Jim Green­wood opens new pol­i­cy shop, with an eye on drug price con­trols; Mod­er­na, CRISPR, Mus­tang re­ceive tax breaks in Mass­a­chu­setts

Capi­tol Hill heavy­weight Jim Green­wood is tak­ing his decades of ex­pe­ri­ence in the in­ter­twin­ing worlds of bio­phar­ma and Con­gress to the law firm DLA Piper, where he’s open­ing up a new pol­i­cy and reg­u­la­to­ry prac­tice along­side for­mer Pfiz­er lawyer Ge­of­frey Levitt.

As Con­gress wran­gles over how to bring down drug prices, the for­mer BIO CEO told End­points News in an in­ter­view that his top three pri­or­i­ties will be, “Price con­trols, price con­trols and price con­trols.”

“It’s not a ques­tion of if, but a ques­tion of when,” Green­wood said on at­tempts by Con­gress to get a drug pric­ing bill across the fin­ish line. He pre­dict­ed that the House is go­ing to move for­ward with a bill like HR 3, which would al­low CMS to ne­go­ti­ate drug prices and which the bio­phar­ma in­dus­try fierce­ly op­pos­es. But Green­wood said he hopes more rea­son­able De­moc­rats un­der­stand that “they’re shoot­ing with re­al bul­lets now” and HR 3 is not just a cam­paign move (as it was when HR 3 first passed the House in De­cem­ber 2019).

Green­wood not­ed that he spoke to Pres­i­dent Biden when he was VP, and he thinks that the pres­i­dent, as the ar­chi­tect of the Can­cer Moon­shot, un­der­stands how the pric­ing sys­tem works, and that cap­i­tal is very sen­si­tive to dra­mat­ic changes. A bill like HR 3 could be “ru­inous to our abil­i­ty to fight can­cer,” Green­wood said. But he not­ed that in­dus­try will be will­ing to ne­go­ti­ate some­what, as they did in push­ing for a cap on out-of-pock­et ex­pens­es as part of a for­mer Sen­ate pric­ing bill from Chuck Grass­ley (R-IA) and Ron Wyden (D-OR).  ⁠— Zachary Bren­nan

Mass­a­chu­setts tax breaks

Mod­er­na has dou­bled its work­force in Mass­a­chu­setts over the past year, in­clud­ing an ad­di­tion­al 650 jobs at its man­u­fac­tur­ing fa­cil­i­ty in Nor­wood, MA, and thanks to a tax break from the Mass­a­chu­setts Life Sci­ences Cen­ter, it will hire an ad­di­tion­al 155 em­ploy­ees, the com­pa­ny an­nounced Fri­day.

The in­cen­tive will re­quire Mod­er­na to re­tain the em­ploy­ees through 2025, and the com­pa­ny will take home $2.35 mil­lion, the largest break of any of the com­pa­nies. The com­pa­ny has been in Mass­a­chu­setts since its found­ing in Sep­tem­ber 2010, and opened its Nor­wood site in 2018.

In a state­ment, CEO Stéphane Ban­cel said:

Mass­a­chu­setts con­tin­ues to be the glob­al leader in the biotech in­dus­try and hav­ing our man­u­fac­tur­ing fa­cil­i­ty in Nor­wood has en­abled close col­lab­o­ra­tion with our re­search and de­vel­op­ment teams in Cam­bridge. It’s al­so al­lowed us to work with state and lo­cal part­ners and to lever­age the in­cred­i­ble in­no­va­tion and di­verse tal­ent from the Mass­a­chu­setts life sci­ences and tech­nol­o­gy sec­tors. We are proud to cre­ate new biotech and man­u­fac­tur­ing jobs in Mass­a­chu­setts as we work to de­vel­op new mR­NA med­i­cines.

The MLSC of­fers com­pa­nies a tax in­cen­tive to cre­ate long-term jobs in life sci­ences re­search and de­vel­op­ment, com­mer­cial­iza­tion and man­u­fac­tur­ing in Mass­a­chu­setts. Mus­tang Bio was al­so among the 28 com­pa­nies award­ed the tax break of $300,000 to add 20 new jobs at its Worces­ter, MA site. That com­pa­ny has al­so been at its cur­rent site since 2018, and cur­rent­ly em­ploys 70 peo­ple.

The tax break comes just in time for Mod­er­na to staff its ex­pan­sion to the Nor­wood site. Ren­o­va­tions will more than dou­ble the amount of square footage at the site, and sup­port a 50% in­crease in Covid-19 vac­cine and boost­er man­u­fac­tur­ing. That comes as part of a rapid ramp-up in pro­duc­tion of its vac­cines, as the com­pa­ny dou­bled man­u­fac­tur­ing at Lon­za’s Visp, Switzer­land site and Rovi’s Spain fa­cil­i­ty. In April, Sanofi signed on with Mod­er­na to pro­duce its vac­cine and in late May, it land­ed a deal with Sam­sung Bi­o­log­ics for fill-fin­ish du­ties at its In­cheon, South Ko­rea plant.

Oth­er big re­cip­i­ents in­clude Al­ny­lam Phar­ma­ceu­ti­cals, which will get $1.95 mil­lion for 130 new jobs at its Nor­ton and Cam­bridge lo­ca­tions, CRISPR which will get more than $1 mil­lion for 59 new jobs in Fram­ing­ham and Cy­ti­va, which land­ed $1.95 mil­lion for 130 jobs in West­bor­ough, Marl­bor­ough and Shrews­bury. ⁠— Josh Sul­li­van

Nue­vo­cor rais­es $24 mil­lion to ad­vance gene ther­a­py

Sin­ga­pore-based Nue­vo­cor has raised $24 mil­lion in Se­ries A Fi­nanc­ing to move its gene ther­a­py for car­diomy­opathies a step clos­er to clin­i­cal tri­als, the com­pa­ny an­nounced Fri­day.

The AAV-based ther­a­py is for pa­tients suf­fer­ing from di­lat­ed car­diomy­opa­thy due to mu­ta­tions in the lamia A/C gene, which caus­es the left ven­tri­cle of the heart to stretch and thin, caus­ing it trou­ble pump­ing blood, as well as oth­er un­treat­able car­diomy­opathies.

In a state­ment, CEO Yann Chong Tan said:

We are de­light­ed to have this strong group of in­vestors join us in de­vel­op­ing gene ther­a­py-based treat­ments that have the po­ten­tial to re­store car­diac func­tion in dis­eased hearts. The cur­rent stan­dard of care for di­lat­ed car­diomy­opa­thy on­ly serves to de­lay dis­ease pro­gres­sion, and the on­ly cure is to have a heart trans­plant. At Nue­vo­cor, we hope to give pa­tients a new lease of life through our tech­nol­o­gy.

 Josh Sul­li­van

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.