sion to cut up to 120 staffers as it re­de­ployed most of the 400 staffers back in­to its on­col­o­gy di­vi­sion does not sig­ni­fy any kind of a “re­treat.”

No­var­tis is still on track to nab the first FDA OK for a CAR-T to treat pe­di­atric acute lym­phoblas­tic leukemia, as­serts a com­pa­ny state­ment. In ad­di­tion, the com­pa­ny said that Us­man “Oz” Azam, the glob­al chief for this unit, has de­cid­ed to leave the com­pa­ny, while oth­er team ex­ecs in­volved in the cut­back still have a chance to land new jobs at the phar­ma gi­ant.

Ear­li­er this week End­points broke the sto­ry that No­var­tis is dis­band­ing the unit, which had been charged with de­vel­op­ing No­var­tis’s CAR-T pipeline, backed with con­sid­er­able hoopla two years ago in a cov­er sto­ry on CEO Joe Jimenez in Forbes.

This morn­ing, we fol­lowed up with a new re­port af­ter gain­ing ac­cess to the full memo that Azam had writ­ten. In it, he not­ed:

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.

The com­pa­ny’s re­sponse, though, is not like­ly to change the grow­ing per­cep­tion that the com­pa­ny is pulling back from the field just as the first CAR-T drugs are be­ing prepped for the FDA. Kite is now the wide­ly rec­og­nized leader af­ter a re­cent set­back at Juno, with plans to hus­tle an ap­pli­ca­tion to the FDA lat­er this year. And a num­ber of oth­er com­pa­nies are in the hunt to fol­low up with new drugs of their own.

Here’s the full re­sponse:

No­var­tis is seek­ing to clar­i­fy mis­in­for­ma­tion in the lat­est End­points re­port on the re-in­te­gra­tion of the Cell & Gene Ther­a­pies Unit (CG­TU) in­to the broad­er No­var­tis or­ga­ni­za­tion.

Con­trary to your head­line that we are “re­treat­ing from CAR-T,” our com­mit­ment to CAR-T and CRISPR tech­nolo­gies re­mains strong.  As we have pre­vi­ous­ly stat­ed, CTL019 is on track to be filed with the FDA ear­ly next year and with the EMA lat­er in 2017.  In fact, we ex­pect CTL019 will be the first chimeric anti­gen re­cep­tor T-cell (CAR T) ther­a­py to be ap­proved for pe­di­atric acute lym­phoblas­tic leukemia.

Dr. Us­man Azam along with his lead­er­ship team helped to de­sign the en­tire re-in­te­gra­tion plan. Ac­tions like re-in­te­gra­tion in­to oth­er parts of busi­ness­es can cause re­dun­dan­cies in roles, e.g. HR, fi­nance, le­gal, and that is why some peo­ple will leave our or­ga­ni­za­tion.  Dr. Azam de­cid­ed that as part of the re-in­te­gra­tion he would like to use this tran­si­tion to look at new op­por­tu­ni­ties out­side of the com­pa­ny. The CG­TU lead­er­ship team, along with ap­prox­i­mate­ly 120 oth­er as­so­ciates who will be im­pact­ed, have the op­por­tu­ni­ty to stay at No­var­tis if there is a role that is avail­able or suit­able for them.  It is im­por­tant to note that most of the CG­TU em­ploy­ees will be re­de­ployed to oth­er parts of the com­pa­ny.

At No­var­tis, we are trans­form­ing the com­pa­ny to be more fo­cused with a less-com­plex, more ag­ile struc­ture. While the CG­TU struc­ture was crit­i­cal to ramp up our ca­pa­bil­i­ties in cer­tain ar­eas like man­u­fac­tur­ing, clin­i­cal tri­als and com­mer­cial­iza­tion for a com­plete­ly new way of treat­ing can­cer, now that the com­pa­ny has re-or­ga­nized un­der a new op­er­at­ing mod­el, the re-in­te­gra­tion of CG­TU is the log­i­cal next step in our evo­lu­tion.

The No­var­tis en­ter­prise has all of the ca­pa­bil­i­ties we need to ef­fi­cient­ly re-in­te­grate CG­TU in­to the broad­er or­ga­ni­za­tion: lead­er­ship in on­col­o­gy and hema­tol­ogy specif­i­cal­ly, a glob­al com­mer­cial and de­vel­op­ment foot­print, a strong en­ter­prise man­u­fac­tur­ing or­ga­ni­za­tion, as well as sup­port func­tions to en­able a suc­cess­ful tran­si­tion.

No­var­tis is proud that we have played a lead­er­ship role in ad­vanc­ing the sci­en­tif­ic con­cept of CAR-T to the point where this com­plex way of treat­ing can­cer can be­come a re­al­i­ty for pa­tients. We look for­ward to con­tin­u­ing to ad­vance the sci­ence and our ca­pa­bil­i­ties in this ex­cit­ing area of med­i­cine.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

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Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

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In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

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Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

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In­tel­li­a's CRISPR pro­gram that ed­its genes di­rect­ly in pa­tients shows dura­bil­i­ty in AT­TR amy­loi­do­sis

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”