Ter­ri­ble op­tics: As­traZeneca shares take a hit fol­low­ing re­port that CEO So­ri­ot is mov­ing to Te­va

You can in­sert this sto­ry in the WTF? file.

Wednes­day af­ter­noon Is­rael’s Cal­cal­ist re­port­ed that As­traZeneca CEO Pas­cal So­ri­ot has agreed to take the CEO’s job at Te­va, fill­ing a role left open at a com­pa­ny that is in the mid­dle of a ma­jor up­heaval.

The Is­raeli fi­nan­cial news web site says that So­ri­ot has per­son­al­ly signed off on the new job, ac­cept­ing a $20 mil­lion bonus, ac­cord­ing to a sto­ry from Reuters. And Haaretz fol­lowed up with its own con­fir­ma­tion that So­ri­ot has agreed to take the Te­va job, the sec­ond non-Is­raeli to take the po­si­tion, though they are still dis­cussing terms. The Haaretz re­port al­so in­clud­ed word of the $20 mil­lion bonus.

If true, So­ri­ot would be leav­ing the phar­ma gi­ant 5 years af­ter he took over, and a long way from com­plet­ing the turn­around that he vowed he would bring to As­traZeneca. In par­tic­u­lar, the move would come as jit­ters con­tin­ue to grow about As­traZeneca’s loom­ing MYS­TIC da­ta, which have be­come a ma­jor cat­a­lyst for the com­pa­ny’s can­cer group as they pur­sue a piv­otal study fo­cus­ing on a com­bi­na­tion of dur­val­um­ab, the new­ly ap­proved PD-L1 drug, and treme­li­mum­ab, a CT­LA4 ther­a­py.

Both Te­va and As­traZeneca de­clined to com­ment to Reuters, say­ing they don’t re­spond to ru­mors. In­vestors, though, quick­ly weighed in, dri­ving the phar­ma gi­ant’s shares$AZN down more than 4% — carv­ing bil­lions off its mar­ket share — while boost­ing Te­va $TE­VA 2.5%.

The com­pa­nies may want to make an ex­cep­tion on their no-com­ment rule. So­ri­ot has been or­ches­trat­ing As­traZeneca’s game plan for five long years, aimed at ful­fill­ing a promise to al­most dou­ble last year’s rev­enue. His de­par­ture now would be a tac­it ad­mis­sion of fail­ure, which will like­ly rock the com­pa­ny’s most loy­al in­vestors, many of whom ques­tioned why So­ri­ot would re­ject a buy­out of­fer from Pfiz­er.

Sea­mus Fer­nan­dez at Leerink counts him­self among the shocked. His com­ment:

Yes­ter­day’s re­port from the Is­raeli dai­ly busi­ness pa­per Cal­cal­ist that cur­rent AZN CEO Pas­cal So­ri­ot may be leav­ing the com­pa­ny to head TE­VA (NR) comes as a ma­jor sur­prise. We spoke with the com­pa­ny, who sim­ply stat­ed that it does not com­ment on ru­mors; how­ev­er it did not out­right de­ny the re­port. If true, the op­tics around his de­par­ture would be ter­ri­ble ahead of the MYS­TIC read­out (Imfinzi [dur­val­um­ab; an­ti-PD-L1] + treme­li­mum­ab [an­ti-CT­LA-4] in first-line (1L) non-small cell lung can­cer [NSCLC]), which are ex­pect­ed any day now. While the news does not ap­pear to be re­lat­ed to the MYS­TIC out­come (as the com­pa­ny con­firmed that if the blind were bro­ken, the top-line re­sults would have to be com­mu­ni­cat­ed al­most im­me­di­ate­ly), his ex­it would leave AZN rud­der­less in the wake of sev­er­al oth­er re­cent de­par­tures.

Te­va chair­man Sol Bar­er has been look­ing for a new CEO, its fourth in the last 4 years, af­ter the com­pa­ny found it­self un­der the gun for a weak pipeline and shrink­ing gener­ic drug sales. If So­ri­ot, a Roche vet, takes over, he’ll find him­self in much the same sit­u­a­tion as he did in 2012, when he took over at As­traZeneca. For So­ri­ot and Te­va, it could be yet an­oth­er shot at a do-over.

Te­va gave the CEO’s job to Je­re­my Levin in 2013, but he ul­ti­mate­ly fell foul of the board and was forced out be­fore he could re­struc­ture. Levin went on to found the biotech Ovid, which re­cent­ly went pub­lic. Levin was re­placed by Erez Vigod­man, who was squeezed out ear­li­er this year as the num­bers came un­der pres­sure, leav­ing the com­pa­ny in search of a per­ma­nent re­place­ment who could try once again to set things right.

Who would take over at As­traZeneca now is any­one’s guess. Big Phar­ma has seen more ex­its that en­trances in the last few years, as top re­searchers and ex­ecs found new roles in biotech. Iron­i­cal­ly So­ri­ot re­port­ed­ly just com­plet­ed an an­gry show­down with Luke Miels, who left As­traZeneca to join GSK.


Im­age: Get­ty

 

 

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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