Third for­mer GSK sci­en­tist pleads guilty to con­spir­ing to steal trade se­crets

A third for­mer Glax­o­SmithK­line sci­en­tist caught in an al­leged plot to steal trade se­crets and sell the work in Chi­na plead­ed guilty to con­spir­a­cy on Mon­day.

Lucy Xi, a 44-year-old sci­en­tist, was ac­cused of feed­ing her for­mer hus­band, Yan Mei, con­fi­den­tial in­for­ma­tion on GSK’s re­search in­to mon­o­clon­al an­ti­bod­ies for his work on a new Chi­nese biotech com­pa­ny called Renophar­ma, ac­cord­ing to the charges.

Mei es­tab­lished Renophar­ma back in 2012 along with Tao Li and Yu Xue, a for­mer top chemist at GSK’s Up­per Meri­on, PA, fa­cil­i­ty. While the com­pa­ny claimed to be do­ing R&D work in on­col­o­gy, US at­tor­ney Jen­nifer Ar­bit­ti­er Williams ar­gued Renophar­ma was ac­tu­al­ly used “as a repos­i­to­ry of in­for­ma­tion stolen from GSK.” Fur­ther­more, the gov­ern­ment of Chi­na sub­si­dized and sup­port­ed the com­pa­ny fi­nan­cial­ly.

Xue and Li plead­ed guilty to their con­spir­a­cy charges more than three years ago, while Mei re­mains a fugi­tive liv­ing in Chi­na, ac­cord­ing to the De­part­ment of Jus­tice. Xue’s sis­ter, Tian Xue, has al­so plead­ed guilty to con­spir­a­cy.

“This de­fen­dant il­le­gal­ly stole trade se­crets to ben­e­fit her hus­band’s com­pa­ny, which was fi­nanced by the Chi­nese gov­ern­ment. The lifeblood of com­pa­nies like GSK is its in­tel­lec­tu­al prop­er­ty, and when that prop­er­ty is stolen and trans­ferred to a for­eign coun­try, it threat­ens thou­sands of Amer­i­can jobs and jeop­ar­dizes the strate­gic ben­e­fits brought about through re­search and de­vel­op­ment,” Williams said in a state­ment.

Xi worked as a GSK sci­en­tist from Ju­ly 2008 to No­vem­ber 2015, ac­cord­ing to the in­dict­ment. In Jan­u­ary 2015, she sent Mei a GSK doc­u­ment con­tain­ing se­cret da­ta and in­for­ma­tion, in­clud­ing a sum­ma­ry of GSK’s re­search in­to mon­o­clon­al an­ti­bod­ies. In the body of the email, she wrote: “You need to un­der­stand it very well. It will help you in your fu­ture busi­ness [RENOPHAR­MA].”

While Xue plead­ed guilty back in 2018, she told the judge that she didn’t think she was shar­ing ac­tu­al trade se­crets. How­ev­er, the judge not­ed that pros­e­cu­tors didn’t need to prove that she un­der­stood the ma­te­r­i­al in­clud­ed trade se­crets, just that Xue knew she was of­fer­ing a look at con­fi­den­tial re­search.

Xi is sched­uled for sen­tenc­ing on April 12, ac­cord­ing to a Reuters re­port.

Chi­nese re­search has re­cent­ly come un­der in­creased scruti­ny by the US, with the Biden ad­min­is­tra­tion black­list­ing and sanc­tion­ing dozens of gov­ern­ment re­search in­sti­tutes and pri­vate-sec­tor firms last month over con­cerns they were po­ten­tial­ly look­ing to weaponize biotech­nol­o­gy, in­clud­ing sup­posed “brain-con­trol weapon­ry,” ac­cord­ing to an ABC News re­port.

Just a cou­ple weeks ago, Charles Lieber, the for­mer Chair of Har­vard Uni­ver­si­ty’s Chem­istry and Chem­i­cal Bi­ol­o­gy De­part­ment was con­vict­ed of ly­ing to fed­er­al au­thor­i­ties about his af­fil­i­a­tion with Peo­ple’s Re­pub­lic of Chi­na’s Thou­sand Tal­ents Pro­gram and the Wuhan Uni­ver­si­ty of Tech­nol­o­gy (WUT), and fail­ing to re­port in­come he re­ceived from WUT. FBI spe­cial agent Joseph R. Bonavolon­ta said Lieber “re­peat­ed­ly lied to his em­ploy­er, the fed­er­al gov­ern­ment, and tax­pay­ers to fraud­u­lent­ly main­tain ac­cess to fed­er­al re­search funds.”

“To­day’s ver­dict re­in­forces our com­mit­ment to pro­tect our coun­try’s po­si­tion as a glob­al leader in re­search and in­no­va­tion and to hold those ac­count­able who ex­ploit and un­der­mine that po­si­tion through dis­hon­esty,” Bonavolon­ta said.

Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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