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.

https://twit­ter.com/Arm­strong­Drew/sta­tus/885919752669057024

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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Af­ter 4 years of furor, the FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. And this time they plan to squash it

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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UP­DAT­ED: Ac­celeron of­fers thumbs up on a PhII suc­cess for would-be block­buster drug — and shares rock­et up

There’s no public data yet, but Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.

Sor­ren­to shrugs off an anony­mous pri­vate eq­ui­ty group’s $1B of­fer to buy the com­pa­ny

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.