Ursula von der Leyen (Christian Hartmann/Pool Photo via AP Images)

Covid-19 roundup: Watch­dog crit­i­cizes EU Com­mis­sion over pres­i­den­t's texts; No­vavax signs vac­cine deal with Is­rael

The Eu­ro­pean Om­buds­man, an in­de­pen­dent in­ves­ti­ga­to­ry body in the EU, called out the EU Com­mis­sion for fail­ing to search for text mes­sages be­tween Com­mis­sion pres­i­dent Ur­su­la von der Leyen and Pfiz­er chief Al­bert Bourla.

Al­bert Bourla

Ac­cord­ing to Politi­co, text mes­sages be­tween von der Leyen and Bourla were re­quest­ed by a jour­nal­ist with net­zpoli­tik.org, a Ger­man-lan­guage news web­site that fo­cus­es on sur­veil­lance and pri­va­cy. Those mes­sages were ref­er­enced in an ar­ti­cle by the New York Times last year on the EU’s pur­chase of 1.8 bil­lion dos­es of the Pfiz­er-BioN­Tech vac­cine.

The NYT ar­ti­cle not­ed that “per­son­al diplo­ma­cy played a big role” in the deal be­tween Pfiz­er and the EU, say­ing that von der Leyen had been ex­chang­ing calls and text mes­sages with Bourla for a month at a low point in the pan­dem­ic, af­ter As­traZeneca an­nounced pro­duc­tion prob­lems for its vac­cine.

And de­spite the jour­nal­ist specif­i­cal­ly re­quest­ing those mes­sages, the om­buds­man, Emi­ly O’Reil­ly, found that the Com­mis­sion didn’t ask von der Leyen’s of­fice to search for text mes­sages. Rather, the Com­mis­sion asked for items that met the Com­mis­sion’s cri­te­ria for record­ing “doc­u­ments.” Those do not in­clude texts.

As for how O’Reil­ly re­spond­ed? It’s mal­ad­min­is­tra­tion.

“The nar­row way in which this pub­lic ac­cess re­quest was treat­ed meant that no at­tempt was made to iden­ti­fy if any text mes­sages ex­ist­ed,” O’Reil­ly said in a state­ment. “This falls short of rea­son­able ex­pec­ta­tions of trans­paren­cy and ad­min­is­tra­tive stan­dards in the Com­mis­sion.”

No­vavax signs deal with Is­rael for up to 10 mil­lion vac­cine dos­es

No­vavax an­nounced a deal this morn­ing with Is­rael’s Min­istry of Health to sell the coun­try sev­er­al mil­lion dos­es of its Covid-19 vac­cine.

Here’s the catch: It’s still not ap­proved in the coun­try.

Ac­cord­ing to the biotech, the two signed an agree­ment for Is­rael to buy five mil­lion dos­es of the vac­cine, and then leave open the op­tion for Is­rael to buy an­oth­er five mil­lion if the coun­try so choos­es. No­vavax said it will work with the health min­istry to ob­tain nec­es­sary au­tho­riza­tions and then fi­nal­ize plans for dis­tri­b­u­tion in Is­rael, pend­ing reg­u­la­to­ry ap­proval.

Any fi­nan­cial de­tails re­main un­spec­i­fied.

And while the vac­cine is await­ing the A-OK from Is­rael’s health reg­u­la­tor, the biotech’s shot has earned con­di­tion­al mar­ket­ing au­tho­riza­tion in the EU and an emer­gency use list­ing from the WHO. This is while No­vavax con­tin­ues to run two Phase III tri­als — one in the US and Mex­i­co, and the oth­er in the UK.

Mol­nupi­ravir shows ac­tiv­i­ty against Omi­cron in pre­clin­i­cal in vit­ro stud­ies

Mer­ck and Ridge­back an­nounced Fri­day morn­ing that their col­lab­o­ra­tive an­tivi­ral mol­nupi­ravir po­ten­tial­ly neu­tral­izes the Omi­cron vari­ant.

Wendy Hol­man

The two com­pa­nies said da­ta are in from six pre­clin­i­cal stud­ies in Bel­gium, Czech Re­pub­lic, Ger­many, Poland, the Nether­lands and the Unit­ed States. Ridge­back CEO Wendy Hol­man said in a state­ment that “based on its mech­a­nism of ac­tion, along with these new find­ings demon­strat­ing in vit­ro ac­tiv­i­ty across mul­ti­ple vari­ants, in­clud­ing Omi­cron, we an­tic­i­pate that mol­nupi­ravir will con­tin­ue to be ac­tive against vari­ants of con­cern.”

These re­searchers didn’t just study how mol­nupi­ravir can af­fect Omi­cron — they al­so looked at oth­er vari­ants and test­ed oth­er drugs.

In one study, re­searchers in Japan wrote a let­ter to the ed­i­tor at NE­JM af­ter look­ing at Gilead’s remde­sivir, along­side mol­nupi­ravir and Pfiz­er’s new an­tivi­ral against Omi­cron. They came to the con­clu­sion that all three may show ef­fi­ca­cy against Omi­cron.

How­ev­er, they ex­pressed that what they found might be lim­it­ed be­cause of a lack of clin­i­cal da­ta, em­pha­siz­ing that ad­di­tion­al da­ta are need­ed to val­i­date their pre­lim­i­nary find­ings.

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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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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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

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.

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.