Novartis milestones be proud ! Management take a bow !

Is Novartis living up to its value of Integrity; high ethical standards?


Corporate tax minimisation costs governments $US1 trillion says accounting insider

The big four accounting firms have been branded as aggressive, unethical, and accused of "perpetrating the greatest tax crimes in history" by a leading corporate tax authority.

At least $US1 trillion in tax revenue is lost worldwide, and $50 billion in Australia, as a result of aggressive tax minimisation schemes established by the four giant firms who audit the books of nearly all the world's major companies, said George Rozvany, a 32-year veteran of the corporate tax industry.

"And I'm a conservative man, I think the figure is actually much higher," he told the ABC.

"It's very clear to me that the big four accounting firms are the masterminds of international tax avoidance.

"They work with government to deliver what they want for their clients. It's not set in a social context; it's designed to deliver an outcome for their clients."

Mr Rozvany spent 32 years working in the corporate tax field, for Ernst and Young, Coopers and Lybrand (now PwC) and the defunct Arthur Anderson.

He was head of tax for chemical giant ICI in Australia as well as for the world's largest insurer, Allianz.

Mr Rozvany is Australia's most published author on transfer pricing, a technique that multinational companies are using increasingly to shift profits from high tax to low tax jurisdictions.

While his legal texts explained how to work within the law, Mr Rozvany argues that sham transfer pricing arrangements are now out of control.

"Transfer pricing behaviour clearly is the greatest concern because it's very easy for a transfer pricing expert to dress up a sham transaction as a real commercial transaction," he explained.

"I'm talking about service arrangements, intellectual property transfers, such as patents or use of patents, and perceived transfer of goods, sham loans between related parties, but in reality it's all about providing services at too high a price which then shifts [income] to a lower tax jurisdiction."

Mr Rozvany likens the aggressive structures the big four accounting firms have developed for profit shifting to corruption, terrorism and Mafioso activity.

"They're all following the same financial sore," he said.

"Basically tax avoidance, corruption, terrorism: the money comes from somewhere. And the money typically needs to be hidden for the purpose of the perpetrators.

He cited the Luxembourg Leaks, which revealed the role of major accounting firms in global corporate tax minimisation as evidence of their aggressive tax behaviour on behalf of clients.

"Sham structures have been set up in Luxembourg, again, looking like normal commercial transactions but really with a view to being taxed in Luxembourg at 1 per cent as opposed to a 25 per cent or 30 per cent rate in another country," Mr Rozvany observed.

"The cost to the international community is enormous."

Mr Rozvany argues that the big four should be broken up, and their tax and audit functions separated out into separate firms, a view shared by some European politicians and regulators.

He is advocating for the use of anti-trust laws to create eight separate accounting firms and eight tax law practices.

"They're simply too big," he argued.

just because something is legal does not mean it is ethical.

"It's an interesting thing, 'within the law'," Mr Rozvany said.

"Many things were once legal. Rape and paedophilia were once legal.

"If you set up a sham transaction in a tax haven with a view to shifting profits from a high tax jurisdiction to a low tax jurisdiction that should be considered unacceptable to the international community."

 

aka Vasella moves to Monaco

 

Novartis Says Profit Could Dip as It Boosts Investment in Heart Drug Entresto
Swiss drug firm’s core net income fell 5% in second quarter to $2.9 billion

Novartis AG cut its full-year profit outlook as it ramps up investment in its new heart-failure treatment to offset declining sales of blockbuster cancer drug Gleevec.

Chief Executive Joe Jimenez said he had made a “hard decision” to boost investment in heart drug Entresto by an additional $200 million this year, a move that could cost the company 1% to 2% of core operating income.


...

Sales of Entresto were $32 million in the second quarter, and Novartis expects the drug to generate $200 million in revenue for the full year.

 

And plan to pay salaries and benefits to 500 new people. Project a loss of a billion easily . Next epic fail right here

 

And plans for 500 new salaries and benefits. Project a billion dollar loss. Next epic fail right here

 

FDA knocks back Novartis copy of Amgen's drug Neulasta

U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections in cancer patients, the Swiss drugmaker said on Tuesday.

Vasant Narasimhan, head of development at Novartis Pharmaceuticals, said the Food and Drug Administration (FDA) had issued a complete response letter for the product at the end of June, without giving further details.

The FDA typically issues such letters when more information is needed to allow approval. Novartis' copy of Neulasta, whose generic name is pegfilgrastim, had been accepted for review by the U.S. regulator in November.

The drug filing marked the company's third biosimilar filing in the United States.



(Reporting by Ben Hirschler; editing by Susan Thomas)

 

European Regulatory Roundup: Novartis Faces MHRA Criticism on Trial Data Access (21 July 2016)
Posted 21 July 2016By Nick Paul Taylor

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Novartis Faces MHRA Criticism Over Access to Trial Data
Novartis has revealed the Medicines and Healthcare Products Regulatory (MHRA) has criticized its UK operation following an inspection. The criticisms center on the systems Novartis’ UK unit uses to provide health authorities with access to trial data.

Specifically, Novartis said MHRA inspectors were critical of the ease of access to its systems. Novartis has downplayed the significance of the regulatory finding, noting that an existing project is set to address the criticism. Neither Novartis nor MHRA has released specific details of the faults found by the inspectors, or what the company is doing to address the shortcomings. Novartis disclosed the outcome of the inspection in a release regarding its second quarter financial results.

In recent years, Japanese regulators have repeatedly criticized Novartis, in part over its approach to data management and reporting. The headline charge against Novartis was that it had failed to promptly report more than 3,000 adverse events relating to more than 20 drugs, an allegation that led to health officials suspending most of the company’s sales operations for 15 days. The suspension was implemented in March 2015, since when Novartis’ Japanese unit has managed to avoid scandal.

The update to disclose the MHRA inspection results adds to the impression that the UK finding is an isolated, rather than systemic, problem. Novartis went through 74 inspections by health authorities in the first half of 2016. FDA conducted 13 of the inspections. MHRA concluded the operation it inspected was unsatisfactory.

 

How much is every additional day of quality living worth?

How much is every lost day of quality living worth?

 

Novartis, Teva generics suspended by EMA over issues with Indian CRO
by Eric Palmer |
Jul 22, 2016 11:52am

Failings at an Indian CRO have tripped up Novartis & Teva as the European Medicines Agency (EMA) today said it would suspend both some approved generic drugs as well as some under review because of problems uncovered by the FDA at the CRO. Novartis and several other drugmakers were able to escape the holds on some products because they had additional data to support them.

The EMA today announced that because of problems uncovered by the U.S. FDA and the World Health Organization (WHO) with studies done at a Bangalore site of Semler Research Centre, it had decided to suspend sales and consideration of applications for drugs that had relied solely on bioequivalence studies from the site.

According to a list of suspended drugs and applications, Teva and Sandoz, the generic unit of Novartis, both had antimalarial drugs approved in Belgium that were affected and Sandoz had an HIV antiviral approved in that market that also will be on hold. Both drugmakers had drug applications for generic versions of Roche’s cancer med Tarceva pending in a variety of markets in Eastern Europe that also are on the list.

Sandoz, as well as Mylan and India’s Lupin, all had some drugs that the EMA has said will be unaffected because the drugmakers had established bioequivalence through other sources.

The findings from FDA and WHO inspections called into question the quality management systems at Semler, and so the reliability of data for all bioequivalence studies there, the EMA said today. The FDA in April sent a letter to Krathish Bopanna--president and CEO of Semler--that failure to adhere to statutory requirements has undermined submissions in support of Abbreviated New Drug Applications, or New Drug Applications.

 

Rhymes with Sham Speaker programs


Novartis Leukemia Drug Buyers Blast 'Sham' Patent Suit
By Brian Amaral

Law360, Boston (August 1, 2016, 6:20 PM ET) -- Third-party purchasers of a Novartisleukemia drug told a Massachusetts federal judge Monday that the company lied to patent examiners about how easy it was to come up with the $2 billion-a-year formulation, then violated antitrust law by engaging in "sham" litigation to protect its patent for another eight months.
During oral arguments in Boston, lawyers for the putative class of drug buyers urged U.S. District Judge Allison Burroughs not to dismiss their antitrust suit against the pharma company, despite Novartis’ arguments that its patent-enforcement suit was not objectively baseless and that it gave the U.S. Patent and Trademark Office all the information it needed to validate the new patent related to the leukemia drug Gleevec.

Tom Sobol of Hagens Berman Sobol & Shapiro LLP, who represents named plaintiff United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund, said the patent was obtained through fraud on the patent office.

"The misrepresentations were the reason the patent was issued," he told the judge.

The purchasers claim that the original Gleevec patents were supposed to expire in July 2015, but that Novartis sought in the early 2000s to get a new patent for what it represented to be a new, crystalline form of the drug. It told the patent examiner that the results of a new process were “surprising,” leading to a more stable drug, and received a new patent on New Year’s Eve 2003, extending its patent protections for years.

But that new crystalline form described in the new patent was not at all surprising, and was just an ordinary, essentially inevitable result of well-known and widespread pharmaceutical methods that anyone with expertise in the industry would have known, Sobol said.

For proof of not only that, but Novartis’ attempts to circumvent the patent process, the purchasers pointed to five studies by the drug’s inventors in the mid-1990s describing the method that was patented almost eight years later — only two studies of which Novartis submitted to the patent examiner, Sobol said.

That, the purchasers said, constitutes Walker Process fraud, referring to the doctrine that enforcement of a fraudulently obtained patent violates antitrust statutes.

Judge Burroughs noted that the examiner could have reversed the issuance of the patent, but Sobol said that was unlikely, given how late in the process it was.

“The studies were ultimately disclosed, after the damage was done,” Sobol told Judge Burroughs.

Compounding matters, the purchasers said, when Indian generic-drug maker Sun Pharmaceutical Industries Ltd. sought to enter the Gleevec market on the expiration of the original patent — July 2015 — Novartis filed a “sham” lawsuit to keep it out. As evidence that Novartis did not have objectively good reasons to file it beyond stifling competition, the purchasers pointed to the relatively quick settlement of the lawsuit, in which Sun was able to get its generic on the market in February 2016.

“The law can’t be that you can file sham litigation and settle it quickly,” Sobol said.

Because it was patently obvious that Novartis couldn't win on the merits, its lawsuit against Sun was a sham, Sobol said.

 

Six former and current Novartis executives at its Korean unit were indicted Monday on charges of paying more than $2 million to doctors in return for prescribing its medicines, a company spokesman confirmed. Among those indicted was the former chief executive in the country.

At the same time, six publishers of medical publications and 15 doctors who work at general hospitals were also indicted. The drug maker funded academic events that were supposedly organized by the publications, but distributed to doctors money disguised as attendance fees and for articles that the doctors contributed to the publications, the Korea Herald reported.

These activities occurred from January 2011 through earlier this year, according to the Seoul Western District Prosecutors’ Office, which raided Novartis’s offices six months ago in search of evidence that the drug maker had paid bribes. Moon Hak-sun,the first Korean chief executive at the unit, had been suspended from all his duties since April.

 

Novartis could face South Korea sales ban amid corruption allegations

• Posted 12 Aug 2016 01:43

GENEVA: Swiss pharmaceutical giant Novartis risks seeing some of its medicines banned in South Korea after company executives were charged with offering illegal discounts to doctors, the Financial Times reported on Thursday (Aug 11).

According to the British business daily, South Korean prosecutors have asked the government to suspend the operations of Novartis Korea after six executives at the unit, including its president, were indicted for allegedly handing out US$2.4-million (€2.1-million) in illegal rebates from 2011 to 2016, in a move that could see the sale of implicated medicines banned for up to six months.

 

HEALTH NEWS | Wed Aug 17, 2016 10:18am EDT
Turkey's investigation into drugmaker Novartis 'ongoing': official

Turkey's investigation into Novartis is "ongoing", a Turkish health ministry official told Reuters on Thursday, after the Swiss drugmaker said last week it was not under investigation over bribery allegations in Turkey.

The Ankara chief prosecutor's office had said in April it was investigating the Turkish unit of Novartis after allegations were made that the company benefited from bribery.

Novartis said last week that it had determined the allegations were unsubstantiated and was not aware of any government authority investigating it. It said it considered the matter "closed".

However, an official at Turkey's health ministry in Ankara told Reuters that an investigation into Novartis was still "ongoing". The official declined to give further details.

Novartis did not immediately return a telephone call and an email seeking comment. It has previously said the allegations were "unfounded" and based on a past complaint.

Reuters reported in March that an anonymous whistleblower accused the company of paying bribes in Turkey through a consulting firm to secure business advantages worth an estimated $85 million.

 

Six Novartis Executives Charged In Illegal Drug Rebate Scheme In South Korea

by Richard Smallteacher, Special to CorpWatch
August 11th, 2016

​

Six executives of Swiss pharmaceutical giant Novartis have been indicted in a South Korean bribery scandal. The indictments follow similar charges in China, Turkey and the U.S. and allegations of falsifying drug trial data in Japan. Korean prosecutors have recommended that Novartis sales be suspended for six months.

One of the six executives charged in the scandal is Moon Hak-sun, who was first hired as a clinical test manger in 1994 and rose through the ranks to be appointed CEO of the South Korean subsidiary last September, the first Korean national to get the top position. "I will make utmost efforts to deepen my understanding about the Korean market and find ways to satisfy the needs of our customers," he announced at the time of his appointment.

Less than a year later, the Seoul Western District Prosecutor’s Office charged that Moon was implicated in a scheme to offer kickbacks to doctors who attended seminars hosted by medical journals in return for recommending Novartis products. All told, 20 billion won ($18 million) was allegedly paid out. A total of 15 doctors and the heads of five medical journals were investigated for their role in the scandal in addition to the Novartis executives.

"We have acknowledged and regret that certain associates in Korea conducted small medical meetings and other scientific-related activities through trade journals, in violation of our policies and inconsistent with our culture and the expectations society has for us and our industry," Klaus Ribbe, the CEO of the global company, said in an official statement. "However, we reject the implication that the alleged conduct was sanctioned by the most senior management of Novartis Korea."

A financial analyst, who asked to remain anonymous, told the Korean Times that Moon was probably 'a scapegoat for his non-Korean predecessors.'

The South Korean government has not sought to detain Moon under the indictment but Novartis has suspended him from his job.

Certianly the company has been accused of similar practices around the world. In 2015, Novartis paid $390 million to settle charges that it paid bribes to specialty pharmacies in the U.S.

This past March, Novartis paid out $25 million to the U.S. Securities and Exchange Commission to settle charges that company employees paid bribes to doctors in China, in violation of the U.S. Foreign Corrupt Practices Act.

U.S. regulators say that Novartis flew 20 Chinese health care professionals and their spouses to a medical conference in Chicago in 2009. Company officials also allegedly provided the doctors $150 in “walking around” money, took them to strip clubs and to see the Niagara Falls.

The month before Novartis settled charges in China, a whistleblower in Turkey came forward to say that the company paid Alp Aydin Consultancy $290,000 plus expenses in 2013 and 2014, to get sweetheart deals from government officials. The consultancy was accused of arranging for government hospitals to buy Novartis drugs as well as a successful effort to get government permission to rename two company drugs. The latter scheme helped Novartis win $50 million in orders because the new names no longer showed up in international price comparisons.

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

Meanhile in Japan, Novartis is battling charges of falsifying drug trial data. The company has been accused of altering clinical test results for Diovan, a blood-pressure drug. Other employees have been accused of shredding documents and hiding severe side effects of a leukemia drug.

"If some of them have destroyed documents, it's a pure violation of our code of conduct and that employee has to leave as soon as we discover that," David Epstein, head of the firm's pharmaceutical division, said at the time. "I'd like to once again apologize for Novartis' involvement in this issue." Epstein has since left the company.

 

Novartis Subsidiary Pays $16m to Settle Charges of Illegally Shipping Drugs and Devices to Iran, Syria and Sudan
Posted 29 August 2016 By Zachary Brennan


Novartis subsidiary Alcon Laboratories has agreed to pay more than $16 million to settle allegations of manufacturing drugs and medical devices in the US and then shipping them to Iran, Syria and Sudan despite US trade embargoes that prohibit such sales.

According to the settlement agreement with the US Department of Commerce, Texas-based Alcon Labs and Switzerland-based Alcon Pharmaceuticals sent at least 100 shipments of devices and medical equipment worth more than $8 million between 2008 and 2011 to Iran via Switzerland.

Between 2008 and 2012, Alcon also sent more than $70,000 worth of medical devices and equipment to Syria without a license, as well as more than 400 unlicensed sales and exports to Sudan.

Douglas Hassebrock, director of the Department of Commerce’s Bureau of Industry and Security’s Office of Export Enforcement, noted that Alcon “was aware of the prohibitions on trade activities under the long-standing and well-known US embargo against Iran.”

A European freight forwarder in 2010 even notified Alcon that its warehouse in Switzerland was shipping items to Iran without the required US government authorization, though Alcon continued to export US-origin devices and equipment to fulfill sales orders.

Melissa Proctor, a lawyer with Polsinelli, wrote on Monday that there are several key takeaways from this enforcement case for US firms: “First, it is critical for U.S. companies to implement formal trade compliance programs—the lack of such policies and procedures can be treated as an aggravating factor in export enforcement action by the U.S. government. U.S. companies should also have formal compliance training processes and issue escalation processes to enable personnel to take swift action and make the necessary internal inquiries when ‘red flag’ information is received—such processes here would have enabled Alcon to ask questions, escalate the company’s freight forwarder’s refusal to ship goods to Iran, Sudan, and Syria, and perform additional due diligence about the overall legality and licensing requirements for its proposed shipments.

“Finally, when export violations are discovered, companies can receive significant mitigating treatment from the U.S. government agencies where they promptly cease the violative conduct, take appropriate remedial actions, and cooperate fully in the export investigation,” Proctor wrote.

According to Sanction Law, this is the second time the US Department of Treasury has said device firms are liable for apparent sanctions violations relating to the export of medical products. In late June, Hyperbranch Medical Technology settled allegations of exporting medical products to Iran.

The Novartis subsidiary did not respond to a request for comment.

 

Alcon's not the only subsidiary doing that.

And how about the news from Europe today?

So long to the Double Irish!

 

Struggling Vaccines From Novartis Turn Into Sales Boon for Glaxo

Ketaki Gokhale KetakiGokhale
August 31, 2016 — 12:00 AM EDT


Outbreaks of the meningitis B disease in the U.S., along with the social-media frenzy that followed the death of a British toddler, have helped propel sales of GlaxoSmithKline Plc’s vaccine well past initial projections for its use.

The U.K. drugmaker is poised to deliver nine times the 2016 sales Novartis AG had forecast for vaccines including the meningitis B shot Bexsero, said Thomas Breuer, chief medical officer at Glaxo’s vaccines division. Glaxo acquired the business in March 2015, and revenue for vaccines last year was five times what Novartis had estimated, Breuer said.

 

It is not rocket science, there is business every where. these NVS idiots have no clue about any business. let investors decide to sell off all divisions to able corporates and see how business is

 

via toxic ingredients

By ED SILVERMAN @Pharmalot

SEPTEMBER 8, 2016


The European Chemicals Agency has given Novartis potentially significant support in its battle over a toxic chemical that the company uses for making an ingredient found in two medicines.

At a meeting last month, the agency decided to support a Novartis request for a seven-year exemption from a pending ban on diglyme, which is used to make indacaterol, an ingredient in treatments for chronic obstructive pulmonary disorder (see section 23 on page 34). A final decision, however, must still be made by the European Commission, and it is unclear when that will happen. The ban goes into effect in August 2017.

The backing by the agency comes as the pharmaceutical industry at large attempts to balance its use of certain chemicals with a need to improve its image as a concerned corporate citizen. As if to underscore this point, Novartis argued in its application to the agency that the company “continuously conducts case studies to further improve the greenness of (its) production processes.”

But a leading environment group had urged the agency to support the ban.

In comments filed with the agency, the ChemSec nonprofit group insisted the ban should be upheld due to “socioeconomic” costs associated with continued use of the chemical, as well as negative consequences for companies that produce potential alternatives. “In order to get a complete picture of the economic impact, it is necessary to look beyond the costs of the applicant alone,” ChemSec wrote.

A ChemSec spokesman added that alternatives to diglyme have been available, but criticized the drug maker for failing to pursue other possibilities until 2013, given that European Union environmental regulations listed diglyme as a candidate for a ban in late 2011. “Novartis knew this and should have done R&D (for) substitution earlier,” he wrote us.

 

Novartis Dissolves CAR-T Unit, Cutting 120 Positions

Novartis is shutting down the business unit it created to develop white blood cells that can attack certain types of cancer
It’s not like we’re abandoning the technology or abandoning the project,” Althoff says. “We’re sticking with it. CTL109 remains on track.”

The view from within the Cell & Gene Therapies Unit is far less stable, though. FORBES obtained a portion of the note that Usman Azam, the unit’s global head, sent to his team.

“The risk of embarking on a new adventure in uncharted territory is that things don’t always work out how you envisioned,” Azam wrote. “Today, I have the unfortunate task of announcing that we are dissolving the Cell & Gene Therapies Unit