Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Bris­tol My­ers builds the case for pso­ri­a­sis hope­ful as it waits in reg­u­la­to­ry lim­bo

Bris­tol My­ers Squibb con­tin­ues to tout more da­ta for its ex­per­i­men­tal pso­ri­a­sis drug that it hopes will shake up the mar­ket.

The phar­ma­ceu­ti­cal gi­ant post­ed two-year re­sults from a long-term ex­ten­sion study of deu­cravac­i­tinib, show­ing the drug re­mained ef­fec­tive af­ter two years. The drug, which an­a­lysts pre­dict can bring in bil­lions in sales by 2026, is an oral TYK2 in­hibitor for adult pa­tients with mod­er­ate to se­vere plaque pso­ri­a­sis.

Ac­cord­ing to the lat­est da­ta, clin­i­cal ef­fi­ca­cy was main­tained through up to two years of treat­ment, with re­sponse rates at week 60 of 77.7% and 58.7% for PASI 75, a mea­sure of the dis­ease’s sever­i­ty. The safe­ty pro­file al­so re­mained con­sis­tent and no new is­sues popped up.

Thurs­day’s re­sults were con­sis­tent with the Phase III pso­ri­a­sis tri­als, dubbed PO­E­T­YK PSO-1 and PO­E­T­YK PSO-2 post­ed in 2021. Bris­tol My­ers may find it more dif­fi­cult to ex­pand in­to oth­er in­di­ca­tions, how­ev­er, as the drug failed a Phase II hur­dle in ul­cer­a­tive col­i­tis.

Jonathan Sadeh

Jonathan Sadeh, se­nior vice pres­i­dent of im­munol­o­gy and fi­bro­sis de­vel­op­ment at Bris­tol My­ers, said in a state­ment that the long-term fol­low-up re­sults on­ly add to the grow­ing body of ev­i­dence for the drug.

The hype start­ed ramp­ing up in Feb­ru­ary 2021 when BMS cleared an­oth­er Phase III study. Full re­sults weren’t post­ed un­til the fol­low­ing April, but Bris­tol My­ers not­ed that tri­al con­clud­ed by dis­play­ing 58.7% and 53.6% of pa­tients on deu­cravac­i­tinib achiev­ing PASI 75 re­sponse in the PO­E­T­YK-PSO-1 and PO­E­T­YK-PSO-2 stud­ies, re­spec­tive­ly. Mean­while, just 12.7% and 9.4% of place­bo pa­tients and 35.1% and 40.2% of pa­tients on Ote­zla achieved the same re­sults.

How­ev­er, de­spite the pos­i­tiv­i­ty, the drug will like­ly go un­der a fine-tooth comb at the FDA and the EMA. The FDA has pre­vi­ous­ly tak­en the ham­mer to a sim­i­lar drug class in JAK in­hibitors such as Pfiz­er’s Xel­janz, find­ing an in­creased risk of se­ri­ous heart-re­lat­ed events. The FDA al­so changed the JAK class’ la­bel af­ter a re­view of Ab­b­Vie’s Rin­voq to lim­it use to cer­tain pa­tients who are not treat­ed ef­fec­tive­ly or who ex­pe­ri­ence se­vere side ef­fects with the TNF block­ers.

Amer­i­can reg­u­la­tors have set a Sept. 10, 2022 PDU­FA date for deu­cravac­i­tinib.

Deu­cravac­i­tinib would be the first TYK2 drug ap­proved by the FDA and Bris­tol My­ers is hop­ing the dif­fer­en­ti­at­ed path­way — and os­ten­si­bly more ef­fi­ca­cious re­sults — will help in its ri­val­ry with Am­gen. Cur­rent­ly, Am­gen’s Ote­zla is the first and on­ly oral treat­ment ap­proved in adult pa­tients with plaque pso­ri­a­sis across all sever­i­ties, in­clud­ing mild, mod­er­ate and se­vere.

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.

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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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.