As­traZeneca's Ul­tomiris hits pri­ma­ry end­point for PhI­II NMOSD study

As­traZeneca caught a trio of re­cent wins — scor­ing an ex­pand­ed in­di­ca­tion for its breast can­cer drug En­her­tu, nail­ing Farx­i­ga’s Phase III win ear­li­er this week, and now, an­oth­er tri­al win.

The UK phar­ma said Thurs­day that its long-act­ing C5 com­ple­ment in­hibitor drug Ul­tomiris (ravulizum­ab-cwvz) hit on its pri­ma­ry end­point in the Phase III CHAM­PI­ON-NMOSD study. That end­point was to show a “sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful re­duc­tion in the risk of re­lapse in adults” with a spe­cif­ic type of a rare au­toim­mune dis­ease that tar­gets the cen­tral ner­vous sys­tem.

Neu­romyelitis op­ti­ca spec­trum dis­or­der, or NMOSD, is cur­rent­ly an in­cur­able dis­ease that tar­gets the spine and op­tic nerves. Most peo­ple liv­ing with NMOSD tend to ex­pe­ri­ence “re­laps­es” (which hap­pen when there is in­flam­ma­tion in the ner­vous sys­tem), or an on­set of neu­ro­log­ic symp­toms or wors­en­ing of ex­ist­ing neu­ro­log­i­cal symp­toms such as blind­ness, par­tial paral­y­sis or spasms.

Ac­cord­ing to As­traZeneca, the drug met the pri­ma­ry end­point of time to first on-tri­al re­lapse. No re­lapse was ob­served in 58 pa­tients over a me­di­an treat­ment du­ra­tion of 73 weeks.

The lead pri­ma­ry in­ves­ti­ga­tor for the tri­al, Sean J. Pit­tock out of Mayo Clin­ic’s Cen­ter for Mul­ti­ple Scle­ro­sis and Au­toim­mune Neu­rol­o­gy, said in a state­ment, “Every NMOSD re­lapse can have de­bil­i­tat­ing and ir­re­versible con­se­quences, so re­duc­ing re­laps­es is crit­i­cal.”

The drug was first ap­proved by the FDA back in 2018 to treat pa­tients at least one-month-old to treat blood dis­ease parox­ys­mal noc­tur­nal he­mo­glo­bin­uria — the same dis­ease be­ing tar­get­ed at BioCryst with its lead can­di­date. BioCryst an­nounced this morn­ing that the FDA im­posed a par­tial clin­i­cal hold on its can­di­date as part of its Q1 earn­ings an­nounce­ment.

The drug is al­so a fol­low-up to Alex­ion’s block­buster Soliris, al­so a com­ple­ment fac­tor 5 in­hibitor, which As­traZeneca now owns af­ter pay­ing a be­he­moth $39 bil­lion last year to ac­quire the com­pa­ny. And so far, there is not a ton of com­pe­ti­tion in the space. To date, there are on­ly three drugs ap­proved for NMOSD, more specif­i­cal­ly AQP4-Ab pos­i­tive NMOSD: As­traZeneca’s Soliris, Viela Bio’s Up­lin­za and En­spryng from Genen­tech.

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:

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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.

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?”

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Bob Nelsen (Lyell)

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 a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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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.

Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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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.

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(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.

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