Teva’s stunning list of cuts targets 14K jobs, $3B in costs and plants around the globe

by Carly Helfand

Teva

Teva unveiled a sweeping plan of cost cuts that will hit facilities and jobs around the globe.

Teva’s layoffs and cost cuts are here—and they’re far larger than reports predicted.

The company said Thursday it would slash its headcount by 14,000, eliminating more than 25% of its worldwide workforce. That’s 4,000 more than the most dire scenario raised ahead of the announcement. It’s aiming to cut $3 billion from its annual costs, $1 billion more than analysts had discussed.

And the ax will fall swiftly, with the majority of job cuts coming in 2018; most of the affected employees will receive notice over the next 90 days, Teva said. Meanwhile, manufacturing plants, R&D facilities and offices around the world will shut down or be sold.

The cost-cutting plan comes courtesy of new CEO Kåre Schultz, whom Teva recently tapped to help get things back on track. The company is burdened by debt at a time when it’s facing competition to its lead drug Copaxone, struggling under industrywide generics price erosion, and suffering from a slowdown in Teva’s generics launch schedule.

“Basically the only thing that we’re really protecting is the product flow,” he said on a Thursday morning call with investors.

The embattled drugmaker expects to save $3 billion by the end of 2019. That’s a large chunk of cash, considering that it estimates its total cost base for this year will check in at $16.1 billion. Teva also expects to rack up a restructuring charge of $700 million, mainly related to severance costs, it said.

And job cuts aren’t the only measure Schultz is taking to reduce costs. The company will also suspend its dividend and keep looking for opportunities to self off pieces of its business. Teva won’t cast off actual pharma products, Schultz said on the call, but it’ll look at jettisoning “all the sort of side things that are not directly linked into product sales,” such as distribution.

It’s scrapping its 2017 bonuses, too, “due to the fact that the company’s financial results are significantly below our original guidance for the year,” it said. Teva has lowered that guidance three times this year, twice by more than $1 billion.

The new restructuring blueprint will deal a big blow to generics, a business that’s struggling mightily. Teva plans to tweak prices and discontinue products, which will in turn speed up closures and selloffs of “a significant number” of manufacturing plants in the U.S., Europe, Israel and emerging markets. Hard times in the copycat drug business recently forced similar action from Novartis’ Sandoz, albeit on a much smaller scale.

Teva plans to shutter a laundry list of R&D facilities, headquarters locations and other offices around the world and review R&D programs across the company in both its generics and specialty portfolios. It plans to scrap some development projects immediately, it said.

Some higher-level workers will also get the boot; as part of the new, pared-down organizational structure Teva announced a couple of weeks back, the company will be “reducing layers of management,” it said.

“These are decisions I don’t take lightly but they are necessary to secure Teva’s future. We will implement these changes with fairness and the utmost respect for our colleagues worldwide,” he said in a Thursday statement, adding that “today’s announcement is about positioning Teva for a sustainable future.”

Schultz has plenty of experience with cost-cutting, which made him an attractive fit for the Teva job. In his previous post as Lundbeck’s chief executive, he rolled out a restructuring that claimed 1,000 jobs—and within a year of his arrival, he had profits exceeding expectations and revenue climbing. And while the Teva effort is much, much larger, he’s taking a similar approach.

“It’s very much following the same pattern, where you basically look at everything and try to optimize everything in one go,” he said on the call. The process also involves making sure the cost-cutting plans are “highly executable” and “borne out of specific targets for specific units.”

And Credit Suisse analyst Vamil Divan, M.D., for one, figures that track record will sit well with investors.

“We believe investors will also be willing to give him the benefit of the doubt that he will be able to successfully execute on this significant restructuring, although there is no clearly defined long-term strategy at this time to allow us to understand what the company will look like following this aggressive period of restructuring,” he wrote to clients.

Of course, pushing mass layoffs through is no easy task in Israel, where workers’ representatives were already mobilizing before Teva made the announcement. Avi Nissenkorn, chief of the Histadrut labor federation, declared a nationwide half-day strike for Sunday.

“The entire economy—from the airport to the banks to the seaports to the municipalities to the government service to the health clinics—will stand until noon on Sunday in solidarity with Teva’s employees,” Nissenkorn told reporters.

Teva’s been down this road before, but Schultz is undeterred. “Consultations with the relevant employee representatives will begin in the near term,” Teva said Thursday.

The cuts are deep, but Bernstein analyst Ronny Gal called executing cost cuts “critical” in a Wednesday note ahead of Teva’s unveiling its detailed plans. “We will judge the company in part on its ability to persevere through the local opposition,” he wrote.

Meanwhile, though, at least one analyst says the moves may be too broad. Wells Fargo’s David Maris, who called the plan “unfortunate” in his own note to clients, noted that “it may also have significant negative effects to Teva’s competitiveness.”

“We question how beneficial it may be to cut a quarter of Teva’s workforce, and whether this disruption will further weaken the business and financial controls,” he said, adding that “Overpaying for Actavis generics, a Mexican generics company, underinvesting in a pipeline and other missteps are some of the factors that have resulted in the current crisis, in our opinion.”

thanks to: FiercePharma

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Novartis pushes past manufacturing slowdown to launch second long-acting Copaxone copy

Copaxone
Novartis’ copy of Teva’s long-acting Copaxone will be second to market behind Mylan’s. (Teva)

Pfizer signaled good news ahead last month, however, with an announcement that the FDA had upgraded the plant’s compliance status. And it’s good news Sandoz needed, particularly now that the FDA has refused to OK the drugmaker’s version of GlaxoSmithKline respiratory giant Advair.

In the meantime, though, Mylan has moved in with the market’s first 40-mg Copaxone approval, which the company snagged in October after its own fair share of delays. Since then, it’s gone on to snap up a sizable piece of the market, with Credit Suisse analyst Vamil Divan last month crediting Mylan with 10% of total Copaxone prescriptions.

On the other side of the coin, more competition is a negative for Teva, although dramatically lowered expectations for the troubled company mean the situation with Copaxone doesn’t look as dire as it once did. Market watchers are already expecting the sales drop.

“We already model steep erosion of U.S. Copaxone sales,” Divan wrote Tuesday, predicting a 60% decline—to $1.2 billion from $3 billion—this year. “Based on recent conversations, most investors appear to be assuming similar erosion rates,” he added.

Teva, whose new CEO Kåre Schultz queued up 14,000 layoffs immediately upon taking the reins, is working its way back from serious debt and hobbling generics pricing pressure. But Divan, for one, likes what he sees so far. He recently upgraded the company’s shares, pointing to “early signs of execution” on the restructuring plan.

And he predicts the dim generic situation will come around, too.

“We expect the focus on healthcare spending and, in particular, increased drug spending, to lead to greater utilization of generic drugs both in the U.S. and outside of the U.S., and this is something that should ultimately be a positive for Teva and other large generic manufacturers,” he wrote.

thanks to: FiercePharma

L’ONU intraprende un primo passo concreto affinché Israele sia ritenuto responsabile per le violazioni dei diritti umani dei palestinesi

Zeid Ra’ad Al Hussein, Alto Commissario dell’ONU per i Diritti Umani, stringe la mano ai delegati prima dell’apertura della trentaseiesima sessione del Consiglio dei Diritti Umani, nella sede europea delle Nazioni Unite. Grazie a: Laurent Gillieron/AP

 

L’ONU intraprende un primo passo concreto affinché Israele sia ritenuta responsabile per le violazioni dei diritti umani dei palestinesi

 

27 settembre 2017 — Informazioni pubblicate oggi dai media hanno rivelato che l’Alto Commissario dell’ONU per i Diritti Umani due settimane fa ha iniziato a inviare lettere a 150 aziende in Israele e nel mondo, avvertendole che potrebbero essere aggiunte a una banca dati delle aziende complici che fanno affari nelle colonie illegali israeliane basate nella Cisgiordania palestinese occupata, compresa Gerusalemme Est.

Le lettere hanno ricordato a queste aziende che le loro attività nelle e con le colonie illegali israeliane sono in violazione di “diritto internazionale e contrarie alle risoluzioni dell’ONU”. Inoltre hanno chiesto che queste aziende rispondano con chiarimenti riguardo a tali attività.

Secondo funzionari israeliani di alto livello, alcune delle aziende hanno già risposto all’Alto Commissario dell’ONU per i Diritti Umani dicendo che non rinnoveranno i loro contratti o non ne firmeranno di nuovi in Israele. “Questo potrebbe trasformarsi in una valanga”, ha detto con preoccupazione un funzionario israeliano.

Delle 150 aziende, circa 30 sono ditte americane e un certo numero sono di nazioni che includono la Germania, la Corea del sud e la Norvegia. La metà restante sono aziende israeliane, compreso il gigante farmaceutico Teva, l’azienda telefonica nazionale Bezeq, l’azienda di autobus Egged, l’azienda idrica nazionale Mekorot, le due maggiori banche del paese Hapoalim e Leumi, la grande azienda militare e tecnologica Elbit Systems, Coca-Cola, Africa-Israel, IDB e Netafim.

Le aziende americane che hanno ricevuto le lettere includono Caterpillar, Priceline.com, TripAdvisor e Airbnb.

A quanto riferito, l’amministrazione Trump sta cercando di impedire la pubblicazione della lista.

 

Omar Barghouti, co-fondatore del movimento BDS, ha commentato:

Dopo decenni di deprivazione dei palestinesi e di occupazione militare e apartheid da parte di Israele, le Nazioni Unite hanno intrapreso un primo passo concreto e pratico per assicurare che Israele sia ritenuta responsabile per le sue continue violazioni dei diritti umani dei palestinesi. I palestinesi accolgono calorosamente questo passo.

Speriamo che il Consiglio per i Diritti Umani dell’ONU sia inflessibile e pubblichi la sua lista completa delle aziende che operano illegalmente nelle, o con, le colonie israeliane sulla terra palestinese rubata, e che elaborerà questa lista come richiesto dal Consiglio per i Diritti Umani dell’ONU nel marzo 2016.

Può essere troppo ambizioso aspettarsi che questa misura coraggiosa dell’ONU concernente la responsabilità possa “fare scendere dal piedistallo” Israele, come il leader anti-apartheid sudafricano, arcivescovo Desmond Tutu ha richiesto una volta. Ma se attuata correttamente, questa banca dati dell’ONU sulle aziende che sono complici in alcune delle violazioni di diritti umani da parte di Israele può presagire l’inizio della fine dell’impunità criminale di Israele.

 

Il Comitato Nazionale BDS palestinese (BNC) è la più grande coalizione della società civile palestinese. Guida e sostiene il movimento globale di Boicottaggio, Divestimento e Sanzioni. Visitate il nostro sito Internet e seguiteci su Facebook e Twitter @BDSmovement.

 

thanks to:  Comitato Nazionale BDS palestinese (BNC)  

Traduzione di BDS Italia

 

 

UN takes first concrete step to hold Israel accountable for violating Palestinian human rights

Zeid Ra’ad Al Hussein, UN High Commissioner for Human Rights, shakes hand with delegates before the opening of the 36th session of the Human Rights Council, at the European headquarters of the United Nations. Credit: Laurent Gillieron/AP

September 27, 2017  — Today’s media reports revealed that the UN High Commissioner for Human Rights began sending letters two weeks ago to 150 companies in Israel and around the globe, warning them that they could be added to a database of complicit companies doing business in illegal Israeli settlements based in the occupied Palestinian West Bank, including East Jerusalem.

The letters reminded these companies that their operations in and with illegal Israeli settlements are in violation of “international law and in opposition of UN resolutions.” They also requested that these companies respond with clarifications about such operations.

According to senior Israeli officials, some of the companies have already responded to the UN High Commissioner for Human Rights by saying they won’t renew their contracts or sign new ones in Israel. “This could turn into a snowball,” worried an Israeli official.

Of the 150 companies, some 30 are American firms, and a number are from nations including Germany, South Korea and Norway. The remaining half are Israeli companies, including pharmaceutical giant Teva, the national phone company Bezeq, bus company Egged, the national water company Mekorot, the county’s two biggest banks Hapoalim and Leumi, the large military and technology company Elbit Systems, Coca-Cola, Africa-Israel, IDB and Netafim.

American companies that received letters include Caterpillar, Priceline.com, TripAdvisor and Airbnb.

The Trump administration is reportedly trying to prevent the list’s publication.

Omar Barghouti, co-founder of the BDS movement, commented:

After decades of Palestinian dispossession and Israeli military occupation and apartheid, the United Nations has taken its first concrete, practical step to secure accountability for ongoing Israeli violations of Palestinian human rights. Palestinians warmly welcome this step.

We hope the UN Human Rights Council will stand firm and publish its full list of companies illegally operating in or with Israeli settlements on stolen Palestinian land, and will develop this list as called for by the UN Human Rights Council in March 2016.

It may be too ambitious to expect this courageous UN accountability measure to effectively take Israel “off the pedestal,” as South African anti-apartheid leader Archbishop Desmond Tutu once called for. But if implemented properly, this UN database of companies that are complicit in some of Israel’s human rights violations may augur the beginning of the end of Israel’s criminal impunity.

The Palestinian BDS National Committee (BNC) is the largest coalition in Palestinian civil society. It leads and supports the global Boycott, Divestment and Sanctions movement. Visit our website and follow us on  Facebook and Twitter @BDSmovement.

thanks to: BDSmovement

UN’s list of companies linked to settlements to be published despite Israeli, US pressure

BETHLEHEM (Ma’an) — The United Nations Human Rights Council reportedly plans to go ahead with the publication of a list of companies operating in illegal Israeli settlements in the occupied Palestinian territory and the Golan Heights, in spite of immense diplomatic pressure from the United States and Israel.

According to a report published Tuesday by Israel’s Channel 2, the full list will be published in December, and will include some of the biggest firms in the Israeli industry as well as major US companies, a translation of the report from Times of Israel said.
Some of the international companies on the list reportedly include Coca-Cola, TripAdvisor, Airbnb, Priceline, and Caterpillar, in addition to Israeli companies such as pharmaceutical giant Teva, the national phone company Bezeq, bus company Egged, the national water company Mekorot, and the country’s two largest banks, Hapoalim and Leumi.
The list was recently delivered to the Foreign Ministry, the report said.
Last year, the United Nations Human Rights Council passed a resolution to support forming a database of all companies conducting business in illegal Israeli settlements in the occupied West Bank, amid fierce opposition by the United States and Israel.
The Washington Post previously reported that Zeid Raad al-Hussein, the UN high commissioner for human rights, said that the UN planned to publish the list by the end of this year, which prompted the Donald Trump administration to work with Israel to obstruct its publication.
However, according to the US newspaper, Israel and the United States had unsuccessfully attempted to block funding for the database.
PLO Executive Committee Member Hanan Ashrawi condemned the US and Israeli efforts at the UN as “morally repugnant” at the time.
The attempt “exposes the complicity of Israeli and international businesses in Israel’s military occupation and the colonization of Palestinian land,” Ashrawi said. “This is a clear indication of Israel’s persistent impunity and sense of entitlement and privilege.”
Ashrawi highlighted in her statement that Israel’s settlement activities constituted a “war crime” and were in direct violation of international law and several UN resolutions. “Any company that chooses to do business in the illegal settlements becomes complicit in the crime and therefore liable to judicial accountability,” she said.
Israeli Prime Minister Benjamin Netanyahu has complained that the list unfairly targets Israel and has noted that it was part of the larger Boycott, Divestment, and Sanctions (BDS) movement, which targets specific companies profiting off of Israel’s occupation of Palestinian territory and falls within the traditions of the nonviolent boycott movement against the apartheid regime in South Africa.
Israel and the United States have been starkly opposed to any move that could give weight to the BDS movement, and have often claimed that any support of a boycott against Israel amounts to anti-Semitism.
Israel has tightened the noose on the BDS movement in recent months, most notably by passing the anti-BDS law, which bans foreign individuals who have openly called for a boycott of Israel from entering the country.
Furthermore, Israel has routinely condemned the UN for what it sees as their anti-Israel stance, as numerous resolutions have been passed in recent months condemning Israel’s half-century occupation of the West Bank, including East Jerusalem, and its relentless settlement enterprise that has dismembered the Palestinian territory.
However, Palestinians and activists have long pointed out that nonviolent movements, expressed both in BDS activities and raising awareness on the international stage, are some of the last spaces to challenge Israel’s occupation, as Israeli forces have clamped down on popular movements in the Palestinian territory, leaving many Palestinians with diminished hope for the future.

 

Sorgente: UN’s list of companies linked to settlements to be published despite Israeli, US pressure

 

 

Teva China API plant smacked by FDA warning letter, adding to drugmaker’s burdens

The FDA has nailed another Teva manufacturing facility with a warning letter, this time for an API facility in China.

The Israel-based drugmaker in a short SEC filing said the letter had been issued April 10, following an inspection of the facility in September that found issues with the plant’s manufacturing control and sampling processes.

Teva said it is already taking steps to deal with the FDA concerns “as well as the underlying causes of those concerns.” It said it will provide the FDA a full response by May 1.

Later in the day, a Teva spokeswoman responded by email, repeating the language of the public filing but adding that, “As a matter of practice, Teva manufactures according to the highest quality and compliance standards.” She said no supply interruptions are anticipated as a result of the warning letter.

We do not anticipate any disruption in the supply of products to patients.

This is Teva’s second warning letter in the last six months. In October, the FDA cited a Teva sterile injectables plant in Hungary, noting significant sterility concerns. The agency had earlier banned the plant from shipping any more products to the United States.

The newest citation adds to the burdens of the floundering company, which recently jettisoned its CEO and is reportedly looking at cutting as many as 6,000 jobs after Passover ends next week. It has been trying to significantly squeeze its costs following its $40.5 billion buyout of Allergan’s generic drug business last year.

Sorgente: Teva China API plant smacked by FDA warning letter, adding to drugmaker’s burdens | FiercePharma

Teva woes keep piling up with another investigation for bribery

Teva

Teva is reportedly under investigation by police in Israel for bribing foreign officials.

When it rains it pours, and Teva is experiencing a flood of bad news of near biblical proportions. The same day that the company showed CEO Erez Vigodman the door, the drugmaker was said to be under investigation by Israeli police for bribing foreign officials in an investigation that mirrors charges it recently settled with U.S. authorities.

The company acknowledged to Haaretz that Israeli police are conducting a bribery investigation similar to the U.S. probe. Sources told Haaretz it centered on Teva paying hundreds of millions of dollars in bribes to foreign officials and then creating falsified documents to hide the payments.

That U.S. case concerned issues that had occurred between 2007 and 2013 in Russia, Mexico and Ukraine. The company agreed in December to pay nearly $520 million to the U.S. Department of Justice and Securities and Exchange Commission to resolve the violations of the Foreign Corrupt Practices Act. The criminal fine to the DOJ totaled more than $283 million, while Teva ponied up $236 million to the SEC.

The latest disclosure is among a mounting list of problems that has embroiled the company and cost Vigodman his job just 18 months after announcing its $40.5 billion deal for Allergan’s generics unit that many thought would be the big turnaround for the company. The problems started with the fact that it took Teva so long to close the Allergan deal that some investors had lost faith in its upside.

Just months after finally getting it closed last August, generics CEO Siggi Olafsson—a cheerleader for the deal—unexpectedly said he was leaving, spooking investors since he was considered essential to making it work. On top of that a tough pricing environment for the generics industry has left questions in investors minds about how Teva will untangle the mess.

As if in answer, the company told them in January the company was going to have to trim its sales guidance for 2017 by more than $1 billion.

Now with the company’s stock price down more than 50% from its August 2015 highs, Vigodman is out and Chairman Yitzhak Peterburg will handle the day-to-day CEO duties while a permanent replacement is sought. Director and Celgene vet Sol Barer will serve as chairman.

On Tuesday, though, one analyst saw something to like in the whole mess. Credit Suisse analyst Vamil Divan told investors in a note that the change at the top may allow for a fresh start.

“We believe the changes underscore the difficulties Teva has faced over the past 18 months and may be well received as investors look for fresh faces to lead a potential turnaround at the company,” Divan wrote.

Divan has some specific issues that he expects management to answer next week when Teva reports earnings. He wants to see if even the revised earnings projections will be walked back further in light of a court ruling late last month that tossed out four patents on long-acting multiple sclerosis star Copaxone, putting billions of dollars at risk. The analyst wants to know what this is going to do to Teva’s ability to pay down debt and what it will mean for the company’s dividend.

As he sees it, “It will be imperative for TEVA to bring in a CEO who understands the intricacies of the generics business but who can also work to bolster a specialty pharma business,” Divan wrote to clients.

thanks to: FiercePharma

Struggling Teva said to plan thousands of job cuts as it hunts for CEO

Teva

Changes are afoot at foundering Teva—and they include job cuts and a recruitment freeze.

Local media reports said Thursday that the Tel Aviv, Israel-based generics giant is looking at cutting up to 6,000 jobs. A company spokeswoman confirmed plans to reduce costs, but said Teva “does not have a headcount target” because the number of job cuts would depend on the “right-sizing of each individual area of our business.”

“As the company previously stated, we are looking to reduce costs in our business in every area, including, among other things, ending unprofitable activities and streamlining some activities and functions throughout the organization,” spokeswoman Denise Bradley said via email.

Israeli newspaper Calcalist had reported that the company already laid off 100 workers and was planning to pink-slip between 5,000 to 6,000 worldwide beginning after Passover in mid-April. In a statement seen by Reuters, Teva said it would be “freezing recruitment” and allowing attrition to reduce employment numbers.

The moves follow a vow from interim CEO Yitzhak Peterburg to “do what it takes” to protect the struggling company’s revenue guidance, “including additional cost reduction if necessary.” The expected revenue range of $23.8 billion to $24.5 billion has already been walked back once—by more than $1 billion—thanks, in part, to a massive slowdown in new product revenue.

Peterburg, who took the helm after former skipper Erez Vigodman’s abrupt February departure, has also pledged a review of Teva’s businesses, prompting split-up speculation from slim down-happy analysts.

“We will leave no stone unturned,” he told investors on a recent conference call, noting that “we are here to fix what is not working.”

These days at Teva, that’s a lot. The company has been suffering from pricing pressure that’s pummeled the generics industry across the board, but it has some unique problems, too.

For one, shareholders have maligned its recent dealmaking efforts—including an arguably too-expensive pickup of Allergan’s generics unit and a Mexican generics buy that went very, very sour. For another, the company has billions in sales at stake if copies of leading multiple sclerosis med Copaxone hit, and a judge’s January tossing of four key patents on the med only improved the likelihood of that scenario.

Those issues and others have taken a heavy toll on the company’s stock, which has sunk by more than 70% in the last 12 months.

The company said that any job cuts would be decided in concert with its workers.

“These processes are conducted through a continuous open dialogue with the employees,” a spokesperson said in a statement, noting that “this will be the practice” even in its home country of Israel, where workers in the past have promised to strike if layoffs hit.

thanks to: FiercePharma

Teva CEO Vigodman exits, piling uncertainty onto the struggling drugmaker

Teva

Teva CEO Erez Vigodman is stepping down, and company chairman Yitzhak Peterburg will take over as interim chief.

So long, Erez Vigodman. After a brutal 2016 and start to 2017 for Teva, the company’s CEO is stepping down.

The move, announced late Monday, comes as the result of a “mutual agreement” between Vigodman and Teva’s board, the drugmaker said. Teva Chairman Yitzhak Peterburg will take up the reins as interim CEO while Teva works with a search firm to tap a permanent replacement. Director and Celgene vet Sol Barer will serve as chairman.

Vigodman’s departure follows several months of turmoil at the Israeli pharma. Last year, it faced lengthy delays to its $40.5 billion pickup of Allergan’s generics unit, which investors weren’t all that keen on by the time it actually closed. Then, Teva’s buy of Mexico’s Rimsa went so awry that Rimsa’s founders sued the company. In December, generics CEO Siggi Olafsson—a big supporter of the Allergan deal—unexpectedly hit the road. A tough pricing environment for the generics industry was the icing on the cake.

And so far, 2017 hasn’t been much kinder. In January, Teva walked back its 2017 sales guidance by more than $1 billion, citing launches that hadn’t gone as planned. Inherited pay-for-delay penalties have taken their toll, and late last month, a court tossed out four patents on long-acting multiple sclerosis star Copaxone to put billions of dollars at risk.

While investors haven’t enjoyed the roller coaster—in October, shares hit a two-year low, and they’ve only gone south from there—“we believe that more investors will be uneasy with the uncertainty of an unexpected and abrupt CEO departure,” Wells Fargo analyst David Maris wrote in a Monday note to clients.

Evercore ISI analyst Umer Raffat has already heard feedback to that effect. “On average, investor reaction has been neutral to slightly negative,” he wrote in his own note Tuesday morning.

One influential shareholder who may not be too torn up over the change: Activist Benny Landa, who has lobbied for years for more pharma experience on Teva’s board.

“What was obvious to me in the past is now clear: the most suitable CEO is someone with a strong background in global pharma—ideally, a person who has managed a pharma company or was in a very senior position in a pharma company,” he told Israeli newspaper Globes.

But seasoned vets aren’t all Landa wants to see at the Petah Tikva-based company. The way he sees it, splitting Teva into two companies—one focused on generics, one on specialty meds—would ensure that “each company gets its fair share of the debt and cash in order to give each company its chance to take off.”

“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,” he said. “These are actually two sectors with almost no connection between them.”

thanks to: FiercePharma

Teva recalls 500,000 units of diabetes drug manufactured by Patheon

 

Teva

Teva has recalled 12 lots of Watson brand Glipizide manufactured by Patheon that didn’t meet specs for dissolution.

It is not as if Israeli drugmaker Teva didn’t already have enough on its plate, what with its CEO having been shown the door, a court overturning patents to its key moneymaker and investors getting restive. On top of that, it is having to recall nearly half a million units of a Type 2 diabetes drug that it picked up in its Actavis buyout.

The drugmaker is recalling 12 lots, comprising 499,320 units of 2.5-mg extended-release tablets of Glipizide, an oral rapid-and short-acting treatment for Type 2 diabetes. The problem is that the product missed dissolution specs at the 10-month testing period. As its letter to retailers points out, that could be a problem for people with diabetes because if the active ingredient is released too quickly then their blood sugars may rise.

The voluntary nationwide recall began Jan. 30. The drug is manufactured under the Watson Laboratories brand. It is actually made in a plant in Cincinnati, OH by contractor Patheon.

The drug is one Teva got in its $40.5 billion buyout of Actavis, the generics business of Allergan. That deal and the debt laid on top of Teva were among the brewing issues that led to Erez Vigodman’s departure this month. Vigodman’s exit came after months of turmoil at the Israeli pharma.

Last year, it faced lengthy delays to its $40.5 billion pickup of Allergan’s generics unit. Between that and a tough pricing environment in the U.S., by the time the deal closed, investors weren’t as revved up by it. Then in December, generics CEO Siggi Olafsson—a big supporter of the Allergan deal—unexpectedly left.

All of this leaves Teva looking for a new CEO and pondering its future, with some analysts wondering if it is time for the company to split itself apart. That is a possibility that might be made more difficult after a court recently upturned four patents on long-acting multiple sclerosis star Copaxone, putting billions of dollars of revenue at risk.

thanks to: FiercePharma

 

Teva faces billions in lost sales as court tosses four long-acting Copaxone patents

 

Copaxone

A U.S. Court has upturned four patents covering Teva’s long-acting version of MS star Copaxone.

It’s déjà vu for Teva Pharmaceutical in a bad, bad way.

Late Monday, the Israeli drugmaker confirmed that the U.S. District Court for the District of Delaware had upturned four of its patents on the long-acting version of multiple sclerosis star Copaxone, putting billions of dollars in revenue at risk.

It’s not an opening of the floodgates for generics makers, who have “several steps still to go” before they can challenge the MS behemoth, as Credit Suisse analyst Vamil Divan put it in a note to clients. Teva CEO Erez Vigodman, for his part, said in a statement that his company “would move forward with an immediate appeal,” and Divan expects the company to request a preliminary injunction preventing any generics from launching until the legal process surrounding all of Teva’s Copaxone IP is completely wrapped up.

Teva has sued its wannabe rivals on a fifth and sixth patent, too, and an inter partes review appeal is underway at the U.S. Patent and Trademark Office. And of course, if knockoffs are to roll out, they’ll need to win the FDA’s green light first.

Still, Divan doesn’t think it’ll be long before copycats show up. He expects a Novartis/Momenta Pharmaceuticals partnership “and potentially one other competitor to launch later this year and lead to pricing pressure on the brand,” the analyst wrote.

The Petah Tikva-based company has been here before. Back in 2013, a court upturned its patents on the original, 20 mg formulation of its star med, but Teva managed to convert most of its patients to the new-and-improved version before generics hit.

Now, though? There will be no backup med to turn to if Teva’s IP shield is struck down.

That’s not a good prospect for a company whose sales are already struggling. Earlier this month, Teva walked down its 2017 guidance by more than $1 billion after new 2016 launches failed to pan out. It now predicts a top-line haul of between $23.8 billion and $24.5 billion for the year, but some analysts—including Bernstein’s Ronny Gal—have found that figure hard to swallow.

It’s “a tough picture,” Gal wrote in early January.

thanks to: FiercePharma

 

Teva wraps up Cipro pay-for-delay suit inherited with Barr buy

 

by Eric Sagonowsky |

 

Teva

Teva agreed to a $225 million settlement on a long-standing class action suit brought by the purchasers of Bayer’s Cipro.

Shortly after paying $520 million to the feds to resolve bribery charges in a couple of markets outside of the U.S., Teva has agreed to deal terms to settle a lengthy class action lawsuit in California.

The Israeli pharma giant agreed to a $225 million settlement with a group that bought Bayer’s antibiotic Cipro, Reuters reports. The plaintiffs argued that alleged pay-for-delay deals from the 1990s between Bayer and Teva’s Barr Laboratories led to higher prices and violated antitrust law, according to the news service.

The plaintiffs brought the case against Barr in 2000. Eight years later, Teva picked up Barr for nearly $9 billion.

In a statement, a Teva spokesperson said the company “reached a settlement in the pending Cipro antitrust litigation that was inherited when Teva acquired Barr in 2008. Teva is pleased that this long-standing litigation has been resolved.”

California’s Supreme Court will need to sign off on the settlement, according to Reuters.

Teva’s deal comes on the heels of a separate pay-for-delay settlement between the FTC and Endo Pharmaceutical, reached just days ago. As authorities announced that arrangement, they said they’d continue to pursue a case against Watson and Allergan.

The new Teva agreement closely follows another move by the company to wrap up a legal issue with federal authorities: violations of the Foreign Corrupt Practices Act. Back in December, Teva agreed to a settlement worth nearly $520 million to resolve bribery charges in several markets. In that case, a criminal fine to the DOJ totaled more than $283 million, and Teva paid $236 million to the SEC.

Together, the two deals amount to nearly three-quarters of a billion dollars in payments in a matter of two months.

In the wake of that settlement, a shareholder went after the company, plus current and former execs, with a petition for approval of a derivative suit.

Despite its multiple recent settlements, Teva might not be out of the woods yet. It’s among a group being investigated by the DOJ for possible generics price collusion.

thanks to: FiercePharma

 

 

FDA cites ‘significant’ sterility concern at Teva injectables plant

Syringe

The FDA has posted the warning letter that Teva recently acknowledged getting for its troubled sterile manufacturing plant in Hungary. The letter outlines concerns about sterility and contamination issues at the plant and gives the company a long list of marching orders that it says must be completed before the plant will be allowed to again ship product to the U.S.

Seven observations were listed in the letter including problems with contamination in media fills, a problem the FDA said “indicates a potentially significant sterility assurance problem” at the plant in Godollo that Teva opened in 2012 to expand its sterile manufacturing capacity. The plant is currently closed while Teva works on solving the problems inspectors first outlined in a Form 483 issued in January.

Among problems noted, inspectors said the plant did not adequately investigate media-fill contamination on aseptic manufacturing lines. It cited as an example a media-fill run performed in September of last year which resulted in 31 contaminated units.

It said employees did not identify the microorganisms found in the contaminated units. Identifying them is essential, the FDA said, because otherwise there is no way to sufficiently understand the potential sources and scope of the contamination, the report said.

The FDA criticized the plant for poor aseptic processing techniques including seeing an operator sitting on the clean-room floor during setup of the filling line but then not changing the gown being worn. Others leaned against clean-room walls.

Additionally, investigators said some colony counts for environmental and personnel monitoring did not match up with the plant’s official records. On top of that, there were “quality-related documents in a waste bin” that raised questions about record keeping. Stand-alone computer systems didn’t have controls like routine audit trail reviews and full data retention that would assure that analysts weren’t deleting data.

Teva acknowledged getting the letter two weeks ago and has said that it is working on the problems, addressing “both the specific concerns raised by investigators as well as the underlying causes of those concerns.”

Additionally, Teva said it is working to replenish critical and priority products as quickly as possible, “in some cases by transferring products to other Teva manufacturing sites and–as needed–by identifying alternate suppliers for products in short supply or out of stock.”

The saga at the Godollo site began in January when the FDA inspected the plant, issuing the Form 483. Teva suspended production to deal with the citations, but in May the FDA put the plant on its import alert list, banning all but two drugs: the cancer treatment bleomycin and antibiotic amikacin, which were exempted to avoid shortages. Teva has been recalling its other drugs produced at the facility.

In the letter posted this week, the FDA presented Teva with a list of its expectations, asking among other things for a comprehensive review of all sterility test positive and media-fill failure investigations since January 2014. It wants Teva to update its standard operating procedures and also to review video taken during production of in-date batches sent to the U.S. to figure out what might have caused the contamination.

thanks to: FiercePharma

UPDATED: Pii produced products recalled by Teva

Teva

Teva ($TEVA) is recalling nearly 43,000 bottles of paricalcitol, a drug used by dialysis patients. But in this case, Teva didn’t manufacture them. They were produced by Pharmaceutics International Inc., or Pii, a U.S. CMO that recently ran into problems with European regulators.

According to the most recent FDA Enforcement Report, Teva is recalling 42,969 bottles of paricalcitol in three dose sizes in 30-count bottles, 32,015 of 1 mcg bottles; 5,556 of 2 mcg bottles and 5,398 of 4 mcg bottles. Paricalcitol is used to treat and prevent overactive parathyroid glands in patients with chronic kidney disease who are on dialysis.

The voluntary recall, which began several weeks ago, was initiated because the products failed stability testing for impurity levels.

The paricalcitol, the FDA report says, was manufactured by Hunt Valley, MD-based Pii. Several months ago, the European Medicines Agency said it was pulling the manufacturing certification for the contract manufacturer after inspectors noted a number of problems. In the critical category was Pii’s failure to minimize the risk of cross-contamination between hazardous and non-hazardous products, the report said. Inspectors also noted the facility had an unqualified HPLC system and unacceptable approach to production equipment qualification.

In response, the company “brought in a team of experts” to address each area of concern and says it is giving the EMA’s action top priority.

While this recall falls on Pii, Teva is facing manufacturing concerns of its own. The FDA last week issued a warning letter to Teva’ sterile manufacturing plant in Hungary, a facility that earlier this year was banned from exporting most products to the U.S. Teva says it is conscientiously addressing the the FDA’s concerns and their underlying causes.

– access the recall report here

thanks to: FiercePharma

UPDATED: Teva’s struggling sterile plant hit with FDA warning letter

fda

The regulatory quagmire has deepened for the Teva Pharmaceutical sterile injectables plant in Hungary which the FDA banned this year over slipshod manufacturing standards. The FDA has now issued the plant a warning letter.

In an SEC filing on Tuesday, Israeli-based Teva acknowledged receiving the warning letter the previous Friday, and for the first time gave some indication of the problem areas. It said the FDA “cited deficiencies in manufacturing operations and laboratory controls, and in the Company’s data integrity program.”

In an emailed statement today, Teva said it “has been using a systems-based approach with respect to our remediation efforts,” addressing both the FDA concerns and the underlying causes. “As a matter of practice, Teva manufactures according to the highest quality and compliance standards.”

The company also said it is working to resupply “critical and priority products as quickly as possible,” by bringing in products from other Teva manufacturing sites and finding other suppliers for products in short supply or out of stock.

The warning letter follows a series of other actions by the FDA, which first issued a Form 483 following a two-week inspection in January at the Godollo plant, a relatively new facility which the company opened in 2012 to expand its injected drug capacity. Teva suspended production to deal with the citations but the FDA in May put the plant on its import alert list, banning all but two drugs–the cancer treatment bleomycin and antibiotic amikacin, which were exempted to avoid shortages. Teva has been recalling from the market its other drugs produced at the facility.

The regulatory issues come when Teva has a lot on its plate. It is in the process of assimilating a huge portfolio of products, plants and employees it got in its $40.5 billion buyout of Allergan’s generics business, while selling off those parts of the business required by regulators to preserve competitive markets.

But Teva has suggested it may not be done with acquisitions to solidify its place as the largest maker of generic drugs, while also looking at moves in the branded market. Earlier this week, a Teva spokesperson said the company would consider opportunities in biosimilars, suggesting to some that Teva might look at buying South Korea’s Celltrion. Celltrion is trying to sell part of its business and the two have a relationship.

CEO Erez Vigodman has said the biosimilars are part of the company’s growth strategy but also said it will be on the hunt for “attractive specialty assets, or branded drug assets or pipeline assets” that fit in with the therapeutic areas it’s already tackling.

– read the filing

thanks to: FiercePharma

UPDATED: Teva recalling all lots of 4 drugs made at troubled Hungary plant

Syringe

Teva continues to deal with the fallout from an FDA ban of its sterile injectables plant in Hungary and is now recalling all lots of four different injected drugs.

According to the most recent FDA Enforcement Report, the Teva Pharmaceutical ($TEVA) recall includes 92,480 containers of antibiotic linezolid; 14,661 vials of heart surgery drug eptifibatide; 13,223 vials of anti-nausea drug ondansetron and 1,299 bags of argatroban, used for treating heparin-related complications. The report says Teva began the recalls in June, although the FDA only last week gave them a class II designation.

The products all came out of Teva’a plant in Gödöllő, a relatively new facility which the company opened in 2012 to expand its injected drug capacity. The $110 million, 15,000-square-meter plant has 6 production lines and the capacity to churn out 160 million to 200 million units of injectable meds annually.

But those lines went idle earlier this year when Teva temporarily halted production following an FDA inspection in January that found a number of manufacturing issues. The FDA followed that up in late May when it issued an import alert for the facility, banning all but two essential products from the facility: cancer treatment bleomycin and antibiotic amikacin.

Teva in a statement today said it had begun recalling “all in-date lots” of the four in the US, “in order to ensure that disposition decisions for U.S. products manufactured at the Gödöllő site were in alignment with FDA’s import alert. In July, we recalled 7 lots of Amikacin for reasons unrelated to the import alert.  This was an extension of a previous recall that Teva initiated in March. We are working around the clock to re-start manufacturing operations in Godollo and expect that to occur in the coming months.”

Teva has not specified the nature of the observations laid out in an FDA Form 483, but said it was working closely with the FDA to resolve the issues and return supplies of its products. It said in some cases it would look for alternative sources of supply. None of the four drugs is currently listed on the FDA’s drug shortages list. Teva has said that it is unaware of any adverse events tied to any of the drugs shipped from the facility.

The plant issues arose at a tricky time for Teva, which was in the midst of trying to close on its $40.5 billion purchase of the generics unit of Allergan ($AGN). After delays and an agreement with the FTC that is would divest 75 products, the deal closed last month.

– access the recalls here

thanks to: FiercePharma

Teva issues another recall of antibiotics, this time from a Canadian plant

For the second time this year, Teva ($TEVA) has issued a recall of antibiotics produced at one of its facilities. This time it’s a plant in Canada.

In the most recent action, the company said it is recalling more than 53,000 bottles of amoxicillin manufactured by Teva Canada Limited in Toronto.

According to an FDA enforcement report, the nationwide voluntary recall of the antibiotic was initiated because it is considered a “superpotent drug” on the basis of an out of specification test result for assay during stability testing. The regulatory agency has classified the recall as a Class II event, which means there isn’t an immediate threat of death or danger from the product.

Earlier this year, the drugmaker began recalling amikacin sulfate from its facility in Hungary due to the potential for the presence of glass particulate, which the company  said could cause reactions from swelling to blood clots. Teva recently expanded that recall to 7 additional lots made at the plant in Gödöllő, Hungary, which the FDA put on its import alert this year.

In May, the Israel-based drugmaker recalled 14,370 units of divalproex sodium delayed-release tablets, which are used to treat certain types of epileptic seizures, as well as for bipolar disorder and migraines, after they failed unspecified specifications.

– check out the FDA enforcement report

thanks to: FiercePharma

Teva recalls antibiotic made at banned plant in Hungary

 

Teva headquarters 

When the FDA put Teva’s sterile manufacturing site in Hungary on its import alert list in May, it banned all but two of its products, cancer treatment bleomycin and antibiotic amikacin. The exclusions didn’t mean the FDA didn’t have some concerns with those drugs, and now the drugmaker is expanding a recall of the antibiotic.

Teva ($TEVA) said last week it was recalling 7 additional lots of amikacin sulfate due to the potential for the presence of glass particulate, which it said could cause reactions from swelling to blood clots. It said it had not received any reports of adverse reactions to the product.

When Teva first recalled a lot of the antibiotic in March, it indicated that it was manufactured at its plant in Gödöllő, Hungary. The company had temporarily halted production at the plant in January after an inspection cited it with a number of shortcomings. The agency followed that up with the ban in May.

After the FDA banned products from the Hungary plant, Teva said it was “working around the clock to restart manufacturing operations as soon as possible, and are working cooperatively with regulatory authorities to minimize any potential impact on product availability.”

That impact was particularly hard on Hungary, which lost access to about 200 drugs as a result of the shutdown. The Hungary drug regulator said it was getting weekly updates from Teva about the situation so that it could avoid shortages, particularly of cancer and morphine drugs.

– here’s the press release
– find the import alert here

thanks to: FiercePharma

 

Teva recalls seizure drug

 

Teva headquarters

 

Teva Pharmaceutical ($TEVA) has its hands full trying to finalize its $40.5 billion buyout of Allergan’s ($AGN) generics business, a deal it expects to close this week. But meanwhile business goes on as usual, and that involves a Teva recall of a seizure drug.

The Israel-based drugmaker is recalling 14,370 units of divalproex sodium delayed-release tablets after they failed unspecified specifications, according to the most recent FDA Enforcement Report. The drug is used to treat certain types of epileptic seizures, as well as for bipolar disorder and migraines. The recall, which was initiated in May, was identified last week by the FDA as a class III.

Teva has been working for more than a year to buy Actavis, the generic drug business of Allergan. Since Teva is already the world’s largest generics producer, the deal has received close scrutiny by regulators around the globe. The FTC said last week that it had approved the merger after Teva agreed to sell the rights and assets to 79 pharmaceutical products, which are being acquired by 11 different generic drugmakers.

Allergan’s generics business has had its own recalls to deal with this year. In February it said it was recalling 54 lots, consisting of nearly 600,000 bottles, of its copy of the ADHD drug Adderall.

– access the recall here

thanks to: FiercePharma

Teva pulls migraine patch Zecuity on reports of burning, scarring

Teva

So much for the $114 million Teva shelled out to get its hands on Zecuity developer NuPathe. After less than a year on the market, the Israeli drugmaker is pulling the migraine patch.

Monday, the company announced that it would stop sales, marketing and distribution of the product on post-marketing reports of burning and scarring at the patch application site. Teva has also launched a recall of the med from pharmacies.

The discontinuation follows an FDA alert on the drug from earlier this month that cited “severe redness, pain, skin discoloration, blistering, and cracked skin.”

“At Teva, the wellbeing of people using our products is always the first priority,” Teva CEO of global specialty meds Rob Koremans said in a statement, noting that the company would “continue our investigation into the root cause of these adverse skin reactions” and work closely with regulators to resolve any outstanding questions.

It’s a blow to the Petah Tikva-based generics giant, which nabbed NuPathe in 2014 in its quest to bulk up on the specialty side before Copaxone copies hit. And while that process took longer than industry-watchers expected–allowing Teva to switch the majority of patients over to a long-lasting, patent-protected formulation of its multiple sclerosis superstar–the therapy still took a hit last year, recording a 14% decline to $960 million and coming in shy of the billion-dollar tally analysts expected.

Meanwhile, Teva is also working hard to close the $40-billion deal for Allergan’s generics unit that it expects to solidify its No. 1 position in the generics space. After coming to terms on the acquisition last summer, the companies have been making divestments to satisfy antitrust regulators; Monday, India’s Dr. Reddy’s said it had agreed to pick up 8 drugs from Teva–including one already-marketed treatment–for $350 million.

– read Teva’s release

thanks to: FiercePharma