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)

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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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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