Neal Fowler, Pathalys Pharma CEO

Pathalys inks de­vel­op­ment deal with Abing­worth com­pa­ny, rais­ing $150M

Pathalys Phar­ma, a pri­vate biotech co-found­ed by Japan­ese VC Catalys Pa­cif­ic and DaVi­ta Ven­ture Group in late 2020 to fo­cus on chron­ic kid­ney dis­ease, an­nounced Wednes­day morn­ing it reached a deal with Launch Ther­a­peu­tics to ad­vance two Phase III tri­als for a drug de­signed to treat a parathy­roid con­di­tion for he­modial­y­sis pa­tients. The drug is called upaci­cal­cet, al­so known as PLS240.

As part of the deal, Pathalys al­so raised $150 mil­lion in se­cured prod­uct fi­nanc­ing and eq­ui­ty to push upaci­cal­cet through Phase III and to sup­port a po­ten­tial launch if it’s ap­proved. Abing­worth led the round, while Car­lyle and Or­biMed joined in, as did Catalys Pa­cif­ic and DaVi­ta Ven­ture Group.

In re­turn for the in­vest­ment, Pathalys re­tains world­wide com­mer­cial rights to upaci­cal­cet out­side Japan and Asia. The prod­uct fi­nanc­ing fund­ing gets paid back out of rev­enues of the drug.

The drug, so far Pathalys’ on­ly drug in its pipeline, is a cal­cimimet­ic — a type of drug that mim­ics the ac­tion of cal­ci­um on tis­sues. Oth­er cal­cimimet­ics al­ready ap­proved in the US come from Big Phar­ma Am­gen, with its brand drugs Sen­si­par and Parsabiv in­di­cat­ed to treat hy­per­parathy­roidism.

Pathalys’ drug was ap­proved as Up­a­sita in Japan back in 2021 for sec­ondary hy­per­parathy­roidism in dial­y­sis pa­tients — the same con­di­tion it’s shoot­ing for in the US. The drug was de­vel­oped by EA Phar­ma, which kicked off in 2016 as a gas­troin­testi­nal dis­ease biotech formed by Ei­sai Group and Aji­nomo­to Group.

Pathalys got the li­cense to de­vel­op the drug in US and Eu­rope in 2021, CEO Neal Fowler told End­points News.

Launch Ther­a­peu­tics, which kicked off in 2022, is es­sen­tial­ly the drug de­vel­op­ment arm of Car­lyle and its-now life sci­ence sub­sidiary Abing­worth. Fowler said that while the com­pa­ny was in dis­cus­sions with in­vestors to find cap­i­tal for Phase III tri­als, Pathalys be­came fa­mil­iar with Launch af­ter start­ing dis­cus­sions with Abing­worth.

Car­lyle, the pri­vate eq­ui­ty gi­ant, leapt in­to the biotech in­vest­ment scene last year when it bought out Abing­worth. At the time of the deal, Abing­worth and Car­lyle brought Launch Ther­a­peu­tics in­to the fold — which takes on clin­i­cal tri­al risk in ex­change for a share of the prof­its.

Launch Ther­a­peu­tics will have the lead role in ex­e­cut­ing and man­ag­ing the clin­i­cal tri­als, while Pathalys will be re­spon­si­ble for man­u­fac­tur­ing, com­mer­cial­iza­tion and work­ing with the FDA. The two iden­ti­cal tri­als, ex­pect­ed to launch in the first half of this year, will en­roll 375 pa­tients each and last for 20 months. Fowler said by that time­line, da­ta will read out in ear­ly 2025.

Fowler said that while the com­pa­ny is ex­cit­ed to get its first clin­i­cal tri­al un­der­way, Pathalys has big­ger am­bi­tions — and wants to ex­pand in­to mul­ti­ple as­sets in chron­ic kid­ney dis­ease.

“It’s just the be­gin­ning, and we’re ea­ger to get mov­ing,” Fowler added.

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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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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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.

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.

Charles Riv­er se­cures $50M ac­qui­si­tion of drug dis­cov­ery tech com­pa­ny

Over the past several years, Massachusetts-based contractor Charles River Laboratories has been busy on the M&A front, with the latest, $50 million buyout coming Monday for a provider of high-throughput screening solutions for discovery research.

Chicago-based SAMDI Tech will now be folded into Charles River’s discovery and safety assessment division, Charles River announced.

The $50 million in cash is for the 80% of SAMDI that Charles River didn’t previously own. Other financial details on the deal were not disclosed.

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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