Ab­b­Vie ac­cus­es ri­val of steal­ing block­buster ‘trade se­crets’ as clock ticks down on biosim­i­lar as­sault

Two years be­fore the first biosim­i­lars to megablock­buster Hu­mi­ra are ex­pect­ed to hit the US mar­ket, Ab­b­Vie is tak­ing one de­vel­op­er to court over al­le­ga­tions it stole trade se­crets to cre­ate its copy­cat ver­sion.

Ab­b­Vie has filed suit against Ice­landic biotech Alvotech for “in­junc­tive re­lief and re­cov­ery of dam­ages,” ac­cord­ing to court doc­u­ments dat­ed Fri­day. The phar­ma ac­cus­es Alvotech of em­bark­ing on an “un­law­ful plot to sur­rep­ti­tious­ly take Ab­b­Vie’s con­fi­den­tial and pro­pri­etary trade se­crets.”

The al­leged scheme re­volves around the hir­ing of Rongzan Ho, a for­mer Ab­b­Vie team leader of Hu­mi­ra’s up­stream man­u­fac­tur­ing. In its com­plaint, Ab­b­Vie says Ho at­tempt­ed three times to email “trade se­cret in­for­ma­tion” about the large-scale man­u­fac­tur­ing of Hu­mi­ra to his per­son­al ac­count be­fore leav­ing the com­pa­ny for Alvotech. The first two tries were blocked by the com­pa­ny’s se­cu­ri­ty sys­tem, Ab­b­Vie al­leges. But the third — an email ti­tled “Keep in touch (Ab­b­Vie)” — was suc­cess­ful, ac­cord­ing to the court doc­u­ments.

Ab­b­Vie says Ho “af­fir­ma­tive­ly mis­rep­re­sent­ed” that he had ex­punged all Ab­b­Vie in­for­ma­tion from any de­vices, in­clud­ing his com­put­er, ex­ter­nal stor­age de­vice, email or cloud stor­age up­on leav­ing the job.

The com­pa­ny al­so ac­cused Alvotech of con­tin­u­ing to re­cruit Ab­b­Vie em­ploy­ees with “in­ti­mate knowl­edge” of Hu­mi­ra’s man­u­fac­tur­ing process, adding that two ad­di­tion­al staffers were hired last May.

“Un­less en­joined, Alvotech’s il­le­gal ac­tions will serve as a roadmap to use Ab­b­Vie’s trade se­crets for both Alvotech and oth­er com­pa­nies that have not ad­e­quate­ly in­vest­ed in their own in­de­pen­dent re­search and de­vel­op­ment,” the com­plaint reads.

Alvotech wrote in an email to End­points News that it “strong­ly dis­putes” the al­le­ga­tions, adding it’s been three years since the “pur­port­ed date of the al­leged wrong­do­ing,” and the em­ploy­ee in ques­tion no longer works for Alvotech.

“Alvotech will vig­or­ous­ly de­fend against these al­le­ga­tions,” a spokesper­son said.

A host of crit­ics, in­clud­ing US law­mak­ers, have called Ab­b­Vie out in the past for its patent-ag­gres­sive ap­proach with Hu­mi­ra. This past June, a US judge ruled in fa­vor of Ab­b­Vie against al­le­ga­tions that it en­gaged in an­ti­com­pet­i­tive con­duct to el­bow out ri­vals.

When Ab­b­Vie’s main patent for Hu­mi­ra ran out in 2016, the com­pa­ny ap­plied for a raft of new patents — a move that was fur­ther strength­ened by agree­ments with Am­gen, Sam­sung Bioepis, and No­var­tis’ San­doz to keep biosim­i­lars off the US mar­ket un­til 2023, that com­plaint said.

Back in Au­gust, Ab­b­Vie paid $24 mil­lion to set­tle a law­suit brought forth by Cal­i­for­nia’s in­sur­ance reg­u­la­tor, al­leg­ing that Ab­b­Vie bribed and re­ward­ed physi­cians for Hu­mi­ra pre­scrip­tions. While Ab­b­Vie de­nied the claims, it agreed to look in­to how Hu­mi­ra is mar­ket­ed in the state, ac­cord­ing to a Reuters re­port. 

With the clock tick­ing on Hu­mi­ra, Ab­b­Vie has start­ed mak­ing the case for its new­er meds. Back in Jan­u­ary, the com­pa­ny read out new Phase III da­ta for its IL-23 Skyrizi, which showed the drug beat a place­bo at re­duc­ing pso­ri­at­ic arthri­tis pa­tients’ symp­toms from base­line af­ter six months of treat­ment.

Re­ports sur­faced ear­li­er this month that Ab­b­Vie is al­so con­sid­er­ing sell­ing off the $5 bil­lion women’s health port­fo­lio it ac­quired from Al­ler­gan, in or­der to pay off debt and fo­cus on new ar­eas.

Un­named sources told Reuters that Ab­b­Vie was work­ing with Mor­gan Stan­ley to auc­tion off the port­fo­lio, which in­cludes the Lo Loestrin Fe birth con­trol pill. But when End­points News reached out for con­fir­ma­tion, a spokesper­son replied: “We don’t com­ment on ru­mors.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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Eli Lil­ly to in­crease in­vest­ment to $1B in­to new Irish man­u­fac­tur­ing fa­cil­i­ty — re­port

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech read­ies for plunge in Covid sales, will boost mR­NA and on­col­o­gy pipelines

BioNTech is estimating €5 billion (nearly $5.4 billion) in Covid-19 vaccine sales this year, a marked drop from €17.1 billion ($18.5 billion) in 2022 — and way off analysts’ expectations of around €8 billion ($8.6 billion).

In BioNTech’s year-end earnings call on Monday, it reported a total of €17.3 billion ($18.7 billion) in 2022 revenue, almost all from vaccine sales, which include those via its Pfizer deal and direct sales.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.