Pfiz­er or­dered to dis­close FBI com­mu­ni­ca­tions in trade se­crets case

A fed­er­al judge has or­dered Pfiz­er to hand over its com­mu­ni­ca­tions with the FBI in a trade se­crets case it brought against the founders of Re­gor Ther­a­peu­tics last year.

Pfiz­er filed suit last Feb­ru­ary against two for­mer em­ploy­ees, Xi­ayang Qiu and Min Zhong, who quit their Big Phar­ma jobs in 2018 to launch the Eli Lil­ly-part­nered start­up Re­gor. About five months af­ter leav­ing Pfiz­er, Qiu and Zhong ap­plied for patents on a set of com­pounds that plain­tiffs al­lege “ap­pear strik­ing­ly sim­i­lar to . . . com­pounds that Pfiz­er had de­vel­oped,” ac­cord­ing to court doc­u­ments.

Pfiz­er ac­cused the de­fen­dants of schem­ing to start a ri­val com­pa­ny while work­ing on its GLP-1 pro­gram and steal­ing trade se­crets. The com­pa­ny claimed to have re­cov­ered ev­i­dence in its foren­sic analy­sis that Zhong down­loaded a num­ber of con­fi­den­tial doc­u­ments in his fi­nal months at Pfiz­er, in­clud­ing in­for­ma­tion on the com­pa­ny’s GLP-1 tech­nol­o­gy, and pur­port­ed­ly saved them in an ex­ter­nal hard dri­ve be­fore delet­ing them, ac­cord­ing to a com­plaint.

“The Pfiz­er trade se­crets and con­fi­den­tial in­for­ma­tion that Qiu and Zhong stole es­sen­tial­ly gave De­fen­dants the play­book and the crit­i­cal un­der­ly­ing sci­ence and da­ta to de­vel­op their own sup­posed di­a­betes-and-obe­si­ty treat­ment, an un­law­ful head start that saved De­fen­dants sig­nif­i­cant mon­ey and years of de­vel­op­ment time,” the com­plaint states.

Re­gor lat­er de­nied the claims and ques­tioned why Pfiz­er wait­ed as long as it did af­ter Qiu and Zhong left Pfiz­er to bring the suit to court.

Be­fore fil­ing suit, Pfiz­er launched its own in­ves­ti­ga­tion in­to Qiu and Zhong’s com­pa­ny-is­sued lap­tops and email ac­counts and even­tu­al­ly turned to the FBI, which had pre­vi­ous­ly en­cour­aged com­pa­nies to share in­for­ma­tion on sus­pect­ed cas­es of trade se­cret theft.

How­ev­er, when de­fen­dants re­quest­ed to see 35 emails and text mes­sages be­tween Pfiz­er and the FBI, Pfiz­er claimed that the cor­re­spon­dence was “pro­tect­ed from dis­cov­ery by the work prod­uct doc­trine, and that thir­ty-one of the thir­ty-five were pro­tect­ed by the at­tor­ney-client priv­i­lege as well.”

De­fen­dants ar­gued that it waived any pro­tec­tions it did have by “re­ly­ing on and cit­ing its foren­sic in­ves­ti­ga­tion and re­lat­ed find­ings” in its ar­gu­ment and by vol­un­tar­i­ly shar­ing the doc­u­ments with the FBI.

Con­necti­cut fed­er­al judge Thomas Far­rish sided with de­fen­dants on Fri­day, rul­ing that Pfiz­er must pro­duce all 35 doc­u­ments by Feb. 17.

“With re­spect to Pfiz­er’s at­tor­ney-client priv­i­lege claims, the Court con­cludes that even if the in­for­ma­tion in the thir­ty-one e-mails and text mes­sages had once been pro­tect­ed, Pfiz­er waived that pro­tec­tion by dis­clos­ing it to the FBI,” the de­ci­sion states.

Pfiz­er said in a state­ment to End­points News on Tues­day that it’s dis­ap­point­ed in the court’s or­der “as we be­lieve the ma­te­ri­als at is­sue are pro­tect­ed by priv­i­lege.”

“This is a dis­cov­ery dis­pute and not a rul­ing on the mer­its of the case. The com­pa­ny re­mains con­fi­dent in its case and be­lieves the full ev­i­den­tiary record will prove that its trade se­crets were mis­ap­pro­pri­at­ed by the de­fen­dants,” the com­pa­ny con­tin­ued in an email.

Re­gor has not re­spond­ed to a re­quest to com­ment as of press time.

Eli Lil­ly inked a col­lab­o­ra­tion and li­cens­ing deal with Re­gor back in 2021 around meta­bol­ic dis­or­ders, giv­ing the Chi­nese biotech an up­front pay­ment of up to $50 mil­lion and up to $1.5 bil­lion in mile­stones.

Qiu and Zhong are still list­ed as Re­gor’s CEO and COO on the com­pa­ny’s web­site. Last April, the com­pa­ny an­nounced the launch of a Phase II tri­al in the US for its GLP-1 re­cep­tor ag­o­nist in pa­tients with type 2 di­a­betes mel­li­tus.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.