Jorge Gomez, former Moderna CFO

Mod­er­na blind­sided by in­ves­ti­ga­tion in­to for­mer CFO Jorge Gomez, com­pa­ny says

It’s been days since Mod­er­na sent its new CFO Jorge Gomez pack­ing — af­ter just one day on the job — over an in­ves­ti­ga­tion launched by his for­mer em­ploy­er. Al­though that probe was ini­ti­at­ed back in March, Mod­er­na says it had no idea un­til last week.

Mod­er­na told End­points News on Mon­day that it was un­aware of Dentsply’s in­ves­ti­ga­tion in­volv­ing Gomez un­til it was pub­licly dis­closed on May 10. The news, first re­port­ed by the Wall Street Jour­nal, comes just five days af­ter Dentsply an­nounced an in­ves­ti­ga­tion in­to “cer­tain fi­nan­cial re­port­ing mat­ters” re­lat­ed to Gomez’s time at the den­tal equip­ment com­pa­ny.

In­ves­ti­ga­tors are dig­ging in­to the “use of in­cen­tives to sell prod­ucts to dis­trib­u­tors in the third and fourth quar­ters of 2021, and whether those in­cen­tives were ap­pro­pri­ate­ly ac­count­ed for and the im­pact of those sales was ad­e­quate­ly dis­closed in the Com­pa­ny’s pe­ri­od­ic re­ports filed with the Se­cu­ri­ties and Ex­change Com­mis­sion,” ac­cord­ing to a Dentsply SEC fil­ing.

The com­pa­ny is al­so as­sess­ing whether “cer­tain for­mer and cur­rent mem­bers of se­nior man­age­ment” used in­cen­tives and oth­er ac­tions to achieve ex­ec­u­tive com­pen­sa­tion tar­gets last year, the fil­ing said.

With­in an hour of learn­ing about the probe, Mod­er­na CEO Stéphane Ban­cel met with the com­pa­ny’s chief le­gal of­fi­cer, chair­man of the board, and ex­ter­nal coun­sel to dis­cuss and sched­ule a meet­ing with the full board, the biotech told End­points.

“Up­on meet­ing, the Board made the de­ter­mi­na­tion that it was ap­pro­pri­ate to sep­a­rate Mr. Gomez from Mod­er­na,” a com­pa­ny spokesper­son said. “Mr. Gomez was im­me­di­ate­ly in­formed of that de­ci­sion.”

The next day, Mod­er­na an­nounced that Gomez was leav­ing the com­pa­ny, ef­fec­tive im­me­di­ate­ly. David Meline, Gomez’s pre­de­ces­sor, will step back in­to the CFO role while Mod­er­na restarts its hunt for a new re­place­ment, Mod­er­na said.

De­spite the end re­sult, Mod­er­na de­fend­ed its de­ci­sion to hire Gomez and its swift ac­tion to let him go. The com­pa­ny an­nounced back in April that it was bring­ing Gomez on­to the team, just hours af­ter its Covid-19 vac­cine ri­val Pfiz­er named its own new CFO.

“The May 11, 2022 an­nounce­ment and de­par­ture of Jorge Gomez from Mod­er­na strong­ly re­flects the se­ri­ous­ness with which Mod­er­na takes cor­po­rate gov­er­nance,” a spokesper­son said. “We are con­fi­dent that Mod­er­na con­duct­ed all ap­pro­pri­ate due dili­gence on this mat­ter pri­or to the hir­ing of Mr. Gomez, based on avail­able in­for­ma­tion.”

Gomez is leav­ing with $700,000 in sev­er­ance pay, which is equal to a year’s salary. How­ev­er, Mod­er­na could ter­mi­nate or sus­pend his sev­er­ance ben­e­fits and seek re­pay­ment if the Dentsply in­ves­ti­ga­tion finds him guilty of any wrong­do­ing, ac­cord­ing to an SEC fil­ing.

The for­mer CFO has not re­spond­ed to a re­quest for com­ment.

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.

Endpoints Premium

Premium subscription required

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

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

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.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.