Dawn O'Connell (Michael Brochstein/Sipa USA/Sipa via AP Images)

Covid-19 roundup: Mod­er­na, US sign con­tract for au­tumn boost­er dos­es; Enan­ta touts PhI re­sults for its an­tivi­ral

The US gov­ern­ment has placed a con­tract for 66 mil­lion dos­es of Mod­er­na’s Covid-19 vac­cine boost­er can­di­date, and the deal could bal­loon to an­oth­er 234 mil­lion dos­es.

The con­tract in­cludes up to $1.74 bil­lion for Mod­er­na to man­u­fac­ture and de­liv­er the dos­es of the bi­va­lent vac­cine can­di­date, dubbed mR­NA-1273.222. The shot con­tains anti­gens against the BA.4/BA.5 Omi­cron sub­vari­ant strains and is part of Mod­er­na’s ef­fort to de­liv­er a boost­er shot this au­tumn, pend­ing the nec­es­sary go-ahead from the FDA and CDC.

Per shot, that’s $26.36. In Au­gust 2020, the US bought 100 mil­lion dos­es of the Mod­er­na vac­cine for about $10 less, at ap­prox­i­mate­ly $15.75 a pop, ac­cord­ing to Reuters. Mean­while, the Eu­ro­pean Union has in the past paid be­tween $22.60 to $25.50 for each Mod­er­na dose, ac­cord­ing to the New York Times.

“We look for­ward to re­ceiv­ing these new vari­ant-spe­cif­ic vac­cines and work­ing with state and lo­cal health­care part­ners to make the vac­cines avail­able for free in com­mu­ni­ties around the coun­try this fall,” Health and Hu­man Ser­vices As­sis­tant Sec­re­tary Dawn O’Con­nell said in a state­ment.

Enan­ta Phar­ma­ceu­ti­cals touts pos­i­tive PhI da­ta for its oral Covid-19 treat­ment

A Mass­a­chu­setts biotech that main­ly works on de­vel­op­ing small mol­e­cule drugs for vi­ral in­fec­tions and liv­er dis­eases is al­so de­vel­op­ing an oral an­tivi­ral for Covid-19 — and is now pro­vid­ing da­ta.

Jay Lu­ly

Enan­ta Phar­ma­ceu­ti­cals an­nounced topline da­ta on Fri­day from its Phase I study as­sess­ing the safe­ty and tol­er­a­bil­i­ty of a once-dai­ly oral can­di­date, dubbed EDP-235, in healthy adults. The can­di­date is a 3CL pro­tease in­hibitor.

Ac­cord­ing to the da­ta from Enan­ta’s Phase I, the re­sults showed the can­di­date had fa­vor­able safe­ty, tol­er­a­bil­i­ty, and PK with strong ex­po­sure mul­ti­ples over the EC90, which sup­ports mov­ing for­ward in a Phase II study in the fourth quar­ter of the year us­ing on­ly one dose.

The com­pa­ny said the can­di­date is safe and well-tol­er­at­ed in healthy sub­jects for up to 400 mg for up to sev­en days. The ad­verse events in­clud­ed headache and gas­troin­testi­nal-re­lat­ed symp­toms dur­ing the in­ves­ti­ga­tion with mul­ti­ple dos­es.

There were three study dis­con­tin­u­a­tions re­port­ed with one mod­er­ate headache in the 400 mg co­hort, one se­vere headache with 800 mg and one grade 3 ALT/grade 2 AST el­e­va­tion al­so in the 800 mg sec­tion. A to­tal of 72 sub­jects were a part of the study.

“Pre­clin­i­cal da­ta show good dis­tri­b­u­tion in­to oth­er key tar­get tis­sues, which may al­low EDP-235 to in­hib­it the virus at pos­si­ble sites of on­go­ing repli­ca­tion po­ten­tial­ly linked to long Covid. Our da­ta sup­port a con­ve­nient dos­ing reg­i­men, with strong ex­po­sure mul­ti­ples for both the 200mg and 400mg dos­es, with­out the need for ri­ton­avir boost­ing. We are tar­get­ing a one pill, a once-a-day an­tivi­ral treat­ment reg­i­men that is ac­tive against all COVID-19 vari­ants of con­cern,” said Enan­ta CEO Jay Lu­ly.

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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