Thomas Lingelbach, Valneva CEO

Once promis­ing an al­ter­na­tive shot, Val­neva's Covid-19 sup­ply deal with Eu­rope on verge of col­lapse

When French vac­cine mak­er Val­ne­va signed a pur­chase agree­ment with the Eu­ro­pean Com­mis­sion in No­vem­ber, ex­ecs tout­ed how the deal — un­der which it would sup­ply 60 mil­lion dos­es of its in­ac­ti­vat­ed, ad­ju­vant­ed whole-virus Covid-19 vac­cine — of­fered an al­ter­na­tive to the mR­NA and ade­n­ovirus-based shots al­ready out there.

But the whole deal may be in jeop­ardy now.

The EC first sent a no­tice of in­tent to ter­mi­nate the pur­chase agree­ment back in May, as the reg­u­la­to­ry re­view of Val­ne­va’s vac­cine stalled. De­spite propos­ing a re­me­di­a­tion plan, Val­ne­va dis­closed Fri­day that the lat­est dis­cus­sions sug­gest the chances of reach­ing a re­vised deal are slim.

Val­ne­va shares (EPA: $VLA) plunged 26% to €7.70 on the Paris stock ex­change.

While the EMA be­gan its rolling re­view of Val­ne­va’s shot in Feb­ru­ary 2021, reg­u­la­tors still had ques­tions as re­cent­ly as Feb­ru­ary. Un­der the orig­i­nal deal, the EC had a right to pull out of its pur­chase if Val­ne­va had not re­ceived mar­ket­ing au­tho­riza­tion by April 30 — and it didn’t (al­though the UK did au­tho­rize it in mid-April).

In re­sponse to the EC’s no­tice of in­tent, Val­ne­va pro­posed a re­me­di­a­tion plan. How­ev­er, the “pre­lim­i­nary, un­of­fi­cial vol­ume in­di­ca­tions” the EC got from the few mem­ber states that ex­pressed in­ter­est in the in­ac­ti­vat­ed shot “would not be suf­fi­cient to en­sure the sus­tain­abil­i­ty” of the pro­gram, not to men­tion fur­ther de­vel­op­ment.

If those or­der num­bers be­come fi­nal, Val­ne­va sug­gest­ed the re­duc­tion would be so dras­tic that it like­ly won’t en­ter in­to an amend­ment. That could spell an end to any ac­cess hopes.

In a state­ment, CEO Thomas Lin­gel­bach said he hopes the EC and mem­ber states will re­con­sid­er.

“There is emerg­ing ev­i­dence that hy­brid im­mu­ni­ty – from a com­bi­na­tion of vac­ci­na­tion and nat­ur­al in­fec­tion – in­creas­es pro­tec­tion against de­vel­op­ment of se­vere Covid-19 caused by dif­fer­ent vari­ants of con­cern, and our in­ac­ti­vat­ed vac­cine close­ly mim­ics nat­ur­al in­fec­tion by ex­pos­ing vac­cines to the en­tire in­ac­ti­vat­ed SARS-CoV-2 virus,” he said. “Ad­di­tion­al­ly, mar­ket re­search stud­ies in six Eu­ro­pean coun­tries in­di­cat­ed ma­te­r­i­al in­ter­est in an in­ac­ti­vat­ed Covid-19 vac­cine for pri­ma­ry or boost­er vac­ci­na­tion. We con­tin­ue to re­ceive mes­sages from peo­ple look­ing for a more tra­di­tion­al vac­cine tech­nol­o­gy and we hope to re­ceive a mean­ing­ful or­der size to fur­ther sup­port pub­lic health in Eu­rope.”

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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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.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

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.

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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.

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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.

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