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

 

 

Teva halts production at sterile injectables plant to address FDA concerns

Teva

The FDA recently issued an import alert for all but two products at the facility in Gödöllő: cancer treatment bleomycin and antibiotic amikacin. The alert gives no insight into the nature of the problems, but a translated notice posted Friday by Hungary’s Food and Drug Administration (OGYE) says Teva suspended production four months ago as a precaution following an U.S. FDA inspection at the facility in late January.

Teva Pharmaceutical ($TEVA) in a statement today said that while it is unaware of any adverse reactions reported about products coming out of the facility, it decided to voluntarily stop production at the Gödöllő plant on a temporary basis while it evaluates and responds to the FDA’s concerns.

“We are 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. We are also identifying alternative sources of supply, where needed. We are very conscious of unnecessarily triggering drug shortages and impacting patients while we focus on resolving regulatory concerns, as patients are always highest priority.”

The notice by the OGYE says the action has taken 200 Hungarian products out of production and the Hungarian agency has asked Teva for weekly updates so that it can avoid shortages, particularly of cancer and morphine drugs. Dr. Csilla Pozsgay, the director general of OGYE, said in the notice that “based on currently available information,  products on the market are safe–the FDA primarily objected to the production environment.”

Teva opened the $110 million, 15,000-square-meter (161,458-square-foot) plant in 2012. It said at the time that its 6 production lines were capable of producing between 160 million to 200 million units of injectable meds annually, mostly cancer meds, that were to be sold in 70 countries, primarily in the U.S., Europe and the Far East.

Other companies have been in the situation in which Teva now finds itself. The FDA last year cited three Mylan ($MYL) sterile injectable plants in India in a warning letter for a host of problems. Pfizer’s ($PFE) Hospira, which is the largest sterile injectables maker in the world, has had to deal with FDA concerns at several plants in the U.S., India and Italy.

– here’s the FDA import alert
– and the OGYE notice

thanks to: FiercePharma

Teva migraine patch gets close FDA scrutiny for causing burns and scarring

Migraine

Seeking to offset early Copaxone sales declines, Teva swept up NuPathe a few years ago to get its hands on the only migraine patch approved in the U.S. But in less than a year after launch, the FDA has laid out concerns about “serious” adverse events including burning and scarring.

Teva’s Zecuity is now under the radar as a “large number” of users have reported those problems plus severe redness, pain, skin discoloration, blistering and cracked skin, the FDA reported. The patch first hit the market last September.

In a statement, a Teva spokesperson said the FDA’s decision was made “as a precautionary measure,” and that “there is nothing more important to us than the health and safety of those who use our products.”

“Patient wellbeing is at the heart of everything we do,” the statement said. “Teva is working closely with the FDA on the investigation.”

The development marks a headache for Teva, which bought Zecuity developer NuPathe in early 2014 for about $114 million, eclipsing Endo’s $105 million offer. At that time, the generics giant was looking to grow sales in the face of an earlier-than-expected patent loss for its megablockbuster multiple sclerosis drug Copaxone. That patent loss is still having repurcussions at the Israeli generics giant, with Q1 2016 results that fell short of expectations.

The investigation may also upset NuPathe investors, who stand to gain from tiered Zecuity sales milestones set up through the Teva deal.

Powered by a battery, Zecuity administers sumatriptan through a single-use device placed around a patient’s upper arm or thigh.

Though the patch has been FDA-approved since 2013 from NuPathe’s efforts, Teva didn’t get the product on the market in the U.S. until the second half of 2015. In promoting the product, the Israeli generics giant cited a study finding that Zecuity outperformed a nonmedicated patch in reducing headache pain and cutting light/sound sensitivity.

The FDA alert comes as Teva works to close a $41 billion deal to buy Allergan’s generics business, a price which some investors and investment bankers called into question this week because market dynamics have changed since the agreement.

– here’s the FDA alert

thanks to: FiercePharma

Teva retrieves amphetamines over impurity concerns

Teva

Teva Pharmaceutical ($TEVA) has its hands full already with its $40.5 billion deal to buy Actavis, the generics business of what is now Allergan ($AGN). But business goes on and that includes the occasional recall.

According to the FDA’s most recent Enforcement Report, Teva has added another lot, consisting of 9,717 bottles, to a recall of amphetamine tablets that were found to be highly out of spec for impurities during their last testing. The mixed salts product is made up of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate.

According to a letter Teva sent to customers, the voluntary recall began in November with the recall of two lots. It said there are no “safety concerns at the level observed.”

Teva CEO Erez Vigodman

The drugmaker had a couple of other significant recalls last year. It recalled three lots of fluoxetine, a generic version of the antidepressants Sarafem and Prozac, because of contamination. Those had been manufactured by its Croatia-based operating unit Pliva at a plant in Krakow, Poland. It also recalled 8 lots of its colon and rectal cancer injectable drug Adrucil (fluorouracil injection) after the drugmaker discovered that the lots might contain particles that it identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

The world’s largest generics maker struck a deal last year to buy the generics business of Allergan. Teva CEO Erez Vigodman told investors at the J.P. Morgan Healthcare Conference this month that the company’s focus this year will be on assimilating the new acquisition into its operations. The buyout comes even as the drugmaker has been significantly reducing its manufacturing operations to cut costs and improve margins.

thanks to: FiercePharma

Teva ‘s $520M bribery settlement with the feds sparks shareholder lawsuit

Justice statue with sword and scales
Teva is starting the new year facing a shareholder lawsuit after it last month paid $520 million to resolve bribery charges in Russia, Ukraine and Mexico.

Just after forking over $520 million to resolve federal bribery charges relating to its operations in Russia, Ukraine and Mexico, Teva is starting the new year facing a shareholder lawsuit.

Ra’bcca Technologies has filed a petition for approval for a derivative suit against Teva and several of its current and former officers, including ex-board members Chaim Hurvitz, Shlomo Yanai, Dan Suesskind, and former chairman Phillip Frost, Israel’s Globes news service reports.

Last month, Teva agreed to pay nearly $520 million to the U.S. Department of Justice and Securities and Exchange Commission to resolve 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 respondents, past and present officeholders in Teva, bear responsibility for Teva’s act and failure in violating U.S. law, and should therefore compensate Teva for all the damages caused to it,” Ra’bcca representatives said, according to Globes.

In announcements detailing Teva’s admitted violations, U.S. authorities say company execs and employees in Russia bribed an official there to boost the government’s purchases of its multiple sclerosis med Copaxone.  The government official made $65 million between 2010 and 2012 setting up the purchases, even as Russia sought to cut costs on foreign drugs, prosecutors said.

Between 2001 and 2011 in Ukraine, Teva bribed a top official in order to “influence” the government’s decisions on Teva drug approvals, prosecutors said, providing the “registration consultant” with $200,000 monthly through a fee and other expenses.

And in Mexico, a Teva subsidiary’s employees bribed doctors to prescribe Copaxone since “at least 2005,” according to the U.S. government’s release. The company additionally admitted it didn’t have an adequate control system in place to catch the violations, and hired managers “who were unable or unwilling to enforce” existing policies, according to prosecutors.

Teva’s settlement—the largest fine paid by a pharma company over FCPA violations—comes after years of investigations into its practices. The company in November notified the Tel Aviv Stock Exchange that it had set aside $520 million to cover expected expenses for the violations. Early in 2015, after conducting its own investigation, the company said it had “likely” violated FCPA in a number of countries.

Along with paying the fines, Teva agreed to continue to work with the feds and to boost its internal compliance efforts. Prosecutors said the company received a 20% discount from the low end of sentencing guidelines due to its “substantial cooperation and remediation.”

The FCPA probe wasn’t Teva’s only legal entanglement, however. Among a number of generics makers, the company now faces a Justice Department probe into possible price collusion.

thanks to: FiercePharma

 

The Israeli pharmaceutical giant Teva must pay over $520 million following corruption charges

Israeli drug firm fined for bribing officials in Russia, Ukraine & Mexico

A building belonging to generic drug producer Teva, Israel’s largest company with a market value of about $57 billion, is seen in Jerusalem. © Baz Ratner / Reuters

The Israeli pharmaceutical giant Teva must pay over $520 million following corruption charges made by the US Department of Justice (DOJ). The company breached the Foreign Corrupt Practices Act (FCPA) by bribing officials in Russia, Ukraine and Mexico.

Teva is the world’s largest manufacturer of generic pharmaceutical products. According to the DOJ, its fully-owned subsidiary Teva LLC (Teva Russia) bribed a top Russian official to increase sales of the multiple sclerosis drug, Copaxone, during drug purchase auctions held by the Russian Ministry of Health.

Between 2010 and at least 2012, Teva earned an extra $200 million from Copaxone sales in Russia. The Russian official allegedly received $65 million through inflated profit margins. His name and department were not disclosed.

Overall, Teva will pay $520 million which includes the US criminal and regulatory penalties for its illegal activity in Russia, Ukraine and Mexico.

In Ukraine, Teva hired a senior government official in the Ministry of Health as “registration consultant.” Between 2010 and 2011, the Israeli company paid him a monthly fee and covered his expenses, amounting to $200,000. In Mexico, Teva bribed doctors to prescribe Copaxone from at least 2005.

“Teva and its subsidiaries paid millions of dollars in bribes to government officials in various countries, and intentionally failed to implement a system of internal controls that would prevent bribery,” said Assistant Attorney General Caldwell.

“Companies that compete fairly, ethically and honestly deserve a level playing field, and we will continue to prosecute those who undermine that goal,” Caldwell added.

“As demonstrated by this case, the Foreign Corrupt Practices Act has a long reach. Teva’s egregious attempt to enrich themselves failed and they will now pay a tough penalty,” said William J. Maddalena, Assistan

thanks to: RT

Teva bribes doctors

Two former Teva sales representatives are claiming that the company used speaker programs to disguise unlawful prescription kickbacks for multiple-sclerosis drug Copaxone and Parkinson’s treatment Azilect.

In a recently unsealed second amended complaint, the reps, Charles Artstein and Hossam Senousy, claim Teva devised an illegal scheme—including unlawful marketing and promotional and sales practices—to sway physicians to write prescriptions for Copaxone and Azilect. They allege that Teva paid them as “speakers or consultants in connection with sham speakers programs and events.” The two whistleblowers filed the complaint against Teva in Manhattan.

A Teva spokesperson told MM&M, “Over the past year, the US Attorney’s office in the Southern District of New York has been conducting an investigation and Teva has cooperated with all aspects of this investigation. The government investigation is now complete and we are pleased that the government has declined to participate further in the matter. The case is now a civil case; however the complaint has not yet been served and therefore, there is no pending deadline for a response.”

The plaintiffs allege that physicians were compensated between $1,500 and $2,700 for each speaker program they participated in and that the payments were disguised as honoraria. They say that the sales representatives would give physicians payments in green envelopes, which were meant to convey the “tacit message to physicians that the more scripts they wrote, the more money they made.”

A Teva sales director, Gary Smith, touted at a company meeting in 2013 that 80% of Azilect prescriptions are written by paid physicians, according to the complaint, and stressed the importance of continuing physician speaker programs as a way to drive greater sales.

The accusers note that the total number of speaker programs for both drugs was 1,329 in 2011— a sum that jumped to 5,036 in 2012. As of August 2013, approximately 4,600 programs had been completed or scheduled. The programs were staffed by 420 trained Copaxone speakers and 410 trained Azilect speakers. In 2013, certain physicians spoke 56, 60 or 80 times.

The plaintiffs claim that one doctor, identified as Dr. O.K. of Detroit, allegedly participated in 80 sessions, earning him an estimated $216,000 in annual honoraria, and that he wrote $200 million in Copaxone prescriptions per year.

The whistleblowers say that many of these speaker programs offered no educational purpose, had very few attendees and often recycled the same content. They allege that the same two topics were repeatedly presented for Copaxone, while Azilect programs often presented the same four topics.

The complaint alleges that in one Copaxone speaker program—attended by a single doctor and a Teva sales rep—the presenting physician “relegated his discussion to four cases from the New England Journal of Medicine, involving progressive multifocal leukoencephalopathy, a life-threatening disease associated with Biogen’s new oral [MS] agent, Tecfidera, none of which is relevant to Copaxone.” The complaint says the primary purpose of this program was to discourage the attending physician from prescribing Tecfidera.

The plaintiffs seek damages for violations of the False Claims Act.

thanks to: MM&M

Campagna di boicottaggio farmaceutico contro Teva, Ratiopharm e Dorom: un farmaco deve portare con sè un certo valore etico!

Teva Pharmaceutical Industries LTD. è una compagnia farmaceutica israeliana presente anche in Italia, insieme alle sue consociate Ratiopharm e Dorom, leader di mercato dei farmaci generici.

Come Teva trae vantaggio dall’occupazione dei Territori Palestinesi?

Come risultato del Protocollo di Parigi i farmaci venduti nel TPO, con l’eccezione di quelli fabbricati in loco, devono essere approvati in Israele. Al contrario, nonostante il carattere bilaterale del Pacchetto Doganale, i prodotti farmaceutici palestinesi non possono essere registrati in Israele per “motivi di sicurezza”. La “libera circolazione” delle merci, quindi, è unilaterale, da Israele al TPO, e gli standard sono fissati secondo gli interessi di Israele.

Il fatto che l’importazione di farmaci in Cisgiordania e nella Striscia di Gaza sia consentita soltanto per i medicinali registrati in Israele implica che tutto il mercato arabo (tranne rari casi) è inaccessibile alla popolazione e all’industria farmaceutica palestinese. Il mercato palestinese non è quindi in grado di mantenere relazioni di importazione o di esportazione con i suoi mercati più vicini e naturali. Altri importanti prodotti farmaceutici cui è negato l’accesso nel TPO sono i farmaci generici a basso prezzo prodotti in gran parte in India, Cina e negli Stati della ex Unione Sovietica. Tale esclusione deriva dal fatto che i farmaci registrati in Israele sono principalmente importati dall’UE, Nord America e Australia.

Le società israeliane e le multinazionali farmaceutiche beneficiano della situazione sopra descritta in diversi modi. In primo luogo, dalle quattro imprese maggiori, originariamente israeliane (Teva, Perrigo Israele – ex Agis, Taro e Dexcel Pharma) a quelle piu’ piccole (come Trima), tutte le aziende israeliane hanno un facile accesso al mercato palestinese, senza grossi problemi alle dogane e ai checkpoint, come le operazioni di carico e scarico delle merci con cambio di camion ai posti di blocco; inoltre, non devono apportare modifiche a nessuno dei loro prodotti per venderli nel Territorio palestinese occupato. 

L’industria farmaceutica israeliana usa questa sua posizione privilegiata, dovuta all’aiuto del governo e alla occupazione militare del territorio palestinese, senza tuttavia ammetterlo.

Nella sua relazione del 2009 sulla responsabilità sociale, la multinazionale Teva ha dichiarato di aver aderito all’iniziativa globale per affermare i valori di responsabilità sociale e ambientale tra le imprese multinazionali. L’iniziativa comprende, tra le altre, un impegno in materia di diritti umani, commercio equo e rispettose condizioni di lavoro. Teva è la leader dell’industria farmaceutica israeliana e quindi il suo dispregio verso le problematiche relative all’occupazione militare della Palestina è indicativo dell’atteggiamento neocolonialista prevalente.

 

Campagna di boicottaggio farmaceutico

Un farmaco è un prodotto particolare, utilizzato per migliorare o salvare la vita delle persone e dovrebbe dunque portare con sé un certo valore etico.

E’ inammissibile che il ricavo di alcuni farmaci vadano a finanziare un regime quotidiano di colonialismo, occupazione ed apartheid come quello israeliano.

Quest’estate, durante l’operazione militare israeliana “Margine Protettivo”, che ha portato alla morte di più di 2.100 palestinesi e al ferimento di più di 10.000 persone, con ospedali e scuole delle Nazioni Unite bombardate e danneggiate, nel Regno Unito è partita una massiccia campagna di boicottaggio contro la TEVA, con più di 300 farmacie che hanno dato la propria adesione.

Chiediamo quindi:

– Ai farmacisti: di comunicare alle ditte consociate Teva, Ratiopharm e Dorom che, a tutela del valore etico del farmaco che viene dispensato, non verranno più commercializzati i loro prodotti (compatibilmente con le necessità terapeutiche del singolo paziente), sino ad una eventuale loro presa di posizione scritta contro le politiche di aggressione indiscriminata dello Stato israeliano.

– Ai pazienti: di rifiutarsi di acquistare i farmaci delle ditte TEVA, RATIOPHARM e DOROM chiedendo al proprio medico e al proprio farmacista, quando sia possibile, di sostituire il medicinale con altri uguali, ma di ditte diverse; ne si ha il diritto ed il costo a carico del paziente è esattamente lo stesso.

» Scarica la lettera da consegnare al tuo farmacista

» Scarica la lettera da consegnare ai pazienti

» Scarica la cartolina da ritagliare e spedire per posta alle farmacie o alla sede TEVA

BDS Italia

www.bdsitalia.org

bdsitalia@gmail.com

BDS Italia è un movimento per il boicottaggio, disinvestimento e sanzioni contro Israele, costituito da associazioni e gruppi in tutta Italia che hanno aderito all’appello della società civile palestinese del 2005 e promuovono campagne e iniziative BDS a livello nazionale e locale.