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

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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 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 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