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.

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Brian Stuglik (file photo)

Turn­ing fo­cus to clin­i­cal work, Ve­rastem ax­es 31 jobs, scales back can­cer drug pro­mo­tion af­ter dis­ap­point­ing sales

Months after taking the helm at Verastem Oncology, Brian Stuglik has a plan to take the biotech in a “new strategic direction” — but not before some layoffs.

Left out of an upbeat press release spelling out its clinical plans, and buried below news of a $100 million private placement in an SEC filing, is a planned restructuring that will claim 31 jobs. Alongside some other cost-saving measures, Verastem expects to cut expenses down by $70 million to $80 million per year.

Olivier Brandicourt (AP Images)

Ex-Sanofi chief Olivi­er Brandi­court, cur­rent Black­stone ad­vi­sor, jumps on Al­ny­lam board

Former Sanofi chief Olivier Brandicourt, who departed his post with an unexpected early retirement last year, has made his move — as most C-suite executives inevitably do — to become a director on the board of a biopharma company.

RNAi player Alnylam is Brandicourt’s destination. Meanwhile, the Cambridge, Massachusetts-based drugmaker — which pioneered the first approval in the field — also disclosed the retirement of Alnylam co-founder Dr. Paul Schimmel from its board.

Dan O'Day (AP Images)

UP­DAT­ED: A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisition, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Jim Wilson's gene ther­a­py start­up Pas­sage Bio bucks mar­ket sen­ti­ments, rais­ing up­sized $216M IPO

A coronavirus fear-induced bloodbath on the Nasdaq has not stopped Passage Bio from making a public debut — and an exuberant one.

By pricing an upsized offering at $18, the top of the range, the gene therapy biotech bagged $216 million from its IPO, 72% more than it’s originally penciled in.

The proceeds likely reflected confidence in Jim Wilson, who gathered all the tools he’s built over decades of gene therapy research to assemble the startup and teamed up with Frazier and OrbiMed to hone its focus on rare, monogenic disorders of the central nervous system. Just before the IPO, Deerfield partner Bruce Goldsmith took over from OrbiMed’s Stephen Squinto as CEO.

Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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