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



Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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