Novartis milestones be proud ! Management take a bow !

Poor Pharma.
Always just trying to make a fair living for it's leaders.
Despite those awful regulations and rules!
How else would we "innovate"....?
HAHAHAHAAAAAAAAAAAAA

 

Novartis Is Struggling To Compete
Nov. 2, 2015 12:54 PM ET | About: Novartis AG (NVS)

Summary
Novartis has seen its operations deteriorate in recent years.
Both margins and top-line growth have contracted in 2015.
With rising competition and a strong U.S. dollar persisting, Novartis's share price could continue to decline in coming quarters.


Swiss drug maker Novartis (NYSE:NVS) continues to struggle as declining demand and increasing competition for products in its portfolio weigh on earnings. Both its eye care business, Alcon, and its painkiller drug, Voltaren, have underperformed in recent quarters, weighing on both revenue and margins. Novartis presents an attractive short opportunity as its operations continue to falter.

In the third quarter, the drug maker reported core-earnings that came in at $1.27 per share, representing an annual decline of 0.8%, while missing estimates for $1.30. The weaker earnings came alongside revenue that fell 5.6% from the previous year to $12.3 billion.

Its Alcon segment saw sales of $2.3 billion, down 2% from the previous year. The weakness was mainly due to lower sales of surgical equipment. In recent years, competition in the intraocular lens space has heated up, leading to lower margins. This, alongside slowing demand for surgical equipment in the U.S., as well as Asia, pushed down overall results.

Furthermore, Voltaren's profits declined at a 2% annual pace to $3.06 billion, missing estimates for $3.13 billion. With the drug, competition was an issue, but currency fluctuations did a lot of damage as well. On a currency adjusted basis, the painkiller segment rose 13% annually.

Below is a chart a both revenue and operating margins for Novartis. As was stated, there are a multitude of issues plaguing top-line growth at present time for the company. Since 2012, revenue has fallen 15%. Slowing sales in its large eye care segment has been an issue management wants to take care of in coming quarters. "[Alcon's] a good business but it's suffering from some intense competition, as well as we have not been as innovative as we should be," Chief Executive Joe Jimenez explained in a conference call to reporters. Moreover, margins have contracted as a result of rising competition among its generics. In 2015 alone, operating margins sharply contracted.

 

I have not heard a single legal-compliance guy ever fired for these achievements,

Nor any ECN or CEO got fired, they still get more and more stock options!

 

think japan.

 

Novartis Japan faces censure for delay in disclosing drug side effects

KYODO

The health ministry will censure a Japanese unit of Swiss pharmaceutical giant Novartis AG for failing to report serious side effects from some of its drugs within a certain period of time, sources close to the matter said Wednesday.

The Ministry of Health, Labor and Welfare will serve Tokyo-based Novartis Pharma K.K. with a business improvement order, possibly as early as this month.

The case centers on side effects observed in around 5,500 patients, which should have been reported to the state within a few weeks of discovery.

It is the third administrative penalty to be imposed on the company over its reporting delays.

The ministry said the drugmaker has told it that the delay was due to an in-house system failure that occurred at the beginning of this year. Contacted by reporters, the company declined comment.

Novartis Pharma was handed a 15-day business suspension order in February this year and a business improvement order in July 2014 for failing to report health problems caused by its leukemia drugs by the deadline.

In July 2014, Novartis Pharma and a former employee were indicted on charges of causing a medical research team to release manipulated data in favor of the company’s blood pressure-lowering drug Diovan in 2011.

Pharmaceutical firms are required by law to report to the state significant side effects of their drugs within 30 days of discovery.

 

so, the new management team gets fired?
or the ones who put them in charge to replace the old team?
anybody else?

 

Pharmaceutical company Novartis will pay $370 million to settle claims that it gave kickbacks to specialty pharmacies in exchange for recommending two of its drugs, the U.S. Justice Department Southern District of New York announced this week.

Novartis, based in Switzerland, will also forfeit $20 million in proceeds from the scheme, authorities said.

As part of the settlement, the pharmaceutical manufacturer made extensive admissions about its relationship with the specialty pharmacies, authorities said.

Novartis gave patient referrals and rebates to pharmacies Bioscrip and Accredo to recommend refills for Exjade, its iron chelation drug, authorities said. To increase sales, Novartis gave incentives to emphasize Exjade's benefits while understating its potentially life-threatening, side effects, according to the Justice Department.

Exjade patient referrals were very valuable for pharmacies, according to the lawsuit originally brought by whistleblower David Kester. The government intervened in April 2013.

Novartis allocated more patient referrals and gave higher rebates to pharmacies that obtained higher refill rates, authorities said.

When it launched Exjade in 2005, Novartis created a "closed distribution network" involving just three specialty pharmacies, BioScrip, Accredo, and US Bioservices, giving it control over how many Exjade patients would be assigned to the pharmacies, the lawsuit stated.

However, starting in early 2007, Novartis saw Exjade sales slide because of low refill rates. To hit sales targets, Novartis pressured BioScrip, Accredo and US Bioservices to hire or assign nurses to call Exjade patients and, under the guise of education or clinical counseling, encourage patients to order more refills, authorities said.

Refill rates were low in large part to side effects of the drug that were more frequent and more severe than initially expected, authorities said.

Novartis knew the pharmacies were emphasizing the benefits of taking Exjade – for example, by telling patients that not taking the drug would cause damage to their organs or lead to infertility – while understating the potentially life-threatening side effects such as kidney and liver failure, the government said.

The FDA characterized claims about Exjade preventing organ damage as "unsubstantiated," authorities said.

For Myfortic, an anti-rejection drug for kidney transplant recipients, Novartis gave rebate contracts to specialty pharmacies that recommended doctors switch their patients from competitors' brands to Myfortic, according to authorities. Novartis offered lucrative rebate offers to five specialty pharmacies in return for the pharmacies' promise to recommend to doctors that they switch patients to Myfortic, authorities said.

This is the third settlement in the lawsuit. In January 2014 and April 2015, the two specialty pharmacies, Bioscrip, Inc. and Accredo Health Group, agreed to pay a total of $75 million to resolve federal and state claims.

With Novartis's settlement, the federal and state governments will recover $465 million from the kickback allegations.

Of the $370 million it owes, Novartis will pay $286 million to the government, and $83 million to the settling states, the Justice Department said.

Novartis's specialty pharmacy relationships are subject to independent review, in a Health and Human Services Office of the Inspector General corporate integrity agreement.

"Novartis turned pharmacies that should have been disinterested healthcare providers into a biased salesforce for the drug-maker," Manhattan U.S. Attorney Preet Bharara said.

 

Sun to launch copy of Novartis' best-selling drug Gleevec Feb. 1
December 4, 2015 | By Eric Palmer

The day of reckoning is on the books for Novartis' ($NVS) top-selling drug, cancer pill Gleevec. Sun Pharma said today that the FDA has approved its generic of the blockbuster and that it will launch its version in two months, beginning Feb. 1.

Because the Indian drugmaker was the first to file with the FDA for a copycat of the drug, it will have the market in the U.S. to itself for 6 months. And a big market it is. Gleevec had $2.2 billion in sales in the U.S. last year. An Express Scripts ($ESRX) report this year showed that Gleevec held the largest piece of the U.S. cancer drug market with a 12.5% share.

First approved in 2001 to treat chronic myeloid leukemia, Gleevec was considered a wonder drug that turned some blood cancers into chronic diseases. Worldwide the drug rang up $4.7 billion in sales last year, slightly more than in 2013.

It is not as if the Sun copy is a surprise. The two companies hammered out a patent lawsuit settlement last year that assured Sun's right to bring out its copy in exchange for delaying that launch by 7 months, a delay that should allow the Swiss drugmaker to reap another $1 billion in sales for its longtime standard bearer.

When Novartis and Sun first started wrangling over the patent, Novartis claimed it had patent protection through 2019. That drew a separate lawsuit this year from two union funds that accused Novartis of using "sham" patent-infringement claims to get Sun to agree to the delay beyond the patent loss last July. Novartis has denied the claims.

While Gleevec has continued to be its best seller, in recent years Novartis has been touting the superior results from follow-up drug Tasigna, trying to get doctors to move patients to it ahead of losing patent protection. While it is also a blockbuster, it has not nearly reached the sales levels that Gleevec enjoys. Tasigna had U.S. sales of $540 million last year and worldwide sales of $1.5 billion.

While generic competition is a big deal for Novartis, having Gleevec to itself for 6 months is a big deal for Sun Pharmaceutical, which has seen its sales hammered by regulatory issues brought up by the FDA for one of its key plants. In its last first quarter, Sun said its U.S. sales of $488 million were down 4%, primarily because of plant issues, and sales were down 28% in the second quarter to $510 million, although that was impacted by its launch of Diovan in the same quarter the year before. One analyst in India told the Business Standard that Sun could conservatively expect to pull in between $250 million and $300 million during the 6-months exclusivity period from its Gleevec copy.

 

FDA Warning Wire: Suspect Records At Sandoz
By Jeff Overley

FDA Decries Sandoz's 'Falsification and Manipulation'

Sandoz Inc. parent company Novartis AG disclosed a warning letter's existence last month without supplying details on the alleged violations. On Tuesday, when the letter was finally released, it became clear why Novartis withheld specifics: The FDA directly and repeatedly accused Sandoz of deception at a manufacturing plant in India.

For example, the FDA said it examined discarded records and discovered an employee's failing marks on a qualifications assessment form. However, the employee's official file showed passing results, and Sandoz had no evidence that the employee had been retrained.

"Falsification and manipulation of employee training records is unacceptable," the FDA wrote.

Other criticism focused on manufacturing activities that were not documented as they occurred. According to the letter, Sandoz improperly altered records after the fact to conceal those failures.

"Backdating [manufacturing] records is unacceptable," the letter stated.

In addition, Sandoz allegedly concealed out-of-specification test results for one product until it was cleared for sale by regulators.

"Your decision to withhold information from the agency raises serious concerns," the FDA wrote.

And Sandoz allegedly failed to create safeguards that would prevent unauthorized access to digital records.

"Your laboratory computer systems lack necessary controls to prevent data tampering and to detect data that may have been compromised," the FDA wrote.

The allegations concern a manufacturing plant in the Indian state of Maharashtra. At a second plant in the same state, Sandoz was accused of shoddy procedures for avoiding contamination of sterile drug products.

 

So this thief is approaching $1 Billion in total fines if it has not surpassed it already. This for what it was caught to do. What about for what it has not? Where are the Whistle-blowers?
Remember the thread: Whistle-blowers of Novartis Unite? If you did unite and acted as a team, the justice would have been done far better and you would have made some real $$$ in rewards for job well done.
So the bastards continue to get away with proverbial murder. Personally I will never get over the tragic fact that where I have an enormous amount of evidence of their crimes, we do not have good laws like your False Claim Act. Use it or lose it.

 

Who says there is no gold in BS?

 

EMA warns of PML, cancer risks from Novartis' Gilenya
December 18, 2015 | By Carly Helfand

Earlier this year, U.S. regulators updated the label of Novartis' ($NVS) multiple sclerosis pill, Gilenya, to reflect cases of serious brain infections linked to the treatment. And now, its counterparts across the pond are following suit.

Friday, the Europeans Medicines Agency (EMA) announced it would add information about the infection--progressive multifocal leukoencephalopathy, or PML--to the med's product information, along with information about basal cell carcinoma and other risks associated with drugs that reduce the immune system's activity the way Gilenya does.

So far, three cases of PML have cropped up in Gilenya patients who had not received previous treatment with Biogen's ($BIIB) Tysabri--another immunosuppressive MS therapy--and 151 cases of basal cell carcinoma have been reported, regulators said.

The agency also issued new recommendations for doctors and patients concerning Gilenya's potential risks. Patients should be evaluated before and during Gilenya treatment in order to flag early signs of either malady, and they should receive a baseline MRI scan and a medical skin evaluation before starting treatment, the EMA said.

The new safety warnings could put a damper on things for Novartis, which counts Gilenya among its growth products. Last quarter, strong volume growth drove a 16% leap in constant currencies to $696 million in sales, the Swiss drugmaker said.

Novartis has other things to worry about, too. This fall, the U.S. Patent Trial and Appeal Board upturned a long-term patent on the med, putting it in line for early generic competition.

"Without novel IP, Gilenya will go generic in 2019 with multiple entrants," Bernstein analyst Ronny Gal predicted at the time.

 

Novartis Unit Settles Sex Bias Suit For $8M
By John Kennedy

New York (December 23, 2015, 6:08 PM ET) -- A Novartis AG unit has agreed to pay $8 million to settle class and collective sex discrimination claims, lawyers for the plaintiffs told a New York federal judge Tuesday as they sought preliminary approval of the settlement.
Novartis and Texas-based eye care giant Alcon Laboratories Inc. deny any wrongdoing and maintain they did not engage in systemic discrimination, but agreed to fork over $8 million to settle all claims brought by four groups of employees alleging sex discrimination in pay, promotions, job assignments and total compensation. Alcon allegedly also violated the Equal Pay Act by denying members of the similarly named collective equal pay for their work.

Sanford Heisler Kimpel LLP is also seeking to be named class and collective counsel and has requested one third of the total settlement in fees — about $2.67 million.

The four groups include current and former employees in director-level positions, manager-level positions, specialist or analyst positions and sales positions. Novartis and Alcon’s defenses have included the argument that the plaintiffs’ claims are based on individual facts and aren’t appropriate for class certification.

When they filed the suit in March, Susan Orr and Elyse Dickerson said that Alcon, bought by Novartis in 2010 for $51 billion, maintains a “boys club” atmosphere that’s hostile towards women and keeps them from advancing their careers. They originally sought $110 million in relief for some collective claims and their own individual ones, but amended the complaint a month later to add class claims and more collective ones.

Dickerson said she was fired from a research scientist job after complaining about the disparities, while Orr, a research scientist, said she was forced to resign because of a lack of advancement opportunities.

Dickerson is not a party to the settlement and continues to separately assert individual claims, which remain unsettled.

The $8 million settlement was the product of many months of negotiations, the plaintiffs said, adding that it easily meets the standard for preliminary approval since there’s no reason to doubt its fairness and it falls within the range of possible approval. None of the money will revert back to Novartis or Alcon.

Each class member will receive a base payment, with the option of an additional payment if she submits a claim form detailing specific discrimination related to the issues of the case.

The total settlement fund, about $5 million after all anticipated deductions, will be split, with 85 percent going to base payments and 15 percent allocated for additional payments.

Of these two portions, 40 percent of each is for specialists or analysts, 25 percent of each is for directors, 20 percent of each is for managers and 15 percent of each is for sales employees.

The 13 representative plaintiffs will receive no more than $110,000 in total and will each get between $5,000 and $20,000, depending on their contributions to the case.

Sanford Heisler expects to deduct about $165,000 in costs and expenses in addition to their total fees.

In 2010, a jury hit Novartis Pharmaceutical Corp. with $250 million in punitive damages after finding the company liable for discriminating against a class of 5,600 female sales employees.

Novartis declined to comment on the matter.

The plaintiffs are represented by Jeremy Heisler, Alexandra Harwin, David Sanford and Felicia Medina of Sanford Heisler.

Alcon is represented by Evan R. Chesler and David R. Marriott or Cravath Swaine & Moore LLP and Kerry Alan Scanlon and Jeremy White of Kaye Scholer LLP.

Novartis is represented by Heather McDevitt of White & Case LLP.

The case is Dickerson, et al., v. Novartis Corp., et al., case number 1:15-cv-01980, in the U.S. District Court for the Southern District of New York.

 

Health | Mon Jan 11, 2016 3:56pm EST
No quick fix seen for Novartis's troubled Alcon unit
ZURICH | BY JOHN MILLER

Introduced a decade ago, glaucoma drug Travatan Z has been a powerful driver behind the success of Novartis's Alcon eye care business, its second biggest division behind the main pharmaceuticals business.

But the drug's patent expiration last month, the latest in a wave of expiries that have left Alcon vulnerable to generics, brings into sharp focus the unit's problems, for which analysts say there is no obvious quick fix.

Having taken its first stake in Alcon eight years ago after it was floated by former-owner Nestle, Novartis now acknowledges the ophthalmic division has become its problem child, with too many old products and too little innovation.

Sales have been in decline since 2014 at Alcon, which the Swiss drugmaker completed buying five years ago for nearly $51 billion, slipping 12 percent in the third quarter last year to just $2.35 billion.

Novartis's total sales in the quarter fell 6 percent to $12.27 billion.

The list of travails is long including laggardly surgical equipment sales, especially in emerging markets like Asia, slumping revenue from intraocular lens (IOL) implants for cataract sufferers and an underperforming over-the-counter contact lens solutions business which could be on the auction block, analysts said.

A management reshuffle has failed to staunch a chronic quarter-on-quarter revenue slide.

Now Novartis Chief Executive Officer Joe Jimenez has promised an innovation-heavy "growth acceleration program" for Alcon which is due to be unveiled on Jan. 27 alongside 2015 results.

Analysts said Jimenez's crisis response is necessary, but tardy: New product development takes years, meaning Alcon may bump along for the foreseeable future.

"I doubt it will be a quick fix," said Alistair Campbell, a London-based Berenberg analyst.

"They know they have lagged behind on innovation in both the intraocular lens and drug segments but fixing both will not happen overnight."

Revenues started to fall in the fourth quarter of 2014 and since last summer Alcon Global Head Jeff George has replaced two thirds of his top managers.

"We've seen a significant slowdown in emerging markets, particularly in Asia, which has led to a corresponding drop in our surgical equipment sales," George said last year.

"We've also seen increasing competitive pricing pressure in our IOL business. The third factor ... is the increasing generic pressure that we've had in our U.S. pharma business."

In addition to Travatan Z, Patanese, one of Alcon's allergy drugs, has gone off patent, while Patanol and Pataday also face imminent generic competition, he said.

But a costly turnaround program is hardly timely, given Novartis's overall revenue could come under pressure with the patent expiry on its blood cancer drug Glivec just as it is stepping up marketing for its new heart-attack drug Entresto.

Disposal of the contact lens solutions businesses, which analysts say ranks second behind Johnson & Johnson, could also be in the offing.

"There are risks of a ramp-up in research and development and marketing spending," said Deutsche Bank analyst Tim Race. "However, they might just say we are selling parts of the business and not ramp costs up as much as they might otherwise have to."

Jimenez has left that option open, saying he is amenable to "peeling off underperforming parts of Alcon." For now, he is committed to Alcon, though his patience is not infinite.

"You have an on-trend business with an aging population," Jimenez told analysts in October. "If it doesn't improve, then we've got a different conversation."

 

Entresto, approved in the U.S. in July, is having a difficult time getting off the blocks. Analysts expected it to generate $79 million in sales last year. It only managed $21 million. The U.S. government and insurers have been slow to embrace the drug and have restricted access. That could take some time to resolve, though Novartis said prescriptions have been accelerating.

The company suggested analyst expectations in the near term were too high. It kept its long-term view of Entresto's multi-billion-dollar potential, but the company needs to find a way to improve sales. Fast.

"Can you say.......Woof Woof ?
Bow Bow ? "

 

How does Capital Group feel about that ?

 

When does Novartis report figures nominally and %effective for "patient outcomes achieved"?

 

I don't know, but they are the single largest holder of Novartis shares.

 

let them sell.
we can buy 'em back with the 10 billion the board wants to allocate for the share repurchase program.

 

that might work for a non-profit company with a sufficient budget and sufficiently skilled human resources for the task.