Scoop: No­var­tis dis­bands its pi­o­neer­ing cell and gene ther­a­py unit

No­var­tis is dis­solv­ing its high-pro­file cell and gene ther­a­py unit op­er­at­ing un­der the guid­ing hand of Us­man “Oz” Azam, End­points has learned.

Us­man “Oz” Azam

Azam has is­sued a note to the 400 staffers in the group, which was ob­tained by End­points, that says:

“The risk of em­bark­ing on a new ad­ven­ture in un­chart­ed ter­ri­to­ry is that things don’t al­ways work out as en­vi­sioned. To­day, I have the un­for­tu­nate task of an­nounc­ing that we are dis­solv­ing the Cell and Gene Ther­a­pies Unit.”

No­var­tis con­firmed that the 400-mem­ber group is be­ing dis­band­ed, with most be­ing “re­de­ployed” to new po­si­tions while 120 could be left with­out a job.

That move is a stun­ner for many in the CAR-T field, es­pe­cial­ly af­ter all the hoopla at No­var­tis around its work.

Azam and his team have played point for one of No­var­tis’s biggest pipeline moves, jump­ing in ear­ly on CAR-T ther­a­pies that reengi­neer a pa­tient’s T cells in­to at­tack ve­hi­cles point­ed at can­cer cells. Work­ing through a part­ner­ship at the Uni­ver­si­ty of Penn­syl­va­nia, the group has ad­vanced one of the lead­ing CAR-T ther­a­pies now in the pipeline, as it races against Kite $KITE and Juno $JUNO to be in the first wave of new drugs to hit the mar­ket.

The field has been mov­ing fast, but not al­ways for­ward. Juno ex­pe­ri­enced a brief in­ter­rup­tion for its lead pro­gram when the FDA im­posed a clin­i­cal hold for a few days that ul­ti­mate­ly de­railed its de­vel­op­ment sched­ule and de­layed any ap­pli­ca­tion un­til 2018. That leaves Kite and No­var­tis rac­ing to the FDA, with Kite plan­ning a sub­mis­sion lat­er this year.

At one point, No­var­tis CEO Joe Jimenez told re­porters that he had made out a blank check for its CAR-T work, de­ter­mined to pay what was nec­es­sary to get these drugs to the mar­ket as fast as pos­si­ble. In a re­cent let­ter to share­hold­ers, Jimenez high­light­ed the CAR-T work as a key part of its strat­e­gy for its on­col­o­gy R&D ef­fort. But in the midst of a heat­ed Phase III ri­val­ry, the phar­ma gi­ant be­lieves that an iso­lat­ed unit no longer makes sense. And that is like­ly to add to the im­pres­sion that No­var­tis is falling be­hind.

The news hit Kite and Juno as well, though. Shares of Juno dropped 5% Wednes­day morn­ing, with Kite down 4%.

In re­sponse to a query from End­points, a spokesper­son for No­var­tis is­sued the fol­low­ing state­ment:

“We have made the de­ci­sion to re-in­te­grate ac­tiv­i­ties con­duct­ed by the Cell & Gene Ther­a­pies Unit in­to the larg­er No­var­tis or­ga­ni­za­tion, as part of a nat­ur­al evo­lu­tion of our in­ter­nal or­ga­ni­za­tion­al de­sign. An iso­lat­ed Unit worked well un­der our pri­or Phar­ma Di­vi­sion struc­ture, but 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.

This or­ga­ni­za­tion­al change will not im­pact the plan to file CTL019 in pe­di­atric r/r ALL with the US FDA in ear­ly 2017 and with EMA lat­er in 2017.

Most as­so­ciates who were pre­vi­ous­ly ded­i­cat­ed to cell & gene ther­a­pies will now be re­de­ployed to ar­eas where they will share their knowl­edge and im­prove ex­e­cu­tion of nov­el ther­a­peu­tics in the im­munother­a­py space to bet­ter de­liv­er on our mis­sion to im­prove and ex­tend peo­ple’s lives.

These or­ga­ni­za­tion­al changes will im­pact ap­prox­i­mate­ly 120 po­si­tions across sev­er­al dif­fer­ent No­var­tis af­fil­i­ates.  No­var­tis is com­mit­ted to as­sist­ing in the place­ment of im­pact­ed as­so­ciates wher­ev­er ap­pro­pri­ate in­ter­nal op­por­tu­ni­ties may ex­ist and in treat­ing dis­placed as­so­ciates fair­ly and with dig­ni­ty.”

In a fol­lowup, No­var­tis added that the move to dis­solve the unit will not af­fect its col­lab­o­ra­tion with Penn.

No­var­tis and Penn have an ex­clu­sive glob­al col­lab­o­ra­tion to re­search, de­vel­op and com­mer­cial­ize CAR T cell ther­a­pies for the in­ves­ti­ga­tion­al treat­ment of can­cers. We con­tin­ue to work with Penn un­der the terms of our agree­ment and look for­ward to ad­vanc­ing CART ther­a­pies.

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.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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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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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

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.

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

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

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.”

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.

Matt Kapusta, uniQure CEO

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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FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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