Pas­cal So­ri­ot is stay­ing at As­traZeneca af­ter all, con­firm­ing up­com­ing pre­sen­ta­tion - re­ports

As­traZeneca has stayed mum for two long days filled with an in­tense round of ru­mors and spec­u­la­tion over the fu­ture of their CEO, Pas­cal So­ri­ot. But the lat­est re­port out of Lon­don is that So­ri­ot has de­cid­ed to stay with the phar­ma gi­ant af­ter all, for­go­ing a re­port­ed of­fer of a $20 mil­lion bonus and a chance to re­or­ga­nize a trou­bled Te­va. And the com­pa­ny, while stay­ing silent on the sto­ry, is con­firm­ing plans for So­ri­ot to make a key pre­sen­ta­tion in about two weeks.

The lat­est news was bro­ken by Bloomberg Fri­day af­ter­noon but didn’t hit the In­ter­net im­me­di­ate­ly. StreetInsid­er cit­ed the re­port in a brief, say­ing that So­ri­ot “is cur­rent­ly plan­ning to stay for the fore­see­able fu­ture, ac­cord­ing to Bloomberg, cit­ing peo­ple with knowl­edge of the mat­ter.”

As­traZeneca in­vestors quick­ly bid up shares in the phar­ma gi­ant by more than 4% as news of the CEO’s plans to stay spread Fri­day, re­plac­ing the bil­lions lost ear­li­er as the mar­ket man­aged to over­come a bad case of nerves spurred by thoughts that an ex­it by So­ri­ot at this stage im­plied bad news for the cru­cial MYS­TIC study for dur­val­um­ab and treme­li­mum­ab. That Phase III da­ta is due any day now.

Of­fi­cial­ly, As­traZeneca is main­tain­ing the same po­si­tion it has held for the past two days. In re­sponse to a query of mine, a spokesper­son for As­traZeneca re­spond­ed: “Re­gard­ing the Te­va ru­mours still the same, we don’t com­ment on spec­u­la­tion.”

But the com­pa­ny did fol­low up with a time­ly note on an up­com­ing re­view of As­traZeneca’s H1 re­sults, for Ju­ly 27, close to two weeks from now, with a pre­sen­ta­tion by So­ri­ot. In­sid­ers are al­so telling the Fi­nan­cial Times that it’s busi­ness as usu­al at As­traZeneca.

There’s been plen­ty of time to chat­ter about all kinds of pos­si­bil­i­ties in the time since Cal­cal­ist first re­port­ed that So­ri­ot was in the fi­nal stages of ham­mer­ing out a con­tract. One of the lat­est dis­cus­sions cen­tered on the pos­si­bil­i­ty that Pfiz­er might make a re­newed bid if So­ri­ot was gone, leav­ing the door open to a deal that he spurned three years ago.

That ev­i­dent­ly won’t be hap­pen­ing, ei­ther.

Te­va Chair­man Sol Bar­er has made it clear that find­ing a cred­i­ble new CEO to lead the com­pa­ny at a time gener­ic pric­ing has erod­ed and its pipeline re­mains weak is a cru­cial task. Now he’ll be ex­pect­ed to go back and find some­one else to fill the po­si­tion — the fourth CEO in as many years. Te­va’s shares plunged 4% as the mar­ket clawed back gains from the last two days.

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So­ri­ot is left in a dif­fi­cult spot, still work­ing on a turn­around as rev­enue slides in­to a trough and the pipeline proves far less ef­fec­tive than the CEO had promised.

One key are­na, on­col­o­gy, has de­liv­ered some sol­id gains with drugs like Lyn­parza and Tagris­so and pos­si­bly Imfinzi (dur­val­um­ab). But the big R&D cat­a­lyst this year cen­ters on As­traZeneca’s ques­tion­able MYS­TIC study, com­bin­ing dur­val­um­ab and treme­li­mum­ab, with plen­ty of deep seat­ed fears about the out­come. As­traZeneca had to set­tle for a fifth place fin­ish among the check­point con­tenders as it cen­tered its plans around So­ri­ot’s strat­e­gy of de­liv­er­ing com­bi­na­tions that could leapfrog the lead­ers in the field.

That strat­e­gy is far from be­ing ex­e­cut­ed on. And oth­er el­e­ments in the pipeline have been sore dis­ap­point­ments. As­traZeneca has ex­pe­ri­enced ma­jor set­backs on a score of big projects.

  • Bril­in­ta was sup­posed to be the un­pol­ished jew­el in As­traZeneca’s crown. It’s been a ma­jor dis­ap­point­ment.
  • Selume­tinib has been a flop, fail­ing back-to-back Phase III stud­ies.
  • There was a Phase III miss for tralok­inum­ab in asth­ma.
  • ZS-9 was kicked back by reg­u­la­tors twice for man­u­fac­tur­ing rea­sons, giv­ing a ri­val time to re­group and so­lid­i­fy its po­si­tion in the mar­ket.
  • The com­pa­ny has qui­et­ly and steadi­ly pulled out of an­tibi­otics.
  • A whole se­ries of drugs — in ad­di­tion to an­tibi­otics — have been sold off to sup­ply some fast rev­enue in place of what had been big peak sales fore­casts, among them bro­dalum­ab.

Most of that laun­dry list of set­backs was racked up in the last year.

All these prob­lem­at­ic drugs were in­tend­ed to play a big role in dou­bling As­traZeneca’s $23 bil­lion in 2016 rev­enue. Keep­ing that promise by 2023, which So­ri­ot used to win over in­vestors and re­ject Pfiz­er’s bid for the com­pa­ny in 2014, has been an in­creas­ing­ly un­like­ly prospect.

When So­ri­ot ar­rived at As­traZeneca, he made a great show of an­nounc­ing plans for a big new cam­pus in Cam­bridge, UK. Now that project, like so many things about As­traZeneca, is un­fin­ished, be­hind sched­ule and way over bud­get. He was sup­posed to have that done in 2016.

Now So­ri­ot will re­port­ed­ly be stay­ing for the fore­see­able fu­ture, to see if he can get this right.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.