Novartis milestones be proud ! Management take a bow !

More Novartis CRIME , let's take a MONTH of reflection on all the SLEAZY CRIMINAL UNETHICAL RACIST SEXIST things Novartis has undertaken since the start of this thread

Novartis, Amgen and Mallinckrodt used aggressive price hikes to meet sales goals, congressional probe finds
Pharma

Eric Sagonowsky |
Oct 1, 2020 9:27am

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For Mallinckrodt, executives raised prices on H.P. Acthar Gel “as high as possible” to meet financial goals, the committee wrote in a 50-page report. And Novartis, marketing the lucrative cancer med Gleevec, raised prices aggressively while seeking to maintain "public pushback," a 46-page report found.


For its part, Novartis aimed to keep Gleevec price increases below a "10% threshold," which, the committee wrote, "appears to have been intended to minimize public pushback." But years of incremental increases added up: Since launching the cancer drug in 2003, Novartis has raised Gleevec's price 22 times to $123,000 for a yearly course.

Novartis also "used several anticompetitive tactics" to delay Gleevec competition and minimize losses after generics launched, the probe found. The company used regulatory procedures, "pay for delay" deals and exclusive contracts to protect its brand against the competition.

A Novartis spokesman said the company spends an “enormous amount of resources” on R&D, but that it recognizes “innovations are immaterial if patients cannot afford them or otherwise access them.” The company prices medicines in “consideration of the value they bring to patients and society," he added.

After Gleevec went generic in 2016, Novartis "offered steep discounts ... and continued to do everything possible to try to ensure that anyone who needed Gleevec but couldn’t afford it still got it," the spokesman said.

Meanwhile, Amgen was taking repeated price increases, too. The company raised prices on immunology drug Enbrel 27 times after acquiring the rights in 2002—for a total increase of 457%. The drug now costs $72,240 annually. And the company raised Sensipar prices more than 20 times after its 2004 launch, the probe found.

Aside from its efforts to meet aggressive revenue targets, Amgen used a strategy of “shadow pricing,” routinely following competitor AbbVie’s price hikes on Humira, the committee found. Rather than pricing Enbrel below Humira to gain market share, Amgen “consistently” followed AbbVie’s increases and used the rival company’s moves as justification for its own, the report said.

To maintain its ability to charge high prices, Amgen also used “anticompetitive tactics” to keep rivals at bay, the probe found. On Enbrel, Amgen “used minor changes to Enbrel’s design—including a new version of the injection device called Enbrel Mini with Autotouch—to drive sales and limit competition,” the committee said. And on Sensipar, the drugmaker entered into settlement agreements to delay generic launches.

An Amgen spokeswoman said the company appreciates "the opportunity to share our views on how best to ensure that innovative medicines ... are accessible and affordable to the many patients who need them."

The company is “committed to working with Congress, the Administration and other stakeholders to advance market-based reforms that will promote competition and improve patient access to therapies without stifling innovation in the U.S.,” she added.

And then there's Mallinckrodt, which purchased Acthar-maker Questcor in 2014 aiming to turn the drug into a blockbuster in part through aggressive outreach to doctors, the committee found. Because it had also acquired the rights to Acthar's closest competitor, Synacthen, Mallinckrodt “expected little to no competition” for the med, the committee wrote. Mallinckrodt later paid $100 million to settle similar allegations with the Federal Trade Commission.

When Mallinckrodt execs were considering 2018 price increases between 7% and 9.9%, an exec wrote that “any price increase obviously has positive results.”

“Really comes down to what we are comfortable with externally,” the exec added. “Personally, I would go high. We will receive the same press regardless within these ranges.”

In all, the drug's price has grown almost 100,000% since Questcor acquired its rights in 2001. Prices were high when Mallinckrodt made the deal, the committee points out, and grew afterward.

When Mallinckrodt management prepared a 2018 strategic presentation to the company’s board, execs initially referred to Acthar as a “cash cow” in the document. One exec wondered whether the language was appropriate, and a later version of the presentation called the drug a “profit maximizer.”

A representative for Mallinckrodt said the company has invested $660 million since the Questcor buyout to build clinical data, and that the drug's price has grown about 5% annually since the deal. The drugmaker doesn't know of any U.S. patients who were prescribed the drug and could not get treatment due to an inability to pay. Acthar's net price fell in 2019, he added, and the company expects the trend to continue this year.

For all three companies, executive pay plans incentivized the price hikes, the committee concluded.

The committee is releasing its findings after the late Rep. Elijah Cummings started a broad probe in January 2019. Lawmakers and staff reviewed 400,000 pages of internal documents from Amgen, 140,000 pages from Mallinckrodt and 100,000 pages from Novartis to inform the reports. Execs for the drugmakers are heading to the Capitol today to testify.

Thursday's reports follow similar documents, released on Wednesday, about actions by Celgene and Teva.

 

BUSINESS NEWS
SEPTEMBER 18, 2020
Milan judge seizes 2.3 million euros from Novartis in fraud probe
By Reuters Staff

MILAN (Reuters) - A Milan judge has seized 2.3 million euros ($2.7 million) from pharmaceutical multinational Novartis NOVS.S as part of a fraud investigation, a document seen by Reuters shows.

The money has been sequestered from the company’s Italian unit Novartis Farma SpA, suspected of selling medicines to hospitals at inflated prices as part of a scheme to fraudulently obtain reimbursement funds from the regional government.

Novartis said in a statement it rejected the “groundless” accusations of the Milan prosecutors and had behaved with full transparency.

Finance police conducting the investigation say that nine private hospitals in Milan took part in the scheme between 2013 and 2018, hurting the finances of the Lombardy region around Italy’s financial capital.

According to the seizure decree, seen by Reuters, the hospitals were reimbursed in full by the region, omitting to declare that the real price they paid was lower thanks to credit notes issued to them by the pharmaceutical companies.

The San Donato group, the company that runs the hospitals, already paid 10.2 million euros in damages to the Lombardy authorities in December last year.

The group, contacted by Reuters, did not comment.

Novartis said it was not aware of the economic or accounting arrangements in place between the hospitals it sells pharmaceuticals to and the regional governments they deal with.

Mylan Italia, the Italian unit of multinational pharmaceutical group Mylan MYL.O, is also among the companies involved in the investigation, the document shows.

The company has filed a plea bargain proposal for a fine of 200,000 euros and a confiscation of 1.2 million euros, according to a source with direct knowledge of the matter.

The request has received a green light from the public prosecutor’s office and it will now be up to a judge to decide whether to accept it, the source added.

Mylan Italia declined immediate comment.

 

NICE's thumbs-up on Lilly's migraine med Emgality leaves rivals from Novartis and Teva in the dust
by Arlene Weintraub
Nov 18, 2020 10:38am

NICE cited data showing that more people taking Emgality who suffer from episodic migraines had a 50% drop in average migraine days per month when compared to placebo. (Eli Lilly)
recommended that the country’s National Health Service (NHS) cover once-monthly injections of Lilly’s Emgality in patients with four or more migraines a month who have failed three other treatments.

That’s notable, given that Novartis’ rival CGRP inhibitor, Aimovig, was rejected by NICE last year. The agency did clear another drug in the CGRP class, Teva’s Ajovy, but with some major strings attached. NICE said Ajovy should only be used by patients who have 15 or more headaches per month for more than three months.

NICE’s recommendation of Emgality was based on clinical trials comparing the drug to placebo. Those trials showed that more people taking Emgality who suffer from episodic migraines had a 50% drop in average migraine days per month, while those with chronic migraine showed a 30% reduction in headache days.

NICE has expressed a preference for Allergan’s Botox in preventing migraines, but the agency conceded that Lilly’s clinical trials demonstrated that Emgality not only outperformed supportive care but also that it “is plausible that [Emgality] may work better than [Botox].”

RELATED: NICE rejects Novartis' Aimovig on data 'uncertainty' despite migraine benefits

No doubt price played a role in NICE’s decision. Emgality’s list price in England is £450 ($597) per injection, and Lilly gave an undisclosed discount to the NHS.

Novartis also offered the NHS a discount on Aimovig, but that wasn’t enough to alleviate NICE’s concern that the drug seemed to offer few clinical benefits over Botox. Patients often have to wait in line for Botox in England and endure multiple injections of it before they get any relief. Aimovig, on the other hand, can be self-administered. Still, NICE didn’t budge.

As for Teva’s Ajovy, its limited NICE approval might make it an option for just 10,000 people, NICE estimated. Lilly will likely have access to a much larger market: England’s Migraine Trust estimates there are more than 610,000 chronic migraine patients in the U.K.

“Migraine is an excruciating and debilitating neurological disorder that significantly impacts the lives of those who live with it. Access to preventive treatment that was developed to prevent migraine attacks will change many people’s lives,” the Migraine Trust said in a statement last month.

Lilly remains in a tight race with Teva and the team of Novartis and Aimovig’s U.S. marketer, Amgen, in the CGRP market. Emgality has brought in $252.9 million in sales so far this year, compared to $382 million for Aimovig and $98 million for Ajovy.

And in March, another competitor entered the CGRP race: Lundbeck. Its IV-administered option, Vyepti, launched in April.

Lilly continues to find new ways to make its migraine drug stand out in the market. In June, it unveiled new clinical trial data focused on “total pain burden,” which patients reported by measuring the severity of their migraines. Patients taking Emgality suffered 68.6 fewer hours of severe pain per month versus 36.2 hours for those on placebo, the company reported.

Now, Lilly is tracking reductions in total pain burden over two years, with the goal of providing strong real-world evidence for Emgality to patients who are thinking about switching from other medications.

 

Great leaders here. What a crew!

 

Novartis corrects idiot chairman's comments about kickbacks case
John Miller
March 24, 2021


By John Miller

ZURICH (Reuters) - Novartis on Wednesday had to correct comments made by Idiot Chairman Joerg Reinhardt to a Swiss newspaper, because his portrayal of conduct that led to a $678 million U.S. settlement over kickbacks last year risked violating the agreement.

Novartis's settlement with the U.S. Justice Department in July 2020 resolved decade-old charges that it organised thousands of sham events, lavished doctors with speaker fees and wined and dined them to boost drug prescriptions.


In a SonntagsBlick interview on March 6, however, Reinhardt objected when a reporter said Novartis had bribed U.S. doctors.

"I don't want to let the term 'bribery' stand without comment," Reinhardt told SonntagsBlick. "Doctors were invited to scientific events. We were possibly here and there too generous."

Reinhardt's moronic comments were inaccurate, said Novartis, whose Chief Executive Vas Narasimhan has prioritized boosting Novartis's ethics performance, including by revising bonus schemes, after scandals over two decades that have cost it some $2 billion hurt its reputation.

Mr. Reinhardt described the programs as scientific events and stated that the company may have been too generous on occasion to the doctors in attendance," Novartis said in a statement.

"These comments were inaccurate and inconsistent with the admissions of conduct that Novartis made in its settlement agreement."

Based on its commitments under the settlement, Novartis said it proactively contacted the U.S. Justice Department after concluding Reinhardt's interview comments were inaccurate and issued the correction after discussions with prosecutors over remedying the issue.

"Mr. Reinhardt's statements were not intended to minimize or dispute Novartis' admissions of conduct," Novartis said, adding that idiot Reinhardt also offered reassurances in the SonntagsBlick interview that the alleged U.S. practices 'are history and will not be repeated.' "

"Novartis reiterates fully the acknowledgements it made in its agreement," the company added.

In its U.S. settlement, Novartis was required to reduce paid-speaker programs and hold them virtually, to reduce potential improprieties.

(Reporting by John Miller;Editing by Elaine Hardcastle)

 

With all the stock buy backs Novartis has executed
& when Pharma's are making # hand over fist
with vaccines etc
Novartis stock languishes at a sub
$90 bargain basement joke

Or a ...sinking ship

Novartis Earnings, Sales Slightly Miss Q1 Views

 

Italy judge sends Bayer, Novartis to trial in drugs fraud probe: sources

Tue, April 27, 2021, 7:53 AM
By Emilio Parodi

MILAN (Reuters) - A Milan judge on Tuesday indicted the Italian units of Novartis and Bayer on charges of operating a scheme to cheat the regional public health service in Lombardy, legal and judicial sources said.

The charges revolve around allegations that the companies sold drugs to hospitals at inflated prices as part of a scheme whereby the hospitals then fraudulently obtained funds from the regional government.

The judge also accepted a settlement request by five hospitals belonging to the San Donato Group, one of Europe's largest private hospital groups, over their alleged involvement in the scheme, the sources said.

Under the settlement the hospitals will pay 200,000 euros ($241,360) each as an "agreed penalty".

San Donato - Italy's largest private healthcare group with 19 hospitals, more than 16,000 employees and 4.7 million patients each year - has already paid a total of 32 million euros in damages to Lombardy authorities.

The hospitals, including the renowned San Raffaele Institute in Milan, were accused of claiming reimbursement for drugs obtained from Novartis and Bayer between 2013 and 2018 in a fraudulent way, prosecutors' documents showed.

The prosecutors alleged that the hospitals charged the regional health service the full price for drugs which they had obtained at a lower price thanks to credit notes issued by the pharmaceutical companies, the documents said.

According to the prosecutors, Novartis and Bayer benefited from the scheme by offering the credit notes to San Donato on condition that the healthcare group made large purchase orders.

Bayer declined to comment on the matter on Tuesday, while Novartis said it acknowledged the judge's decision "with regret" and denied any wrongdoing in the case.

Novartis said it had always carried out transparent commercial relations with the San Donato Group, similar to those with other public and private health companies, in line with the company's policy and in full respect of current laws.

In September, a Milan judge seized 2.3 million euros from Novartis in relation to the investigation.

The trial will start on July 14 in Milan and will also include eight individuals, including a former executive and consultant for San Donato, a Bayer sales manager, a Novartis manager and two executives and a former employee of the Italian unit of pharmaceutical group Mylan, the sources said.

Mylan itself settled the case by paying a 200,000 euro fine and agreeing to a confiscation of 1.2 million euros. Mylan declined to comment on the matter.

At the end of Tuesday's closed-door hearing, Marco De Luca, the leading lawyer for San Donato, said the settlement reached with the healthcare group "seemed to be fair" as well as being the most useful outcome for everyone involved.

Settling a criminal case in Italy does not involve any admission of guilt or responsibility.

Under Italian law, companies are liable for any offences committed by their managers in their own interest.($1 = 0.8286 euros)

(Reporting by Emilio Parodi, editing by Giulia Segreti and Gareth Jones)

 

Yup Entresto aka Cherry flavored Diovan loses to 30 year old ACEI Ramipril

Amid impressive growth, Novartis' blockbuster Entresto falls short in post-heart attack trial
by Fraiser Kansteiner | Fierce Pharma
Apr 27, 2021 12:14pm

Novartis is banking on a broader label to expand the reach of its blockbuster heart med Entresto, but in patients who've suffered prior heart attacks, the drug just hit a setback.

In the phase 3 Paradise-MI trial, Entresto missed its primary endpoint to reduce the risk of cardiovascular death and heart failure after an acute myocardial infarction, Novartis quietly revealed in its first-quarter earnings statement. In the study, "numerical trends consistently favored" the drug against standard of care ramipril, but Entresto fell short of its goal. Novartis says it'll “continue to evaluate the data.”

“In light of the results, we are conducting additional analyses to understand the data fully in the context of Entresto’s clinical profile,” a Novartis spokesperson said via email. The company plans to roll out topline results at the American College of Cardiology 70th Annual Scientific Session on May 15.

 

Novartis catches chill as mask wearing keeps flu at bay
Reuters John Miller

Mask wearing during the pandemic kept the flu largely at bay this year, dampening Novartis's (NOVN.S) generic cough medicines business and helping drag the Swiss drugmaker's first-quarter profit below analyst expectations.

Novartis on Tuesday joined drugmakers including domestic rival Roche (ROG.S) in reporting drug sales, including for cancer and eye disease, had taken a hit as people skipped visiting the doctor during the coronavirus crisis. read more

In addition a historically weak cough-and-cold season, kept in check by broad mask wearing and social distancing, further dented Novartis's Sandoz generics unit that is also grappling with persistent price pressure from rivals.

"A really tough cough and cold season - you see that in record low influenza rates, which led to impacts on both Sandoz's anti-infectives business as well as OTC (over the counter) businesses across Europe," Novartis Chief Executive Vas Narasimhan told reporters on a call.

First-quarter core net income slipped 4% from a year earlier to $3.4 billion, compared to the $3.5 billion average analyst estimate in a Refinitiv poll. Sales were 1% higher at $12.4 billion, compared to the $12.5 billion forecast.

Net income fell 5% to $2.06 billion.

Sandoz sales slid 9% to $2.3 billion, with core operating income tumbling 34% to $445 million. Narasimhan expects Sandoz full-year revenue to shrink in the low- to mid-single-digit percentages, from a previous target of little changed growth.

Novartis confirmed its overall 2021 outlook, which foresees sales growing at low- to mid-single-digit percentages, with core operating income seen growing at a mid-single-digit percentage rate.

While Novartis has no vaccine business, it is helping bottle mRNA vaccines against COVID-19 for Germany's BionTech (5CV.DE) and has a deal to make 50 million doses of CureVac's (5CV.DE) coronavirus vaccine in 2021 and up to 200 million doses in 2022.

With CureVac now poised for a European regulatory decision next month, Narasimhan said Novartis could boost production beyond levels agreed so far.

"If it were required... we feel confident we could supply additional vaccine doses," Narasimhan said.

 

Dutch advisory group says Zolgensma shouldn’t be covered unless Novartis halves price
By Ed Silverman May 10, 2021
In a challenge to Novartis (NVS), a Dutch advisory body has recommended that the government not cover the cost of the Zolgensma gene therapy unless the company cuts the price in half and agrees that it will not get paid without a so-called pay-for-performance arrangement.

The National Health Care Institute, known as Zorginstituut Nederland, explained in a statement that Zolgensma, which is used to treat a type of spinal muscular atrophy that is generally fatal in children, is a “promising drug. But the results of the research do not yet show that convincingly and do not justify the high price that the manufacturer asks for it.”

 

U.S. Supreme Court snubs Novartis appeal over arthritis drug Enbrel
By Syndicated ContentMay 17, 2021 | 9:06 AM

By Andrew Chung

(Reuters) – The U.S. Supreme Court on Monday dashed Novartis AG’s hopes of launching a generic version of Amgen Inc’s multibillion-dollar rheumatoid arthritis Enbrel, declining to hear the company’s challenge to two patents on the drug.

The justices turned away Novartis subsidiary Sandoz Inc’s appeal of a lower court decision that upheld the validity of the patents.

Enbrel, a biologic also known as etanercept used to treat adults with moderate to severe active rheumatoid arthritis, is Amgen’s top-selling drug, accounting for nearly $5 billion of the company’s $24.2 billion in product sales for 2020. Enbrel was launched in 1998 by Immunex Corp, which Amgen acquired in 2002.

At issue in the case is a principle of U.S. patent law that prevents inventors from extending the life of their existing patents by obtaining more than one patent on the same invention, or an obvious variation of it.

The case involves the active ingredient in Enbrel. After Sandoz sought to market Erelzi, a generic version of Enbrel, Immunex sued in 2016 for patent infringement.

Sandoz accused Immunex of impermissibly extending the life of its monopoly on Enbrel through a 2004 deal that effectively took over rival Roche’s patent applications on similar research and amended them to cover Enbrel. The successful applications now protect Enbrel from competition until 2029.

In 2020, the Washington-based U.S. Court of Appeals for the Federal Circuit, which specializes in patent cases, rejected Sandoz’s argument, saying that Roche did not transfer all of the rights to the new patents to Immunex.

(Reporting by Andrew Chung in New York; Editing by Will Dunham)

 

Slashing 186 jobs, Novartis hands off U.S. sales, marketing duties for migraine med Aimovig to Amgen
by Noah Higgins-Dunn |
Jun 15, 2021 11:40am

Novartis said it will hand off shared Aimovig U.S. operations over to Amgen and slash 186 jobs. (Novartis)

Novartis and Amgen were the first onto the CGRP scene with migraine drug Aimovig, but tensions ensued shortly into the drug's launch as both partners filed dueling lawsuits against each other. But now with the migraine market becoming increasingly crowded, Novartis will cede U.S. Aimovig operations over to Amgen.

Novartis will hand previously shared joint U.S. business operations for Aimovig over to Amgen, including, but not limited to, sales, marketing and medical support functions, a spokesperson said on Tuesday.

As a result, Novartis will slash 186 jobs supporting Aimovig. Those include brand marketing and field sales positions that report to Novartis' U.S. headquarters in East Hanover, New Jersey. The layoffs, effective in September, were first filed on the state's Worker Adjustment and Retraining Notification website. Novartis' spokesperson said the move will "enhance operational efficiencies in the increasingly competitive migraine space."

Financial aspects of the U.S. collaboration, including "sharing the commercialization costs and receiving royalties on sales," will remain in tact. Novartis will also retain the right to sell Aimovig outside of the U.S., except in Japan.

The move comes amid a court battle between the two drugmakers dating back to early 2019. Novartis first sued Amgen in Manhattan federal court for trying to inappropriately back out of their collaboration. Amgen originally had rights to the drug, but Novartis in 2015 partnered on Aimovig and spent more than $800 million on its development and commercialization, the lawsuit said.

Amgen sued back, arguing that Novartis breached the agreement by helping bring a potential competitor to market. Novartis' Sandoz unit teamed with Alder BioPharmaceuticals on a rival CGRP drug known as eptinezumab. Lundbeck snapped up that drug, now FDA approved and sold as Vyepti, as part of its $2 billion buyout of Alder BioPharmaceuticals in late 2019.

Novartis' latest move is for efficiency's sake and "does not resolve the litigation Novartis currently has with Amgen," the spokesperson said. The Swiss drugmaker said two claims in its U.S. litigation against Amgen related to commercialization expenses and the drug's launch will be resolved while the others remain pending.

RELATED: Novartis, shrinking 19% of its workforce, faces big challenges with thinned ranks

While Aimovig may have been the first preventative CGRP-target migraine therapy to score an FDA approval in 2018, it's since been followed by a slew of rival treatments. In the injectable monoclonal antibody market, Aimovig competes with Teva’s Ajovy and Eli Lilly’s Emgality. But while Aimovig had a head start, Eli Lilly's rival has since passed the first-mover in quarterly sales. Emgality generated $119 million during the first quarter, compared with $66 million for Aimovig.

Meanwhile, Biohaven Pharmaceutical's oral Nurtec ODT became the first FDA-approved option to both prevent and treat migraines in late May. The FDA is also reviewing an oral drug from AbbVie, known as atogepant, for the prevention of migraines. AbbVie's Ubrelvy won FDA approval in late 2019 as an acute treatment option.

The Novartis layoffs come amid a four-year restructuring process initiated in 2018 by CEO Vas Narasimhan. At the time, the Novartis chief outlined plans to reduce the company's overall footprint by at least 19%, from 124,000 employees to under 100,000 by 2022. The drugmaker currently has about 110,000 employees globally.

 

So, another 10,000 jobs to be cut. Anyone nervous yet?

 

Against Novartis ......of course

Novartis hit with $178 million verdict in cancer drug patent dispute

 

The strategy reduction started in 2018 to go from 124k employees to less than 100k by 2022. Here’s the article discussing this from Vas:

https://www.fiercepharma.com/pharma/novartis-slims-down-business-services-efficiency-unit-a-bid-to-ax-19-its-workforce

 

The Novartis layoffs come amid a four-year restructuring process initiated in 2018 by CEO Vas Narasimhan. At the time, the Novartis chief outlined plans to reduce the company's overall footprint by at least 19%, from 124,000 employees to under 100,000 by 2022. The drugmaker currently has about 110,000 employees globally.

That's the last paragraph of the article from above. Clearly states it started in 2018. Clearly says currently 110,000 employees. Clearly states goal is 100,000 by 2022.

Do the math!

 

LOL @ NVS Legal Eagles XD

Novartis on the hook for $178M after losing Tafinlar patent fight with Daiichi's Plexxikon business
by Kevin Dunleavy |
Jul 23, 2021 6:30am

Competing skin cancer drugs were at issue in Plexxikon's patent infringement lawsuit against Novartis. (iStockPhoto)
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A Northern California jury ruled in favor of Daiichi Sankyo’s Plexxikon Inc., finding that Novartis infringed on two patents for a skin cancer drug. The jury awarded Plexxikon $177.8 million, but Novartis could be on the hook for much more.

The case, which was filed four years ago, surrounded the development of Plexxikon’s melanoma treatment Zelboraf and GlaxoSmithKline’s melanoma therapy Tafinlar. In 2015, GSK traded the drug, along with other cancer assets, to Novartis.

According to Durie, Plexxikon will receive royalty payments for future sales of Tafinlar. Additionally, because the jury found that the infringement was “willful,” the award could be increased up to threefold.

A Novartis spokesperson said in an email that the company is considering options, including an appeal, "but otherwise can't comment on ongoing litigation."

Plexxikon argued that more than a decade ago, GSK scientists acquired knowledge to develop Tafinlar after consulting with Plexxikon in potential partnership talks, which never materialized into a deal.

“Evidence came in at trial that the GSK inventor had looked at Plexxikon patent applications disclosing the core structure of the molecule before shifting the program focus in a way that ultimately led to the infringement,” Durie wrote.

Novartis had challenged the validity of the patents, contending that GSK was first with the invention.

Plexxikon filed for its patents in 2005 and won approval for Zelboraf in 2011. Roche secured marketing rights to the drug in 2006. GSK applied for its patents on Tafinlar in 2008 and captured a 2013 approval.

Once it reached the market, Tafinlar quickly overtook Zelboraf. By 2016, for example, when Zelboraf registered sales of $218 million, Tafinlar earned $672 million. Last year, as a combination treatment with another Novartis drug, Mekinist, Tafinlar rang up sales of more than $1.5 million.

Zelboraf and Tafinlar inhibit the growth of cancer cells that have a mutated form of the BRAF gene. According to the original complaint, Plexxikon’s patents were for a class of "BRAF kinase inhibitors which selectively bind to the BRAF kinase that results from the V600E mutation.”

“Genus patents—like those in the lawsuit—are routinely used to prevent competitors from knocking off our scientific innovations with slight molecular changes," said Plexxikon CEO Chao Zhang in a release. "We are gratified that the jury upheld their validity, protecting our investment.”

 

Novartis falls behind rivals in race to bring CAR-T to early lymphoma
Published Aug. 24, 2021

Ben FidlerSenior Editor

• Novartis' cancer cell therapy Kymriah didn't outperform standard treatment in a late-stage study of patients with relapsed or refractory lymphoma, a setback in the company's plans to expand the drug's use into earlier lines of care.
• Without providing details, the Swiss pharmaceutical giant announced Kymriah couldn't cut the risk of disease progression or death, the study's main goal, compared to treatment with chemotherapy and a stem cell transplant. Side effects were consistent with what's been observed with Kymriah, the company said in a statement. Novartis will present detailed findings at a future medical meeting.
• The disappointing results put Novartis behind top rivals Gilead and Bristol-Myers Squibb in the race to bring CAR-T treatments into earlier disease settings, a key way to help broaden their reach. Since June, both Gilead's Yescarta and Bristol Myers' Breyanzi have each succeeded in similar trials.

 

Novartis Under New DOJ Scrutiny Over Potential Kickback Allegations
Published: Oct 28, 2021 By Alex Keown



Harold Cunningham/Getty Images

A little more than a year after Novartis' generics unit Sandoz paid the U.S. government $195 million to settle price-fixing charges, the company is once again in the crosshairs of a federal investigation. This time over its blockbuster cardiovascular drug, Entresto.

Buried in its quarterly financial earnings report (page 36) released earlier this week, Novartis noted that it is the subject of a DOJ inquiry over the company’s marketing and pricing of Entresto over the past five years, receiving a Civil Investigative Demand from the government. The Swiss pharma giant specifically noted that the government is seeking information regarding “remuneration provided to healthcare professionals,” meaning kickbacks paid to the doctors to prescribe the drug.

Novartis is no stranger to kickback allegations. Not only did Sandoz pay out $195 million to settle price-fixing allegations last year, but the parent company also paid more than $642 million in multiple settlements last year to resolve government charges that the company violated the False Claims Act.

Novartis has agreed to pay $51.25 million to resolve allegations that it illegally paid the copay obligations for patients taking its drugs in the first settlement. That agreement was related to the company’s alleged illegal use of three foundations as conduits to pay the copayments of Medicare patients taking Novartis’s drugs Gilenya, a multiple sclerosis drug, and Afinitor, which is prescribed for advanced renal cell carcinoma. Federal law prohibits companies and organizations from providing payment for a Medicare copay to secure prescriptions for a particular drug.

The second settlement resolves claims arising from the company’s alleged payments of kickbacks to doctors. To satisfy that claim, Novartis agreed to pay the government $591,442,008 to resolve allegations that the company provided kickbacks to doctors to encourage them to prescribe a slew of medication developed by the company, including Lotrel, Valturna, Starlix, Tekturna, Tekturna HCT, Tekamlo, Diovan, Diovan HCT, Exforge and Exforge HCT.

Novartis will forfeit $38.4 million under the Civil Asset Forfeiture Statute, according to the DOJ.

In 2015, the company also paid out $390 million to settle a civil lawsuit related to the kickback payments to specialty pharmacy companies that distributed Exjade and Myfortic.

Entresto is one of the company’s biggest revenue drivers. According to its quarterly report, Entresto sales increased 41% to bring in $2.6 billion for the company over the first nine months of 2021. Analysts predict the drug could generate $5 billion in sales before it loses exclusivity in four years.

Novartis said it is currently evaluating the Department of Justice’s inquiry.

Novartis announced plans to conduct a strategic review of its Sandoz unit in its quarterly report, which could mean a potential sale. Sandoz is Novartis’ generics business and is also the company’s business unit for the development of biosimilar drugs. The review will explore all options, including retaining the business to complete separation.

Novartis also noted scrapping clinical trial plans for its experimental Rett Syndrome gene therapy, OAV201. The company will continue to explore additional options to treat the genetic disease. OAV201 was initially developed by AveXis, which Novartis acquired. AveXis, now known as Novartis Gene Therapies, is the same company that developed Zolgensma, the approved gene therapy for spinal muscular atrophy.

Preclinical data for OAV201 failed to live up to expectations, Novartis said in its report.

 

The only thing worth a damn it's entire pathetic portfolio
&/or perhaps raise cash for it's future fines
( think Entresto lawsuit / 4x repeat offender & 2x CIA violator)

Novartis cuts uneasy 20-year ties to Roche with $20.7 billion voting stake sale