Novartis milestones be proud ! Management take a bow !

Cost cutting and spending "freeze" for lawyer and settlement fees?

The U.S. is asking Novartis AG to provide records of about 80,000 “sham” events in which the government says doctors were wined and dined so they would prescribe the company’s cardiovascular drugs to their patients.

The Swiss drugmaker and the Manhattan U.S. Attorney are engaged in a whistle-blower lawsuit that alleges Novartis provided illegal kickbacks to health-care providers through bogus educational programs at high-end restaurants and sports bars where the drugs were barely discussed.

In a filing Friday, the U.S. said it needs Novartis to provide information to support its allegation that the company defrauded federal health-care programs of hundreds of millions of dollars over a decade by inducing doctors to prescribe its medications through sham speaker events.

“The requested documents go to the core issues in this case: whether educational materials were provided at these events; which doctors actually attended the events; how much money was spent on meals and honoraria; and indeed, most fundamentally, whether the underlying documentation shows that a particular event actually took place,” the government said in its court filing...​

Every year or two, the US justice system sets new records in large cash settlements from pharmaceutical firms. Will 2016 be any different?

“We disagree with the way the government is characterizing our conduct in both of these matters and we stand behind our Compliance program,” said the president of Novartis' US pharmaceuticals unit, André Wyss...​

The proof is in the pudding AW. If the conduct is mis-characterized, then the evidence should speak for itself. If the evidence remains silent, is a 10-figure settlement that difficult to imagine?

 

That's like entire payroll of a huge multinational corp!
wonder if they followed CIA guidlines post 2010?

 

or at least 10% of the recently announced share buyback programme

 

Citi Downgrades Novartis Following SAG Investigation
Manikandan Raman , Benzinga Staff Writer
March 29, 2016 10:10am

Citi has downgraded Novartis AG (ADR) NVS 2.27% to Neutral from Buy on SAG investigation.

Analyst Andrew Baum reported, "The ongoing action of the formidable State Attorney General (SAG) of the Southern District of NY, Preet Bharara, casts a reputational shadow over the incumbent Novartis Chairman and CEO, who both had operational responsibilities at Novartis during the alleged period of widespread kickbacks."

Further Details
"Similar to GlaxoSmithKline plc (ADR) GSK 0.14% before it, Novartis faces a high probability of significant fines (in excess of $2 billion) as well as an additional punitive Corporate Integrity Agreement providing material risk to already lowered consensus Entresto (cardiovascular) estimates," analyst Baum wrote in a note to clients.

The analyst cut his 2025 Entresto estimate to $2 billion from $10 billion.

The State Attorney General alleges "Novartis allowed kickbacks or inducements to prescribers of their cardiovascular drug through a stream of round table and education events, typically at restaurants," Baum elaborated.

The analyst continued, "The provision of nine years' worth of records and salesmen testimony could indeed generate sufficient evidence to ensure a successful prosecution. The highest individual payment under the FCA was a $2 billion settlement from GSK in 2012 in relation to extensive off-label promotion over a prolonged period.

"Much more importantly, the DoJ imposed a strict CIA on GSK that continues to negatively impact the performance of GSK primary care portfolio, including the newly launched respiratory products (Breo and Anoro).

"We think the issuance of a GSK-like CIA to Novartis would likely severely impact Novartis' earnings and valuation outlook given the important anticipated contribution of future Entresto revenues (cardiovascular disease)," Baum noted.

"It is possible that Novartis's decision to delay aggressive marketing of Entresto in the US was related to the ongoing SAG investigation," Baum added.

 

will anyone go to jail?

 

Business | Tue Mar 29, 2016 4:21pm EDT
Exclusive: Novartis investigating $85 million bribery allegations in Turkey

REUTERS/MARCO BELLO

An anonymous whistleblower has accused Swiss drugmaker Novartis (NOVN.S) of paying bribes in Turkey through a consulting firm to secure business advantages worth an estimated $85 million, according to a Feb. 17 email seen by Reuters.

The alleged benefits, which Novartis confirmed it was investigating, included getting medicines added to lists, or formularies, of drugs approved for prescription in government-run hospitals, and avoiding price cuts in other countries by securing government approval to change the names of two drugs.

The anonymous sender's 5,000-word email to Novartis Chief Executive Joe Jimenez and Srikant Datar, chairman of its audit and compliance committee, said Novartis had paid Alp Aydin Consultancy the equivalent of $290,000 plus costs during 2013 and 2014, before the Turkish Social Security Institution (SSI) launched an investigation, leading the drugmaker to end the association.

Novartis, which said it was committed to the highest standards of ethical business conduct, confirmed Aydin had consulted for it in the past and no longer did so. The pharmaceutical giant also said it was investigating the allegations Aydin had passed on funds to Turkish healthcare officials, and that Novartis Turkey had hired relatives of high-prescribing doctors.

"We take any allegation of inappropriate behavior extremely seriously and investigate all allegations thoroughly. As a matter of policy we don’t comment on such investigations even if the complainant decides to make them public," said company spokesman Eric Althoff.

Officials at the SSI and Aydin did not immediately respond to requests for comment.

Novartis' difficulties in Turkey highlight the problems faced by healthcare companies as anti-corruption authorities around the world investigate industry practices.

Last week Novartis agreed to pay more than $25 million to settle a U.S. Securities and Exchange Commission (SEC) case over bribery in China.

China has been a particularly tricky market for Western drugmakers. In a high-profile corruption case, GlaxoSmithKline (GSK.L) was slapped with a record 3 billion yuan ($460 million) fine by a Chinese court in 2014.


FOREIGN CORRUPT PRACTICES ACT

The whistleblower email said Novartis had gained $20 million from Aydin's ability to have new drugs for multiple sclerosis, chronic lung disease and juvenile arthritis added to hospital formularies.

It also benefited from advantageous pricing decisions and a special import permit for a drug with an expired manufacturing certificate, the email said.

The biggest gain of $50 million, according to the whistleblower's email, came from Turkish officials allowing Novartis to rename its drugs Ilaris and Gilenya as Ibecta and Fingya. This meant they dropped out of international pricing comparisons, since such cross-referencing is based on commercial names.

Reuters could not independently confirm these benefits or the value attributed to them by the whistleblower.

The whistleblower said Novartis' activities had breached the U.S. Foreign Corrupt Practices Act (FCPA), which bans U.S. firms and those whose stock is traded in the United States, such as Novartis, from bribing government officials overseas.

"Novartis’ use of the government relations consultant as well as other practices noted ... violated the FCPA’s anti-bribery, internal controls, and books and records provisions," the email said.

A U.S. Department of Justice (DOJ) spokesman declined to speculate on the legality of these particular activities.

The sender, who asked for anonymity in the email to avoid retaliation, first emailed Jimenez on Feb. 17 and re-sent the message on March 4, after failing to receive a reply. In a brief response to the sender on March 4, the Novartis CEO said: "We will investigate".

Turkey is currently the world's 18th largest pharmaceuticals market but is expected to rise to 15th spot by 2020, according to healthcare consultancy IMS.

Novartis also faces problems in South Korea, where its offices were visited by local authorities last month in relation to suspected bribery, while the U.S. government is suing Novartis over 79,236 "sham" marketing events it says involved illegal kickbacks.

Novartis said it was cooperating with the South Korean authorities and could not comment further. In the ongoing U.S. lawsuit, Novartis has complained that the government suddenly expanded the size of the case by highlighting thousands more events.

In the email sent to Novartis concerning Turkey, the author said that the information would be passed on to the DOJ and SEC. Both the DOJ and SEC declined to say if they had received it.

An SEC program provides cash incentives for whistleblowers to report corporate malpractice, including breaches of the FCPA.

 

Novartis Is Under SEC Investigation, Probes Reporter Says
Rebecca Sheppard , Benzinga Staff Writer
March 31, 2016 4:33pm

Novartis AG (ADR) NVS 1.86% is under SEC investigation, according to a new report from Probes Reporter.

New Findings
In a Thursday research update, Probes Reporter stated, "These guys are playing you about an on-going, confirmed SEC investigation."

"Novartis has repeatedly "sort of" disclosed an SEC investigation, by stating it is "communicating" with the SEC about an internal investigation," the report continued. Those disclosures are made in two separate previously filed 20-F documents from January 27, 2015 and January 27, 2016.

However, in a letter dated February 1, 2016, the SEC confirmed to Probes Reporter Novartis' involvement in ongoing enforcement proceedings.

"Apparently, Novartis has been doing a lot more than just "communicating" with the SEC," Thursday's report said of this development.


What It Means
In a comment to Benzinga, Probes Reporter's John Gavin explained what this means for Novartis:

"Novartis made what we call a "stealth disclosure" of an SEC probe. That is, while their disclosures repeatedly refer to having "communicated" with the SEC, the company does not directly come out and say it actually under investigation. Our data confirms they are. This is typically – and willfully – done to keep an SEC investigation from showing up in searches many people routinely run on SEC filings."

When asked to confirm or deny it is under SEC investigation, Novartis directed Benzinga to its 2015 20-F document.

 

Is there a company in existence more corrupt than this?

 

“World’s biggest bribe scandal”: Report on oil corruption exposes how corporations help destabilize Middle East
Leaked docs show how the shadowy company Unaoil bribes Middle Eastern regimes for oil contracts for multinationals

 

https://panamapapers.icij.org/video/

The Panama Papers is a global investigation into the sprawling, secretive industry of offshore that the world’s rich and powerful use to hide assets and skirt rules by setting up front companies in far-flung jurisdictions.

A massive leak of documents exposes the offshore holdings of 12 current and former world leaders and reveals how associates of Russian President Vladimir Putin secretly shuffled as much as $2 billion through banks and shadow companies.

The leak also provides details of the hidden financial dealings of 128 more politicians and public officials around the world.

The cache of 11.5 million records shows how a global industry of law firms and big banks sells financial secrecy to politicians, fraudsters and drug traffickers as well as billionaires, celebrities and sports stars.

• Files reveal the offshore holdings of 140 politicians and public officials from around the world
• Current and former world leaders in the data include prime ministers of Iceland and Pakistan, the president of Ukraine, and the king of Saudi Arabia
• More than 214,000 offshore entities appear in the leak, connected to people in more than 200 countries and territories
• Major banks have driven the creation of hard-to-trace companies in offshore havens

 

UBS Downgrades Novartis AG (ADR) to Neutral
By Alex Simms -

April 6, 2016
Brokerage firm UBS Downgrades its rating on Novartis AG (ADR)(NYSE:NVS). The shares have been rated Neutral. Previously, the analysts had a Buy rating on the shares. The rating by UBS was issued on Apr 1, 2016.

 

ATMOSPHERE: Adding aliskiren to ACE inhibitor does not benefit patients with HF

April 5, 2016
“There seems to be a ceiling to the benefit that can be obtained with renin-angiotensin system blockers,” said John J.V. McMurray, MD, professor of medical cardiology at the University of Glasgow, Scotland, during a press conference. “Above a certain level of blockade, there were no additional benefits and [potential] harm.”




John J.V. McMurray

ATMOSPHERE was a multicenter, randomized, double-blind trial that enrolled 7,016 patients with HF. All patients (mean age, 63 years; 78% men) had already been treated with enalapril or another ACE inhibitor and a beta blocker.

Patients were switched from their existing ACE inhibitor and then entered the first part of a two-part run-in phase, in which they received 1 to 4 weeks of enalapril 5 mg twice daily in a single blind fashion and then 2 to 4 weeks of enalapril 10 mg/twice daily. Then patients were stratified by dose of enalapril that did not cause unacceptable adverse events. In the second part of the run-in phase, patients were given a daily dose of aliskiren (Tekturna, Novartis) 150 mg plus enalapril in a single blind fashion.

Patients who didn’t have serious adverse reaction to both drugs were then randomly assigned to either take enalapril alone at a dose of 300 mg/daily (n =2,336), aliskiren alone at a dose of 300 mg/day (n = 2,340) or both drugs (n = 2,340). The primary endpoint was a composite CV death and hospitalization for HF. Median follow-up was 36.6 months.

Study results were simultaneously published in The New England Journal of Medicine.

 

Novartis (NYSE:NVS) Hit With Downgrade by Morgan Stanley, Is This a Concern?
by Linda Rogers — April 12, 2016
Novartis (NYSE:NVS) Downgrade
Novartis (NYSE:NVS)’s “Equal-weight” rating is no longer valid. equity analysts at Morgan Stanley downgraded Novartis (NYSE:NVS)’s rating to “Underperform”.

 

April 18, 2016 2:36 pm

Clouds gather over Novartis as it battles series of setbacks
Andrew Ward in London and Ralph Atkins in Zurich

Joe Jimenez is facing a battle to restore investor confidence in Novartis after a series of setbacks which have sent shares in the Swiss pharmaceuticals group down more than a quarter in the past year.

Disappointing sales of a new heart drug have combined with problems in the group’s Alcon eyecare business to create arguably the rockiest period for Mr Jimenez since the American took charge six years ago.

Legal risks have added to the gloom as Novartis faces investigation for suspected marketing abuses in the US, South Korea and Turkey on top of recent cases in Japan and China.

All these problems have been brewing for months but the heat has turned up in the past few weeks as a succession of analysts cut growth forecasts for the group.

Mr Jimenez still has credit with investors for asweeping overhaul in which Novartis has narrowed the sprawling range of businesses built by his predecessor, Daniel Vasella. He is likely to trumpet progress towards cutting costs and restructuring Alcon when the group announces first-quarter results on Thursday.

However, the headline numbers are unlikely to part the clouds hanging over Novartis. Analysts expect sales and profits to be down as the eyecare business continues to drag on performance.

The mood was much different a year ago when the group was preparing to launch Entresto, a much-anticipated treatment for heart failure. Data showing that the drug cut deaths by a fifth in clinical trials fuelled confidence that it would be the new blockbuster Novartis desperately needed to offset the looming loss of patent protection on its best-selling Gleevec cancer drug.

Yet, instead of the expected gush, sales of Entresto started at a trickle. The $5m registered in the final quarter of 2015 was less than a tenth of analysts’ forecast. They have described the launch as “glacial” and a “huge disappointment”.

Novartis declined to comment, citing the quiet period ahead of its results. But analysts sympathetic to the group point out that Mr Jimenez was always clear that it would take time for Entresto to gain momentum. There has, so far, been no retreat from his long-term target for peak annual sales of $5bn from the drug. Others are no longer as confident. Citigroup last month slashed its Entresto sales forecast from $10bn in 2025 to just $2bn.

The worry for investors is that Entresto’s weak start may be a harbinger of tougher times ahead in the US. Two much-hyped cholesterol-lowering drugs from Sanofi andAmgen have also been stuck in the slow lane since their launch last year.

This has added to evidence that US insurers and healthcare providers are becoming more aggressive in their bargaining with big pharma as structural changes in the health system increase incentives for cost savings.

Without a strong contribution from Entresto this year, Novartis has been left badly exposed to a decline at Alcon — a business acquired from Nestlé for $50bn in a two-part transaction completed in 2010. Mr Jimenez announced a change of leadershipat the unit in January and narrowed its focus to contact lenses and surgical equipment, while its eye drugs were transferred to the main pharma division.

A target was set for Alcon to return to growth by the end of the year and Mr Jimenez insisted that eyecare remained an attractive market given rising demand from an ageing world population. However, Seamus Fernandez, analyst at Leerink, says the business may be sold if the turnround falters.

Further uncertainty comes from the series of investigations facing Novartis over suspected marketing abuses in the US, Turkey and South Korea. That is on top of a $25m settlement paid to the US Securities and Exchange Commission last month for bribery in China and a suspension of its business in Japan last year as punishment for manipulating clinical trial data.

By far the biggest peril is from a lawsuit being pursued by Preet Bharara, the formidable US attorney-general for the southern district of New York. He has accused Novartis of funnelling kickbacks to prescribers through as many as 80,0000 “sham” educational meetings where doctors were wined and dined.

Mr Bharara, has already secured a $390m settlement from Novartis in a separate case last year, and Andrew Baum, analyst at Citigroup, says there is a “high probability” of another fine that could be similar in scale to the record $3bn paid byGlaxoSmithKline to the US justice department in 2012.

Like GSK, Novartis might also have to commit to marketing reforms that would make it harder to aggressively push Entresto. Mr Baum said this could “severely impact” earnings and cast “a reputational shadow over the incumbent Novartis chairman [Joerg Reinhardt] and CEO”.

In an attempt to clean up, Novartis has appointed a chief ethics officer and is in the process of tightening its rules on relations with doctors.

For all the challenges, some analysts still see reasons for optimism. While Entresto has flopped so far, another new product, Cosentyx for psoriasis, has started strongly with forecasts of $2.5bn in annual sales by 2020. Michael Nawrath, analyst at Zürcher Kantonalbank, says Mr Jimenez could refresh the business with bolt-on deals. “It doesn’t have to be a mega merger, but there are smart asset swaps, collaborations, or purchases . . . which could convince shareholders that there is future growth.”

 

Novartis’ ‘breakthrough’ muscle drug bimagrumab flunks a late-stage trial

by John Carroll |
Apr 21, 2016 3:10am

Novartis ($NVS) buried some bad pipeline news in its quarterly report today. The pharma giant says that its “breakthrough” drug bimagrumab (BYM338) failed a Phase IIb/III study for a rare, muscle-wasting disease called sporadic inclusion body myositis--putting a drug that has garnered blockbuster peak sales projections under a cloud.

Novartis kept it short and sour, saying that the drug did not hit the primary endpoint. The company plans to evaluate the full data set before it decides on next steps. But for now, it looks like the latest--and biggest--failure in a string of flops in this niche R&D field.

 

http://finance.yahoo.com/news/novartis-prepare-sale-roche-stake-135549787.html

 

Any countries left ???


12:37 pm ET
Apr 22, 2016
BRIBERY
Novartis Discloses Korean Criminal Investigation

• BRIBERY
• FCPA
• FOREIGN CORRUPT PRACTICES ACT
• NOVARTIS AG

• By STEPHEN DOCKERY
• local reports of the company’s Korean offices being searched by police.
  
  “In Q1 2016, the Seoul Western District Prosecutor initiated a criminal investigation into allegations that Novartis Korea utilized medical journals to provide inappropriate economic benefits to health-care professionals,” the Swiss company said in its filing.
  
  Novartis paid $25 million in March to settle with the Securities and Exchange Commission over alleged Foreign Corrupt Practices Act books and records violations in China. The SEC said the company gave gifts to health-care professionals to boost sales from 2009 to 2013.
  
  The company said Monday in an emailed statement it is conducting its own investigation into issues raised by Korean authorities.
  
  “Novartis is cooperating with the investigation being conducted by the Seoul Western District Prosecutor’s office,” the company said in an emailed statement Friday. “Novartis is committed to the highest standards of ethical business conduct and regulatory compliance in all aspects of its work and takes any allegation of misconduct extremely seriously.”
  

 

The message therein screams: $1billion in provisions ain't enough!

 

JAIL TIME?

 

Are you kidding....No where even close.
We alredy have a Corp Intreg Agreement in place and same allegations have been readdressed. selling Roche shares will cover it, but fine will set new records.

come on, like nobody saw this coming? Really?? LOL
#HEADINTHESAND