Guardant Health fires back at Il­lu­mi­na suit, claim­ing re­tal­i­a­tion over its role in FTC an­titrust in­ves­ti­ga­tion

Two months ago, Il­lu­mi­na sued Guardant Health’s two co-founders (and ex-Il­lu­mi­na em­ploy­ees), Helmy El­toukhy and Ami­rali Ta­lasaz, al­leg­ing the pair stole trade se­crets, and used Il­lu­mi­na ser­vices and equip­ment to set up the com­pa­ny. At the time, Guardant hit back — claim­ing it was re­tal­i­a­tion.

“Il­lu­mi­na filed a law­suit against Guardant to pro­tect its in­tel­lec­tu­al prop­er­ty rights,” an Il­lu­mi­na spokesper­son wrote at the time. “There is no mer­it to Guardant’s claim that the law­suit was filed to sup­press com­pe­ti­tion in the mar­ket.”

Now Guardant Health has filed a mo­tion to dis­miss the case.

Filed on Wednes­day, the mo­tion is be­ing heard in the US Dis­trict Court in Delaware. The 32-page doc­u­ment starts to lay out Guardant’s first ar­gu­ment about the tim­ing of the case and delves head­first in­to its own ar­gu­ments for why the law­suit from Il­lu­mi­na was an act of re­tal­i­a­tion.

Ini­tial­ly, Il­lu­mi­na and Guardant have both been work­ing on de­vel­op­ing liq­uid biop­sy screen­ing tests to po­ten­tial­ly de­tect can­cer ear­li­er. And on this front, the com­pa­nies had been in a part­ner­ship to­geth­er — with Il­lu­mi­na sup­ply­ing se­quenc­ing in­stru­ments to Guardant, up­on which “Guardant’s can­cer de­tec­tion test­ing tech­nol­o­gy is built,” ac­cord­ing to Guardant.

The biotech fur­ther added in its open­ing mo­tion that this sup­ply part­ner­ship had been go­ing on for al­most a decade at this point, and ac­cord­ing to Il­lu­mi­na’s spokesper­son when the law­suit was first filed, the busi­ness re­la­tion­ship will re­main un­in­ter­rupt­ed.

Fast for­ward to 2021, Il­lu­mi­na spent $8 bil­lion to ac­quire Grail, which ac­cord­ing to Guardant is its main com­peti­tor. And while Eu­ro­pean and Amer­i­can reg­u­la­tors ob­ject­ed — with the FTC su­ing to try and stop the deal cit­ing po­ten­tial an­titrust law vi­o­la­tions, ac­cord­ing to the fil­ing — Il­lu­mi­na com­plet­ed the deal. And then it was short­ly a few months af­ter that deal of­fi­cial­ly closed that Il­lu­mi­na filed suit against Guardant. And from Guardant’s view, that tim­ing is an is­sue.

From the fil­ing:

The tim­ing of this law­suit re­veals Il­lu­mi­na’s true mo­tives. Il­lu­mi­na’s law­suit comes short­ly af­ter Guardant co­op­er­at­ed with the FTC in its an­titrust in­ves­ti­ga­tion of the pro­posed Il­lu­mi­na-GRAIL trans­ac­tion, and just two months af­ter two Guardant ex­ec­u­tives pub­licly tes­ti­fied against the trans­ac­tion dur­ing the FTC’s ad­min­is­tra­tive tri­al.

At­tor­neys for the de­fen­dants went on to say that Il­lu­mi­na ad­mits it knew about the al­leged “mis­ap­pro­pri­a­tion of con­fi­den­tial in­for­ma­tion since at least June 2019,” and said that Guardant’s own pub­lic patent ap­pli­ca­tions had been on­go­ing for longer than that. And ac­cord­ing to Guardant, wait­ing un­til re­cent­ly to file the law­suit makes clear that it is re­tal­ia­to­ry.

Fur­ther, the at­tor­neys claim that Il­lu­mi­na’s claims of mis­ap­pro­pri­a­tion are “time-barred” and must be dis­missed since the con­tent that Il­lu­mi­na is su­ing for was is­sued more than three years be­fore the suit was filed.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.