Novartis milestones be proud ! Management take a bow !

Prosecutors Raid Novartis Office in Tokyo
Raid Part of Criminal Investigation
2/19/2014 WSJ by Kana Inakagi

TOKYO—Japanese prosecutors raided the Tokyo office of Novartis AG NOVN.VX -0.68% on Wednesday, as part of a criminal investigation into whether a unit of the Swiss drug giant violated the law by releasing misleading advertising for one of its drugs.

The move came after health regulators in January filed a criminal complaint with Tokyo prosecutors against Novartis. They alleged that the company misled consumers through advertisements that used research that the health ministry described as altered to support the benefits of its blood-pressure lowering drug Diovan.

The research was conducted by several Japanese universities, some of which later found that the results had been falsified. They also found that an employee of Novartis had participated in all of the studies—without acknowledging his affiliation in published papers.

In the raid prosecutors collected relevant documents that they'll examine to get to the bottom of the case, a person familiar with the investigation said. The Tokyo District Public Prosecutor's Office declined to comment. In a statement, Novartis said it will "cooperate fully with the Prosecutor's investigation."

During an earlier probe by the health ministry, Novartis officials denied the company's involvement in the research that the universities said was flawed, and also denied that it knew the data had been altered when it was touting the benefits of Diovan. The company has acknowledged the involvement of the company employee in the studies was a conflict of interest. On Thursday, a spokesman at the Japanese unit of Novartis said it cannot comment further since the investigation is ongoing

A finding that Novartis violated the law through misleading advertising could lead to punishment for the company and any employees found guilty. The penalties—a fine of up to ¥2 million ($19,500) and possible prison terms of up to two years—are relatively light, however.

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. Today, Novartis is betting on new treatments, including cancer drug Afinitor and multiple sclerosis pill Gilenya, to help offset declining revenue from Diovan.

Still, a prolonged criminal investigation could damage the company's reputation further in Japan, where sales of Diovan had already fallen sharply since the scandal broker last summer. Ahead the drug's patent expiration at the end of 2013, Diovan sales dropped to ¥22.03 billion in the quarter ended Sept. 30, down 16% from year earlier and down 24% from the same quarter of 2011, according to research firm IMS Health
 






Novartis Can't Shake $1.3M Zometa Verdict

By Kira Lerner
Law360, New York (February 21, 2014, 4:54 PM ET) -- A Florida federal judge on Thursday refused to vacate a $1.3 million judgment against Novartis Pharmaceuticals Corp. or grant a new trial in a suit alleging it caused a Zometa user's jaw death, ruling that the jury correctly found against it on a negligent failure-to-warn claim.

U.S. District Judge Gregory A. Presnell ruled that Novartis should have known about the association between Zometa and osteonecrosis of the jaw, which plaintiff Nancy Guenther developed
 






Novartis will cease all operations at its Horsham site later this year it was confirmed today (Wednesday February 26 2014).


The pharmaceutical giant announced in November 2013 that it was consulting on the closure of the site, off Parsonage Road, with nearly 400 jobs at risk.

Following that announcement Novartis, which is one of the largest employers in the town, said today it expected research operations to cease by the end of June.

A spokesperson for Novartis said: “Following the announcement we made in November 2013 about the possible future of the R&D site in Horsham, we can now confirm that we will closing the site later this year. We expect research operations at the site to cease by the end of June.

“This is a result of a global review of our R&D locations and where best to co-locate research teams to support collaboration. It is part of the company’s ongoing efforts to align resources to serve patients and customers better in a challenging healthcare marketplace.

“This will be difficult news for our employees, and supplier partners, based at the site and we will work closely with everyone over the next few months to provide them with suitable support.

“Associates impacted by these changes have been engaged in a full and committed group consultation process. Novartis has provided support to associates throughout this process and will continue to do so during the individual consultations which will now take place.

“We do not yet know the future of the site but are committed to exploring a range of options, working closely with our partners to identify potential new owners. These options could include the use of part of the site for a science or business park.

“This news does not affect the rest of Novartis current UK business in developing, manufacturing and marketing prescription and over the counter medicines, vaccines and eye care products for patients who need them, as well as animal health products.

“Novartis will continue to employ over 2500 people and be a major inward investor to the UK. We will retain an extensive footprint in the UK with manufacturing sites at Grimsby (Chemical Operations), Liverpool (Vaccines) and Dundee (Animal Health), commercial offices in Surrey, and a team at Sittingbourne, Kent, developing near patient diagnostic testing products.”
 






Report: Novartis reorganization quietly claims 3,000 jobs in just 4 months
February 28, 2014 | By John Carroll

Unlike every other Big Pharma company in the world, Novartis tends to prefer to communicate rather selectively when it chops a facility here or winnows out its ranks over there in its global structure. Specifics on the secretive Basel-based company tend to leak out through local reports, if at all, with releases targeted at publications specifically located in the area where the ax is falling. And Novartis rarely explains itself or adds detail where a simple, dismissive remark will do.

Confronted by the corporate stone wall, an enterprising reporter at Switzerland's Tages-Anzeiger tallied up 3,000 job cuts Novartis has announced at various sites around the globe over the last 4 months. Close to 1000 of those jobs are being axed in Europe; half in the corporation's Basel home. There's the 400 or so confirmed layoffs in its Horsham, U.K., R&D site, not to mention some 170 consultants, often overlooked when job losses are added up.

Then there are 760 positions being eliminated in the U.S., with the reductions largely focused on sales reps, largely due to Novartis' concentration on therapies used in hospitals, which require fewer marketing people. And on the manufacturing side, the numbers-conscious Novartis has either closed or reduced some 20 facilities since 2010, looking for maximum efficiency at all its production centers.

It's not over yet. In conversations with analysts, company officials have specifically cited pharma R&D, where the company spends about $7 billion a year, as a likely source of additional spending cuts. For a company that likes to ruthlessly hunt down and eliminate any excess or waste, as it concentrates R&D in three key hubs, the global reorganization appears to be far from over.

Just don't expect Novartis to tell the global media.

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Novartis may be fined for submitting ‘fake’ document to Drug Controller General of India
By Soma Das, ET Bureau | 5 Mar, 2014, 04.29AM IST

NEW DELHI: Swiss drug innovator firm Novartis may face penalties in India for submitting 'fake' document to the Drug Controller General of India (DCGI) for a veterinary medicine. The Indian arm of Novartis has admitted before the DCGI that it had submitted a document that was later found to be 'fake' with regard to its site of manufacturing for Tiamulin Hydrogen Fumarate (80% granule).

Top officials of Novartis IndiaBSE 0.36 %, who appeared during a hearing in the drug regulator's office last week, have 'tendered an unconditional apology for the commission of the act', according to an order passed by the DCGI and reviewed by ET.

The drug regulator has cancelled the import licence and registration for the drug used for respiratory problems in animals and ordered its immediate recall from the market, said the order. The matter of furnishing a fake certificate to get registration of a drug has been forwarded by the watchdog to the health ministry for further 'legal action'.

A Novartis spokesperson told ET that its application for the re-registration of the drug has been rejected by the DCGI.
 






Italy fines Novartis, Roche €182.5M for alleged collusion
Mar 5 2014, 07:26 ET

The Italian Competition Authority has fined Novartis (NVS) €92M and Roche (RHHBY) €90.5M for forming a cartel to push doctors to prescribe their jointly marketed and more expensive Lucentis therapy to treat vision problems instead of Roche's Avastin, which is older and far cheaper.

The agency accused the companies of portraying Avastin as riskier than Lucentis in order to influence prescriptions.

Both firms said they would appeal.

Novartis and Roche could face further problems if the EU looks into the case and finds that the collusion extended beyond Italy.
 






Italian watchdog says Novartis, Roche colluded over eye drug

ZURICH/MILAN Wed Mar 5, 2014 4:58am EST

(Reuters) - Italy's antitrust authorities said Novartis and Roche colluded to try and stop cancer drug Avastin being used to treat a serious eye disease, and fined the Swiss drugmakers 182.5 million euros ($251 million).

In a statement on Wednesday, the Italian regulator accused the two Basel-based companies 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.

It fined Novartis 92 million euros ($126.4 million) and Roche 90.5 million euros.

Novartis and Roche strongly denied the regulator's assertions and said they would appeal.

Although the fines are relatively small, they underline how cash-strapped governments are scrutinizing more closely the way drug companies sell their products.

The authority said it estimated that the alleged collusion has cost the Italian health service an additional 45 million euros in 2012, and said that figure could possibly exceed 600 million euros a year in the future.

Although Avastin is not licensed for AMD, it works in a similar way to Lucentis and is widely prescribed on a so-called "off label" basis. A 2011 study concluded that the drug worked as well as Lucentis in treating vision loss from AMD but that it had more adverse side effects.

Lucentis is marketed by Novartis outside of the United States and is an important drug for the company with sales of $2.38 billion last year, making it its third-biggest seller.

Sales of Lucentis for Roche, which markets the drug in the United States, were 1.69 billion Swiss francs in 2013.
 






bet those layoffs makes paying for these wonderful investments much easier

http://www.ft.com/cms/s/0/85556e18-a51e-11e3-8988-00144feab7de.html#ixzz2vbTosjzQ

Novartis campus wakes up sleepy home town of Basel

By Andrew Ward

Pedestrians pass a campus building designed by Frank Gehry at Novartis AG's headquarters in Basel, Switzerland, on Wednesday, Jan. 29, 2014. Novartis AG, Europe's biggest drugmaker by sales, said fourth-quarter profit fell as currencies in emerging markets weakened against the dollar. Photographer: Gianluca Colla/Bloomberg
©Bloomberg

In the entrance to Novartis’s research and development centre in Basel, there hangs a mosaic of 365 pieces of Iron Pyrite – or fool’s gold.

It is a useful reminder to staff, perhaps, that in the world of medical science, apparently brilliant discoveries rarely lead to riches.

Other artworks are dotted throughout the group’s headquarters on the banks of the River Rhine – legacy of a grand vision by Daniel Vasella, former chief executive and chairman, to transform the once decaying chemical site into an attractive campus.

More than SFr2bn ($2.3bn) has been spent on the project, with renowned architects commissioned to design a series of distinctive buildings interspersed by green spaces, courtyards and roof gardens.

The centrepiece is what surely counts as the world’s most impressive human resources department, cocooned inside a futuristic shell of glass cubes jutting out from each other at chaotic angles.

It was designed by Frank Gehry, best known for the Guggenheim Museum in Bilbao, and won praise from the New York Times as one of his “most original designs in years”.

The campus was intended to help Novartis attract global talent to its relatively sleepy home town and encourage teamwork and innovation.

But it has also become a symbol of Mr Vasella’s ambitious empire-building in the 17 years after he created Novartis through the merger of two chemical companies in 1996.

He once boasted that authorities had moved the border crossing between Switzerland and France, which adjoins the site, to fit his master plan.

A year after Mr Vasella retired, executives say they remain committed to completing the campus, with at least two more buildings planned and one under construction. Harry Kirsch, chief financial officer, says the project has encouraged collaborative working and
 






French Competition Regulator Probes Roche, Novartis on Avastin
By Albertina Torsoli Mar 11, 2014 11:43 AM ET

France’s competition authority is investigating Novartis AG (NOVN) and Roche Holding AG (ROG) for possible collusion to prevent the use of Roche’s Avastin cancer drug as a treatment for an eye disease, the health-care ministry said.

French Health Minister Marisol Touraine wrote a letter to Finance Minister Pierre Moscovici at the end of 2012 urging him to ask the competition authority to investigate the matter, Henri Pitron, an official at the Health Ministry, said in a phone interview. The Finance Ministry proceeded with the request and the regulator’s investigation is “ongoing,” Pitron said.

Roche and Novartis are under scrutiny after Italy’s antitrust regulator said last week it fined the two Basel, Switzerland-based companies 182.5 million euros ($253 million) for alleged collusion on the medicine. Novartis must pay 92 million euros and Roche 90.5 million euros, the agency said.
 






Italian prosecutors open probe against Roche, Novartis
ROME Fri Mar 14, 2014 2:55pm GMT

(Reuters) - Prosecutors in Rome have opened an investigation into four executives at Swiss drugmakers Roche (ROG.VX) and Novartis (NOVN.VX) on suspicion of fraud and manipulation of the pharmaceutical market, judicial sources said on Friday.

The sources did not name the managers.

Earlier this month, 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 (£153 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 favour of the more expensive drug Lucentis made by Novartis.

A Novartis spokesman had no immediate comment on Friday.
 






Patient info leaked to Novartis in dubious clinical research
10:30 pm, March 15, 2014

The Yomiuri Shimbun
Data on all 255 patients who participated in questionable clinical research on a therapeutic drug for leukemia sold by Novartis Pharma K.K. was leaked to the pharmaceutical company, according to the University of Tokyo Hospital.

The hospital, one of 22 that participated in the research, has been investigating the case. On Friday, the hospital announced an interim report on its findings.

“[The leak] is a serious breach of confidentiality as well as a violation of the Personal Information Protection Law,” hospital director Takashi Kadowaki said at a press conference.

The research was aimed at finding differences in side effects between conventional leukemia drugs and Novartis’ new drug Tasigna through a questionnaire survey given to patients.

According to the University of Tokyo Hospital’s investigation, employees of the pharmaceutical company were assigned to the hospital and handled part of the research work at the hospital’s research secretariat. They are suspected of giving copies to Novartis of records of registration in the study and questionnaire answer sheets for all 255 patients who participated. The hospital said it could not confirm whether answers were altered.

The leaked data included such personal information as the names of patients’ hospitals and the doctors treating them, their initials, birth dates and hospital ID numbers. The company’s employees were also involved in creating the questionnaire and slides that doctors used in their presentations at meetings of academic societies.

Novartis employees assigned to the hospitals also monitored e-mails written by representatives of the hospitals’ research teams.

Novartis volunteered to do these things, according to the university hospital. In addition to the research now in question, employees of the company were also involved in four other leukemia research programs. The university hospital is also investigating the other four cases.
 


















Novartis might face legal action, penalty for faking documents
Loses import licence, registration for its veterinary drug Tiamulin

Sushmi Dey | New Delhi March 18, 2014 Last Updated at 17:39 IST

Swiss Drug maker Novartis is likely to face legal action for allegedly faking documents to seek registration of its veterinary product Tiamulin Hydrogen Fumarate (80% granules) in India. The drug regulator, Drugs Controller General of India (DCGI), has already cancelled the company's import licences as well as existing registration certificate for the product.

"Our application for the renewal or re-registration of Tiamulin Hydrogen Fumarate (80% granules) has been rejected by the DCGI. While we will re-apply for the registration, Novartis had already stopped further marketing and distribution of the product," said a Novartis spokesperson in response to an email questionnaire.

In an order issued last month to Novartis' animal health business unit by the Directorate General of Health Services (DGHS), the licensing authority has said the alleged fraud would be investigated according to the applicable law of the land. "For this purpose, the matter would be referred to the Ministry of Health and Family Welfare for their considered opinion for taking further legal action in the matter," DCGI G N Singh said in the order, reviewed by Business Standard.

Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against the company along with imposition of hefty penalty. Separate email questionnaires regarding the same sent to both the health ministry and the DCGI did not elicit any response.
 






Data on Novartis' Afinitor
by Zacks Equity Research Published on March 20, 2014 | No Comments

Novartis (NVS - Snapshot Report) announced additional results from a phase III trial, BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) on cancer drug, Afinitor.

The results from the trial (n=700) were presented at the 9th European Breast Cancer Conference in Scotland.

The study evaluated Novartis’ Afinitor plus Roche’s (RHHBY - Analyst Report) Herceptin and vinorelbine for the treatment of women suffering from human epidermal growth factor receptor-2 positive (HER2+) advanced breast cancer.

The trial did not meet the secondary endpoint, which included overall survival, overall response rate, and incidence of adverse events, patient reported outcomes and clinical benefit rate.

The results showed that even though Afinitor plus Herceptin extended overall survival by 4.4 months as compared to Herceptin alone, it was not statistically significant.
 












By Anna Edney Mar 25, 2014 9:14 AM ET

Novartis AG (NOVN)’s experimental heart failure medication shouldn’t be approved for sale, U.S. regulators said, potentially dealing a blow to the company’s plan to build a portfolio of cardiac therapies around the drug.

“There is insufficient evidence to support” Novartis’s claim the drug, serelaxin, helps prevent worsening of the disease that causes the heart to malfunction, Food and Drug Administration staff said today in a document posted online. The FDA on March 27 will convene advisers to consider serelaxin.

The therapy failed to win backing from European Union regulators in January who questioned the drug’s benefit. Serelaxin, which is similar to the hormone relaxin that is elevated in pregnant women, is being developed along with another experimental compound for heart failure called LCZ696. Serelaxin could generate $523 million in sales in 2018, based on the average of eight analysts’ estimates compiled by Bloomberg.

The Basel, Switzerland-based drugmaker needs to make up for anticipated revenue losses as the heart medicine Diovan and cancer treatment Gleevec, its biggest sellers, start to face generic competition. The two made up about $8.2 billion of Novartis’s $58 billion in 2013 revenue.

Novartis relied on one clinical trial instead of two that the FDA prefers, and the benefit serelaxin showed may not be meaningful, according to the clinical review prepared by the FDA’s Melanie Blank and Tzu-Yun McDowell. Novartis’s main goal in the trial was to measure serelaxin’s effect on labored breathing even though the company is seeking approval to reduce worsening of heart failure, which the FDA staff called “an exploratory finding” in the study.
 






FDA panel votes against Novartis drug for acute heart failure

Thursday, March 27, 2014 3:09 p.m. CDT

(Reuters) - A drug to treat acute heart failure made by Novartis AG should not be approved because there is insufficient evidence that it improves symptoms, a panel of advisers to the U.S. Food and Drug Administration concluded on Thursday.

The panel's vote was unanimous. The FDA is not obliged to follow the advice of its advisory panels but typically does so.
 






Novartis meds Use In Livestock
By Sindhu Sundar
New York (March 27, 2014, 6:33 PM ET) -- Novartis Pharmaceuticals Corp.'s U.S. animal health unit and two dozen other veterinary pharmaceutical companies have agreed to participate in a program by the U.S. Food and Drug Administration to restrict the use of antibiotics in livestock for nonmedical purposes such as artificial weight gain, the agency said Wednesday.

SAY WHAT??????????????? NOVARTIS IS DRUGGING OUR BEEF TO GET THE COWS FAT ????????? WTF ??????????????????????? THIS PROBABLY CAUSES MORE DISEASE
THAN THEY ATTEMPT TO TREAT >:-o
 






Japanese Panel Finds Novartis Staff Covered Up Evidence
By Hiroyuki Kachi

April 2, 2014 9:04 a.m. ET

TOKYO—A third-party probe into the Japanese unit of Swiss drug giant Novartis AG NOVN.VX +0.34% said its staff tried to cover up evidence and were involved in a number of questionable activities.

The findings revealed Wednesday by an outside investigation panel come amid harsh criticism of the local company over the involvement of its staff in the clinical research. The company is also undergoing a criminal investigation into whether it violated the law through misleading advertising for its blood-pressure drug Diovan.

The list of shady activities by staff at the company will likely cast further doubt on the pharmaceutical industry's cozy ties with doctors in Japan, as drug makers battle to prevent a falloff in market share in a competitive market.

The panel of three attorneys found more than 20 improper activities involving Novartis sales staff in clinical research at 22 medical institutions in Japan looking into the side effects of leukemia drugs.

"I didn't expect to come across this many," Kunio Harada, the head of the panel, told reporters.

In its report, the panel said one sales representative wrote out the grading of side effects of leukemia treatments on behalf of doctors, results that could pave the way for a switch to Novartis's next generation drug Nilotinib.

The panel said it held hearings with the sales staff member and two doctors who the staff member assisted, and concluded that the sales staffer didn't make the actual diagnoses. But Mr. Harada said that writing out the doctors' results for them was "ethically inappropriate" nevertheless.

"It isn't too much to say that the research was given all-embracing support by the drug maker," Mr. Harada said, adding that doctors were expecting to receive assistance from company staff when taking part in the clinical research.

The panel also found that at least nine Novartis sales staff were collecting questionnaires written by patients at 11 hospitals. They later faxed them to the head office of the University of Tokyo Hospital from the company but often filed the personal information as well. That practice contravenes protocol that personal data should be faxed directly from each medical institution by the doctors themselves.

Since the allegations surfaced last year, the report said many Novartis sales staff had taken part in a coverup by shredding documents or deleting online files related to the clinical research.

"These activities haven't been carried out on an individual basis. We can't rule out that these activities have been carried out at an organizational level," he said. "Even more surprisingly, these things have become an everyday occurrence for them, without any notion that this was inappropriate."

Novartis said in a statement that "we seriously take the possibilities that our Japanese staff obtained personal information and engaged in destruction of evidence. These are activities that go against Novartis's code of conduct. We will examine details of the report and will take necessary action against employees who behaved in an unethical way."
 







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