Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

As­traZeneca kicked off Mon­day with a flur­ry of good news. Apart from un­veil­ing pos­i­tive re­sults on its stroke tri­al test­ing its clot-fight­er Bril­in­ta, and wel­com­ing its ex­per­i­men­tal IL-23 in­hibitor brazikum­ab back from Al­ler­gan — the British drug­mak­er al­so dis­closed some up­beat gas­tric can­cer da­ta on its HER2-pos­i­tive on­col­o­gy ther­a­py it is col­lab­o­rat­ing on with Dai­ichi Sankyo.

Buoyed by the per­for­mance of its on­col­o­gy drugs, last March As­traZeneca chief Pas­cal So­ri­ot bet big to part­ner with Dai­ichi on the can­cer drug, with $1.35 bil­lion up­front in a deal worth up to rough­ly $7 bil­lion. Rough­ly 8 months lat­er, as 2019 drew to a close, the FDA swift­ly ap­proved the drug — trastuzum­ab derux­te­can — for use in breast can­cer, months ahead of the ex­pect­ed de­ci­sion date.

Trastuzum­ab derux­te­can, brand­ed as En­her­tu, is an an­ti­body-drug con­ju­gate (ADC) — ther­a­peu­tics in which a can­cer-killing tox­in is at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er — for can­cers that ex­press HER2, a pro­tein as­so­ci­at­ed with ag­gres­sive dis­ease that of­ten re­sides on cer­tain breast can­cer cells. Rough­ly one in five gas­tric can­cers are HER2 pos­i­tive, As­traZeneca said.

The piv­otal mid-stage tri­al, DES­TINY-Gas­tric01, test­ed En­her­tu against chemother­a­py in 189 pa­tients from Japan and South Ko­rea with HER2-ex­press­ing ad­vanced gas­tric can­cer or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma, whose dis­ease pro­gressed de­spite two or more pri­or treat­ment reg­i­mens in­clud­ing flu­o­ropy­rim­i­dine and plat­inum chemother­a­py and trastuzum­ab.

The tri­al met the main goal of in­duc­ing sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in ob­jec­tive re­sponse rate (ORR), as well as the key sec­ondary end­point of over­all sur­vival. De­tailed da­ta are still to come.

Whilst a small­er in­di­ca­tion than HER2+ metasta­t­ic breast can­cer, this still rep­re­sents a sig­nif­i­cant op­por­tu­ni­ty with an es­ti­mat­ed rough­ly 10,000 HER2+ metasta­t­ic gas­tric can­cer pa­tients in the US, top 5 EU mar­kets and Japan, Jef­feries’ an­a­lyst Pe­ter Welford wrote in a note.

Welford’s $2.05 bil­lion in risk-ad­just­ed glob­al peak sales for En­her­tu is pre­dom­i­nant­ly based on the ther­a­py’s oth­er in­di­ca­tions, par­tic­u­lar­ly metasta­t­ic breast can­cer, he said, adding that just $330 mil­lion of that ac­counts for gas­tric can­cer.

Most pa­tients di­ag­nosed with gas­tric can­cer present with ad­vanced, in­cur­able dis­ease — trastuzum­ab in com­bi­na­tion with chemother­a­py is typ­i­cal­ly the first line of de­fense in pa­tients with metasta­t­ic HER2-pos­i­tive gas­tric and gas­troe­sophageal can­cer. Once the dis­ease no longer re­sponds to trastuzum­ab — pa­tients have lim­it­ed op­tions.

Dai­ichi, which ex­pects the drug to reap peak sales up to $4.5 bil­lion across dif­fer­ent in­di­ca­tions, is on track to take for­ward the drug’s ap­pli­ca­tion ini­tial­ly in Japan where gas­tric can­cer is high­ly preva­lent. En­her­tu is an HER2-tar­get­ed ADC with a topoi­so­merase I in­hibitor pay­load — a chemother­a­peu­tic agent de­signed to in­ter­rupt DNA repli­ca­tion in can­cer cells, and is al­so be­ing test­ed in oth­er can­cers.

In 2015, Roche’s Kady­cla, known chem­i­cal­ly as trastuzum­ab em­tan­sine, failed to elic­it any ben­e­fit in pa­tients pre­vi­ous­ly treat­ed for HER2-pos­i­tive ad­vanced gas­tric can­cer. Last April, Mer­ck’s star PD-1 ther­a­py Keytru­da failed to po­si­tion it­self in the front­line gas­tric can­cer set­ting, al­though it has al­ready se­cured ap­proval as a third-line treat­ment.

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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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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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.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

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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