Novartis milestones be proud ! Management take a bow !

WWTD? https://offshoreleaks.icij.org/search?utf8=✓&q=novartis&c=&j=&e=&commit=Search

 

Ruling against Novartis could have wider implications for generic drug labels
12/27/2017

In a surprising twist, California's high court has sided with plaintiffs who sued a brand-name drugmaker for failing to warn users of a generic about the potential risks. At the center of the case is terbutaline (Brethine—Novartis), which could impair fetal brain development when taken during pregnancy. Novartis denied responsibility for informing generic users on the grounds that it never manufactured the copycat and had divested ownership of the original version. The state Supreme Court ruled that Novartis was indeed liable, however, because federal regulations require generics to bear the same warning label that the branded product carries. In the decision, the justices wrote that during the time that Novartis owned terbutaline, the company "did have control over the warning label and could have modified it ... Recognizing a brand-name drug manufacturer's potential responsibility for injuries proximately caused by deficiencies in its warning label—regardless of whether the injury occurred before or after divestment—provides a further incentive to the brand-name manufacturer to update the label as soon as it knows (or should have known) of the unwarned risks." The ruling comes as FDA has pushed back finalization of a contentious proposed rule from 2013 that would allow generic drugmakers to revise their product warning labels and deviate from the labeling of their brand-name counterparts. The Association of Accessible Medicines, which represents the generic drug industry, has called on FDA to pull the proposed rule permanently.

 

Novartis Blasts Attempt To Revive Pay-For-Delay Suit
By Chuck Stanley

Washington (January 29, 2018, 4:16 PM EST) -- Novartis Pharmaceuticals Corp. on Friday urged the First Circuit to nix allegations it used a sham litigation to extend its monopoly over the leukemia drug Gleevec, saying a lower court correctly found a group of buyers had not shown the company’s efforts to enforce the patent at issue were baseless.

 

Ten politicians linked to Novartis bribery scandal
2-5-2018

The Supreme Court’s Public Prosecution Office has submitted to Parliament a case file concerning an ongoing probe into charges that Swiss drug firm Novartis paid bribes in order to receive preferential treatment, so that lawmakers can decide whether eight former ministers and two ex-premiers should be prosecuted for their alleged role in the affair.

The file reportedly pertains to charges of accepting bribes and breach of faith – crimes for which the statute of limitations has expired – while the investigation continues into the charges of money laundering, concerning which MPs will be sent a separate file.

While it is not clear which category of charges the 10 politicians listed in the file will face if their immunity from prosecution is lifted, prosecutors are seeking to probe eight former ministers from different parties from 2006 to 2015, as well as the head of the 2012 caretaker government, Panayiotis Pikrammenos, and ex-prime minister Antonis Samaras.

 

We can't let the Greeks be the downfall of this company...
Fuck that!

 

Novartis: Bribery allegations against 10 former Greek ministers

• 7 February 2018

Greek prosecutors have named eight former ministers and two former prime ministers in connection with a major corruption investigation.

Investigators allege the pharmaceutical company Novartis paid doctors to prescribe its drugs at high prices.

Prosecutors said the former politicians received bribes, but did not name them.

Those allegedly involved held office from 2006-2015. Novartis said it is cooperating with the investigation.

Prosecutors believe the alleged price-fixing could have cost the state billions during a financial crisis which imposed hardship on many families.

AMNA news agency reported that about €50m (£43m) was paid to politicians, and said the prosecutor's case included testimony from 20 people.

Greek media has named those allegedly linked to the investigation, all of who have denied knowledge or involvement in the scheme.

Among them are former prime minister Antonis Samaras (2012-2015) and caretaker prime minister Panagiotos Pikramenos (May-June 2012).

Mr Samaras told the Associated Press the allegations were "slander" and he would file a lawsuit against the sitting prime minister, Alexis Tsipras, in response.

The Greek parliament has now been given a case file

The Swiss pharmaceutical giant was investigated by US authorities in 2014, accused of paying bribes in order to boost sales of some of its medicines, and was later fined $390 million (314 million euros) by the US Justice Department.

In March 2017, Novartis also paid $25 million to settle claims involving its Chinese subsidiary.

 

FEB 8, 2018 @ 08:50 AM 6,065 2 Free Issues of Forbes
Patient Advocate Says Novartis' $475,000 Breakthrough Should Cost Just $160,000


Matthew Herper , FORBES STAFF I cover science and medicine, and believe this is biology's century. David
David Mitchell, receiving cancer drugs.

David Mitchell, 67, says he’s sure that Novartis’ Kymriah is a breakthrough medicine, and that he will need a similar medicine to treat his own blood cancer. He’s sure of something else, too: Novartis is charging too much.

Mitchell, a veteran PR man who is president of Patients for Affordable Drugs, says that Kymriah, which costs $475,000 per treatment for children with acute lymphoblastic leukemia, should cost only $160,000. That means the price is triple what it should be, by his math, and that Novartis’ breakthrough is overpriced by $315,000. A research analysis to back up this assertion, co-authored by Mitchell, is being published in the journal Health Affairs this morning, with more detailed results published on Patients for Affordable Drugs’ web site.

“We’re prepared to have Novartis come back and tell us the real numbers,” Mitchell challenges the drug giant. “But don’t pick. If this isn’t right, tell us all the places these numbers aren’t right.”


The piece could have an impact on more than just Kymriah. Treatments called CART cells, which genetically engineer patients' own white blood cells to attack cancer, are hot--and high-priced. Gilead purchased Novartis' rival, Kite Pharmaceuticals, for $11.9 billion last summer. Kite's CART product, Yescarta, has a list price of $373,000 for a different blood cancer. Celgene just agreed to purchase a third CART company, Juno Therapeutics, for $9 billion.

Novartis spokesman Eric Althoff says the company has not had time to review Mitchell's paper in detail. But he notes that the usually critical Institute for Clinical and Economic Review (ICER), found Kymriah to be cost-effective in children in a draft report, says that Mitchell’s assumptions about Novartis’ manufacturing cost are false, and says Novartis remains committed to “innovative pricing arrangements” to help deal with the treatments high cost.


Mitchell has multiple myeloma, a blood cancer. He says his current drug regimen costs $450,000 a year. “When I got diagnosed seven years ago, I came face-to-face with what happens when you have a disease with extremely high cost drugs to keep you alive,” he says. “The experience was searing for me, and that was made worse for me as a patient because there were no patients groups speaking out a about pricing.” He was inspired, he says, to retire and start his foundation, for which he says he is not paid. Patients for Affordable Drugs is funded in part by the billionaire John Arnold, who is targeting high drug costs as part of his philanthropy.

He says he was inspired to try to systematically evaluate Kymriah’s price after I challenged him on Twitter to actually say what the treatment should cost, not just to say it is too expensive, and was further enthused when Novartis’ former chief executive, Joseph Jimenez, told me that the drug giant had spent $1 billion in bringing the drug to market. (See: Novartis CEO's Dilemma: Is $475,000 Too Much For A Leukemia Breakthrough? Or Is It Not Enough?)

Mitchell allied himself with Paul Kleutghen, who had served as the chief executive of the generic drug company LEK Pharmaceuticals, sold to Novartis in 2004, and had advised another generic firm, Lupin, on its entry to the U.S. market. Kleutghen has a different rare blood cancer, and was on vacation and unreachable when this article was being written, Mitchell says. They hooked up with three epidemiologists and economists from Harvard’s Brigham and Women’s Hospital in Boston.

Using publicly available information, the group estimates that at the $190,000 price, Novartis could still invest 19% of its earnings in research and development, and would still generate a profit margin of 65%, 2.5 times what the company generates on its current product portfolio.

Novartis counters that the group’s estimate for it cost of goods -- $20,000, a figure given multiple times by Carl June, the researcher at the University of Pennsylvania who spearheaded the early development of the treatment – is wrong. “The oft-cited $20,000 to manufacture Kymriah is false,” Althoff says. The Health Affairs estimate uses a $40,000 cost of goods, but Althoff says the cost of goods “far exceeds” that, although he refuses to share actual figures, citing “proprietary reasons.”

“They’re charging what they think they can get away with, which is what all drug companies do,” Mitchell says. “We’re going to be bankrupting families and bankrupting our system. We can’t keep doing it this way.”

At the core of the paper’s argument isn’t just an idea that Novartis has overpriced the drug, but that, while profits should support innovation, there should be limits on them. Of course, on some level, lower drug prices mean less innovation, says Ameet Sarpatwari, one of the co-authors. “I don’t deny the tradeoff,” he says. “I think that is just basic economics. I think the question is: are we where we want to be as a society?”

 

Novartis layoffs to start in April at closing Broomfield plant
By Lucas High
Staff Writer

POSTED: 02/09/2018 12:57:15 PM MST | UPDATED: 2 DAYS AGO

Novartis, a Switzerland-based global health care company, will begin layoffs in April at its Sandoz division in Broomfield.

The company announced the closure of its generic drug manufacturing facility late last year.

The first wave of layoffs, set for April 7, will include 65 employees, according to a a notice filed by the company with the Colorado Department of Labor and Employment.

A letter to the department indicates Novartis' intent to terminate those 65 employees over a two-week period.

About 450 employees will be laid off when the Broomfield facility shuts down. Those layoffs "will occur in approximately three waves ending is 2019," the letter, dated Feb. 6, said.

The company is consolidating all commercial production of generic solid drugs to its Wilson, N.C., manufacturing site and will close all commercial production operations at the Broomfield site.

Representatives for Sandoz and Novartis could not immediately be reached for comment Friday.

In a prepared statement released when the closure was announced in October, the company said "double-digit price erosion caused by customer consolidation and increased competition taking place within the U.S. generic drug market" led to Novartis experiencing above-average pricing pressure in the United States.

"With several products no longer competitive in saturated markets, we have made the decision to discontinue or divest these limited growth products to optimize our product portfolio," the statement reads.

The local site manufactures products for numerous therapeutic areas, including cardiovascular, infection, oncology, allergies and diabetes.

Lucas High: 303-684-5310, lhigh@times-call.com

 

The Greek Union of Judges and Prosecutors called for “calmness and sobriety” on Friday (16 February), following a lawsuit by former Prime Minister Antonis Samaras against Premier Alexis Tsipras and Prosecutor of Corruption Eleni Touloupaki over the Novartis scandal.

“Calmness and sobriety are a prerequisite for shedding light on the case,” the Union said in a statement and expressed its concerns about the lawsuit launched by the former conservative prime minister (New Democracy-EPP).

Samaras, whose name appears in the Novartis case file, noted on 15 February that under Tsipras’s responsibility a “miserable conspiracy was set up”, which threatens the democratic regime.

“At a time when Greece faces great challenges and threats, they [the government] are lying and besmearing their opponents by dividing the Greek people,” Samaras said.

Samaras also sued two of the three protected witnesses, three prosecutors and Alternate Minister for Corruption Issues Dimitris Papangelopoulos.

The leftist government reacted with irony, referring to a “persistent persecution complex”.

“The only thing, however, that persecutes him, is his past. We recommend that he sues it too.”

Government spokesperson Dimitris Tzanakopoulos called Samaras’ lawsuit and “unprecedented move” and accused him of interfering with the work of Justice.

“The way he refers to prosecutors, in this case, could be interpreted as an attempt to manipulate, terrorise, or even blackmail the Greek justice,” Tzanakopoulos said.

EU Migration Commissioner Dimitris Avramopoulos, whose name is also in the case file, has also sued the two protected witnesses for perjury and defamation.

The European Commission has declined to make a comment on the issue.

“Those who threaten, intimidate or sue judges trying to do their job in accordance with the Constitution, I refer them to the announcements of the Supreme Court and even the ‘delayed’ announcement of the Union of Judges,” European Parliament Vice-President Dimitris Papadimoulis [Syriza] told EURACTIV.com.

The Novartis investigation was launched in mid-December 2016 with evidence of bribery of thousands of state officials and doctors in order for Novartis to get preferential treatment in the market.

The scandal has opened the Pandora’s Box in Greek politics as ten high-ranking politicians, all belonging to the opposition parties of New Democracy and Pan-Hellenic Socialist Movement (S&D), appeared in the case file.

The Greek probe followed a two-year investigation conducted by the US authorities on the methods Novartis allegedly used to prevail in the market.

It is estimated that the cash-strapped country has lost approximately €3 billion due to the scandal.

Next Wednesday (21 February), a debate and vote on the proposal by the parliamentary majority to set up a preliminary investigation committee for the Novartis case will take place

 

ATHENS (Reuters) - Greek self-proclaimed anarchists threw paint and smashed windows at the entrance of the Athens headquarters of Swiss drugmaker Novartis on Sunday, police said.

About 30 people were involved in the attack at 0515 local time (0315 GMT), a police official said. There were no injuries.

In a statement published on the Internet, the Rouvikonas group said the attack was linked to a probe into allegations of bribery by the drugmaker to doctors and public officials.

Greek parliament voted on Thursday to probe the role of ten politicians in the case. They have all denied any wrongdoing, saying the case is an attempt by authorities to discredit opposition politicians a little over a year before scheduled elections. Prosecutors are already investigating the role of non-politicians.

Novartis Hellas was not immediately available for comment on Sunday’s incident.

The drugmaker has promised to take “fast and decisive action” should the investigation in Greece find that its managers engaged in unethical or illegal conduct.

Small-scale attacks on businesses, state buildings, police and politicians are frequent in Greece, which is emerging from a its worst debt crisis in decades and has slashed healthcare spending, wages and pensions to shore up its finances.

 

Advocates protest Novartis ‘bullying tactics’ over access to medicines in poor countries
By ED SILVERMAN @Pharmalot

MARCH 2, 2018

Joerg Reinhardt, the chairman of Novartis, seen here during the company's general assembly in Basel.ANTHONY ANEX/KEYSTONE VIA AP



Nearly a dozen advocacy groups began a series of protests against Novartis this week for using “lies, threats and bribes” to pressure developing countries not to pursue measures to widen access to medicines.

The groups are targeting Novartis because the drug maker figures prominently in an intensifying effort by the U.S. Trade Representative and pharmaceutical industry trade groups to lean on the Colombian government to revamp its policies toward pricing and patents.

 

Rock on with your bad Marxist self

 

why is that cute dog always on the Left!?

 

Novartis investors demand action amid 'swamp' of bribery allegations in Greece
by Tracy Staton |
Mar 5, 2018 11:10am

Novartis, facing allegations of bribery in Greece, has said it will take quick action if the investigation proves wrongdoing.

Novartis investors want the company to tighten up. At the company’s Friday annual meeting—barely a week after Greek lawmakers officially opened a bribery investigation into 10 politicians there—shareholders said top brass needs to be more vigilant.

The Swiss drugmaker has already said that it would take “fast and decisive” action if the investigation shows its managers there acted improperly, and it previously strengthened its compliance program to avert bribery and other misbehaviors at its far-flung operations around the globe.


But the allegations in Greece are just the latest in a series of scandals that forced those changes, including bribery in North Korea and data-tampering in Japan. And shareholders warned the Novartis board Friday that it may not have done enough to keep employees in line.

“Corruption cannot be allowed to become a tradition,” Veronika Hendry, president of the sustainable investing proxy group Actares, said during the meeting, as quoted by Reuters.

RELATED: Novartis, slammed by Korean scandal, tweaks its ethics, compliance policies

The alleged bribery scheme in Greece goes back a decade and encompasses 10 former ministers. Among the allegations are that Greece’s health minister from 2006 to 2009 took €40 million ($49 million) in exchange for ordering “a huge amount” of Novartis products, while the health minister working between 2009 and 2010 allegedly accepted €120,000 ($147,000) from the company and laundered it through a computer hardware firm.

The politicians named in the probe have called the allegations spurious and attacked the whistleblowers themselves. In addition to the parliamentary probe there, U.S. and Swiss authorities are said to be looking into the accusations, which initially surfaced last year when three anonymous Novartis employees turned whistleblower. Novartis itself has launched an internal investigation.

On Friday, Chairman Joerg Reinhardt again promised that staffers and managers in Greece will bear the consequences if they behaved illegally or unethically. “If anybody was responsible for any misdeed, we will act accordingly,” Reinhardt said.


RELATED: Greek prime minister steps in to police exploding Novartis bribery investigation

Given the morass of allegations in Greece—and the subsequent political infighting that has made the investigation a media sensation there—Novartis is likely to remain in the headlines for some time. And that’s a big distraction at a time when the company needs to be focused on new launches and regulatory approvals, not legal problems.

According to Reuters, Mike Moran of the Swiss not-for-profit shareholders group Suishare, told the gathering Friday that he’s not convinced Novartis will break free of the scandal soon.

“I think the Greek thing will be the swamp that keeps on giving,” Moran said.

 

I didn’t know we had sales in North Korea....

 

http://www.pmlive.com/pharma_news/novartis_pushes_virtual_clinical_trial_concept_1226748

 

Novartis blazes Big Pharma trail, striking deal with Canadian company to distribute medical marijuana products
Eric Palmer |
Mar 19, 2018 10:22am



In what may be the first foray by Big Pharma into the sale of medical marijuana products, Novartis has struck a deal with a Canadian company that sells medical cannabis products not only in its home country but also in Europe.

Nanaimo, British Columbia-based Tilray announced today that it has a binding agreement with Sandoz Canada to be its exclusive supplier of “non-smokable/non-combustible medical cannabis products.”


While Canadian law only allows companies to mail their products directly to patients, the company said that “subject to future regulatory changes,” Sandoz Canada will wholesale and distribute the products to Canadian hospitals and pharmacies. It also calls for the Swiss company to use its expertise to educate pharmacists about the products and to help Tilray develop new products and dose forms.

No financial details were provided, but a Tilray spokesperson told the Financial Post that Sandoz has not taken a financial stake in the company.

In an email, a spokesperson for Sandoz Canada today said that the agreement was a "local one" focused on Canada. "I am not aware about any long-term plans from Novartis," she said.

“We are thrilled to form a strategic alliance with Tilray to strengthen our portfolio,” Michel Robidoux, president and GM of Sandoz Canada, told the newspaper in a statement. “We are committed to making every reasonable effort to respond to patients’ medical needs by increasing the number of high-quality, adequately dosed non-smokable, non-combustible medical cannabis products at the disposal of doctors.”

Tilray claims to be the first Canadian cannabis company to get manufacturing approval from the European Medicines Agency and says it sells products in 10 countries “across the continents.” It also has a deal with a German wholesaler to distribute its products to pharmacies in that country.


“To have the Sandoz logo co-branded on some of our products will help establish trust with patients and pharmacists and physicians who are used to seeing that Sandoz brand on products that they consume and trust,” Tilray CEO Brendan Kennedy told the Post.

Given Sandoz’s expertise in manufacturing dose forms like patches, sprays and creams, Kennedy said he expects the two companies to develop new cannabis-based products over time.

While Novartis may be the first Big Pharma player to step into the new but burgeoning world of medical marijuana, it is not the only drugmaker to make a bid for the business. In 2016, Teva struck a deal to be the sole distributor in Israel of a cannabis inhaler developed by Syqe Medical. At the time, Syqe had 26,000 medical cannabis consumption licenses but projected that number would double by 2018.

Insys Therapeutics, which got into a world of hurt over past marketing practices of opioid drug Subsys, won FDA approval in 2016 for a liquid formulation of dronabinol, a pharmaceutical version of THC, the active ingredient in marijuana.

 

Novartis sales reps will testify about lavish meals, US says



By Erik Larson BLOOMBERG NEWS MARCH 20, 2018


US prosecutors said numerous Novartis AG sales representatives will testify they plied doctors with lavish meals, booze, and other benefits in exchange for promises to prescribe the Swiss company’s drugs, as a seven-year-old case moves toward trial.

One sales representative said he and his colleagues were “essentially buying scripts” by providing health-care providers across the country with perks, including paid speaking opportunities at events with “little to no educational content,” prosecutors said in a filing Monday in federal court in Manhattan.

The government sought to highlight the depth of its evidence after Novartis had asked a judge to rule that there was insufficient proof to move forward. The government urged US District Judge Paul Gardephe to reject the request and set a trial date.

“Novartis has identified multiple aspects of the government’s case for which the government lacks evidence to support its claims,” spokesman Eric Althoff said in a statement. The company “disagrees with the government’s characterization of our conduct and continues to dispute the allegations concerning certain speaker programs from 2002 through 2011.”

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The government said that both health care providers and sales representatives will also testify that doctors got paid to speak at events that never occurred, and that participants would sometimes take turns playing the part of speaker and attendee at events that did take place, according to the filing.

The United States sued Novartis in 2013, intervening in a case filed earlier by a whistle-blower alleging the company regularly provided doctors with expensive dinners, fishing trips, and fees to speak at events to boost sales of the company’s drugs.

In March 2017, Novartis was ordered to give prosecutors records from about 80,000 events that the government says were used to wine and dine doctors so they would prescribe the company’s cardiovascular drugs.

Novartis has recently faced other accusations of improper sales practices. In 2015, the company entered into a $390 million settlement with the Department of Justice to settle allegations that it had given kickbacks to specialty pharmacies in return for recommending two of its drugs.

The case is US. v. Novartis Pharmaceutical Corp., 11-CV-0071, in US District Court for the Southern District of New York.

 

I hope the government strips this company of all medicare and medicaid contracts.

 

Former Novartis sales reps will testify they ‘essentially’ bought prescriptions by wooing doctors
By ED SILVERMAN @Pharmalot

MARCH 20, 2018

FABRICE COFFRINI/AFP/GETTY IMAGES
Former Novartis sales reps from around the U.S. are expected to testify they were “essentially buying” prescriptions in exchange for providing doctors with paid speaking engagements, fancy meals, and alcohol in a closely watched lawsuit that is being pressed by the federal government.

And both doctors and sales reps are expected to testify that payments were made for speaking engagements that never took place, and that many of these events had little to no educational content, but were really just schmoozefests, according to a court filing on Monday by federal prosecutors.