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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.