Novartis milestones be proud ! Management take a bow !

WHO WERE THE REPS??????

Fla. Hospital Inks $2.5M FCA Deal Over Bogus Brain Care
By Jeff Overley
New York (May 06, 2014, 8:15 PM ET) -- A Florida hospital will pay $2.5 million to resolve a whistleblower’s False Claims Act allegations that two neurologists intentionally misdiagnosed patients with multiple sclerosis and brain diseases in order to bill Medicare for unnecessary services and drugs, the U.S. Department of Justice said Tuesday.
The settlement with Jacksonville-based Baptist Health System Inc. will result in a roughly $425,000 payout to hospital referral coordinator Verchetta Wells, who brought the case in 2012, as well as roughly $20,000 for the state of Florida based on overbilling of Medicaid.

Still unresolved are FCA claims brought individually against Sean Orr, who was described in the original complaint as “the most visible, important and prolific physician” in Baptist Health’s neurology group. The DOJ said it had not yet reached a decision on whether to intervene in the portion of the case targeting the doctor.

The alleged fraud was said to have taken place from September 2009 to October 2011 and to have involved misdiagnoses by two neurologists who falsely told patients they had multiple sclerosis and an array of brain disorders, including hardened blood vessels. Patients then were directed to take a number of potent medicines, including Acorda Therapeutics’ Ampyra, Novartis AG’s Gilenya and Biogen Idec Inc.’s Tysabri.

 

U.S. regulator rejects Novartis heart failure drug

ZURICH Fri May 16, 2014 8:34am EDT
(reuters) - U.S. health regulators turned down an application to approve Novartis' experimental heart failure drug due to insufficient evidence that it improves symptoms, the Swiss drugmaker said on Friday.

Novartis said in a statement the Food and Drug Administration (FDA) had asked for further evidence to determine the efficacy of serelaxin, also known as RLX030.

The decision follows a unanimous recommendation from a panel of advisers in March against approving the drug.

Serelaxin is one of several potential "blockbuster" drugs the Basel-based pharmaceutical company is looking to as it bets on cancer, heart and respiratory treatments to fill the gaps left by patent expiries on drugs such as Diovan, which lost U.S. patent rights and faces generic competition.

Tim Wright, global head of development at Novartis, said Novartis still believed serelaxin had the potential to become "an important treatment" for acute heart failure.

 

any real scientist knew this was going to happen with the quality of submission made.
could have slow-payed the hand, banking on a PARADIGM-HF like opportunity to materialize.
oh well...

i understand the eagerness to deliver with speed to market under current regulations, but just get it right on the first time go or don't bother developing it at all.

 

Novartis: CHMP Confirms Negative Opinion After Re-examination Of RLX030
5/23/2014 7:52 AM ET
RTT news

Novartis (NVS: Quote) said the Committee for Medicinal Products for Human Use or CHMP has adopted a negative opinion for the use of RLX030 in the treatment of acute heart failure or AHF, indicating that further evidence is required for a license to be granted in the EU. This follows the firm's request for re examination following a previous negative opinion issued in January. Novartis hopes to resubmit for approval once the additional data is available from the ongoing global trial program, including the 6,300 patient RELAX-AHF-2 trial.

"We are disappointed that patients in Europe will not have access to RLX030 in 2014 but we believe in the value that RLX030 can bring to patients and are committed to extending the current evidence base to confirm this," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals

 

I would have expected better than us playing blackjack with the regulatory agencies. Sure, what's there to lose by submitting RLX030 with the current data?

 

opinionated?

 

Italy seeks anti-trust compensation from Roche, Novartis, Pfizer
ROME Wed May 28, 2014 2:35pm EDT

(Reuters) - Italy said on Wednesday it was seeking billion-euro payouts from multinational drug companies following a ruling by the country's anti-trust authority that their unfair policies had been detrimental to Italy's national health service.

The health ministry said in a statement it was requesting damages totaling 1.2 billion euros from Novartis (NOVN.VX) and Roche ROGPHF.UL for the damages incurred in 2012-2014, and was requesting 14 million euros from Pfizer (PFIZ.NS).

It cited several recent anti-trust rulings that the companies' repeated anti-competition policies had caused the national health service "considerable damage".

In March, Italy's antitrust authority said Roche and Novartis colluded to try to stop cancer drug Avastin from being used to treat a serious eye disease and fined the companies 182.5 million euros ($254.2 million).

Italy's regulator accused the two Basel-based firms of striking an alliance to prevent distribution of Roche's Avastin as a treatment for wet age-related macular degeneration (AMD) in favor of the more expensive drug Lucentis made by Novartis.

Roche and Novartis have both denied malpractice and have said they will appeal against the regulator's ruling.

Italy's state council, the highest administrative court, in February ruled that Pfizer had abused its dominant position relating to the Glaucoma drug Xalatan "with a clear and persistent intention to suppress competition."

 

PART 1

UPDATE 2-Novartis must face U.S. gov't lawsuit alleging drug kickbacks
Thu May 29, 2014 5:28pm EDT
(Reuters) - A federal judge on Thursday refused to dismiss a U.S. government lawsuit accusing Novartis AG of civil fraud for having conducted two illegal kickback schemes to boost sales of drugs covered by Medicare and Medicaid.

U.S. District Judge Colleen McMahon in Manhattan rejected the argument by the Swiss drugmaker's Novartis Pharmaceuticals Corp unit that the lawsuit should be dismissed because the government had failed to show how it had been defrauded.

McMahon, however, invited Novartis by June 13 to seek dismissal on a different ground, that the claims were legally inadequate, saying she needed to more fully review that issue.

The government accused Novartis of having from 2005 to 2013 induced at least 20 pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic by providing kickbacks, in the form of discounts and rebates.

It also claimed that in a scheme lasting from 2007 to 2012, Novartis provided kickbacks, in the form of patient referrals and rebates, to BioScrip Inc in exchange for that pharmacy recommending refills of Exjade, a drug meant to reduce excess iron in patients who receive blood transfusions.

These activities allegedly led Medicare and Medicaid to pay tens of millions of dollars of improper reimbursements, violating an anti-kickback law that prohibits paying people to buy drugs or services covered by federal healthcare programs.

"The government has provided a strong factual basis for its assertion that claims tainted by the Novartis kickback scheme were actually submitted to Medicare and Medicaid, given that it used actual claims data as the basis for its detailed allegations," the judge wrote.

Eleven U.S. states joined the case as co-plaintiffs. BioScrip settled for $11.7 million in January.

Novartis spokeswoman Julie Masow said the company, which has offices in East Hanover, New Jersey, intends to renew its bid to dismiss the case by McMahon's deadline.

"The use of specialty pharmacies to support patients with complex medical conditions is an effective, well-established practice to help ensure patients comply with their physician-directed treatment plans," she said.

A spokeswoman for U.S. Attorney Preet Bharara in Manhattan declined to comment.

Three separate state complaints remain pending in related litigation, McMahon said.

The lawsuit was brought under the federal False Claims Act, which lets the government pursue triple damages.

It stemmed from a whistleblower lawsuit by David Kester, a former Novartis respiratory account manager from Raleigh, North Carolina. He is also pursuing separate claims against Novartis and other companies regarding other drugs.

Shelley Slade, a lawyer for Kester, declined to comment.

In announcing the lawsuit in April 2013, Bharara had called Novartis a "repeat offender," referring to its 2010 agreement to pay $422.5 million to settle criminal and civil claims over its marketing of the epilepsy drug Trileptal and other drugs.

The case is U.S. v. Novartis Pharmaceuticals Corp, U.S. District Court, Southern District of New York, No. 11-08196. (Reporting by Jonathan Stempel; Additional reporting by Nate Raymond; Editing by Lisa Shumaker and Richard Chang)

 

Drug authority offices searched in Roche-Novartis probe
05/06/2014

Rome, June 5 - Finance police on Thursday searched the offices of the Italian Medicines Agency (Aifa), the authority responsible for drug regulation in the country, as part of a criminal probe into Swiss pharmaceutical companies Roche and Novartis for alleged market manipulation and fraud. The companies are suspected of collusion to hamper use of a cheap eye drug in favour of a more expensive one. The alleged cartel promoting Novartis's Lucentis over Roche's Avastin is believed to have cost Italy's national health service over 45 million euros in 2012 alone, while future costs could potentially reach 600 million euros a year. When news of the probe emerged in March Italian consumer association Codacons said it would ask the country's audit court to verify whether Aifa had acted negligently in the affair.

 

Novartis side effects unreported
Jun 10, 2014

Tokyo-based Novartis Pharma K.K. said employees have failed to report up to 10,000 cases of serious side effects caused by its drugs for leukemia and other diseases to an internal department since 2002.

The Japanese unit of Swiss drug giant Novartis AG found this as a result of an in-house probe covering all 4,500 employees that was conducted following the revelation that workers were improperly involved in clinical trials for leukemia drugs at medical institutions.

The reporting failure violated in-house rules, according to the company.

The 10,000 cases are believed to include ones that should have been reported to the government. All of the cases had been reported to the Health, Labor and Welfare Ministry by Monday, the company claimed. Novartis Pharma said the unreported cases are now being examined in detail.

 

FINALLY! TIME TO CLEAN UP BASEL & EH TOO !!!!

Japan News
Former Novartis Employee Arrested in Japan
Prosecutors Allege He Illegally Altered Research Data

By Kana Inagaki
June 11, 2014 2:48 a.m. ET

A Novartis employee works in a laboratory in Prangins near Nyon, Switzerland. Associated Press

TOKYO—Japanese prosecutors on Wednesday arrested a former Novartis AG NOVN.VX -0.25% employee on suspicion of falsifying research data, deepening a scandal over the Swiss drug giant's practices in its second-largest market.

Prosecutors, making their first arrest in the scandal, alleged that Nobuo Shirahashi altered data in a study involving the blood pressure drug Diovan to make the drug look better than competitors.

Mr. Shirahashi, 63, couldn't be reached for comment and the identity of his lawyer wasn't immediately clear. Before the arrest, he denied to Japan's national broadcaster NHK that he falsified data.

In addition to the Diovan problems, a panel of lawyers commissioned by Novartis found earlier this year that the company's staff hid side effects experienced by some patients in a trial for a leukemia treatment. Some staff took part in a coverup by shredding documents and deleting online files, according to Novartis's internal investigation.

The firm has revamped its top management in Japan and implemented steps to beef up governance, but lawyers say the fallout from the scandal is still far from winding down.

Eric Althoff, a spokesman at Novartis headquarters in Basel, Switzerland, said the company stands by Diovan's health benefits, citing the results of clinical trials conducted outside of Japan. He added its own investigation had not discovered "any evidence of willful manipulation or falsification of data" in the studies under question.

The research on Diovan was conducted by several Japanese universities, some of which later found that the results had been falsified. Novartis has acknowledged a conflict of interest in the studies since it knew that Mr. Shirahashi took part without acknowledging his affiliation in published papers. Mr. Shirahashi left the company in May 2013 after his contract ended, according to Novartis.

The Tokyo District Public Prosecutor's Office alleged that Mr. Shirahashi altered data in 2010 and 2011 to show a lower risk of stroke for the group taking the Novartis drug. Those data were later published in medical-journal articles that the company cited to promote Diovan.

In January, Japanese health regulators took the unusual step of filing a criminal complaint with Tokyo prosecutors against the Japanese unit of Novartis. They alleged that the company misled consumers through advertisements citing the altered research.

Nobuo Gohara, a former prosecutor and an expert on regulatory compliance, said Novartis itself may eventually face punishment since the decision to place advertising was unlikely to have been made by Mr. Shirahashi.

"We are cooperating fully with the authorities and cannot comment any further," Mr. Althoff of Novartis said by email.

Diovan has powered Novartis's sales for years, ranking as the company's best-selling product in 2010. As the drug began to lose patent protection around the world a year later, sales started to falter. In Japan, the patent expired last year and sales fell 13% from a year earlier. For the quarter through March, sales tumbled 25%, according to IMS Health. IMS -0.52%

The charges made by prosecutors on Wednesday involve a clause in Japan's pharmaceutical law that bans false or misleading advertising. If found guilty, Mr. Shirahashi could face a fine of up to ¥2 million ($19,541) or a prison term of up to two years.

Four months ago, prosecutors raided the Tokyo office of Novartis. Mr. Gohara, the former prosecutor, said the relatively speedy arrest reflected authorities' resolve to get to the bottom of a scandal that has embarrassed the country with multiple retractions of articles from reputable medical journals world-wide.

Regulatory scrutiny is already expanding. The country's biggest drug maker, Takeda Pharmaceutical Co. 4502.TO +0.92% , admitted in March that it used "inappropriate expressions" in promoting its drug used to treat high blood pressure. The company denied it tampered with research data.

"We are likely to see ripple effects. This case will have a significant impact on the industry as a whole," Mr. Gohara said.

 

Novartis Japan’s Office Raided by Prosecutors, Adding to Probes
By Masatsugu Horie and Kazuyo Sawa Jun 11, 2014 11:39 PM ET

Novartis AG (NOVN)’s Japanese unit said prosecutors raided its office in Tokyo today, adding to probes of the maker of the Diovan hypertension pill.

Novartis will cooperate fully with the investigation, Yumi Ishii, a Tokyo-based spokeswoman at the drugmaker, said by telephone. Novartis’s office in the city was searched over a possible breach of a law regulating exaggerated advertisements, Kyodo News reported.

The Japanese unit has been investigated over claims of improper involvement in independent drug trials. A former director of the unit’s scientific affairs department was arrested in Tokyo yesterday and accused of manipulating data on a drug study.

Nobuo Shirahashi, the former employee, violated pharmaceutical law by understating side effects in a study that evaluated Diovan’s efficacy in cutting stroke risk and getting researchers to publish it, the Tokyo prosecutors office said.

In January, Japan’s health ministry filed a complaint to Tokyo prosecutors against Novartis, seeking a criminal probe of the subsidiary for possible breach of rules by exaggerating Diovan’s efficacy in marketing materials.

Novartis Japan yesterday apologized for “the concerns and inconvenience” it caused and said it would continue to cooperate with the probe.

An investigation by a third-party commission appointed by the company disclosed earlier this year that Novartis employees destroyed evidence and may have obtained patients’ personal information during a doctor-led leukemia study.

In April, the company named new top executives at the unit amid the probes, including Dirk Kosche, who took over from Yoshiyasu Ninomiya as head of the Japan business.

Japan accounted for about $4.52 billion, or 7.8 percent, of revenue at Basel, Switzerland-based Novartis last year, according to data compiled by Bloomberg.

 

3 RECENTLY THAT IS.....

WSJ
2:42 pm ET
Jun 20, 2014

Novartis Offices are Raided by Italian Authorities Over Vaccine Pricing
By - Ed Silverman

For the second time over the past year, Italian authorities are investigating Novartis NOVN.VX +0.25% over allegations of wrongdoing.

In the latest episode, police raided two plants – in Siena and Origgio – in connection with suspected fraud committed against the Italian health ministry. Prosecutors believe Novartis cheated the government out of $3.6 million in 2012 by inflating the price of a component of its flu vaccine, and Francesco Gulli, who heads the Novartis vaccines unit in Italy, is under investigation, Gazetta del Sud, an Italian newspaper.

A vaccination campaign to immunize up to 40% of Italy’s 60 million people began in November 2009 after six deaths related to swine flu were reported. The health ministry suspended supplies the following year after the swine flu emergency abated, the paper writes, adding that the probe is connected to yet another investigation involving suspected tax fraud at the drug maker.

A Novartis spokesman sent Pharmalot a statement saying the drug maker is aware of the raid and is cooperating with authorities, but is committed to high ethical standards. The drug maker says that the agreement for the flu vaccine with the Italian health ministry was “equitable” for “all parties involved,” and “stands behind the terms.” The statement adds that “procurement for all seasonal influenza vaccines is through transparent and competitive” bidding procedures.

Earlier this month, authorities searched the offices of the Italian Medicines Agency, known as Aifa, as part of a criminal probe into Novartis and Roche for alleged market manipulation and collusion. The drug makers are suspected of collusion in order to hamper use of one eye medication in favor of a more expensive one. The drug makers jointly market both treatments.

The Italian regulator had agreed to reimburse patients who are given the Avastin cancer drug to treat age-related macular degeneration, a common disease among the elderly that can cause blindness. Avastin is not approved for this use, but costs significantly less than Lucentis, which is approved for this purpose. Antitrust authorities, which are seeking $1.6 million in fines from the drug makers, say the episode cost the Italian national health service more than $61 million in 2012, according to the paper.

Italy is not the only locale where Novartis is under government scrutiny and generating scandalous headlines. In Japan, the drug maker is being investigated over its clinical research practices – alleged instances of fraudulent studies and failing to report thousands of patient side effects. And in the U.S., the Department of Justice last year filed lawsuits alleging Novartis paid kickbacks to boost prescriptions and caused federal health care programs to pay for medicines based on false claims.

 

Panel: 'Serious Faults' In Novartis Clinical Study
Tue, 06/24/2014 - 9:42am

TOKYO (Kyodo) -- Novartis Pharma K.K. violated Japan's personal information protection law and ethical guidelines in a clinical study, led by the University of Tokyo, of a leukemia drug, the university's investigation panel said Tuesday.

Following release of its final report, the university will consider punishing those responsible, a university official said.

The clinical study led by Professor Mineo Kurokawa involved research on side effects of the leukemia drug Tasigna sold by the Japanese arm of the Swiss pharmaceutical giant. Kurokawa apologized in a statement, saying "we have caused great concern and trouble."

According to an interim report released in March by the University of Tokyo Hospital, Novartis employees were deeply involved from the planning stage of the clinical study, though patients were told the study would be conducted mainly by doctors.

Doctors also gave to Novartis information from a patient questionnaire, such as numbers allotted to the patients, their sex and initials, according to the report.

The final report said that violated a law requiring such personal information be kept confidential, as well as ethical guidelines for clinical studies.

The report also found that Novartis employees were involved inappropriately in four other clinical studies of other drugs, leading to the resignation of then Novartis Pharma K.K. president Yoshiyasu Ninomiya and other executives in April. All of the studies have been aborted.

 

Surviving FCA Claims In Novartis Kickback Row To Stay Put
By Erica Teichert

Washington (June 26, 2014, 7:01 PM ET) -- A New York federal judge on Thursday refused to reconsider whether he should toss several state and reverse False Claims Act accusations against pharmacies that allegedly received kickbacks from Novartis Pharmaceuticals Corp. for pushing its drugs, criticizing the pharmacies for raising new arguments.

Although U.S. District Judge Colleen McMahon asked Accredo Health Group Inc., CuraScript Inc. and CVS Caremark Corp. to submit additional briefing on specificity issues in former Novartis employee David Kester's and the federal government's complaints, she determined that the pharmacies raised completely new

 

Japan Prosecutors Charge Novartis Unit over Research
Charges Are First Such Action Against Drug Giant in Deepening Scandal

By Kana Inagaki
July 1, 2014 7:56 a.m. ET

TOKYO—Japanese prosecutors on Tuesday brought charges against the local unit of Novartis AG NOVN.VX +1.00% , the first such action against the Swiss drug giant in a deepening scandal over its research practices.

Prosecutors also brought charges against Nobuo Shirahashi, a 63-year-old former Novartis employee, alleging he altered data in a study involving the blood pressure drug Diovan to make the drug look better than competitors.

They also rearrested Mr. Shirahashi, who was first arrested in June, for allegedly tampering with data in another Diovan study.

Japanese authorities have increased their scrutiny of clinical research practices and the role of drug makers in such studies, which are often used later to promote their products.

 

Ex-Novartis Exec Says She Was Fired Over Study Concerns
By Martin Bricketto

New York (July 02, 2014, 3:12 PM ET) -- A former Novartis Pharmaceuticals Corp. executive is contending in a whistleblower suit in New Jersey state court that the company fired her for voicing concerns over a proposed study that she claims appeared to represent a kickback disguised as research.

In a June 13 complaint filed in Morris County Superior Court, Min Amy Guo, a one-time executive director of Novartis' Health Economics and Outcomes Research Group, contends that the study that pharmaceutical distributor McKesson Corp. was to perform under the watch of another group breached procedures...

 

Novartis AG (NVS) Layoffs Announced: More Cuts May Be Looming
7/14/2014 1:09:07 AM
July 14, 2014

By Linda R. Bernstein, Pharm.D., BioSpace.com Exclusive Story

"It was like a slaughter," one long time Novartis employee commented.

A source has reported that hundreds of Novartis employees worldwide recently lost their jobs. The majority of cuts were in Global Clinical Operations. Development IT laid off half their employees and the UK site and Suffern, NY plant were shut down, laying off all employees. All contractors were let go as well.

This first round of layoffs occurred June 30th after notice was provided the first week in April. The layoffs are part of a reorganization process as the company is reportedly trending toward a CRO-based model for Global Clinical Operations. According to the source, Novartis shut down the data manager department in its East Hanover, NJ site and purchased a data management CRO in India. Additional layoffs are expected September 1st, with a third round of cuts possibly in November...........

Novartis has provided comment on this report as follows:

"The healthcare environment is changing rapidly and our product portfolio is also changing which is why we regularly evaluate our business to ensure that we are investing in areas where we can significantly advance patient care........

.....These steps, while difficult, will help strengthen our organization by allowing us to invest in areas where we can significantly advance patient care.

 

Jul 8, 2014
Former Novartis Exec: I was Fired for Complaining About a Possible Kickback

By
Ed Silverman

—Tim Foley
A former Novartis NOVN.VX +0.19% Pharmaceuticals executive is suing the drug maker, contending she was fired after complaining that a study appeared to be a kickback, according to a lawsuit filed in a New Jersey state court last week.

Min Amy Guo, who had been executive director of the Health Economics and Outcomes Research Group, two years ago objected to a proposed study that would look at uses of the Affinitor breast cancer treatment that were not approved by the FDA. This is also known as off-label use.

The study was to have been performed by McKesson MCK -1.57%, one of the biggest pharmaceutical wholesalers, and was to be overseen by another Novartis group called Oncology Scientific Operations, Managed Markets, according to the lawsuit.

However, Guo contended the arrangement was not only too expensive, but would have violated internal procedures governing third-party studies. She also noted the OSO-MM group was “chiefly focused on client interaction, not health outcomes research,” the suit states.

After complaining internally, Guo was told that McKesson purportedly promised the Novartis executive who headed the OSO-MM group that the distributor would influence its network to use Affinitor based on the proposed study, according to the lawsuit.

Consequently, Guo argued this “presented a conflict of interest and an appearance of a kickback under the disguise of research.” Moreover, she objected to the proposal because she asserted it would have violated review processes established as part of a Corporate Integrity Agreement, or CIA.

Four years ago, Novartis paid $422.5 million in penalties and pleaded guilty to a misdemeanor to resolve criminal and civil allegations for improperly promoting several drugs. As a result, the drug maker signed a five-year CIA that required establishing an internal compliance program and reporting violations, among other things.

In her lawsuit, Guo alleges she was later vindicated when, in July 2013, an executive director of clinical operations refused to approve the study “for the same reasons” she had cited. But shortly afterwards, she contends that she fired in retaliation for lodging her complaints, according to the lawsuit.

This is not the first time that the alleged violations of the CIA have been raised. Twice last year, the U.S. Department of Justice filed lawsuits alleging Novartis paid kickbacks to boost prescriptions and caused federal healthcare programs to pay for medicines based on false claims.

One government complaint seeks damages and civil penalties for creating multi-million-dollar dispensing programs that targeted doctors. The other involves alleged kickbacks in the form of rebates and discounts to pharmacies in exchange for switching patients from rival medicines.

A Novartis spokeswoman writes us that, “contrary to Dr. Guo’s allegations, she was terminated based on a pattern of inappropriate conduct, including lack of compliance with Novartis Pharmaceuticals policy. NPC is confident that should this case proceed to litigation, there is ample evidence to refute the claims put forth in the lawsuit.”

“The evidence will show the reasons for terminating Dr. Guo were just pretexts. The real reason was retaliation,” Jay Webber, her attorney tells us. McKesson was not named as a defendant in the lawsuit, although we have reached out to the wholesaler for comment and will update you accordingly.

 

http://www.fiercepharma.com/story/roche-novartis-protest-moves-eu-pay-label-avastin/2014-07-28?utm_medium=rss&utm_source=rss&utm_campaign=rss

Wah wah wah forking basel crybabies