Hori­zon claims mid-stage vic­to­ry in rare dis­ease, lines up PhI­II for new own­ers at Am­gen

As Hori­zon ties up the loose ends for its $28 bil­lion sale to Am­gen, a drug it picked up from a pre­vi­ous ac­qui­si­tion of its own is de­liv­er­ing a mid-stage win.

Hori­zon had al­ready de­clared Phase II suc­cess for da­zo­dal­ibep among one group of pa­tients with Sjö­gren’s syn­drome back in Sep­tem­ber. Now, it is an­nounc­ing that the drug al­so met the pri­ma­ry end­point for the sec­ond pa­tient pop­u­la­tion in the tri­al, set­ting up a 2023 launch for a Phase III pro­gram it will work with the FDA to de­sign. That time­line is ahead of ex­pec­ta­tions, the com­pa­ny added.

A CD40 lig­and an­tag­o­nist that blocks T cell in­ter­ac­tion with CD40-ex­press­ing B cells, da­zo­dal­ibep came to Hori­zon by way of Viela Bio, which in turn got the drug from As­traZeneca along­side a slate of oth­er rare dis­ease pro­grams that were be­ing swept out in a re­org.

By the time Hori­zon bought Viela for close to $3 bil­lion in 2021, Viela had al­ready start­ed a Phase II tri­al in Sjö­gren’s syn­drome, a chron­ic au­toim­mune dis­ease af­fect­ing sali­vary and tear glands but al­so mul­ti­ple or­gans in se­vere cas­es.

It en­rolled two dif­fer­ent groups of pa­tients: The first 74 pa­tients had mod­er­ate-to-high sys­temic dis­ease as de­fined by a gold stan­dard ac­tiv­i­ty in­dex. The sec­ond group, with 109 pa­tients, had on­ly mild sys­temic dis­ease ac­tiv­i­ty based on that in­dex, but were con­sid­ered mod­er­ate-to-se­vere based on a dif­fer­ent score of sub­jec­tive symp­toms.

In­ves­ti­ga­tors tracked those symp­toms, in­clud­ing dry­ness, pain and fa­tigue de­spite lack­ing ad­di­tion­al or­gan is­sues, on a com­pos­ite score dubbed ES­SPRI.

“Par­tic­i­pants in this study had been ex­clud­ed from oth­er re­cent tri­als, de­spite their sub­stan­tial dis­ease bur­den,” said Fred­er­ick Vivi­no, for­mer di­rec­tor of the Penn Sjö­gren’s Cen­ter and chief, di­vi­sion of rheuma­tol­ogy at Penn Pres­by­ter­ian Med­ical Cen­ter, in a pre­pared state­ment.

Eliz­a­beth Thomp­son

At Day 169, pa­tients treat­ed with da­zo­dal­ibep achieved a 1.8-point re­duc­tion in their ES­SPRI scores com­pared to place­bo-treat­ed pa­tients, who achieved a 0.53-point re­duc­tion. Ac­cord­ing to Hori­zon, that’s good for a least squares mean dif­fer­ence of 1.27 (p=0.0002).

Eliz­a­beth Thomp­son, Hori­zon’s ex­ec­u­tive vice pres­i­dent of R&D, de­scribed it as a “sig­nif­i­cant sep­a­ra­tion in symp­tom in­ten­si­ty.”

In the first batch of Phase II re­sults re­leased on the first group of pa­tients, the drug spurred a 6.3-point re­duc­tion on the ESS­DAI score com­pared to 4.1 points on place­bo, trans­lat­ing to a least squares mean dif­fer­ence of 2.2 points (p=0.017).

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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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.

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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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.

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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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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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.

#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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