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

Te­va Jerusalem – (c) Flash 90 2013

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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.”

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.