Novartis milestones be proud ! Management take a bow !

HOW MANY MILLIONS WASTED HERE ? LIKE A CONTRACT VERSION OF THE NIBR !

Idenix, Novartis revise collaboration agreement
PBR Staff Writer
Published 02 August 2012

Biopharmaceutical company Idenix and Novartis Pharma have signed a termination and revised relationship agreement, which restructures the development and commercialization collaboration established in May 2003.

As part of the revised agreement, Novartis' optional right to license Idenix's current and future development-stage drug candidates in any therapeutic area has terminated while it enjoys non-exclusive option to conduct clinical trials with any of Idenix's and Novartis' HCV drug candidates.

The agreement further states Idenix will no longer receive royalty or milestone payments from Novartis product sales of Tyzeka /Sebivo (telbivudine) for the treatment of hepatitis B.

Idenix president and CEO Ron Renaud said the agreement affords Idenix flexibility to optimize the value of the company's pipeline for the benefit of Idenix, shareholders and ultimately HCV patients.

''By regaining the worldwide rights to develop, commercialize and license all of our drug candidates, we believe Idenix will be well-positioned to develop pan-genotypic all-oral direct-acting antiviral combination treatments with potential collaborators," Renaud added.
 






Here's How Novartis May Be Failing You
Keep your eye on margins.

By Seth Jayson

updated 8/9/2012 6:51:51 AM ET

Here's the current margin snapshot for Novartis over the trailing 12 months: Gross margin is 68.3%, while operating margin is 20.9% and net margin is 14.8%.

Unfortunately, a look at the most recent numbers doesn't tell us much about where Novartis has been, or where it's going. A company with rising gross and operating margins often fuels its growth by increasing demand for its products. If it sells more units while keeping costs in check, its profitability increases. Conversely, a company with gross margins that inch downward over time is often losing out to competition, and possibly engaging in a race to the bottom on prices. If it can't make up for this problem by cutting costs -- and most companies can't -- then both the business and its shares face a decidedly bleak outlook.

Of course, over the short term, the kind of economic shocks we recently experienced can drastically affect a company's profitability. That's why I like to look at five fiscal years' worth of margins, along with the results for the trailing 12 months, the last fiscal year, and last fiscal quarter (LFQ). You can't always reach a hard conclusion about your company's health, but you can better understand what to expect, and what to watch.

Here's the margin picture for Novartis over the past few years.

Source: S&P Capital IQ. Dollar amounts in millions. FY = fiscal year. TTM = trailing 12 months.

Because of seasonality in some businesses, the numbers for the last period on the right -- the TTM figures -- aren't always comparable to the FY results preceding them. To compare quarterly margins to their prior-year levels, consult this chart.

Source: S&P Capital IQ. Dollar amounts in millions. FQ = fiscal quarter.

Here's how the stats break down:
•Over the past five years, gross margin peaked at 73.3% and averaged 72.1%. Operating margin peaked at 25.0% and averaged 22.6%. Net margin peaked at 30.7% and averaged 20.6%.
•TTM gross margin is 68.3%, 380 basis points worse than the five-year average. TTM operating margin is 20.9%, 170 basis points worse than the five-year average. TTM net margin is 14.8%, 580 basis points worse than the five-year average.

With recent TTM operating margins below historical averages, Novartis has some work to do.

Can your portfolio provide you with enough income to last through retirement? You'll need more than Novartis.
 






ONE A CROOK ...............

Bloomberg News

Novartis Unit Sued by Oriel Shareholders Over Buyout

By Jef Feeley on August 11, 2012
Novartis AG (NOVN), Europe’s largest drugmaker by revenue, was sued by investors in Oriel Therapeutics over claims one of its units defrauded them as part of an acquisition of the U.S. maker of respiratory drugs.

Officials of Novartis’s Sandoz AG’s generic-drug business made “fraudulent misrepresentations” in connection with the 2010 purchase of Durham, North Carolina-based Oriel and those statements prompted Oriel investors to sell their shares too cheaply, lawyers for former shareholders said in complaint filed yesterday in federal court in Manhattan.

The purpose of the alleged misrepresentations was “to induce the Oriel Shareholders to sell Oriel’s securities and to do so at an artificially deflated price,” lawyers for the investors said in complaint.

Novartis, based in Basel, Switzerland, agreed to buy closely held Oriel seeking to gain generic medicines for asthma and smoker’s cough and a potential share of a $32 billion market, Andrew Weiss, an analyst at Bank Vontobel AG in Zurich, said in a 2010 note to investors.

In July 2009, Oriel’s directors decided to seek a buyer for the drugmaker and later entered into “exclusive negotiations” with Novartis’ Sandoz unit, according to the suit. The companies closed the deal in June 2010.

‘Adverse Facts’

Oriel shareholders later learned Sandoz executives duped them into selling their shares by “misrepresenting and concealing adverse facts,” lawyers for the former shareholders said in the suit. Many of the investors’ claims were redacted, or blacked out, of the complaint.

“Defendants had the opportunity and the motive to defraud plaintiffs into selling Oriel’s securities,” the attorneys said. “Sandoz used improper means to obtain Oriel for less than fair consideration.”

Oriel’s investors at the time of the buyout included New Leaf Venture Partners, Thomas McNerney & Partners, HealthCare Ventures and CHF Medical Partners.

The case is Shareholder Representative Services LLC v. Sandoz Inc., 12-cv-06154, U.S. District Court, Southern District of New York (Manhattan).
 






Novartis win 'death sentence' for poor

London, Wed Aug 22 2012, 14:21 hrs

Health campaigners in India have warned that granting Swiss pharmaceutical company Novartis an Indian patent for the cancer drug Glivec would mean handing down a ‘death sentence’ for the poor and ill in the developing world.

The Supreme Court of India would be hearing the landmark drug patent case between the Swiss firm and India’s patent office, which could have a huge impact on the health sector of the country, and could also decide whether cut-price generic drugs for cancer and other serious ailments will continue to be available in much of the developing world.

Campaigners have argued that victory for Novartis could result in the deaths of thousands of people who will no longer be able to afford the drugs they need.

“It would quite simply be a death sentence for us. I am quite sure that if Novartis wins, other multinationals will follow suit and other drugs will become prohibitively expensive,” The Guardian quoted Vikas Ahuja, as saying, who was diagnosed with HIV in 1993 and is now the President of the Delhi Network of Positive People.
 






Novartis win 'death sentence' for poor

London, Wed Aug 22 2012, 14:21 hrs

Health campaigners in India have warned that granting Swiss pharmaceutical company Novartis an Indian patent for the cancer drug Glivec would mean handing down a ‘death sentence’ for the poor and ill in the developing world.

The Supreme Court of India would be hearing the landmark drug patent case between the Swiss firm and India’s patent office, which could have a huge impact on the health sector of the country, and could also decide whether cut-price generic drugs for cancer and other serious ailments will continue to be available in much of the developing world.

Campaigners have argued that victory for Novartis could result in the deaths of thousands of people who will no longer be able to afford the drugs they need.

“It would quite simply be a death sentence for us. I am quite sure that if Novartis wins, other multinationals will follow suit and other drugs will become prohibitively expensive,” The Guardian quoted Vikas Ahuja, as saying, who was diagnosed with HIV in 1993 and is now the President of the Delhi Network of Positive People.

This should be decided sept 11 ironically
watch for the massive protests & occupy anarchists
if NVS were to prevail
 






NVS GOING TO THE DOGS & AND BEGGING LIKE MONGRELS LOL !!!!!!!!!!!!!!

Novartis begs vets for loyalty through animal drug shortages

August 30, 2012 | By Tracy Staton

Novartis ($NVS) isn't pussyfooting around its animal-drug shortages. But with supply problems still dogging the most popular products, veterinarians are howling--and switching their four-pawed patients to rival products.

As the Veterinary Information Network reports, the Swiss-based drugmaker recently wrote vet customers to plead for patience. Novartis Animal Health Sales VP Andy Ferrigno admitted that the shutdown of a Lincoln, NE, plant last September has cut off supplies of key products, particularly the parasite-fighters Interceptor and Sentinel. But Novartis is "working diligently" to get its products back on the distribution list, he wrote.

The problem for Novartis is that its competitors are ready and willing to take advantage of the market vacuum. "Your clinic will be approached in the coming months by our competitors, offering you load-in deals and terms that may draw your interest," Ferrigno wrote (as quoted by VIN News). "[W]e beg you will seriously consider saving us a spot on your shelves."

That dog won't hunt for some veterinarians, who tell VIN News that they're moving away from Novartis products, probably permanently. Some are frustrated by a lack of information about when the drugmaker's products will be available again. Others are angry that the Interceptor and Sentinel products--which are given monthly as a preventive measure--are still available via some online outlets.
 






TOO FALKING FUNNY ! NVS COUNSEL = LMFAO !!!

Why don't you reduce cancer drug price, SC asks Novartis
Tuesday, September 11th 2012, 04:29 PM

New Delhi, Sep 11 — Pharma major Novartis AG Tuesday said it was the author of beta crystalline, a form of a compound used in an anti-cancer drug, while the Supreme Court asked the company why it could not reduce its medicine's price.

"Why don't you reduce the price ... that will be a better and stronger way of establishing your bonafides of helping the poor," the court said, adding: "Rs.1.2 lakh per month is too high to afford a treatment."

The company was asserting its claim for getting a patent for the compound form in India and its exclusive marketing rights.

As Justice Alam said: "You have no legal obligation (of proving free medicine)", Subramanium replied: "I have commitment and responsibility." However, counsel said that he would take instructions on the query by the court.

Justice Alam asked Novartis: "I am surprised that you can reduce the price and knock out your competitors" and yet you were not adopting that course.

"There are some constraints when it comes to pricing," Subramanium said adding that Novartis was a corporate entity with stake holders.

Novartis challenged in the apex court the Intellectual Property Appellate Board's (IPAB) decision which held that beta crystalline form of imatinib mesylate was an invention but did not agree to grant patent for it.

Subramanium told the court that its medicine which was being marketed by the trade name of "Gleevec" had been patented in 35 countries including by the US.

As Justice Alam observed "this is a difficult country", Novartis's counsel Subramanium said: "I don't think so".

Subramanium told the court that Novartis was not fighting legal battle for the sake of money but as a matter of honour. "The purpose of this case is not for money but the vindication of honour."

The court was told that a large number of poor patients were being provided with the cancer treating medicine free of cost.

The court asked Subramanium what was the guarantee that if Novartis' prayer was allowed then it would continue with its scheme of providing free cancer treatment medicine to deserving patients.
 






Novartis, A Superfund Site & A Local Mayor
Make a comment
By Ed Silverman // September 13th, 2012 // 10:34 am


Nearly a decade ago, a landfill that is located just a few miles from the sprawling Novartis US headquarters campus was declared a Superfund site. Known as Rolling Knolls, the former dumping ground covers about 200 acres and is bounded by the leafy New Jersey suburb of Chatham Township and a national wildlife refuge. But a simmering dispute recently broke out over plans for the site that put the drugmaker on the defensive.

Here’s the background. Novartis is one of the so-called responsible parties. This means that, along with a few other entities, the drugmaker would be expected to pay to remediate the site, which is in a residential zone. The final costs are not yet known, however, since the US Environmental Protection Agency has not performed a baseline risk assessment, which gauges contamination and required remedial steps, according to an EPA spokesman (read more here).

Meanwhile, the local Chatham Township government decided to pursue a redevelopment plan that initially included changing the zoning for the landfill site to allow agricultural activities, or what officials called market gardens. This would become a permitted use under an ordinance that was proposed and also dovetail with usage permitted by the New Jersey Right to Farm Act (read here).

Several residents, however, have expressed concerns about the extent and type of commercial activity that may eventually take place and recently filed a lawsuit against the town in hopes of thwarting the ordinance. There were also questions about whether the ordinance might benefit the responsible parties, notably Novartis. That’s because the township effort to pursue redevelopment has been led, in part, by Mayor Nicole Hagner.

Hagner is a clinical trial head at Novartis Consumer Health. Initially, she recused herself from Planning Board meetings, but over the past year, she participated in other public meetings where the ordinance and related issues were discussed, according to court documents and local media reports (see here). In their lawsuit, the residents contend, among other things, that the ordinance could, ultimately, lower clean-up costs for Novartis, depending upon EPA actions.

“I believe that the Mayor’s administration fully intended this ordinance to benefit her personal financial interests, the business needs of her supporters and was an attempt to reduce the clean-up costs to her employer, Novartis Pharmaceuticals,” says Erich Templin, one of several residents who filed the lawsuit. “The only reason that the Township has been forced to pull back from this irresponsible stance is through the efforts of our citizens group making the Township, our Mayor and Novartis accountable for their actions.”

The residents argue that market garden usage – or any related commercial activity – may also increase traffic and potentially affect surrounding property values in what is otherwise a residential neighborhood. They have also alleged that illegal dumping has taken place at the site and town hall has not acted sufficiently to prevent such activity. A recent inspection did find signs that some debris had been left there (see this).

While the Chatham ordinance would not be binding on how the EPA proceeds, current land use typically drives risk assessment, says Bill Wolfe, a former policy analyst and planner with the New Jersey Department of Environmental Protection and former policy director for the Sierra Club in the state, who now heads the state chapter of Public Employees for Environmental Responsibility, which supports environmental enforcement efforts.

“A clean up would look at things like whether gas or ground water is migrating through the subsurface. So you need to build something to prevent them from migrating to homes. And these devices cost a lot of money to build and to install,” he tells us. “If people are going to live there, you obviously want a cleaner site. If there’s agricultural use, you wouldn’t have to look at those kinds of things during configuration of a clean up plan, so you’d have a less costly clean up plan.

“That’s the sort of thing that can vary, though. So it’s premature to make that argument now, because it’s too early in the process. But in a few years, it will be front and center,” he explains. “Depending on the future use of the site, it can impact the nature and cost of the clean up. And so in that case, there is a relationship between zoning and land use and a clean up in the future.”

However, Chatham Township attorney Carl Woodward says Novartis will not benefit, because the ordinance, which was adopted this past spring, was specifically designed to call for conditional use. This means, he explains, that underlying residential zoning remains intact and the EPA would later assess clean-up requirements on that basis. “The zoning remained in place as residential and did not change,” says Woodward, who is a real estate attorney with the Carella Byrne law firm. “Any clean up will have to comply with residential standards” overseen by the EPA.

One expert agrees that conditional use would not alter zoning status. “The underlying zoning district that a parcel is identified with does not change when an application for conditional use, which in some places, is also known as a special exception, is approved,” says Notre Dame Clinical Law Center professor Jim Kelly, who specializes in community development law. “The changing of a zoning district designation is invariably called a rezoning and usually requires approval by the local legislative body that enacted the zoning ordinance and zoning map.”

In other words, any EPA clean-up requirements would have to adhere to the stricter standards applied to residentially zoned areas. “Right now, the zoning for the site is residential and EPA intends to (plan for and oversee a) clean up for a residential zone,” an EPA spokeswoman tells us. “If the zoning were to change, that could change” the approach. She confirms that “residential is our more stringent standard.”

In any event, Woodward adds that a second ordinance was subsequently adopted this summer when the township committee decided to exempt the Rolling Knolls site from being used for market garden purposes. As a result, he says, the residential zoning status of the landfill site continues to remain intact. The second ordinance was proposed and then adopted just weeks after the residents filed their lawsuit.

But Woodward says the second ordinance, which was adopted last month, was proposed only to correct a typographical error in the first ordinance, which included the landfill site in the market garden proposal (you can read both ordinances here and here). “It was something that people did not recognize at one point,” he says, but denies the change was made in response to community opposition. “It’s an academic discussion, though. There is no benefit to Novartis” (you can read his certification here).

However, the residents who filed their lawsuit continue to maintain the entire episode was not pursued in good faith, in part because they allege the landfill was not initially disclosed in proposed zoning changes. And while Woodward maintains Hagner properly recused herself, the residents also argue that Hagner should never been present at any proceedings in which the ordinance was discussed. And they cite these arguments in a proposed amended complaint they hope to have approved by a state court judge as soon as this week (here is the complaint).

For the record, the Novartis code of conduct says that “employees may not act as elected or appointed officials of any branch of government or any governmental agency or as an advisor or consultant to any governmental agency, which has any regulatory or supervisory power over the company or any of its affiliates.” Hagner did not respond to requests for comments, but a Novartis spokeswoman defended her in an e-mail she sent us.

Hagner, she wrote, “cleared her appointment as Chatham Township Mayor with Novartis Pharmaceutical Corporation’s Ethics and Compliance committee and she has an agreement with the Chatham Township Committee to recuse herself from any discussions or votes that have anything to do with Novartis so there aren’t conflicts of interest…. Our understanding of the Market Gardening ordinance is that it has nothing to do with the Rolling Knolls site and has no benefit to Novartis. In fact, the recent Town Committee ordinance was passed to ensure that market gardening would not be allowed on the Rolling Knolls site, as it is a former landfill.”
 






BYE BYE GILENYA

Sanofi Challenges Novartis For Multiple Sclerosis Market Share

September 13, 2012 by: Todd Campbell

Multiple Sclerosis ("MS") patients got another treatment option this week as the FDA granted approval to Sanofi's (SNY) Aubagio.

The drug, which was transferred from Sanofi's pipeline to the Genzyme banner following Sanofi's acquisition, enters a crowded, yet lucrative market.

Taken once daily, Aubagio gives patients yet another option versus injectibles such as Biogen's (BIIB) Avonex. It also became the second oral treatment, joining Novartis (NVS) Gilenya.

Multiple sclerosis needs new treatment options.

MS is one of the most common neurological disabilities among young people, particularly in women. That does pose a risk for the drug. MS affects young women at a 2:1 rate to men and Aubagio's label requires a negative pregnancy test prior to prescription.

Despite the label warning, there remains a significant need for alternative treatments. Many patients avoid treatment altogether to avoid unwanted side affects. And Aubagio's side affects are less severe than other alternatives, such as Novartis Gilenya, which has been tied to heart rate problems.

Sanofi has priced the drug at $45k annually, which undercuts rivals. Novartis' Gilenya is nearly 30% more expensive.
 






POOR VICTIMIZED KIDS :(

FDA Is Urged To Suspend Trials Of Novartis Drug

By Ed Silverman


In letters to the FDA and the Office for Human Research Protections, Public Citizen charges that clinical trials being run by Novartis for its Ilaris medication – which is approved for treating several rare and serious genetic disorders – should be suspended. Why? The watchdog group says Novartis is taking a “shotgun approach” to its research and argues the drug is dangerous and the studies are unethical because patients are not being protected according to law.

One study involves children, which the group argues may violate federal regulations designed to protect children in research. The drug, Public Citizen notes, can cause widespread inflammation in the body. Last month, an FDA panel did not recommend Ilaris be used to treat gout, and Public Citizen wants the agency to investigate ongoing trials involving patients with heart disease and diabetes.

“Since even a single dose…has many serious risks, including the known risk of life-threatening infections and possibly cancer due to suppression of the immune system, further clinical trials of this drug should proceed only if there is a reasonable basis justifying these great risks to subjects,” Michael Carome, deputy director of Public Citizen’s Health Research Group says in a statement. “For at least two of the ongoing studies, such a justification is lacking.”

We have asked Novartis for a comment and will update you accordingly.

In a study begun in April and sponsored by Novartis, 7,200 adults who have had heart attacks are being given injections or a placebo every three months. The subjects are to be followed for three years to see if Ilaris decreases the chances of further heart attacks, strokes and death from cardiovascular disease, according to Carome. But he maintains there is an apparent lack of preliminary data about potential benefits in preventing heart attacks and strokes and, therefore, there is “no reasonable justification for initiating such a large trial in heart attack patients.”

In a study funded by the National Institutes of Health, 66 patients ranging in age from six to 45 years old with newly diagnosed type-1 diabetes are being given monthly injections or a placebo for one year to see if their pancreases still produce insulin. The study began in October 2010. “The involvement of children raises additional serious ethical and regulatory concerns,” Carome says, because the risks “are not offset by any prospect of reasonably foreseeable benefits to the children.”

In the letter, Public Citizen asks the Office of Human Research Protections, which is part of the US Department of Health and Human Services, to investigate why the study was approved by an investigational review board, or IRB (read the letter here) and if Novartis has offered informed consent appropriately. The watchdog group notes that a search of ClinicalTrials.gov shows the drugmaker is also conducting trials in patients with type-2 diabetes, osteoarthritis and polymyalgia rheumatica, among others, with several studies involving repeated dosing over a prolonged time period.
 






FOLLWING DEBACLE AFTER DEBACLE !!!!!!!!!!!!! LOL !!!!!!


New Novartis general counsel completes overhaul of in-house team

Author: Caroline Hill
05 Oct 2012 | 00:00

Pharma giant shakes up in-house function under new leader

Novartis has shaken up its global in-house legal team following the arrival of new general counsel Felix Ehrat (pictured) at the end of last year.

Ehrat, who joined the pharma giant in October 2011 from leading Swiss law firm Baer & Karrer, began his review at the beginning of this year.

The most recent stage of the review has seen Ehrat make a number of changes in Novartis' global legal team.

Greg Tole, the former European legal head of Novartis' over-the-counter division was last month promoted to divisional GC, while Christina Ackermann has taken over as GC of Alcon, which was acquired by Novartis last year for around $50bn (£31bn).

Ackermann, who was formerly GC of Novartis' generic pharmaceuticals division Sandoz, has been replaced by Shannon Klinger, the former legal head of Sandoz's US arm.

Meanwhile in March, Sean Reilly took over as GC of Novartis' largest division, pharma, which has annual sales of around $35bn (£22bn). He was formerly GC of Novartis' oncology division.

The appointments came after Ehrat's review of group legal in February, which saw the merger of its intellectual property (IP) and global litigation groups, with the combined team now led by head of group IP Alisa Harbin.

Ehrat said: "A key aspect of all the newly appointed divisional GCs is that they have all been internally recruited. This has been received extremely well within the legal function."

Novartis this year announced the result of its latest global panel review, with magic circle trio Allen & Overy, Linklaters and Freshfields Bruckhaus appointed alongside US firms Morrison & Foerster and Simpson Thacher & Bartlett.

Novartis' national panels are currently being reviewed, with the results expected
to be announced later this year.
 






FANAPT ?! BWAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAH :)

Novartis drops long-acting version of Vanda Pharmaceuticals drug

Washington Business Journal by Bill Flook, Staff Reporter
Date: Thursday, October 11, 2012, 2:52pm EDT

Novartis Pharma AG is discontinuing development on a long-acting injectable version of Vanda Pharmaceuticals Inc.’s Fanapt, the District-based biotech reported in a securities filing.

Novartis has marketed Fanapt, a schizophrenia drug and Vanda’s lead product, since 2010. The pharma giant has exclusive rights to develop and commercialize other formulations of Fanapt in the U.S. and Canada, as well. But in a blow to the local drugmaker, Novartis gave word on Oct. 8 that it would cease development on the long-acting “depot” formulation, according to Vanda’s filing, which did not give an explanation for the program’s demise.

The original version of Fanapt won a surprise approval in 2009, but sluggish sales have not lived up to the original enthusiasm. The company posted a net loss of $8 million in the second quarter of 2012, up from $1.3 million in the same period last year.
 






Novartis balks at Eylea-vs.-Lucentis data

Bayer, Regeneron hope to match successful U.S. launch in Europe
October 22, 2012 | By Tracy Staton

Bayer and Regeneron ($REGN) are touting new data on their macular degeneration drug Eylea. And no wonder: The VIEW 1 and VIEW 2 studies found that Eylea matched rival drug Lucentis in head-to-head comparisons.

Approved in the U.S. in November 2011, Eylea is waiting for an OK from European regulators. It appears to be forthcoming; the European Medicines Agency's drug-review committee recommended it for approval last month, PharmaTimes notes.

But in the meantime, Novartis ($NVS) is striking back. The Swiss drugmaker, which markets Lucentis outside the U.S., questioned the new trials, saying that their dosing regimens didn't match actual treatment practices. "t should be noted that the monthly dosing regiment of [Lucentis] used in these studies is not reflective of ... the way Lucentis is used in the 'real life' clinical setting," the company told PharmaTimes.

Novartis has a lot at stake. It's already faced with a low-cost competitor in the form of Avastin, the cancer drug used off-label to treat wet AMD. With Eylea on the market, at a price slightly lower than Lucentis's, Novartis could lose share, if U.S. sales are any indication.

Within 9 months of its launch in the States, Eylea had grabbed 13% of the wet AMD market, BioTrends Research Group said in a report. Regeneron is now projecting higher sales for the year than initially expected: $700 million to $750 million, compared with previous projections of $500 million to $550 million.
 






Germany orders recall of Novartis flu shots

BERLIN (AP) — German authorities ordered a recall Thursday of some batches of Novartis flu vaccine as a precautionary measure after the company reported the appearance of small particles in the manufacturing process.

"In the interest of risk prevention and consumer safety it is necessary to cancel the approval for certain vaccines, since the formation of particles in the vaccine and therefore the risk of serious side effects cannot be ruled out," Institute President Prof. Klaus Cichutek said in a statement.

The decision affects four batches of the influenza vaccine Begripal and one batch of Fluad. It does not affect the seasonal vaccine Optaflu.

Italy's health ministry banned the sale of four Novartis flu drugs on Wednesday. These included Fluad and Begripal — sold as Aggripal in Italy — as well as two others: Influpozzi Adiuvato and Influpozzi Subunita.

Switzerland's regulator Swissmedic also suspended deliveries of flu vaccines from Novartis as a preventive measure.

Britain's Medicines and Healthcare products Regulatory Agency said there was no evidence yet to pull the vaccines off the market but added it was gathering further information on the Novartis vaccines.

The Swiss pharmaceutical company said Thursday it was cooperating with the Ministry of Health in Italy, where the vaccines are produced, and was committed to providing vaccines to patients for the current flu season.

"Novartis confirms that these particles can occur in the vaccine manufacturing process"
 






THE GLOBE & MAIL
Monday October 29th 2012

On Sunday, Ontario and Quebec finally responded to the Health Canada decision to halt distribution of flu vaccines manufactured by Novartis, revealing that it will have no impact on their plans. Canada is to be commended for its swift action after problems with the Novartis vaccine cropped up in Europe

In the era of instant communication, you need to get messages out clearly and swiftly, especially when you are dealing with emotion-laden issues such as vaccination.

Dr. Paul Gully, a senior adviser at Health Canada revealed that only 20 per cent of Canada’s flu vaccine supply came from Novartis so there would not be severe shortages, at least in the short term. (The dominant supplier of flu vaccine in Canada is GlaxoSmithKline, and Sanofi also has a small share.)
 






Third-Quarter 2012 Financial Reports Show Novartis Down
Oct 30, 2012
By: Jennifer Markarian

Pharmaceutical industry douchbag Novartis released second-quarter 2012 results showing global sales down in third-quarter 2012 due to patent expirations.

Novartis reported global sales of $13.8 billion, down 7% from third-quarter 2011, said the company in a press release. Novartis’ Diovan lost exclusivity on Sept. 21, 2012, and, although no generic competitor has yet been approved by FDA, the company expects generic competition to come at any time. The company, however, was positive about the performance of its pharmaceuticals group in the third quarter.
"While Novartis net sales were impacted by the patent expiration of Diovan and a down quarter in Sandoz and Consumer Health, our launch brands performed well,” said Joseph Jimenez, CEO of Novartis, in the relase. “Our excellent record on innovation continues with new approvals for innovative products like Afinitor in advanced breast cancer, the recent EU filing of QVA149 in COPD, and encouraging news in heart failure. I am confident that this improves the long-term growth prospects of the business."

YEAH SURE YOU ARE JOE ! YOU FLIPPIN IDIOT !!! LMFAO !!!!!!
 






Novartis to Pay $19.9 Million to Settle False Claims Charge

By EditorFiled in NewsOctober 31st, 2012 @ 10:00 pm


The Swiss-based pharmaceutical giant Novartis will pay Texas $19.9 million to settle allegations that it violated the False Claims Act.

The lawsuit was originally filed by Donald Galmines in federal court in Pennsylvania. Galmines is a former Novartis marketing representative.

Galmines is being represented by Jennifer Verkamp and Rick Morgan of Morgan Verkamp of Cincinnati, Ohio.

Galmines’ responsibilities included the marketing of the topical cream Elidel, which had been approved by the Food and Drug Administration (FDA) for use on patients more than two years old who suffer from eczema and whose condition is not well-controlled by preferred, “first-line” treatments.

The lawsuit alleged that Novartis engaged in a practice known as “off-label marketing” by requiring its sales representatives to induce doctors to prescribe Elidel for uses not approved – and specifically rejected – by the FDA.
 












Novartis Jury Awards $10.45 Million for Drug, Lawyer Says

By Christie Smythe - Nov 2, 2012 7:34 PM ET.

Novartis Pharmaceuticals Corp. (NVS) was found liable by a federal jury for jawbone damage in a woman who took the drug Zometa, and she was awarded $10.45 million, a lawyer for the plaintiff said.

A jury in Central Islip, New York, returned the verdict this afternoon, several hours after they began deliberations in the case, said John Vecchione, a lawyer for plaintiff Barbara Davids.

The verdict, which couldn’t be immediately confirmed in court records, is the second-largest among similar cases over Zometa, Vecchione said. It is the fourth win for plaintiffs out of eight Zometa-related jawbone cases that have gone to trial, he said. The jury in the Davids case awarded $450,000 in compensatory damages and $10 million in punitive damages, he said.

“What’s happening is these juries are seeing very bad behavior,” Vecchione said in a phone interview. “These juries are finding this evidence particularly egregious.”

A New York-based spokeswoman for Basel, Switzerland-based Novartis, Julie Masow, said in an e-mail statement that the company is reviewing its options for appeal.

“We are disappointed and disagree with the jury’s verdict,” she said.

2006 Complaint

In a complaint filed in February 2006, Davids alleged that she developed osteonecrosis, or bone death, in her jaw after taking Zometa, a drug she had been prescribed as part of her treatment for breast cancer. Zometa, a bisphosphonate, is a treatment for bone complications that can result from cancer, according to a Novartis website.

During the trial, which began Oct. 2, the attorneys for Davids showed the jurors a May 2003 e-mail in which a Novartis marketing employee described a proposed report linking Zometa to jawbone complications as “quite damaging.” In another e-mail from May 2003 used as evidence in the trial, the employee outlined a strategy to colleagues for “next steps,” including a public relations effort.

“In summary: we’ll try to avoid that the paper is ever published; we will be ready to react in case it gets published,” the employee said in the e-mail. The e-mails were provided to Bloomberg News by Vecchione.

The largest verdict in Zometa-related jawbone osteonecrosis cases was $12.8 million, awarded to a North Carolina woman’s family in November 2010. The award was later reduced to about $1.1 million under state law.

The case is Davids v. Novartis, 2:06-cv-431, U.S. District Court, Eastern District of New York (Central Islip).
 






Novartis Nebraska Factory Restart Delayed; OTC Sales Drop


By Eva von Schaper on October 25, 2012
Novartis AG (NOVN) backed off a prediction that a U.S. factory will resume making products such as the athlete’s foot gel Lamisil this year after shutting the facility in January because of manufacturing flaws.

Consumer-health sales plunged 22 percent in the third quarter, a fourth straight drop, because of lost revenue from the Lincoln, Nebraska, site, the Basel, Switzerland-based company said today. Novartis, Europe’s biggest drugmaker by sales, has new woes as well -- Italy and Switzerland yesterday halted sales of the company’s flu vaccines because unwanted clumps of protein were found in some doses, and Germany today withdrew some lots as well.

Novartis’s Sandoz generic-drug unit also received a warning letter from U.S. regulators last year over manufacturing missteps at three North American plants.

“That brings the number of divisions with manufacturing quality issues to three out of five,” Alexandra Hauber, an analyst at JPMorgan Chase & Co., wrote in a report today. “The profitability trends are overshadowed by manufacturing issues.” She has a neutral rating on the stock.

In April, Novartis predicted the Lincoln plant would be back on line by mid year, and in July the company said it would be the fourth quarter before shipments resumed. Today, Chief Executive Officer Joe Jimenez said recovery at the site is taking longer than expected.

Stock Drop

“What I would like to do is stop making projections because we have proven that we’re not able to accurately project,” Jimenez said on a conference call with reporters today. Consumer-health sales accounted for 7.9 percent of Novartis revenue last year.

Novartis fell 0.7 percent to close at 56.80 Swiss francs in Zurich.