Novavax CEO Stanley Erck and CureVac CEO Franz-Werner Haas (Andrew Harnik/AP Images; Christoph Schmidt/picture-alliance/dpa/AP Images)

New year, new CEOs for Covid vac­cine mak­ers Cure­Vac and No­vavax

Two biotech com­pa­nies that have been on long jour­neys to push through Covid vac­cines are get­ting new CEOs this year.

Alexan­der Zehn­der

Cure­Vac CEO Franz-Wern­er Haas is step­ping aside af­ter three years in the po­si­tion for a new chief who’s com­ing from Sanofi. Alexan­der Zehn­der will join Cure­Vac as CEO of the mR­NA biotech on April 1, leav­ing his cur­rent po­si­tion as glob­al head of on­col­o­gy at Sanofi. Ac­cord­ing to a Cure­Vac rep­re­sen­ta­tive, “it’s cur­rent­ly not planned” that Haas will re­main on the man­age­ment board af­ter step­ping down as CEO.

Mean­while, No­vavax pres­i­dent and CEO Stan­ley Er­ck is re­tir­ing and mak­ing way for John Ja­cobs to take over lead­er­ship on Jan. 23. Er­ck will serve as an ad­vi­sor for the next 15 months. Ja­cobs joins No­vavax from Har­mo­ny Bio­sciences, where he served as pres­i­dent and CEO.

Cure­Vac’s Haas, whose term ends on March 31, spent more than 10 years as a mem­ber of the Cure­Vac man­age­ment board and over­saw the re­lease of safe­ty-fo­cused in­ter­im Phase I da­ta on its mR­NA vac­cines for Covid and the flu, caus­ing its stock $CVAC to jump 25% ear­li­er this month.

John Ja­cobs

The Phase I tri­al is ex­pect­ed to fin­ish in the next cou­ple of weeks, fol­lowed by plans for a Phase I/II tri­al for the flu study around the mid­dle of 2023 and a Phase II Covid tri­al lat­er in the year.

Haas start­ed as CEO at Cure­Vac in April 2020, right af­ter the start of the pan­dem­ic. Cure­Vac’s new Phase I da­ta are an­oth­er at­tempt for the com­pa­ny to get back in­to the race af­ter the com­pa­ny’s first at­tempt at an mR­NA vac­cine failed. Cure­Vac at­trib­uted the fail, in part, to the rise of new vari­ants.

“With our re­cent­ly re­port­ed plat­form val­i­da­tion we are en­ter­ing a new chap­ter in Cure­Vac’s de­vel­op­ment, which marks a nat­ur­al tran­si­tion for me,” Haas said in its news re­lease.

Er­ck, the long­time No­vavax leader who was named pres­i­dent and CEO in 2011, led the com­pa­ny through the pan­dem­ic and the long-await­ed FDA EUA ap­proval of its pro­tein-based Covid vac­cine, Nu­vax­ovid.

Nu­vax­ovid won FDA au­tho­riza­tion in Ju­ly of 2022, be­com­ing the first pro­tein-based Covid vac­cine in the US, af­ter sev­er­al de­lays for its EUA fil­ing. The FDA had had con­cerns over heart safe­ty is­sues ahead of ap­proval, send­ing the com­pa­ny’s share prices tum­bling at the time.

In No­vem­ber, No­vavax an­nounced that it was pulling out of a deal with Gavi, the Vac­cine Al­liance, af­ter an al­leged con­tract vi­o­la­tion. The Vac­cine Al­liance is a glob­al part­ner­ship work­ing on im­prov­ing vac­cine ac­cess in low­er-in­come coun­tries.

But the com­pa­ny an­nounced ear­li­er this month that Spain and Italy rec­om­mend­ed Nu­vax­ovid as a boost­er dose for peo­ple 18 and old­er, while France rec­om­mend­ed it as a two-dose pri­ma­ry vac­ci­na­tion in ado­les­cents ages 12 through 17.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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