Novartis milestones be proud ! Management take a bow !

Quote
Novartis Warping Kickback Standard In FCA Case, DOJ Says
By Jeff Overley

(September 19, 2018, 3:54 PM EDT) -- Novartis Pharmaceuticals Corp. has flatly “misstated the law” in its bid to escape a whistleblower’s False Claims Act suit alleging illicit kickbacks aimed at boosting Medicare Part D business, the U.S. Department of Justice told a New Jersey federal court Tuesday.

In a statement of interest, the DOJ accused Novartis of baselessly asserting that discounts it provided to pharmacy benefit manager Express Scripts Inc. are immune from Anti-Kickback Statute liability because there’s no evidence that they were commercially unreasonable or didn’t reflect fair market value.
 






Novartis to cut 2,550 jobs in Switzerland, UK in profit push
By John Miller

ZURICH (Reuters) - Novartis will cut 2,550 jobs in Switzerland and Britain over four years, it said on Tuesday, as the Swiss drugmaker strives to boost profits and focus on new medicines.

Switzerland will bear the brunt, with 2,150 cuts planned at four factories and its Swiss-based business services unit. Some 400 jobs will also go in Grimsby, northeast England, where the company will close a plant that makes pills.

Novartis currently employs around 124,000 people worldwide. But following the planned spin-off of eyecare unit Alcon in early 2019, that will fall to fewer than 100,000 people by 2022, Chief Executive Vas Narasimhan said.

Novartis's network of 66 global factories is operating below capacity after the expiry of patents on high-volume pills such as Diovan for heart disease, he added.

As the company shifts to gene therapies and biologics like arthritis treatment Cosentyx, Narasimhan said the cuts were needed to help him boost the drugs unit's operating margin to around 35 percent of sales, what he calls the industry standard, from 31.3 percent now.

"Our medicines portfolio is evolving from high-volume products to more specialised and more personalised innovative medicines," the 42-year-old U.S. doctor told reporters.

"We don't need the same scale we've historically needed. That's the evolution you're seeing in our portfolio, and that's being reflected in our manufacturing footprint."

Unions blasted the move, saying the Swiss pharmaceuticals industry would be the worse for it.

"There will be massively damaging side effects for Swiss workers, the drug industry and Switzerland's export economy," Employees Switzerland wrote in a statement. "We're not going to let Novartis destroy Basel as a centre of industry."

MORE TO COME?

Narasimhan, whose company's net income rose 15 percent last year to $7.7 billion, is seeking to transform Novartis from a traditional pills maker to a maker of cutting-edge therapies like its $475,000-per-patient Kymriah cancer treatment.

He announced the sale of a U.S. generics drugs business last month to India's Aurobindo and a consumer healthcare joint venture to GlaxoSmithKline earlier this year.

Meanwhile, he spent $8.7 billion to take over U.S.-based Avexis to get its experimental gene therapy against potentially deadly spinal muscular atrophy that is nearing a filing for U.S. approval.

The cuts join those at other drugmakers: 1,000 Takeda workers will be affected as it moves a U.S. headquarters, while GlaxoSmithKline is axing 650 U.S. jobs.

Severin Schwan, CEO of Novartis's crosstown rival Roche, said this month he also had his eyes on costs as his top-selling medicines face incursions from cheaper copies.

Novartis's restructuring comes as part of a programme announced in 2016 to save about $1 billion annually, Narasimhan said. Previous moves have included closing a U.S. pill factory in Colorado that resulted in 450 job losses, as well as redundancies in Japan.

The company did not announce the cost of the latest cuts, but said it would take charges over the four-year period.

The net effect of the restructuring is about 2,100 jobs lost, Novartis said, taking into account new positions it is creating at soon-to-be-built Swiss facilities to make Kymriah.

Novartis shares were up about 0.8 percent at 0900 GMT.

Analysts said the measures were in line with expectations - this month, Novartis Chairman Joerg Reinhardt hinted they were coming.

"The company's ambition to deliver a mid-30s EBIT (earnings before interest and taxes) margin in Innovative Medicines requires productivity programmes," UBS analyst Michael Leuchten said.

"We expect the above will not be the last programme to be announced."
 






Novartis challenges court ruling allowing use of Avastin in wet AMD

October 15, 2018

Novartis is appealing against a High Court ruling that it is lawful for the NHS to prescribe Roche’s Avastin (bevacizumab) in an unlicensed use in wet age-related macular degeneration (AMD), instead of pricier approved drugs.

Novartis’s Lucentis (ranibizumab) and Bayer’s Eylea (aflibercept) are approved in wet AMD, but Avastin’s manufacturer Roche has never applied for a licence in ophthalmology.

Novartis is now taking a stand against the decision by England’s High Court, stating that the regulatory system ‘must not be compromised’.

The NHS welcomed the court decision, which was made in September, as it means money will be saved through use of the cheaper Avastin.

But in a statement, Novartis said: “Today, people living with wet AMD are now being asked to compromise on the assured quality and safety of their treatment, purely on the basis of cost.

“This is inappropriate and unnecessary when there are two NICE approved – and therefore cost effective – licensed treatments available. In the future, on the basis of this judgment, it may be people living with cancer, diabetes, or any other long-term condition being asked to compromise on the quality and safety of their treatments. This must not be allowed to happen.”

It went on to say that the judgement puts the financial burden faced by the NHS above patients’ right to medicines approved by the MHRA and EMA.

AMD is the most common cause of poor sight and blindness in older people. It usually affects those in their 50s and 60s and can progress through a succession of stages. The disease is deemed either ‘wet’ or ‘dry’.

Wet AMD develops when abnormal blood vessels grow into the macula. These can leak blood or fluid, leading to scarring of the macula and rapid loss of central vision.

Avastin, a drug licensed to treat cancer, works by attacking the blood vessels that feed oxygen to tumours – a mechanism that also tackles the symptoms of wet AMD.

Despite its lack of licence, a trial of Avastin for wet AMD showed that it was as effective as Lucentis in treating wet AMD, although serious adverse events were slightly more common with the Roche drug than with Lucentis.

This meant, due to the comparably low cost, Avastin was used off-label, sparking calls for a judicial review by Novartis and Bayer in a bid to make clinical commissioning groups use their more expensive licensed alternatives.
 


















Exforge Generic Deal Is Clear Antitrust Violation, Court Told
By Matthew Perlman

(October 25, 2018, 5:25 PM EDT) -- A proposed class of drug buyers told a New York federal court Wednesday that an agreement between Novartis Pharmaceuticals Corp. and Par Pharmaceutical Inc. that allegedly delayed the launch of a generic version of exforge was a clear violation of antitrust laws
 






Antitrust Violation said:
Exforge Generic Deal Is Clear Antitrust Violation, Court Told
By Matthew Perlman

(October 25, 2018, 5:25 PM EDT) -- A proposed class of drug buyers told a New York federal court Wednesday that an agreement between Novartis Pharmaceuticals Corp. and Par Pharmaceutical Inc. that allegedly delayed the launch of a generic version of exforge was a clear violation of antitrust laws
Click to expand...
Such an unethical company, they always have us doing learning assignments for ethics & compliance. WTF !
 






anonymous said:
Such an unethical company, they always have us doing learning assignments for ethics & compliance. WTF !
Click to expand...

Norvasc went generic in 2007 & Diovan went generic in 2012
There's no reason patients were gouged with an overpriced
branded version of these generic drugs for the past 6 years

Trying to extend exforge 6 years after individual components
became generic is unconscionable

In fact sandoz has been selling it's own generic version for 3.5 years

"Sandoz launches authorized generic version of EXFORGE®
in the US. Princeton, New Jersey, March 31, 2015 –"
 






Novartis dumps 20% of programs following pipeline review
by Nick Paul Taylor
Oct 30, 2018 9:31am

Jay Bradner, M.D., has revealed that Novartis has scrapped one-fifth of its drug programs. The cull is designed to limit Novartis’ pipeline to potentially transformative therapies that fit with the company’s ambitions.

Talking to Bloomberg, Novartis Institutes for Biomedical Research President Bradner shared top-line details of the results of a pipeline review. Novartis went into the review with 430 drug programs in its pipeline. It is exiting the review with 340 drug programs. Some of the scrapped drugs will languish at Novartis. Others may be licensed out.

Novartis has yet to share details of the programs affected by the cull. But Bradner did provide insights into the thinking that led Novartis to identify pipeline prospects as surplus to requirements.

“The sadness about these 90 projects is there’s some great science there,” Bradner said. “These are not bad ideas. Many of them have momentum, but they either are not likely to be transformative for patients, or are ill-suited to the focused business ambitions of Novartis.”

Novartis’ recent third-quarter results featured some news of drug program comings and goings but nothing on the scale of the cuts outlined by Bradner. More details may emerge at the R&D update event Novartis is holding in London on Monday.

Whatever the identities of the drugs on the block, the contours of the results of the pipeline review are familiar. As happened at GlaxoSmithKline following the appointment of Emma Walmsley as CEO, the arrival of a new leader at Novartis has triggered a cull of pipeline programs. Over the past two years, Alexion, Biogen and Eli Lilly have been through similar post-leadership change reviews.

The scale of the cull sets Novartis’ actions apart, though. GSK decided to scrap or offload 65 drug programs in the 15 months after Walmsley’s appointment. Novartis, a bigger company, has decided to drop 90 programs within nine months of Vas Narasimhan taking over.
 






Novartis says $4m price is reasonable for SMA gene therapy :eek:
Ptaylor-100x100.jpg

Phil Taylor
November 6, 2018

Novartis says it thinks its one-off gene therapy for spinal muscular atrophy (SMA) could deliver value for money even if its price was set upwards of $4 million – which would set a record for a pharmaceutical product.

AVXS-101 is Novartis’ lead gene therapy and the centrepiece of its $8.7 billion acquisition of US biotech AveXis earlier this year, and according to the company’s R&D update yesterday could be approved for marketing for type 1 SMA – the most severe form – in the US, Europe and Japan next year.

Clinical trials with AVXS-101 have raised massive expectations for the gene therapy, which could be transformative for children with SMA and their families. The disease causes debilitating muscle-wasting as a result of the death of neurons in the spine, and can be fatal in the most seriously affected patients within two years. Novartis’ therapy is a one-time treatment to restore production of the protein (SMN) missing in SMA.

Novartis’ price calculations for AVXS-101 no doubt derive in part from the high price of Biogen’s Spinraza (nusinersen), an antisense drug that is the first approved treatment for SMA and costs $750,000 in the first year, dropping to $375,000 thereafter, as well as other rare disease therapies. Of course, Spinraza needs to be delivered on an ongoing basis.

The company’s cost-effectiveness modelling for AVXS-101 is based on a 10-year cost set against quality-adjusted life years (QALY) gained, and at the $4 million mark represents a QALY of 13.3. That’s well in excess of the $100,000 to $150,000 per QALY typically used by health technology assessment (HTA) agencies but within the ballpark for lifelong medicines for rare diseases, including Spinraza, according to Novartis.

A final judgment on the cost-effectiveness of AVXS-101 would of course depend on how sustained the effects of the gene therapy were, in other words whether it might have to be re-dosed in future to maintain its effects. At the moment, there is data up to around two years after administration, with all 15 treated infants event free at that time point, compared with an event free survival rate of 8% in an historical cohort.

Arguably, a thornier issue will be whether it is possible to charge that kind of money for any therapy – regardless of its benefits – given the current political climate on medicine pricing. Novartis acknowledged during the update that it would have to get creative in developing a value and pricing argument for AVXS-101 in order to get insurers to cover screening and treatment programmes, and stressed that it hasn’t decided yet what it will charge if it is ultimately approved.

The US-based Institute for Clinical and Economic Review (ICER) acknowledged last year that gene therapy will heighten concerns about the affordability of emerging treatments “under existing paradigms of pricing and payment,” particularly when there is no guarantee of long-term safety or of the durability of clinical benefit.

“Estimates suggest that 10% of Americans have a rare condition related to a genetic defect,” said ICER. “Based on the initial pricing experience with gene therapy in Europe, should a growing number of gene therapies come into use at costs of $1-$2 million, the cumulative budget impact would be substantial, and perhaps unsustainable.” Even if gene therapies were developed for 1% of the population the cost could reach $3 trillion, it suggested.

There’s estimated to be roughly 1,300 patients with SMA type 1 in the US, so assuming a $4 million price tag, 100% penetration of the therapy would generate around $5 billion. Meanwhile, Novartis is trying to extend the use of its gene therapy into other forms of SMA (types 2 and 3), adding another 3,000-4,000 patients apiece according to some estimates.
 






FDA warns about severe worsening of MS related to Novartis' Gilenya
Nov. 20, 2018 3:03 PM ET|About: Novartis AG (NVS)|By: Carl Surran, SA News Editor


Novartis (NVS -1.6%) turns lower after the Food and Drug Administration says it is adding a new warning to the prescribing information of the drug label and patient medication guide for the Gilenya multiple sclerosis medicine.

The FDA says when Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken, adding the worsening of the MS is rare but can result in permanent disability.

Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse.
 






Novartis is messed up due to constant removal of good people and replacing them with useless people to fulfill personal goals of middle and upper management so these losers can just take up free salary and live off Novartis for their entire career. Where the heck are new ideas when mgmt is the same s**** and they use ideas from new people for themselves and then throw these people out.
 






J&J beats Novartis’ blockbuster rival in a head-to-head showdown over the psoriasis market
by john carroll — on December 12, 2018 08:08 AM EST
Updated: 10:25 AM


Score a round in the battle of the psoriasis blockbusters for J&J.

The pharma giant heralded a win for their head-to-head study of Tremfya (guselkumab) against Novartis’ dominant rival Cosentyx. Researchers said that 84.5% of the psoriasis patients taking their IL-23 drug hit a PASI90 score at 48 weeks, compared to 70% for the IL-17 drug Cosentyx.

That bodes well for ongoing late-stage studies of their drug in psoriatic arthritis and Crohn’s disease.
 






J&J Wins said:
J&J beats Novartis’ blockbuster rival in a head-to-head showdown over the psoriasis market
by john carroll — on December 12, 2018 08:08 AM EST
Updated: 10:25 AM


Score a round in the battle of the psoriasis blockbusters for J&J.

The pharma giant heralded a win for their head-to-head study of Tremfya (guselkumab) against Novartis’ dominant rival Cosentyx. Researchers said that 84.5% of the psoriasis patients taking their IL-23 drug hit a PASI90 score at 48 weeks, compared to 70% for the IL-17 drug Cosentyx.

That bodes well for ongoing late-stage studies of their drug in psoriatic arthritis and Crohn’s disease.
Click to expand...
worked for both. Mirrored images of operating principles. Both could f up a set dream.
 






J&J Wins said:
J&J beats Novartis’ blockbuster rival in a head-to-head showdown over the psoriasis market
by john carroll — on December 12, 2018 08:08 AM EST
Updated: 10:25 AM


Score a round in the battle of the psoriasis blockbusters for J&J.

The pharma giant heralded a win for their head-to-head study of Tremfya (guselkumab) against Novartis’ dominant rival Cosentyx. Researchers said that 84.5% of the psoriasis patients taking their IL-23 drug hit a PASI90 score at 48 weeks, compared to 70% for the IL-17 drug Cosentyx.

That bodes well for ongoing late-stage studies of their drug in psoriatic arthritis and Crohn’s disease.
Click to expand...

Big test for salesforce.
 






Who didn't see this coming? :rolleyes:

Tilray partners with Novartis in Big Pharma’s first deal of its kind with Big Marijuana

Published: Dec 18, 2018 10:16 a.m. ET

Tilray CEO says distribution deal is first global partnership, ‘will allow us to expand into more markets, more quickly’
MW-GM028_tiilra_20180705143217_ZH.jpg
Tilray Inc.
Tilray grows marijuana for the medical and recreational markets.


Tilray Inc. announced early Tuesday that it has inked a global supply and distribution agreement for medical marijuana with pharmaceutical giant Novartis AG, continuing a trend of legacy industries linking up with the new breed of marjiuana producers.

Tilray TLRY, +11.34% shares opened nearly 10% higher Tuesday morning, after the deal was officially announced, and touched gains of 12% in the first few minutes of trading. Novartis NVS, -0.12% stock was close to even at the open.

Following investments by big beverage and tobacco companies in Canadian pot producers focused on the recreational market, the Novartis-Tilray pact adds further legitimacy to an industry that until recently was dominated by drug cartels, outlaw motorcycle clubs and smugglers. For Tilray, the deal is the culmination of months of work for Chief Executive Brendan Kennedy, who said in an interview that the partnership will give his company a sales and distribution channel in dozens of countries.

“Around the world, people are substituting medical cannabis for traditional pharmaceutical products,” Kennedy said in a telephone interview Monday evening. “Medical cannabis is disrupting Big Pharma, and Sandoz and Novartis are smart for being ahead.”

A guide to pot stocks: What you need to know to invest in cannabis companies

Kennedy said that the pact is the first major partnership of its type between a cannabis company and a big pharmaceutical business. The deal has its origins in Canada, the second country in the world and only member of the G-7 to legalize marijuana for recreational use. Through the Novartis subsidiary Sandoz, Tilray signed a similar agreement to distribute and sell medical cannabis products in 2017 — an agreement that prompted this much larger deal, which expands the agreement to the roughly 35 countries around the world that have medical cannabis laws, a number that Kennedy says will likely increase in the future.


As a part of the agreement, Tilray will be able to use Sandoz’s muscular global sales channels to help smooth the way for the marijuana producer to introduce medical products where it is legally allowed to do so, Kennedy said. Tilray said that it cut an exclusive deal with Novartis, which is not allowed to partner with another pot company, and Tilray cannot make a pact with another pharmaceutical business on non-combustible products.

“The key point is that it will allow us to expand into more markets, more quickly,” Kennedy said. “This is an agreement that will take advantage of Sandoz’s global footprint and leverage their brand, which inspires trust and confidence with pharmacists around the world. Also, we can use their salesforce to educate physicians and pharmacists around the world — which can be a challenge.”

Kennedy also said that the companies will work together to develop new products, and have several that focus on defined dosage. The agreement announced Tuesday covers non-smokable and non-combustible medical products.

Earlier this year, Constellation Brands Inc. STZ, -1.98% invested $4 billion in the Canadian pot producer Canopy Growth Corp. CGC, -1.74% WEED, -0.46% . And in December, Altria Group Inc. MO, -1.73% announced a $1.8 billion investment in Cronos Group Inc. CRON, +3.50% CRON, +5.14% . Kennedy said Novartis was in talks with “a number” of Canadian-licensed marijuana producers but ultimately settled on a deal with Tilray.

Kennedy said that the deal with Novartis doesn’t signal that Tilray is going to prioritize the medical cannabis market ahead of recreational pot, which it currently sells in Canada. “For Tilray, both are equally important,” he said.
 






Novartis oncology boss Barrett makes quick exit

Silke Koltrowitz, John Miller

ZURICH (Reuters) - Novartis is getting its third oncology chief in less than a year after Liz Barrett said on Thursday she was leaving the Swiss drugmaker to become chief executive of a U.S. biotech firm only 11 months after taking up the role.

Barrett, a U.S. citizen who previously worked at Pfizer and Johnson & Johnson J&J.N before joining Novartis in February, will be replaced from January by Susanne Schaffert, a longtime Novartis executive.

Barrett, who could not be reached for comment, cited challenges in moving her family to Basel, Novartis’s headquarters, as the reason for her departure. She did not name the biotechnology firm she was joining.

Novartis is trying to build up its oncology portfolio with new therapies including its costly Kymriah cell therapy, nuclear-based medicines and immuno-oncology.

“After much personal reflection, it became clear that my family would be unable to relocate,” said Barrett, who had replaced Bruno Strigini as oncology chief less than a year ago.


A Novartis spokesman said he did not know where Barrett had taken a job.

Schaffert, a 20-year Novartis veteran, had for five years been Region Head, Novartis Oncology Europe, before this year taking over at its Advanced Accelerator Applications (AAA) unit, purchased late last year for $3.9 billion.

AAA makes therapies that deploy trace amounts of radioactive compounds to treat cancer.

Schaffert will replace Barrett on the Novartis executive committee, where she will report to Chief Executive Vas Narasimhan.

“She has our full support and confidence as we continue to invest in both our internal pipeline as well as external assets to strengthen our presence,” Narasimhan said in a statement.
 






Rite Aid Sues Novartis Over Generic Delay
Dec. 18, 2018, 11:26 AM

Drugmakers Novartis, Endo, and Par Pharmaceutical conspired to exclude generic competition to a brand-name hypertension drug made by Novartis, Rite Aid Corp.says in a complaint filed Dec. 17.

Par and Endo agreed not to compete by releasing a generic version of Novartis’s drug Exforge, and Novartis agreed to hold off on releasing its own generic, the suit filed in the U.S. District Court for the Southern District of New York alleges.

This type of deal is called “pay-for-delay.” It raises prices for drug buyers and can violate the antitrust laws.

A similar complaint was filed May 17 by Puerto Rican pharmacy Drogueria Betances on behalf of a class of direct buyers of the drugs.

Rite Aid argues the class complaint has tolled the statute of limitations on its claims. The tolling allows Rite Aid’s suit to include purchases of Exforge and its generics since May 2014, it argues.

The pharmacy seeks a permanent injunction and treble damages.

Novarits declined to comment on the suit. The other drugmakers didn’t immediately respond to requests for comment.

Hangley Aronchick Segal Pudlin & Schiller represented Rite Aid.

The case is Rite Aid Corp. v. Novartis Pharm. Corp., S.D.N.Y., No. 18-4361, filed 12/17/18.
 






Police raid house of suspect in Novartis case
IOANNA MANDROU
TAGS:Justice, Crime, Corruption

Police on Thursday raided the house of a former protected witness in an alleged bribery scandal involving Swiss drugmaker Novartis, as part of an ongoing investigation, according to judicial sources.

Academic and former Health Ministry advisor Nikos Maniadakis is being accused by two other protected witnesses that he had accepted 120,000 euros from Novartis as payment for influencing the government’s health policies.

His house has also been searched in the past. His lawyer, Theodoros Mandas, said his client is at the disposal of judicial authorities.

Speaking to Skai TV on Wednesday night, Maniadakis said that he was pressured by judicial authorities to reveal whether prominent Greek politicians had received money from the Swiss drugmaker, adding that he believed his involvement was “politically motivated.”
 






POLICE RAID Novartis !! said:
Police raid house of suspect in Novartis case
IOANNA MANDROU
TAGS:Justice, Crime, Corruption

Police on Thursday raided the house of a former protected witness in an alleged bribery scandal involving Swiss drugmaker Novartis, as part of an ongoing investigation, according to judicial sources.

Academic and former Health Ministry advisor Nikos Maniadakis is being accused by two other protected witnesses that he had accepted 120,000 euros from Novartis as payment for influencing the government’s health policies.

His house has also been searched in the past. His lawyer, Theodoros Mandas, said his client is at the disposal of judicial authorities.

Speaking to Skai TV on Wednesday night, Maniadakis said that he was pressured by judicial authorities to reveal whether prominent Greek politicians had received money from the Swiss drugmaker, adding that he believed his involvement was “politically motivated.”
Click to expand...
Oh how twisted and messed up.
 






Top Bottom
Back
Quote