Covid-19 roundup: Can­cer biotech to sub­mit EUA for Covid drug; FDA OKs Eli Lil­ly JAK in­hibitor

As vac­cine talk wanes, re-pur­posed treat­ments take cen­ter stage for Covid-19.

Veru, which start­ed out as a can­cer out­fit, plans to re­quest an EUA for its drug sabiz­ab­u­lin as a Covid-19 treat­ment for pa­tients at high risk for acute res­pi­ra­to­ry dis­tress syn­drome (ARDS), it an­nounced to­day.

Last month, Veru said its Phase III study for its Covid-19 treat­ment was shut down by an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee due to the drug’s “over­whelm­ing ef­fi­ca­cy.” Ac­cord­ing to the com­pa­ny, sabiz­ab­u­lin re­duced deaths by 55% com­pared to the stan­dard of care group, which re­ceived remde­sivir, dex­am­etha­sone, an­ti­bod­ies, and JAK in­hibitors.

To­day, the biotech said that in a pre-EUA meet­ing with the FDA, the reg­u­la­to­ry agency agreed that it has enough da­ta to sup­port both an EUA and NDA sub­mis­sion for sabiz­ab­u­lin, which is al­so cur­rent­ly in clin­i­cal tri­als for breast and prostate can­cer.

Veru said it plans to sub­mit an EUA in the sec­ond quar­ter of 2022.

Eli Lil­ly gets ap­proval for Olu­mi­ant

The FDA has ap­proved Eli Lil­ly and In­cyte’s JAK in­hibitor ​​baric­i­tinib, mar­ket­ed as Olu­mi­ant, for adults with Covid-19 who need sup­ple­men­tal oxy­gen, ven­ti­la­tion or EC­MO, the agency an­nounced yes­ter­day.

Olu­mi­ant has al­ready been in use un­der an EUA as a stand­alone treat­ment for Covid-19 since Ju­ly 2021, af­ter it was ini­tial­ly giv­en an EUA in 2020 as part of a com­bo treat­ment with Gilead’s Vek­lury (remde­sivir). With this ap­proval, Olu­mi­ant be­comes the first ap­proved im­munomod­u­la­to­ry treat­ment for Covid-19, the FDA not­ed in its press re­lease.

How­ev­er, it has not been ap­proved for pe­di­atric Covid-19 pa­tients and re­mains un­der EUA there, the reg­u­la­to­ry agency said.

In its own press re­lease, Eli Lil­ly said the ap­proval was sup­port­ed by two Phase III clin­i­cal tri­als — one of which was for the com­bo treat­ment of Olu­mi­ant and Vek­lury, and the oth­er of which com­pared Olu­mi­ant alone to stan­dard of care, but did not reach its pri­ma­ry end­point. The FDA had giv­en Olu­mi­ant its so­lo EUA based on the re­sults from the sec­ond study, say­ing the da­ta did show the treat­ment re­duced the pro­por­tion of pa­tients who died com­pared to stan­dard of care.

In the first quar­ter of 2022, Eli Lil­ly made $255.6 mil­lion from Olu­mi­ant sales.

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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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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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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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.

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.

(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.