No­var­tis un­veils a new glob­al R&D struc­ture, cre­at­ing cen­ters in Cam­bridge, MA and Basel


No­var­tis is un­veil­ing some big new changes to its R&D or­ga­ni­za­tion to­day, fo­cus­ing heav­i­ly on new re­search op­er­a­tions based in Cam­bridge, MA as well as Basel while shut­ter­ing two units in Chi­na and Switzer­land and re­lo­cat­ing an­oth­er from Sin­ga­pore to the Bay Area.

Hot on the heels of its stun­ning de­ci­sion to shut down its cell and gene ther­a­py group while lay­ing off 120, the com­pa­ny plans to tell em­ploy­ees at town hall meet­ings lat­er to­day that it is es­tab­lish­ing a new ear­ly-stage op­er­a­tion along with the cre­ation of two new re­search cen­ters. Here’s a quick look at the over­all plan as out­lined by No­var­tis in re­sponse to a query from End­points News:

— The phar­ma gi­ant is set­ting up an ear­ly dis­cov­ery re­search group in Basel and Cam­bridge, MA, which it says will be “in­te­grat­ed with NI­BR’s drug dis­cov­ery teams around the world.” The Chem­i­cal Bi­ol­o­gy and Ther­a­peu­tics team will merge two ex­ist­ing teams and fo­cus on “har­ness­ing the pow­er of chem­i­cal bi­ol­o­gy and oth­er cut­ting edge tech­nolo­gies such as CRISPR, DNA-en­cod­ed li­braries and tar­get­ed pro­tein degra­da­tion to dis­cov­er new drug tar­gets. CBT will al­so in­clude teams fo­cused on path­way bi­ol­o­gy and high through­put screen­ing.”

— Two new “cen­ters of ex­cel­lence” for bio­ther­a­peu­tics re­search in Basel, Switzer­land and Cam­bridge, MA, USA will “ex­plore new di­rec­tions for de­liv­er­ing bi­o­log­ic ther­a­pies.” And the phar­ma gi­ant says that the de­vel­op­ment of those two cen­ters will force the clo­sure of a group in Shang­hai as well ES­BAT­e­ch, a bi­o­log­ics unit based in Schlieren, Switzer­land. Twen­ty to 25 new po­si­tions will be opened in the bi­o­log­ics cen­ter of ex­cel­lence in Basel.

— No­var­tis is al­so cre­at­ing a new re­search group fo­cus­ing on dis­cov­er­ing new med­i­cines for res­pi­ra­to­ry dis­eases while re­lo­cat­ing the No­var­tis In­sti­tute for Trop­i­cal Dis­eases (NITD) from Sin­ga­pore to Emeryville, CA.

Al­con ac­quired ES­BAT­e­ch and its an­ti­body frag­ment tech un­der the watch­ful eye of No­var­tis, which was com­plet­ing its own deal to ac­quire Al­con, back in 2009. That deal cost $150 mil­lion up­front plus an­oth­er $439 mil­lion in mile­stones. The group re­port­ed­ly has 73 staffers who are now be­ing axed.

“The Shang­hai Bi­o­log­ics group that is clos­ing has 18 peo­ple,” a spokesper­son for No­var­tis tells me via email. ” The re­lo­ca­tion of NITD pro­grams and op­er­a­tions to Emeryville will af­fect 84 peo­ple in Sin­ga­pore. In ad­di­tion to the 20-25 jobs that will be added in Basel for bi­o­log­ics, we will add jobs in Emeryville for NITD and in Cam­bridge for the Res­pi­ra­to­ry group. De­tails on Cam­bridge and Emeryville jobs are still be­ing worked out.”

No­var­tis still has big plans for Shang­hai, where it’s been build­ing a ma­jor R&D op­er­a­tion in the grow­ing Asian biotech hub.

NI­BR has a fa­cil­i­ty in Emeryville, just north of Oak­land in the Bay Area. And a whole group of Big Phar­mas have been con­cen­trat­ing their forces in the big re­search hubs like the San Fran­cis­co area, in­clud­ing Mer­ck and As­traZeneca. Cam­bridge, MA, mean­while, has al­so ben­e­fit­ed great­ly from the glob­al mi­gra­tion of Big Phar­ma to the big hubs, while Basel is home to the multi­na­tion­al com­pa­ny.

No­var­tis has been fo­cused on a shake­up for much of the year, dat­ing back to its de­ci­sion to carve out an on­col­o­gy group in May. No­var­tis shocked the 400 staffers at its cell and gene ther­a­py group re­cent­ly when it un­ex­pect­ed­ly an­nounced plans to lay off 120 and in­te­grate the re­main­ing play­ers in the can­cer re­search op­er­a­tions. The com­pa­ny is known for one of the biggest re­search bud­gets in bio­phar­ma, spend­ing $9 bil­lion last year on R&D. But it’s al­so well known for look­ing for greater ef­fi­cien­cies wher­ev­er they can be found.

That can make job se­cu­ri­ty a risky prospect at No­var­tis.

“Mov­ing the (No­var­tis In­sti­tute for Trop­i­cal Dis­eases) is re­al­ly in­tend­ed to em­pow­er the re­search through the strength of col­lab­o­ra­tive prox­im­i­ty,” NI­BR chief Jay Brad­ner told the lo­cal Sin­ga­pore press. No­var­tis doesn’t like to sim­ply fire work­ers, of­fer­ing some the chance to re­lo­cate or ap­ply for oth­er po­si­tions. But clear­ing the hur­dle be­tween Sin­ga­pore and the Bay Area couldn’t be easy.

This isn’t the first time that No­var­tis switched up its glob­al R&D struc­ture, and it like­ly won’t be the last. Big Phar­ma got re­al se­ri­ous about cut­ting back the head count and out­sourc­ing work sev­er­al years ago, and prac­ti­cal­ly all of them have tak­en the ax to their re­search or­ga­ni­za­tions. Giv­en the ane­mic flow of new drug ap­provals this year, there’s no rea­son to be­lieve that the pres­sure be­hind these changes is de­clin­ing at all.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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David Liu, Liu Group

David Liu un­veils newest ad­vance­ment in CRISPR tech: Prime edit­ing

The researcher behind base-editing is out with what some scientists are hailing as the biggest advancement in CRISPR technology since that 2016 breakthrough: “prime editing.” The new molecular gadget is capable of erasing any base pair and stenciling in another and cutting or adding long segments of DNA without breaking both strands of the helix.

David Liu, base editing pioneer and founder of Beam Therapeutics, published the findings in Nature alongside Andrew Anzalone. They estimated that the breakthrough “in principle” puts 89% of human diseases in purview — although experts cautioned that human therapies were a long way off.

UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Frazier Healthcare Partners’ Bhaskar Chaudhuri has been carefully and quietly grooming Arcutis Therapeutics, a new dermatology play he co-founded to deliver topical formulations of well-known drugs. Now that the biotech is poised to enter Phase III, he’s being joined by a marquee syndicate for its $94.5 million Series C.

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs jumped on board, joining Bain Capital Life Sciences, OrbiMed and RA Capital Management in backing Arcutis’ lead topical cream for plaque psoriasis.

A new com­pa­ny en­ters the Tec­fidera fight, of­fer­ing to kill two birds

The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.

Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experiences. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.

UP­DAT­ED: Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.

Take­da tees up $420M deal for celi­ac an­ti­dote, con­tin­u­ing R&D re­fo­cus

Sometime in the 1st century AD, a patient presented to Arataeus looking like a varicose ghost. He was “emaciated and atrophied, pale, feeble and incapable of performing any of his accustomed works,” the Greek physician wrote, with hollow temples and huge veins running all over his body.

A dysfunctional digestive system, Arataeus concluded – an imbalance he attributed to a “heat” deficiency in a system he and other Greeks regarded as functioning similarly to an oven – and coined a term: coeliac disease, after the Greek word for abdomen.

IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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