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

 

 

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.