As cri­sis deep­ens, Teva's board sees off CEO Erez Vigod­man and an ac­tivist urges a split in­to two com­pa­nies


The re­volv­ing door out­side Te­va’s ex­ec­u­tive suite is spin­ning again. A lit­tle more than three years af­ter Je­re­my Levin was un­cer­e­mo­ni­ous­ly pushed out of the CEO’s job, his suc­ces­sor is fol­low­ing in the same path, just days af­ter back-to-back set­backs on sales pro­jec­tions and the loss of some key patents. And an ac­tivist in­vestor says the lat­est signs of tur­moil at Te­va should spur a move to split the com­pa­ny be­tween its gener­ic op­er­a­tions and the brand­ed group backed by a pipeline.

Te­va says that Erez Vigod­man is gone by “mu­tu­al agree­ment.” Chair­man Yitzhak Pe­ter­burg is step­ping up to the helm while the hunt be­gins for a new CEO. And Cel­gene co-founder and biotech en­tre­pre­neur Sol Bar­er is tak­ing the chair­man’s job.

The Is­raeli com­pa­ny has been a per­pet­u­al dis­ap­point­ment over the past year to many an­a­lysts. Vigod­man has been crit­i­cized for pay­ing too much in its gener­ics deal with Al­ler­gan. And his rep for tak­ing the wrong step was re­in­forced at the be­gin­ning of this year when Te­va was forced to slash a bil­lion dol­lars off its 2017 sales fore­cast af­ter its rev­enue from new prod­ucts fell dras­ti­cal­ly short of ear­li­er pro­jec­tions for 2016.

The tur­moil has caused Wells Far­go’s David Maris to ques­tion whether Te­va — the world’s largest gener­ics play­er which al­so has a pipeline of ex­per­i­men­tal drugs — had the right team in place. For ac­tivist in­vestor Ben­ny Lan­da, though, the re­al ques­tion is whether the com­pa­ny needs to split its op­er­a­tions.

“I hope that this vi­sion in­cludes split­ting Te­va in­to two com­pa­nies,” Lan­da told Globes. “When you look at the suc­cess­ful com­pa­nies in the world, the key word is fo­cus. Com­pa­nies split so that each com­pa­ny af­ter the split will be able to fo­cus on its sec­tor. Te­va should be split in­to a gener­ics com­pa­ny and a sep­a­rate brand­ed drug com­pa­ny. Te­va has re­cent­ly fo­cused on gener­ics to the ex­tent that it lost di­rec­tion, and didn’t re­al­ize that it should in­vest in the in­no­v­a­tive field for the sake of its fu­ture. These are ac­tu­al­ly two sec­tors with al­most no con­nec­tion be­tween them.”

“On my end, in­vestor feed­back track­ing 60-40 in fa­vor of split in­to brand­ed vs gener­ics,” notes Ever­core ISI’s Umer Raf­fat in re­sponse. “ A split wouldn’t cre­ate val­ue out of thin air … but in­vestors point out that it would al­low a brand­ed and gener­ics biz to run sep­a­rate­ly with a laser fo­cus … with nei­ther side tap­ping in­to the re­sources of the oth­er side and with full cost cut ex­e­cu­tion on gener­ics side. Hav­ing said that, in­vestors ac­knowl­edge a split isn’t im­mi­nent, and may like­ly take some time to ex­e­cute (as­sum­ing it hap­pens).”

I asked Levin what he thought about Vigod­man’s ex­it. His re­ply:

The com­pa­ny has a lot of work to do and the Board will have to make de­ci­sions to re­build man­age­ment, so­lid­i­fy the strate­gic di­rec­tion and pro­vide con­fi­dence to the share­hold­er base.  Te­va is an im­por­tant com­pa­ny and it has a ma­jor role to play in de­liv­er­ing med­i­cines to pa­tients and so­ci­eties around the world.

Vigod­man’s sud­den fall al­so came on the heels of some un­usu­al­ly blunt crit­i­cism from Kite Phar­ma CEO Arie Bellde­grun, who just re­cent­ly re­signed his seat on the board at Te­va. Bellde­grun ze­roed in on Te­va’s chron­ic prob­lems with ad­vanc­ing new drugs through the pipeline.

“Every drug com­pa­ny has to change con­stant­ly,” Bellde­grun told Globes, just days af­ter Te­va lost a court fight to pro­tect the patents on its flag­ship prod­uct, Co­pax­one. “Te­va was very com­fort­able with Co­pax­one, but it should have al­ready pre­pared 8-10 years ago for its sub­se­quent life, and no such prop­er prepa­ra­tions were made. You can’t ac­cuse the com­pa­ny; it grew so fast. Now it is in­vest­ing in its fu­ture de­vel­op­ment, but a tem­po­rary hole has been left, and must be sur­vived. Te­va’s fu­ture will come from Prof. Michael Hay­den’s de­part­ment (the in­no­v­a­tive de­part­ment, G.W.). Every­one is sor­ry that (for­mer gener­ics di­vi­sion head) Sig­gi (Sig­ur­dur) Olaf­s­son left, but Sig­gi wasn’t work­ing on Te­va’s fu­ture.”

“The Com­pa­ny is fo­cus­ing on ex­e­cut­ing its strate­gic pri­or­i­ties to trans­form Te­va, with im­me­di­ate fo­cus on re­al­iz­ing the cost syn­er­gies and strate­gic ben­e­fits of the Ac­tavis Gener­ics ac­qui­si­tion,” said Pe­ter­burg in a state­ment. “I look for­ward to work­ing with the en­tire Te­va team to con­duct a thor­ough re­view of the busi­ness to find ad­di­tion­al op­por­tu­ni­ties to en­hance val­ue for share­hold­ers. Te­va has a deep bench of tal­ent­ed lead­ers and to­day’s an­nounce­ment has no im­pact on our abil­i­ty to ex­e­cute go­ing for­ward. With the strength of our gener­ics pipeline, unique R&D ca­pa­bil­i­ties and un­par­al­leled foot­print, cou­pled with our ex­ist­ing as­sets and grow­ing pipeline in spe­cial­ty med­i­cines, I be­lieve in Te­va and the Com­pa­ny’s long-term growth prospects.”

https://twit­ter.com/Arm­strong­Drew/sta­tus/828737610235379713

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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