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.”


Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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