Te­va de­nies big lay­offs are planned, but will push greater ef­fi­cien­cy and shut­ter floun­der­ing ef­forts

Te­va Jerusalem – (c) Flash 90 2013

Click on the im­age to see the full-sized ver­sion

With its ex­ec­u­tive suite in tur­moil, its flag­ship drug un­der at­tack and its books bur­dened by debt fol­low­ing years of drought in its R&D arm, Te­va is re­port­ed­ly prepar­ing to un­leash a ma­jor re­or­ga­ni­za­tion that will cost thou­sands of jobs. But af­ter first stay­ing mum on the sub­ject, the Is­raeli phar­ma com­pa­ny now says it isn’t bring­ing out the ax but will in­stead pur­sue a va­ri­ety of ef­fi­cien­cy mea­sures.

The Is­raeli news­pa­per Cal­cal­ist re­port­ed that the bio­phar­ma hy­brid, which sells gener­ics as well as brand­ed drugs, is plan­ning to cut up to 6,000 staffers — 11% of its to­tal — af­ter Passover. In a state­ment, though, Te­va fired back that it won’t pink slip thou­sands, pre­fer­ring in­stead to end­ing cer­tain ac­tiv­i­ties, con­sol­i­dat­ing op­er­a­tions and freez­ing any new hires.

Te­va In­ter­im CEO Yitzhak Pe­ter­burg

“The ef­fi­cien­cy pro­gram is an in­te­gral part of Te­va’s busi­ness re­al­i­ty. The pro­gram in­cludes, among oth­er things, end­ing un­prof­itable ac­tiv­i­ties and con­sol­i­dat­ing func­tions, in ad­di­tion to freez­ing re­cruit­ment and nat­ur­al em­ploy­ee turnover,” the com­pa­ny said, ac­cord­ing to Reuters.

The lat­est signs of tur­moil come just weeks af­ter CEO Erez Vigod­man left the com­pa­ny. Vigod­man went out the same door Je­re­my Levin was thrown through in late 2013 af­ter he tried, and failed, to push through a re­struc­tur­ing.

That hap­pened soon af­ter a fed­er­al court tossed sev­er­al patents pro­tect­ing Te­va’s 40 mg dose of Co­pax­one, its mul­ti­ple scle­ro­sis main­stay that brought in close to 20% of the com­pa­ny’s rev­enue last year. And the Is­raeli com­pa­ny has been feel­ing the heat af­ter a $40.5 bil­lion gener­ics ac­qui­si­tion deal with Al­ler­gan last year left a heavy debt to work out as gener­ic prices have dropped.

Te­va start­ed the year by low­er­ing its 2017 guid­ance by $1 bil­lion, which did noth­ing to en­dear the com­pa­ny with an­a­lysts and in­vestors.

Ac­tivist in­vestor Ben­ny Lan­da, mean­while, has been push­ing for an ex­pe­ri­enced glob­al play­er to take over the top job. He al­so wants to see the com­pa­ny split up in­to two, with one side tak­ing the gener­ics busi­ness and an­oth­er group spin­ning off the brand di­vi­sion.

There might be some re­luc­tance on the part of the best can­di­dates, how­ev­er. Levin tried to re­or­ga­nize the com­pa­ny and slash staff years ago. But the board re­spond­ed an­gri­ly and pushed him out of the com­pa­ny.

Work­ers won’t take any lay­offs sit­ting down, if it comes to that.

“We were in a sim­i­lar sit­u­a­tion and we went to the bat­tle,” Eli­ran Ko­zlick, the head of Te­va’s work­ers’ com­mit­tee, wrote in a Face­book post ear­ly on Thurs­day, ac­cord­ing to a re­port in Bloomberg. “If the man­age­ment wants to do this again, we will all work to­geth­er and win as we did in the pre­vi­ous strug­gle.”

Te­va, though, is run­ning out of op­tions.

“Every drug com­pa­ny has to change con­stant­ly,” Kite CEO Arie Bellde­grun told Globes af­ter he re­signed from the board. “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.”

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

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

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.