EU re­port­ed­ly eye­ing vac­cines deal for mon­key­pox out­break; Nas­daq tells Mereo to get stock price up or face delist­ing

The EU is re­port­ed­ly work­ing to­ward a cen­tral­ized pro­cure­ment deal for small­pox vac­cines to tack­le the ris­ing num­ber of cas­es of mon­key­pox, ac­cord­ing to sources who spoke to the Fi­nan­cial Times.

An­drea Am­mon, di­rec­tor of Eu­rope’s CDC, told the FT that the Eu­ro­pean Com­mis­sion is “def­i­nite­ly look­ing at what can be done cen­tral­ly” and cen­tral pro­cure­ment is “one of the op­tions that are looked at but of course coun­tries are al­so” look­ing in­to bi­lat­er­al av­enues.

While small­pox was erad­i­cat­ed decades ago, a vac­cine for that virus is about 85% ef­fec­tive at pre­vent­ing mon­key­pox in­fec­tion, ac­cord­ing to WHO, and at least one undis­closed coun­try has placed a deal for Bavar­i­an Nordic’s vac­cine, Jyn­neos.

The EU news comes a day af­ter the deputy di­rec­tor of Africa CDC warned against vac­cine hoard­ing by wealth­i­er na­tions and two days af­ter Roche un­veiled three new tests to de­tect the virus. Aside from Jyn­neos, the FDA has al­so pre­vi­ous­ly ap­proved SIGA Tech­nolo­gies’ Tpoxx as a treat­ment for mon­key­pox in 2018.

Bavar­i­an Nordic told End­points in a state­ment that the com­pa­ny is speak­ing with Eu­rope’s Health Emer­gency Pre­pared­ness and Re­sponse Au­thor­i­ty and in­di­vid­ual coun­tries in the EU, but de­clined to pro­vide fur­ther com­ment “on spec­u­la­tion about po­ten­tial deals at this time.” — Kyle LaHu­cik

Mereo head­ed to AS­CO with TIG­IT drug da­ta as it seeks to stay on Nas­daq

UK on­col­o­gy biotech Mereo Bio­phar­ma is go­ing to AS­CO with da­ta from a Phase Ib/II com­bi­na­tion study with TIG­IT drug etig­ilimab and Bris­tol My­ers’ Op­di­vo (nivolum­ab). Ac­cord­ing to Mereo, the study looked at 27 ef­fi­ca­cy-evalu­able sub­jects with se­lect lo­cal­ly ad­vanced or metasta­t­ic sol­id tu­mors.

Out of the 27 pa­tients, 12 had a clin­i­cal ben­e­fit with 1 com­plete re­sponse, 2 par­tial re­spons­es, 9 sta­ble dis­ease des­ig­na­tions, and 15 sub­jects had “ra­di­o­log­i­cal/clin­i­cal pro­gres­sion.” In to­tal, Mereo is re­port­ing an over­all re­sponse rate of 11% and dis­ease con­trol rate of 44% — and no new safe­ty sig­nals.

While Mereo will be at AS­CO with a poster on this da­ta, it is al­ready keep­ing an eye on the fi­nan­cial side. Mereo al­so an­nounced Thurs­day that it re­ceived a let­ter from Nas­daq af­ter its Amer­i­can de­pos­i­to­ry shares failed to list at a min­i­mum bid price of $1 over the last 30 busi­ness days. Mereo $MREO not­ed that it had been giv­en 180 days — un­til Nov. 21, 2022 — to get its clos­ing bid price over $1 for 10 days in a row. If not, the biotech can be sub­ject to delist­ing, pend­ing a po­ten­tial fur­ther grace pe­ri­od or an ap­peal to a hear­ing pan­el. — Paul Schloess­er

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

UP­DAT­ED: As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In an interview with Endpoints News, ARCH managing director and co-founder Bob Nelsen brushed off concerns about the broader market troubles, saying the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels won’t impact ARCH’s mindset too much because it typically focuses on company formation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

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?”

Endpoints Premium

Premium subscription required

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

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.