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

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


Teva woes keep piling up with another investigation for bribery


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


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 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 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 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


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) 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


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


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


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


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 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

I malati di Gaza pagano il prezzo del blocco di Gaza

A Palestinian pharmacist stands next shelves which empty from medicines  in hospital in Rafah southern Gaza Strip on April, 15, 2012 as Gaza Strip faces a lack of medicines. Photo by Eyad  Al Baba

A Palestinian pharmacist stands next shelves which empty from medicines in hospital in Rafah southern Gaza Strip on April, 15, 2012 as Gaza Strip faces a lack of medicines. Photo by Eyad Al Baba

EI. Huda Jalal è ancora in lutto per la morte di suo figlio, lo scorso maggio.

La 32enne ha partorito prematuramente, prima che i polmoni del bambino fossero sufficientemente formati. L’ospedale ha messo il piccolo Sami in un’incubatrice per essere pronto alla somministrazione di betametasone. Il farmaco è usato per stimolare la crescita dei polmoni nei neonati prematuri. Ma il betametasone, che non è un farmaco particolarmente costoso, come sostiene da Mahmoud Deeb Daher, capo del dipartimento di Gaza della World Health Organization, non era disponibile. Sami è spirato dopo appena un giorno nell’incubatrice.

“Capisco che non sia facile dare alla luce neonati all’ottavo mese, ma esistono farmaci e trattamenti sanitari che possono aiutare a salvare queste vite”, ha detto la donna, madre di altri due bimbi, a The Electronic Intifada.

Hamsa Abu Ajeen, medico all’ospedale di Al-Aqsa a Deir al-Balah, Striscia di Gaza, dove Jalal ha perso suo figlio, ha parlato della carenza di medicine come risultato del blocco imposto su Gaza, ormai quasi dieci anni fa. Il ministero della salute a Gaza lotta costantemente contro la mancanza di medicine e attrezzature mediche vitali. La mancanza di fondi è una diretta conseguenza dell’assedio che penalizza l’economia.

Inoltre Israele proibisce l’accesso a Gaza a tutta una serie di prodotti e materiali da costruzione per “ragioni di sicurezza” e per la possibilità di un loro uso doppio, sia civile che militare.

Ma la lista dei prodotti vietati è in molti casi vaga e generale, includendo cose come “attrezzature di comunicazione” e, mentre medicine e prodotti sanitari non sono inclusi, macchinari a raggi x e altre attrezzature radiografiche vengono importate a mala pena e spesso trattenute in Israele.

Bambini a rischio

Osservatori internazionali come l’OMS, l’Organizzazione Mondiale della Sanità, le Nazioni Unite e personalità politiche, hanno riferito in numerose occasioni che il blocco su Gaza influenza negativamente la somministrazione di cure mediche e porta a una carenza di farmaci potenzialmente salva-vita.

Abu Ajeen ha affermato che iniezioni di betametasone dovrebbero essere somministrate a donne in condizioni di gravidanza difficoltosa e con rischio di parto prematuro, e preferibilmente prima e non dopo la nascita. Se somministrato in tempo, il betametasone può salvare molti di questi bambini; può essere iniettato anche dopo la nascita, come nel caso di Sami se la medicina fosse stata disponibile.

“Nel nostro reparto la mancanza di tali medicine e di attrezzature mediche ha eroso la nostra abilità nell’offrire cure mediche avanzate ai nostri pazienti”, ha raccontato Abu Ajeen.

Non ci sono sufficienti iniezioni per stimolare le contrazioni uterine per accelerare il parto, ha proseguito il dottore, mentre c’è un numero limitato di macchine per elettrocardiogramma funzionanti, per controllare il cuore dei neonati. Nel reparto scarseggiano anche le incubatrici e i letti, rispetto a quelle che sono le esigenze locali.

“In molti casi dobbiamo dimettere donne che hanno appena partorito per liberare i letti, persino se queste necessitano ancora di attenzioni”, ha proseguito Abu Ajeen.

In aggiunta si devono considerare le frequenti interruzioni di corrente, le autorità di Gaza non sono in grado di importare l’attrezzatura necessaria per riparare l’unica centrale elettrica della Striscia, e la scarsità di combustibile per i generatori significa che i dottori sono perennemente preoccupati che le attrezzature salva-vita e le incubatrici possano smettere di funzionare.

Carenze critiche

Secondo Munir al-Bursh, a capo del dipartimento di farmacia del ministero della Salute di Gaza, ospedali, farmacie e cliniche sono a corto di 149 farmaci, e dotati solo del 69 per cento di quanto realmente serva.

I farmaci che scarseggiano nelle farmacie ne comprendono alcuni usati per il trattamento di malattie croniche come l’emofilia, la talassemia, il cancro e le malattie del sangue, ha riferito al-Bursh. Inoltre una grave carenza di vaccini e antibiotici ha ulteriormente ostacolato la capacità dei dottori di curare i loro pazienti. In risposta un sempre maggior numero di pazienti tenta di curarsi all’estero, ma viene ostacolata dall’embargo su Gaza e dalla continua chiusura del valico di Rafah, al confine con l’Egitto, l’unico passaggio disponibile per quasi 1,9 milioni di residenti.

Ma non è solo l’embargo su Gaza che causa la carenza di farmaci. I contrasti politici tra Hamas, che amministra gli affari interni nella Striscia, e Fatah, che guida l’ANP con il supporto di Stati Uniti e Europa, giocano un ruolo importante.

Il dottor Ashraf al-Qedra, portavoce del ministero della Salute a Gaza, ha detto che non ricevono l’assegnazione di medicine concordata dal ministero della Sanità dell’ANP in Cisgiordania. Secondo il dottor al-Qedra, Gaza riceverebbe solo il 16 per cento di quello che invece dovrebbe ottenere in medicine e attrezzature mediche.

“Gaza dovrebbe avere il 40 per cento del suo fabbisogno medico sanitario soddisfatto dalla Cisgiordania. Abbiamo meno del 20 per cento. Questo significa che siamo prossimi ad una crisi sanitaria che potrebbe mettere le vite dei pazienti a rischio”, ha continuato.

La mancanza di fondi e l’esaurimento di risorse umane e materiali hanno spinto il ministro a porre fine ad alcuni dei servizi medici essenziali, ha riferito al-Qedra.

Wael Alyan ha denunciato la questione; il 43enne soffre di insufficienza renale da cinque anni e necessita di trattamenti di dialisi quattro volte a settimana. “E’ difficile adattarsi a questa nuova vita, ogni volta devo assicurarmi di arrivare in ospedale per tempo per sottopormi al trattamento”. L’uomo spera di poter ricevere delle cure fuori Gaza, ma per adesso non se ne può permettere i costi. Ha sentito le storie di pazienti abbastanza fortunati da aver ricevuto un trapianto di rene, e oggi spera che anche il suo calvario possa finire presto. “Spero di riuscire un giorno a risparmiare i soldi necessari all’operazione, per poter condurre di nuovo una vita normale”.

Cercando una soluzione

La difficoltà nel reperire farmaci ha portato alla costituzione di un team di farmacisti che oggi studiano soluzioni alternative per prolungare il ciclo vitale di alcune medicine fondamentali.

Il team ha lavorato per quattro anni e alla fine è riuscito a convalidare – si parla di farmaci da utilizzare dopo la data di scadenza indicata – 23 medicinali usati per il trattamento del cancro e della disfunzionalità renale, e per i quali gli ospedali, se dovessero trovarsi a corto, non hanno alternative.

Nahed Shaat, a capo della squadra, ha dichiarato che il gruppo ha ottenuto informazioni importanti dalla passata esperienza militare americana.

“La terribile realtà di Gaza ci ha spinto a cercare soluzioni alternative, e i tentativi effettuati dal Dipartimento della Difesa nel 1986 per convalidare 122 farmaci sono stati una guida utile nel nostro progetto”.

Naima Siam, membro del team, ha affermato che il percorso non è semplice, perché si devono seguire le rigide linee guida dell’Organizzazione Mondiale della Sanità.

“Ogni farmaco deve essere convalidato nei termini e nelle modalità corrette. Finora siamo stati in grado di estendere il ciclo di vita fino a tre mesi”.

La dottoressa ha stimato che con il loro lavoro hanno risparmiato al ministero della Salute circa 200 mila dollari, dando contemporaneamente accesso ai pazienti a farmaci salva-vita.

“Il benessere dei nostri pazienti è la priorità”, ha affermato la dottoressa Siam, che ha dato voce alla sua rabbia sia contro Israele che contro l’ANP in Cisgiordania, le cui politiche tengono le medicine lontano da Gaza.

“Il diritto di accesso a cure e medicine dovrebbe essere rispettato per ogni abitante di Gaza, e non essere ostaggio di questo gioco politico”.

thanks to: Traduzione di Marta Bettenzoli

Agenzia stampa Infopal

Il prezzo della salute

Il fatto che ci siano uomini che muoiono solo perché non possono accedere alle cure necessarie è un problema ampiamente dibattuto.

Il fatto che l’industria farmaceutica prediliga lo sviluppo di farmaci per la cura delle malattie tipiche dei paesi sviluppati che hanno un sistema sanitario funzionante, e trascuri, invece, i paesi a basso reddito costituisce un’ulteriore questione. L’abbondanza di medicinali per la cura di tutte le malattie reali e immaginarie delle popolazioni più ricche, pone sfide sempre maggiori sul piano economico per i nostri sistemi sanitari. Da un lato, a volte, si mettono in discussione i farmaci contro i sintomi del cambio di stagione, gli psicofarmaci per bambini iperattivi e lavoratori sotto stress o i tranquillanti per le popolazioni mentalmente instabili dei paesi sviluppati. Dall’altro, invece, la ricerca per una nuova cura per la tubercolosi è ferma al 1965 sebbene la vecchia terapia combinata spesso non sia efficace contro i germi multiresistenti e sia scarsamente tollerata. Ogni anno si ammalano di tubercolosi nove milioni di persone e ne muore un milione e mezzo. Si stima che i germi multiresistenti siano responsabili di 480.000 casi di infezione che non si risolvono con la terapia tradizionale. Ma questa è una malattia dei poveri.

viaPressenza – Il prezzo della salute.

Appello per una sottoscrizione straordianaria





A 24 giorni dall’attacco israeliano continua il massacro nella Striscia di Gaza.

Oltre 1400 morti di cui 252 bambini, 230.000 sfollati, 11.000 case totalmente distrutte, interi quartieri rasi al suolo.

Bombardata la centrale elettrica, manca l’acqua perché non funzionano le pompe. Si usano (per chi li ha) i generatori ma la benzina per alimentarli scarseggia. Manca il cibo e quel poco che si trova non si può conservare perché i frigoriferi non funzionano.

Il settore sanitario è al collasso. All’Ospedale Shifa di Gaza il personale sanitario opera ininterrottamente nelle 10 sale operatorie. Le camere mortuarie non riescono più a contenere i cadaveri. Molti feriti vengono curati sul pavimento perché non ci sono più letti disponibili.

Le ambulanze e i soccorritori vengono bombardati e non si riesce a recuperare i morti sotto le macerie. Si rischiano epidemie. Mancano antibiotici, antidiarroici e materiale mono uso.

Gazzella Onlus promuove una raccolta straordinaria di fondi per acquisto materiali sanitari per gli ospedali di Gaza.


c/c presso Banca Etica Roma

IBAN: IT43D0501803200000000105279

Causale: Emergenza Gaza

 (dall’estero SWIFT: CCRTIT2T84A)

Gazzella Onlus è un’associazione senza fini di lucro: si occupa di assistenza, cura e riabilitazione dei bambini palestinesi feriti da armi da guerra nella Striscia di Gaza, collaborando con associazioni locali. Negli ultimi 14 anni ha dato assistenza a migliaia di bambini.

Per maggiori informazioni vedi


Il “Progetto Gaza”, che da 2 anni opera a sostegno della pediatria a Gaza, sta raccogliendo fondi e coordinando invio di medicine a Gaza con UNRWA, WHO, MEDICAL AID FOR PALESTINE ed INTERPAL.
La situazione degli ospedali a Gaza è drammaticamente grave anche per mancanza di medicine sia per le emergenze (più di 700 feriti) sia per i dipartimenti di cura intensiva, dialisi, tumori e malattie croniche.
La chiusura dei tunnel tra l’Egitto e la striscia di Gaza che rappresentavano una via di entrata anche di medicine, aveva ridotto le scorte e annullato proprio la disponibilità del 30% delle medicine già prima dell’attacco. La crisi dell’economia che ne è seguita ha reso ancora più difficile ottenere medicine.
Adesso, I medici sono disperati perché non riescono a trattare le emergenze che continuano ad arrivare.
Alcuni ospedali hanno dovuto chiudere i reparti, anche in conseguenza a danni derivanti dagli attacchi e le emergenze si concentrano sugli ospedali governativi privi di scorte anche semplicemente per fili di sutura, antibiotici, analgesici, e alter medicine salvavita. Presto anche la popolazione si concentrerà sulla città ed il suo maggiore ospedale, se ci sarà una invasione di terra.


Versamento sul conto corrente postale n° 68817899 intestato a: Associazione Maniverso... Onlus;
Con bonifico bancario sul conto corrente Banca Prossima IBAN IT29 D033 5901 6001 0000 0069 894 intestato a: Organizzazione
Umanitaria Maniverso... Onlus.

Maniverso... onlus


EMERGENZA GAZA: Invio urgente di medicinali nella Striscia di Gaza


Il sistema sanitario di Gaza e’ al collasso.


DOCTNegli ospedali e nelle farmacie manca circa la meta’ dei farmaci inclusi nella lista dei farmaci essenziali stilata dall’Organizzazione Mondiale della Salute (; mancano 470 tipi di materiali sterili e monouso, tra cui aghi, siringhe, cotone, disinfettanti, guanti e molto altro.


Manca il carburante per alimentare ambulanze e generatori che permettono di far funzionare i macchinari salvavita e le sale operatorie durante le almeno 12 ore al giorno in cui l’unica centrale elettrica non riesce a fornire elettricita’.

Mancano le sacche di sangue necessarie a soccorrere le centinatia e centinaia di feriti.


MEDICINELa Striscia di Gaza e’ isolata dal mondo. Le frontiere con Egitto e Israele sono chiuse, ospedali, ambulanze e centri di pronto soccorso sono costantemente sotto la minaccia dei bombardamenti.  Nonostante questo, il personale sanitario continua a prestare soccorso incessantemente.


Ad oggi, i feriti sono almeno 1600. Per aiutare la popolazione inerme, abbiamo bisogno del vostro aiuto. Ora. Subito. Stiamo raccogliendo donazioni per far entrare medicine, materiali sanitari, e altri beni di primissima necessità. Qualsiasi donazione e’ indispensabile per salvare la vita di vittime innocenti.


Alla iniziativa partecipano TUTTE le ONG Italiane presenti in Palestina. Tuttavia, per motivi logistici, useremo il conto di Terre des Hommes Italia come canale per la raccolta.


Via Banca:
Monte dei Paschi di Siena Ag.57 Milano
IBAN: IT53Z0103001650000001030344
Via Posta:
c/c postale 321208
Causale: Medicine Gaza