Te­va ax­ing 14,000 work­ers, putting R&D and man­u­fac­tur­ing fa­cil­i­ties on the block in mas­sive re­struc­tur­ing

Im­age: Kåre Schultz, Te­va CEO. News Øre­sund

New­ly ap­point­ed Te­va CEO Kåre Schultz un­veiled a mas­sive re­or­ga­ni­za­tion of the com­pa­ny to­day, with plans to ax 14,000 work­ers, shut­ter R&D and man­u­fac­tur­ing fa­cil­i­ties in var­i­ous places and rad­i­cal­ly pare down $3 bil­lion in costs glob­al­ly to re­make the com­pa­ny in the wake of a pun­ish­ing down­turn in the gener­ic drug busi­ness.

Schultz and the team he’s putting to­geth­er for Te­va are mak­ing a rad­i­cal break from the past, shed­ding a long run­ning re­luc­tance to cut staffers in Is­rael. Al­to­geth­er, the com­pa­ny is cut­ting more than 25% of its work­force and slash­ing a large por­tion of its $16 bil­lion cost struc­ture.

That is a bit­ter pill for staffers at the com­pa­ny, but it is mu­sic to the ears of its in­vestors who have watched the num­bers de­te­ri­o­rate. Te­va’s stock spiked 16% af­ter the re­struc­tur­ing news hit.

The com­pa­ny’s state­ment says that they will close or sell off a “sig­nif­i­cant num­ber of R&D fa­cil­i­ties.” Man­u­fac­tur­ing fa­cil­i­ties will al­so be put on the block. And Schultz plans to launch a top-to-bot­tom R&D re­or­ga­ni­za­tion, start­ing with a com­plete re­view of its spe­cial­ty and gener­ic pipelines. When it’s done, he says, Te­va plans to have a sub­stan­tial pipeline in place able to pro­duce new and gener­ic ther­a­pies. But a com­pa­ny spokesper­son tells me there are no specifics yet on who’s get­ting cut in R&D and which fa­cil­i­ties will be shut­tered.

Te­va is meld­ing to­geth­er its gener­ics and spe­cial­ty drug busi­ness, in­te­grat­ing two re­search groups for brand­ed and gener­ic drugs and look­ing for “syn­er­gies” that al­low the com­pa­ny to cut deep in­to R&D. R&D chief Michael Hay­den is al­so head­ed out, as the com­pa­ny an­nounced ear­li­er.

“The on­ly thing we are re­al­ly pro­tect­ing is the prod­uct flow,” Schultz told an­a­lysts Thurs­day morn­ing. Every­thing else, with the ex­cep­tion of man­u­fac­tur­ing of prof­itable prod­ucts, faces the ax. The cuts are “all over the place,” both in the dif­fer­ent groups as well as the ge­o­gra­phies where Te­va works glob­al­ly.

Fo­cus­ing on man­u­fac­tur­ing, Schultz says that Te­va has 80 man­u­fac­tur­ing sites un­der re­view and there will be “dou­ble-dig­it plant clo­sures the next two years.” If the com­pa­ny was to wipe the slate clean and then start over, it would have a to­tal of on­ly 8 to 12 sites. It’s not re­al­is­tic to do that now, he adds, but over the next 10 years that’s the di­rec­tion the com­pa­ny plans to take fol­low­ing ini­tial cut­backs

Te­va will al­so set the stage for a planned launch of Auste­do and their CGRP mi­graine drug fre­manezum­ab. And the CEO cit­ed CNS dis­eases as Te­va’s best hope for de­liv­er­ing new med­i­cines as Te­va re­fo­cus­es R&D.

The CEO is al­so scrap­ping div­i­dends and bonus­es for 2017 as Te­va grap­ples with its fi­nan­cial cri­sis.

Says Schultz:

To­day we are launch­ing a com­pre­hen­sive re­struc­tur­ing plan, cru­cial to restor­ing our fi­nan­cial se­cu­ri­ty and sta­bi­liz­ing our busi­ness. We are tak­ing im­me­di­ate and de­ci­sive ac­tions to re­duce our cost base across our glob­al busi­ness and be­come a more ef­fi­cient and prof­itable com­pa­ny.

Rum­blings about these cuts have al­ready in­spired a string of protest plans on the part of Is­raeli unions, which hold a pow­er­ful po­si­tion at Te­va. Over the past year, though, Te­va has been in a fi­nan­cial tail­spin. Its deal to buy Al­ler­gan’s gener­ic busi­ness just ahead of the price ero­sion in the field has af­flict­ed all play­ers.

“I am aware that we will be part­ing with peo­ple who have ded­i­cat­ed years and con­tributed a great deal to this com­pa­ny,” Schultz says in a note to staffers, “and I deeply ap­pre­ci­ate their com­mit­ment. We are al­so aware that these changes im­pact not on­ly our work­force, but ven­dors, sup­pli­ers and com­mu­ni­ties where we have played a key role for years. How­ev­er, there is no al­ter­na­tive to these dras­tic steps in the cur­rent sit­u­a­tion.”

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

With pos­i­tive topline PhII da­ta, NGM Bio takes a gi­ant leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution, and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50 companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

A the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Tim Mayleben (file photo)

Es­pe­ri­on's goldilocks cho­les­terol fight­er wins FDA ap­proval — will its 'tra­di­tion­al' pric­ing ap­proach spur adop­tion?

It’s more effective than decades-old statins but not as good as the injectable PCSK9 — the goldilocks treatment for cholesterol-lowering, bempedoic acid, has secured FDA approval.

Its maker, Esperion Therapeutics, is betting that their pricing strategy — a planned list price of between $10 to $11 a day — will help it skirt the pushback the PCSK9 cholesterol fighters, Repatha and Praluent, got from payers for their high sticker prices.

The sky-high expectations for the pair of PCSK9 drugs that were first approved in 2015 quickly simmered — and despite a 60% price cut, coupled with data showing the therapies also significantly cut cardiovascular risk, sales have not really perked up.

Esperion is convinced that by virtue of being a cheaper oral therapy, bempedoic acid will hit that sweet spot in terms of adoption.

“We’re kind of like the old comfortable shoe,” Esperion’s chief commercial officer Mark Glickman remarked in an interview with Endpoints News ahead of the decision date. “It’s an oral product, once-daily and nontitratable — these are things that just resonate so true with patients and physicians and I think we’ve kind of forgotten about that.”

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No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

The drug, known as ofatumumab or Arzerra, has performed consistently well across late-stage trials in patients with the most common form of MS, including in head-to-head studies against Sanofi’s old blockbuster Aubagio. But, if the drug is approved, Novartis will find itself in a crosstown game of catch-up; since a 2017 approval, Roche’s Ocrevus has become the second best-selling MS drug on the market, nearly eclipsing Biogen’s Tecfidera last quarter with over a $1 billion in sales.

Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.