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.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.