Ver­tex is re­or­ga­niz­ing and con­sol­i­dat­ing R&D, shut­ter­ing a site in Cana­da

Ver­tex has pulled out the ax in a move to chop down the size of its R&D op­er­a­tion.

The big biotech not­ed in its 10-K that the com­pa­ny de­cid­ed last month to shut­ter a re­search site in Cana­da while “con­sol­i­dat­ing” R&D in three lo­ca­tions scat­tered across the coun­try. And com­pa­ny sources tell me that there have been a num­ber of re­cent cuts as well in the home­town R&D group in Boston stretch­ing back over the past year.

From the 10-K: “In Feb­ru­ary 2017, we de­cid­ed to con­sol­i­date our re­search ac­tiv­i­ties in­to our Boston, Mil­ton Park and San Diego lo­ca­tions and are in the process of clos­ing our re­search site in Cana­da.”

A spokesper­son for the com­pa­ny con­firmed the con­sol­i­da­tion to me, say­ing that it had al­ready been an­nounced, and added that “we will con­tin­ue to in­vest sig­nif­i­cant­ly in sci­en­tif­ic in­no­va­tion.”

“There were no lay­offs in Boston re­search,” the spokesper­son added lat­er. “Our plan is to con­tin­ue to in­crease the num­ber of peo­ple in our re­search or­ga­ni­za­tion.”

Ver­tex staffers, though, tell me that there were some lay­offs in the Boston R&D or­ga­ni­za­tion, though there were “not many.” The cuts were main­ly aimed at the “Old Guard, from what I saw,” one added. The last round ac­count­ed for “on­ly ten or twelve,” I’m told, “but there have been oth­ers over the last year or so.”

They asked not to be iden­ti­fied, as they weren’t au­tho­rized to speak on the cuts.

A for­mer Ver­tex staffer told me, al­so anony­mous­ly, that the com­pa­ny fre­quent­ly used such “stealth lay­offs” to root out 10 to 15 re­search staffers in par­tic­u­lar groups at a time. None of them were an­nounced, as new hires were brought in and the over­all head­count didn’t drop.

That’s the ex­act same strat­e­gy that Bio­gen staffers laid out to me a few years ago.

Fan Pier Ver­tex Phar­ma­ceu­ti­cals Lab­o­ra­to­ry Re­search/Head­quar­ters, 50 North­ern Av­enue (Turn­er Con­struc­tion Com­pa­ny)

Click on the im­age to see the full-sized ver­sion

R&D dis­rup­tion is the or­der of the day in well-es­tab­lished bio­phar­ma com­pa­nies. Mer­ck, As­traZeneca and Am­gen are all go­ing through the lat­est re­struc­tur­ings, fol­low­ing huge cuts with­in the last few years. In most cas­es, these com­pa­nies are shut­ter­ing out­ly­ing op­er­a­tions and con­cen­trat­ing forces in their top hubs.

Ver­tex, which is care­ful­ly fo­cused on cys­tic fi­bro­sis, is a bell­wether com­pa­ny in the big Boston hub. Just a few months ago Ver­tex sold off a slate of can­cer ther­a­pies to Mer­ck KGaA for $230 mil­lion up­front. Mer­ck KGaA took over pro­grams on an atax­ia telang­iec­ta­sia and Rad3 re­lat­ed (ATR) pro­tein ki­nase in­hibitor pro­gram — cov­er­ing VX-970 and VX-803 – as well as a DNA-de­pen­dent pro­tein ki­nase (DNA-PK) in­hibitor pro­gram for VX-984.

Last sum­mer Ver­tex al­so scrapped a late-stage study us­ing a com­bi­na­tion of VX-661 and its all im­por­tant cys­tic fi­bro­sis drug Ka­ly­de­co (iva­caftor) in peo­ple with one copy of the F508del mu­ta­tion and one copy of a mu­ta­tion that re­sults in min­i­mal CFTR pro­tein func­tion (F508del het/min). The study stum­bled in its first phase, with­out an im­prove­ment in lung func­tion.

VX-661 is Ver­tex’s sec­ond-gen cor­rec­tor, a suc­ces­sor to the first-gen cor­rec­tor lumacaftor, in­clud­ed in the drug com­bi­na­tion for Orkam­bi. Two third-gen cor­rec­tors, VX-152 and VX-440, have been in ear­ly-stage stud­ies as Ver­tex plumbs new ap­proach­es that can treat CF bet­ter than Orkam­bi, which has suf­fered a high dropout rate. The treat­ment tar­gets the un­der­ly­ing ge­net­ic cause of the dis­ease.

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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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II 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.

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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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 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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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

UP­DAT­ED: 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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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.