Novartis milestones be proud ! Management take a bow !

[fevipiprant fails]

Novartis' asthma drug fails in phase 3, raising doubts about Gossamer's prospects
by Nick Paul Taylor |
Oct 22, 2019 3:45am

Novartis is continuing with two other phase 3 trials of fevipiprant. (Novartis)
results (PDF). Fevipiprant failed to improve lung function, as measured by FEV1, over placebo in either clinical trial.

The trials each enrolled around 700 patients with uncontrolled asthma and randomized them to take either fevipiprant or placebo once a day on top of standard of care treatment. The primary endpoint looked at change in FEV1 after 12 weeks. Novartis is yet to comment on the secondary endpoints, which tracked metrics including daytime asthma symptom score and quality of life.

Novartis’ brief statement intensifies the doubts raised by its phase 2b. Fevipiprant improved FEV1 at 12 weeks over placebo in the phase 2b, but details of the data, such as the lack of dose response, left scope to doubt whether it would succeed in phase 3. Analysts at Jefferies assigned a 30% probability of success, in part because of the failure of AstraZeneca and Amgen’s DP2 candidates.

The addition of fevipiprant to the list of DP2 failures could have negative implications for Gossamer Bio, which has a DP2 antagonist in phase 2b. When Gossamer raised $276 million in an IPO earlier in the year, it said Novartis’ fevipiprant phase 2 had clinically validated DP2 antagonism. That statement now looks premature, particularly when viewed in light of the failures of other DP2 drugs.

Gossamer expects to perform an interim analysis on its asthma phase 2b in the first half of 2020, with full top-line results to follow in the second half of the year. A failure there could sound the death knell for the DP2 antagonist class. The biotech's shares were down more than 30% premarket, as investors read this as a negative read-through.

Novartis is continuing with two other phase 3 trials that are looking at the effect of fevipiprant on moderate-to-severe asthma exacerbations. Top-line data are due in the first quarter.

 

[Novartis Charity Scam]

Novartis PR spin "Because everyone else was doing it"

Two charities to pay $6 million to resolve U.S. pharma kickback probe

Nate Raymond

BOSTON (Reuters) - Two charities will pay $6 million to resolve claims they operated as pass-throughs for seven pharmaceutical companies to pay kickbacks to Medicare patients using their high-priced medications, the U.S. Justice Department said on Friday.

The settlements with the patient assistance charities Good Days and Patient Access Network Foundation were the first to be reached with foundations linked to an industry-wide probe that has resulted in $840 million in settlements with drugmakers.

Both of the foundations provide assistance to patients seeking to pay out-of-pocket costs for medications. Good Days agreed to pay $2 million while PAN Foundation agreed to pay $4 million. Neither admitted wrongdoing.

Good Days in a statement said the settlement will allow it to concentrate on providing help to people in need of life-saving medications. PAN said the settlement involved “legacy matters” rather than its current operations.

Drug companies are prohibited from subsidizing co-payments for patients enrolled in the government’s Medicare healthcare program for those aged 65 and older. Companies may donate to non-profits providing co-pay assistance as long as they are independent.


But the government has alleged that various drugmakers have used charities like Good Days and PAN as means to improperly pay the co-pay obligations of Medicare patients using their drugs, in violation of the Anti-Kickback Statute.

The department said Good Days, previously known as the Chronic Disease Fund, from 2010 to 2014 conspired with companies including Novartis AG, Astellas and Questcor, now owned by Mallinckrodt Plc, to pay kickbacks to Medicare patients.

PAN similarly permitted four companies including Bayer AG , Astellas, Dendreon Pharmaceuticals and Amgen Inc to use it as a conduit to pay patients kickbacks, the government alleged.

Astellas and Amgen in April agreed to pay $100 million and $24.75 million, respectively, to resolve related claims. Mallinckrodt is fighting a lawsuit by the Justice Department over its donations to Good Days and denies wrongdoing.

Representatives for the other companies did not immediately respond to requests for comment on Friday.

 

[anonymous]

It seems that we don’t get out of one to get into another.

 

[anonymous]

Vas is very happy this news came out after 3Q earnings release

 

[Novartis Settles Case]

Pharmaceutical companies settle state lawsuit for $242 million

October 28, 2019
https://advantagenews.com/api/content/89cf0636-f98a-11e9-8df5-1244d5f7c7c6/

Attorney General Kwame Raoul announced he has recovered $242 million for the state of Illinois in a settlement with numerous drug companies, which resolves allegations the companies inflated wholesale prices used in setting the rates for Medicaid reimbursements.

The companies are Abbott Laboratories Inc., Aventis Pharmaceuticals Inc., Aventis Behring LLC, n/k/a ZLB Behring; B. Braun Medical Inc., Forest Laboratories Inc., GlaxoSmithKline LLC, Johnson & Johnson Inc., Janssen Pharmaceutical Products LP, McNeil-PPC Inc., Ortho Biotech Products LP, Ortho-McNeil Pharmaceutical Inc., Novartis Pharmaceuticals Corp., Pfizer Inc., Pharmacia Corp. and TAP Pharmaceutical Products Inc. This is the final settlement in the attorney general’s lawsuit against about four dozen drugmakers for fraudulently inflating prices for prescription medications. The Attorney General’s Office has recovered more than $678 million in settlements from the suit.

“These companies engaged in a deceptive and illegal scheme to manipulate the drug pricing system to boost their own earnings, and the people of Illinois paid the price,” Raoul said. “I am pleased that we were able to hold them accountable for their actions and recover $678 million for the state. My office is committed to continuing to fight on behalf of consumers to stop unfair conduct by drug companies.”

In 2005, the Attorney General’s Office filed a lawsuit against the drug companies for deceptive practices related to the average wholesale price of numerous prescription drugs. The lawsuit alleged drugmakers fraudulently published inflated average wholesale prices seeking larger profits for themselves. State Medicaid programs use the average wholesale price to determine reimbursement amounts for drugs prescribed to Medicaid patients. The lawsuit alleged the inflated prices have resulted in overpayment in drug costs by the state of Illinois. The Oct. 28 settlement resolves the 2005 lawsuit.

 

[Zolgensma study halted]

HEALTH NEWS
OCTOBER 30, 2019 / 5:15 AM
Novartis' Zolgensma study halted by FDA amid safety questions

John Miller

ZURICH (Reuters) - U.S. regulators have halted a trial of Novartis’s Zolgensma treatment after an animal study raised safety concerns, the company said on Wednesday, in a setback for the drugmaker’s plan to expand its use to older patients.
The U.S. Food and Drug Administration’s partial hold on the so-called STRONG trial impacts patients aged up to five with spinal muscular atrophy (SMA) who were to receive a higher dose of the gene therapy via a spinal infusion.

The hold was issued after Novartis told health authorities about the animal study’s findings that showed dorsal root ganglia (DRG) mononuclear cell inflammation, a neurological condition sometimes accompanied by nerve damage or loss.

Novartis shares fell 1% at 0715 GMT, while other European drugmakers rose. Analysts said more information was needed to assess whether these findings could have an impact on Zolgensma’s long-term prospects.

“We need to better understand, what the issues are and whether there really is a read-through to the human trial,” Vontobel analyst Stefan Schneider said.

Novartis said it was working with regulators, in hopes of having the hold released.

Zolgensma, whose $2.1 million list price makes it the world’s most-expensive treatment, is already approved for children aged up to two with the deadly muscle wasting disease and is given by infusion into the young patients’ veins.

The medicine had $160 million in sales in its first full quarter on the market.

The STRONG study is meant to underpin its expanded approval for older children, where Novartis would also compete with Biogen’s Spinraza that is already on the market, and Roche’s investigational risdiplam that is due to seek approval this year.

Roche shares were up 0.7%.

“The clinical significance of the DRG inflammation observed in this pre-clinical animal study is not known and was not seen in prior animal studies,” Novartis said in a statement.

“We are working with health authorities to confirm further guidance to clinical investigators.”

The partial FDA hold halts enrollment of patients getting a higher dose of Zolgensma, also known as AVXS-101, via an spinal infusion, also called intrathecal administration.

Low- and mid-dose portions of the STRONG trial have already been completed, as has presentation of interim results.

“Of note, we have completed a thorough review of human safety data from all available sources to date and no adverse effects related to sensory changes have been seen,” Novartis said.

 

[Another Zolgen red flag]

Another Zolgensma red flag, another delay in data reporting at Novartis’ AveXis
by Angus Liu |
Oct 31, 2019 11:42am


Turns out, there was another delayed data reporting at Novartis’ AveXis for Zolgensma, once again putting the gene therapy unit’s data management into serious question.

Wednesday, Novartis said the FDA had halted enrollment in a phase 1/2 trial testing Zolgensma’s spinal-injection delivery after preclinical data showed a safety red flag. The thing is, the signal wasn’t so new—seven months old to be exact.

The issue was in fact uncovered in March and should have been included in the investigator brochure in a planned annual update in September. However, “a mistake was made” and the information was left out, a Novartis spokesperson confirmed to FiercePharma

Once the missing data were identified, Novartis notified investigators and the FDA “in a timely manner” at the end of last week, the spokesperson said.

According to analysts at Guggenheim Partners, the preclinical trial in question was carried out to examine the potential impact of a contrast agent used to guide injections into the spine. It involved 12 monkeys and it turned up spinal-cord inflammation and neuronal cell degeneration, the Swiss drugmaker said. The condition can be associated with sensory changes.

The FDA’s Wednesday order stopped enrollment in the Strong trial's high-dose group, but only because the low- and mid-dose cohorts are already fully recruited. So far, 32 patients have received Zolgensma via spinal injection in the study, including a small number of patients in the high-dose cohort. So far, none of those patients have symptoms of the problems found in monkeys, Novartis said.

The study is key to Novartis’ plan to expand Zolgensma into patients older than 2 years of age. Zolgensma as an intravenous infusion is currently only approved in spinal muscular atrophy patients younger than 2, and older patients represent a bigger market.

As Evercore ISI analyst Umer Raffat sees it, the high dose is the key focus for Zolgensma’s success for older patients via spinal injection. In patients between 2 to 5 years of age, clinical improvement was “more marginal” on the two lower doses, versus a “clear” improvement with the two dosing strengths in younger patients, he said in a Wednesday note to clients.

New safety findings are not uncommon during the drug development process. That’s why the FDA is asking trial sponsors—usually drug companies—to alert the agency and investigators with new important safety information and to update their investigator brochures on an ongoing basis, as mandated by federal regulations.

While new findings that represent a significant risk to study subjects require an immediate update, other changes can be made on an annual basis.

Novartis found out about the missing update during its ongoing investigation of AveXis data integrity, as it promised the FDA in the wake of the Zolgensma data manipulation scandal and the Form 483 posted by the FDA soon after.

As the FDA announced in August, some mouse testing data in Zolgensma's application package were falsified. Rather than immediately alert the FDA when it confirmed the data-tampering, Novartis sat on the information while it continued investigating for more details. The company finally told the FDA a month after the drug was approved.

The delay raised eyebrows as critics suggested the company deliberately withheld the intel so that Zolgensma could be approved on time.

In response to the Form 483 issued in August, Novartis said it is addressing the gaps in AveXis’ data integrity and documentation practices. It started a data integrity remediation plan, including a “comprehensive investigation into the extent of the inaccuracies in data records and reporting.”

At least this time, the company’s alert to the FDA came in the middle of a clinical trial and before any regulatory decision is made. The company said it’s working with the agency to confirm further guidance to clinical investigators.

 

[Cosentyx Fails]

HEALTH NEWS
NOVEMBER 1, 2019 / 2:48 AM / UPDATED AN HOUR AGO
Novartis arthritis drug falls short in challenge to global bestseller

John Revill, Ludwig Burger

ZURICH/FRANKFURT (Reuters) - Novartis said a trial fell short of producing statistical evidence that its anti-inflammatory drug Cosentyx can beat the world’s best-selling drug Humira in treating a type of arthritis.

The Swiss pharma giant said on Friday that Cosentyx, used in a trial to treat active psoriatic arthritis, yielded “numerically higher results versus Humira” but the statistical readout was not reliable enough to count as evidence.

The Swiss group said that Cosentyx, its second-bestselling drug with $2.8 billion in revenue last year, “narrowly missed statistical significance for superiority” over Humira, a drug made by AbbVie..

Cosentyx is already approved for use in psoriatic arthritis, psoriasis and other conditions, and a clear win over auto-immune disease treatment Humira would have boosted its sales prospects.

Still, Novartis said it hoped the full trial data on easing symptoms such as tender or swollen joints, to be disclosed later at a medical conference, would convince physicians.

“We view the results as confirming our vision of Cosentyx becoming standard of care in psoriatic arthritis,” said Eric Hughes, the company’s head of development in immunology, hepatology and dermatology.

The drugmaker has said it believes its product could achieve peak annual sales of $4 billion to $5 billion thanks to its broad potential.

Abbvie’s Humira, in turn, chalked up close to $20 billion in sales in 2018, but the drug has come under fire from cheap rivals in Europe and faces a loss of patent protection in the United States in 2023.

Psoriatic arthritis affects around 50 million people worldwide.

This week U.S. regulators halted a trial of Novartis’s Zolgensma treatment after an animal study raised safety concerns.

In other setbacks, Novartis’s heart failure drug Entresto failed a trial in a new use, the Swiss drugmaker said in July, calling into question billions of dollars in potential revenue and taking the shine off one of the company’s biggest growth prospects.

 

[Novartis dumps asthma]

Novartis dumps asthma program after another set of phase 3 flops
by Nick Paul Taylor |
Dec 16, 2019 5:29am

In October, Novartis revealed fevipiprant had failed to improve lung function, as measured by FEV1, over placebo in two phase 3 trials that enrolled patients with moderate, uncontrolled asthma. The blow left Novartis looking to a pair of trials in moderate-to-severe asthma exacerbations for results to support approval of the drug, which some analysts have tipped as a blockbuster.

Now, Novartis has shared top-line data from the two asthma exacerbation trials. Pooled analyses of the data showed neither dose of fevipiprant met “the clinically relevant threshold for reduction in rate of moderate-to-severe exacerbation compared to placebo over a 52-week treatment period.”

Novartis will share the numbers from the study at an upcoming medical congress. Whatever the trial found was bad enough for Novartis to kill fevipiprant in asthma on the grounds that “the totality of these results do not support further development.”

That conclusion is the latest in a series of blows for the hypothesis that DP2 antagonism can improve outcomes in asthma. DP2 is a receptor involved in inflammatory processes behind allergic asthma, a function that raised hopes a new class of drugs against the target could help the large numbers of patients whose conditions are poorly controlled by current treatment options. Those hopes have been hurt by clinical failures at Amgen, AstraZeneca and now Novartis.

Gossamer may deal a further blow to the DP2 hypothesis when it shares an interim analysis from a phase 2b trial next year. The potential of Gossamer’s DP2 drug, GB001, led investors to power the biotech to a $276 million IPO. Shares in Gossamer have risen around 50% since Novartis shared data on its first set of phase 3 fevipiprant flops, but fell more than 30% in early trading Monday morning on the news.

On the flipside, if Gossamer can guide GB001 to market, it will not face competition from fevipiprant in asthma. Novartis still retains an interest in DP2, though, noting the educational value of the phase 3 flops.

“While the results of the LUSTER studies with fevipiprant are disappointing, they meaningfully contribute to our understanding of the DP2 pathway in asthma,” John Tsai, head of global drug development and chief medical officer at Novartis, said in a statement.

 

[Aduro stung]

Aduro stung as Novartis drops work on STING drug
by Ben Adams |
Dec 18, 2019 9:10am

SEC filing, Aduro said Novartis “has removed ADU-S100 (MIW815), an intratumoral STING pathway activator product candidate, from its portfolio based on clinical data generated to date,” adding that this wasn’t due to safety concerns.

Novartis spent $750 million on a pact with Aduro in 2015 but will now be halting early-stage combo tests it had undertaken with ADU-S100 based on lackluster clinical data to date.

But the drug is not completely dead: Aduro said an ongoing phase 2 for ADU-S100 alongside Merck’s Keytruda as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma continues.

“Aduro is also preparing to initiate a clinical trial of ADU-S100 as an intravesical monotherapy for non-muscle invasive bladder cancer (NMIBC) in the second half of 2020,” the biotech said in the SEC filing, but these are now funded only by Aduro.

The biotech noted that the “collaboration and license agreement between Novartis and Aduro otherwise remains in effect, and both parties continue to jointly pursue STING pathway activation through systemic delivery as a therapeutic strategy.”

Back in January, Aduro hit the reset button, laying off about 37% of its workforce to throw all of its resources behind a handful of lead programs: namely, those assets that target the STING pathway, including ADU-S100, and APRIL pathways, both of which target cancer.

 

[LAWYERS Investigate NVS]

ROSEN, NATIONAL TRIAL LAWYERS, Continues to Investigate Securities Claims Against Novartis AG – NVS

GlobeNewswire
December 27, 2019
On August 6, 2019, the U.S. Food and Drug Administration (“FDA”) issued a statement revealing that data submitted in the Company’s biologics license application (“BLA”) for its gene therapy drug, Zolgensma, had been manipulated. Moreover, it stated that Novartis “became aware of the issue of the data manipulation that created inaccuracies in their BLA before the FDA approved the product, yet did not inform the FDA until after the product was approved.” Novartis is currently being investigated by the FDA and may be subject to further penalties.

On this news, Novartis’ share price fell $2.50 per share, or nearly 3%, to close at $88.22 on August 6, 2019, thereby injuring investors.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has secured hundreds of millions of dollars for investors.

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

 

[Price Gouging]

Novartis, Merck and Allergan join those raising U.S. drug prices for 2020

Michael Erman


NEW YORK (Reuters) - Novartis AG, Merck & Co Inc and Allergan Plc were among companies that raised U.S. prices on more than 100 prescription medicines on Friday, bringing the tally to 445 drugs that will cost more in 2020, according to data analyzed by healthcare research firm 3 Axis Advisors.

That is above the average of 404 drug price increases in the first three days of January over the past five years. Nearly all of the price increases are below 10%, with the median price increase around 5%, according to 3 Axis.

Swiss drugmaker Novartis raised prices on nearly 30 drugs including psoriasis treatment Cosentyx and multiple sclerosis medicine Gilenya, 3 Axis said. Most of those increases were in the range of 5.5% to 7%.

Novartis said that while it is raising the list prices of about 7 percent of its U.S. medicines, after discounts and rebates to commercial and government payers it expects a net price decrease of 2.5% in 2020.

Soaring healthcare costs for U.S. consumers, and prescription drug prices in particular, are expected to again be a central issue in the 2020 presidential campaign for both parties. President Donald Trump, a Republican who made bringing them down a core pledge of his 2016 campaign, is running for re-election in 2020.


Under pressure from politicians and patients, many makers of branded drugs have pledged to keep annual U.S. price increases below 10% a year.

Prescription drug prices are higher in the United States than most developed countries where governments directly or indirectly control the costs, making it the world’s most lucrative market for manufacturers.

 

[Price Gouging 2020]

HEALTH NEWS
JANUARY 24, 2020 / 11:39 AM / UPDATED 5 HOURS AGO
Novartis, GBT sickle cell drugs too expensive, draft U.S. report says

John Miller

ZURICH (Reuters) - Sickle cell disease drugs made by Novartis and Global Blood Therapeutics (GBT) may not be cost effective at current prices, a draft report published on Friday suggested, widening the debate over U.S. healthcare affordability.

Novartis and GBT disputed the preliminary conclusions by the
Boston-based Institute for Clinical and Economic Review (ICER). The institute scrutinised Novartis’s Adakveo and GBT’s Oxbryta, both approved last year, and Emmaus Medical’s Endari, to treat the inherited disease that disproportionately affects African Americans.

The finding that the costs of all three medicines would likely have to be slashed to achieve acceptable cost-effectiveness thresholds comes as Congress and U.S. President Donald Trump weigh action over high healthcare costs.

Insurers and governments use privately funded ICER’s conclusions to help set reimbursement rates.

ICER said it concluded that Adakveo’s annual cost should be $25,410, down from an estimated $88,000 bill, and that Oxbryta must be trimmed to $9,218 from about $84,000, to meet cost-effectiveness thresholds. Endari must be cut to $3,859 from $24,000 to be cost-effective, the group added.

“Treatment costs were the main driver of the cost-effectiveness results,” said ICER, which is taking public comment until Feb. 20 before final publication this year.

Shares in GBT fell more than 5.5% on Friday, while Novartis shares closed 0.3% lower.

ICER seeks to measure how many years of good health - a quality-adjusted life year, or QALY - may be gained with a new treatment, and the incremental cost for that health gain.

At the current estimated costs for Adakveo, Oxbryta and Endari, all the QALYs exceeded $1 million, ICER said, well above the $150,000 the group ordinarily considers an appropriate cost-effectiveness threshold.

 

[Novartis Exec GUILTY]

"Unbossed"

Former Novartis exec pleads guilty in generics price-fixing conspiracy
by
Kyle Blankenship |
Feb 18, 2020 10:10am

Hector Armando Kellum was charged for his role in an industrywide price-fixing scheme between 2013 and 2015. pleaded guilty Friday to federal conspiracy charges for his role in a scheme to fix prices for a range of the drugmaker's products, including topical steroid clobetasol and antifungal nystatin triamcinolone cream.

Kellum faces 10 years in prison and a $1 million fine, prosecutors said in a release. In exchange for his plea, Kellum agreed to cooperate with the ongoing federal investigation.


Kellum's plea has now confirmed Sandoz's role in the scheme––easily the biggest company so far––but more generics giants could be in the firing line as the lineup of cooperating witnesses expands.

Kellum's deal comes just two weeks after prosecutors snagged a guilty plea from Ara Aprahamian, a former sales executive at Taro Pharma. Aprahamian pleaded guilty Feb. 4 to three counts of conspiring to fix prices for the company's generic drugs and lying to investigators.

 

[safety scare]

February 25, 2020
Safety scare knocks Novartis

• 
• Amy Brown

Heightened Beovu safety concerns could turn into a big problem for Novartis, while rival Regeneron will make the most of any uncertainty.
Trial Results

On a day when the markets were already trading down on jitters about coronavirus, the American Society of Retina Specialists added to the gloom for Novartis investors. A note to eye doctors warning about worrying side effects seen with the Swiss pharma giant’s new macular degeneration treatment, Beovu, helped wipe $15bn from the company’s market cap yesterday. Today, the shares were down a futher 4% in late trading.

Beovu is seen as one of Novartis’s most important sales growth drivers: the $1.4bn in sales forecast for 2024 will make it the company’s sixth biggest product that year, according to EvaluatePharma. But much depends on Novartis’s ability to grab share from entrenched competitor Eylea, sold by Regeneron, an effort that could be severely hampered by safety concerns.

Most worrying was the medical body’s alert about several cases of a dangerous form of eye inflammation called vasculitis; although this was seen in Beovu’s clinical programme, these occurrences appear to confirm that this is a real issue for the product. Retinal vasculitis can lead to blindness and although only 14 cases were reported to the ASRS, 11 were classified as occlusive retinal vasculitis. This happens when the smaller retinal vessels become blocked, and is of even greater concern.

The database of Advera Health Analytics, which specialises in compiling and curating US adverse event reports, shows that vasculitis has been seen with all three anti-VEGF eye products. They count two for Beovu, 17 for Eylea and 46 for Lucentis, although it is not immediately clear which specific forms of vasculitis these figures refer to.

Advera gets its data from FAERS, the FDA’s adverse event reporting system, and must be read in the context of vastly greater use of Eylea and Lucentis, which have been on the market for much longer.

However Advera calculates that these drugs' reporting odds ratios, a disproportionality measure for adverse events, currently sits at 6.02 for Beovu, 0.50 for Eylea and 1.10 for Lucentis. This means that vasculitis has a higher relative occurrence in FAERS compared to the other drugs.


Novartis will be hoping that what looks to be a vasculitis signal turns out to be a function of heightened physician alertness when using a new drug. But Beovu is also associated with higher rates of intraocular inflammation – this was seen in 4% of patients, compared with 2% with Eylea – and is contraindicated in patients with active intraocular inflammation. Moreover, the label notes a 1% rate of retinal artery occlusion.

Throw in another, potentially more serious side-effect and physicians will be struggling to find reasons to reach for the Novartis product. Beovu’s USP was a less frequent dosing schedule, but this naturally becomes irrelevant with worse safety.

Exactly why Beovu might be associated with these inflammatory issues is unknown: as an antibody fragment the molecule is much smaller than Eylea and Lucentis, and autoantibodies are seen much more frequently in patients treated with Beovu. But to persuade physicians and patients that the product is worth trying, Novartis needs to quickly work out how to identify people at risk.

Regeneron meanwhile got a 6% boost to its stock price yesterday, as one of the big clouds on Eylea’s horizon started to look a lot less threatening. The company still has the looming prospect of Lucentis biosimilars to contend with, but for now Novartis’s setback will provide a great help as it tries to convince physicians to stick with what they know.

 

[Workplace Retaliation]

Novartis employee claims she was fired for complaining about incorrect data

By ED SILVERMAN @Pharmalot

FEBRUARY 28, 2020

As Novartis (NVS) geared up to win approval for a new eye medication that was pegged to become a blockbuster, an employee tried to push the company to disclose incorrect safety data and claims she was fired for her trouble. And at the heart of the dispute is the same drug about which a leading association of eye physicians raised serious safety concerns to its members earlier this week.

In a lawsuit filed last year, Zuhal Butuner described how she suggested in March 2018 that Novartis either issue a press release or send letters to doctors about a “material error” in published safety data concerning Beovu, which was being developed to treat wet age-related macular degeneration. The medicine was approved last October by the Food and Drug Administration

 

[anonymous]

sounds a butblike the scandals going on with AveXis

Novartis has it’s hands full with all of its CIAs, data manipulations, and safety violations

 

[Novartis Settles !!!]

Novartis’ Sandoz Settles U.S. Drug Price-Fixing Charges
By
David McLaughlin
and
Riley Griffin
March 2, 2020, 4:34 PM EST Updated on March 2, 2020, 5:16 PM EST

Novartis AG’s Sandoz unit agreed to pay $195 million to settle U.S. criminal charges that it conspired with other pharmaceutical companies to fix prices of generic drugs, the most significant settlement to come from a long-running Justice Department investigation.

Sandoz conspired with four of its competitors between 2013 and 2015 to rig drug prices, the Justice Department said Monday. The settlement marks the largest penalty obtained by the U.S. in a domestic cartel case, the government said. Sandoz agreed to cooperate with the antitrust division’s continuing investigation.

Sandoz admitted that the sales affected by the conspiracies exceeded $500 million and involved drugs for common skin conditions, high blood pressure and cystic fibrosis, according to the Justice Department.

“Today’s resolution, with one of the largest manufacturers of generic drugs, is a significant step toward ensuring that prices of generic drugs are set by competition, not collusion,” said the Justice Department’s antitrust chief, Makan Delrahim, in a statement.

Novartis said that Sandoz had cooperated with the government’s investigation, and individuals implicated in the underlying contact are no longer employed at the company. Sandoz will also work to enhance its compliance program, employee training and monitoring as a part of the three-year deferred-prosecution agreement.

“We take seriously our compliance with antitrust laws, and in reaching today’s resolution, we are not only resolving historical issues but also underscoring our commitment to continually improving our compliance and training programs and evolving our controls,” Sandoz President Carol Lynch said in a statement.

Sandoz said it’s also in settlement negotiations with the civil division of the Justice Department to resolve potential related claims and is setting aside $185 million for that case. Sandoz is facing a civil lawsuit filed by state attorneys general led by Connecticut.

Sandoz, which accounts for one-fifth, or nearly $10 billion, of Swiss drug giant Novartis’s annual revenue, is the largest and best-known company to reach a resolution of U.S. price-fixing allegations so far. The government has reached settlements with two small generic drugmakers and charged four executives.

The agreement helps resolve a cloud that has hung over Sandoz after becoming the subject of state and federal investigations that began in 2014 into price-fixing allegations by generic-drug companies. The probes have targeted the biggest names in the industry, including Mylan NV and Teva Pharmaceutical Industries Ltd.

The generics industry has been navigating years of increasingly thin profit margins on copycat medicines in the U.S., which has weighed on their businesses. Nine in 10 prescription drugs dispensed in the U.S. are generics. Lawmakers have alleged that illegal generic pricing coordination over the years has cost federal health programs billions of dollars.

The pact is a sign that prosecutors are continuing to press forward with a sprawling investigation that at times has encountered substantial roadblocks in securing the cooperation of witnesses, among other obstacles. Last year, Bloomberg News reported that a number of drugmakers have talked to the Justice Department about resolving the probe.

The accord, known as a deferred-prosecution agreement, will stay in effect for three years and comes after a former Sandoz executive, Hector Armando Kellum, pleaded guilty in February to a price-fixing charge and agreed to cooperate with the Justice Department’s investigation. At least two other Sandoz executives are also cooperating with the government, according to court papers.

Prosecutors said Kellum conspired with Ara Aprahamian, a former marketing executive at Taro Pharmaceutical Industries Ltd., now a unit within Indian generics giant Sun Pharmaceutical Industries, to fix prices for medications and allocate customers.

According to the government, executives at the two firms discussed which customers each company would solicit for new drugs, rather than compete against one another for business. And when Taro planned to or had raised prices, Aprahamian would encourage Sandoz to follow suit, which it usually did, according to prosecutors. Aprahamian was indicted in February.

Representatives for Sun Pharma didn’t immediately respond to requests for comment.

In the settlement with Sandoz, the Justice Department said the drug maker conspired with Rising Pharmaceuticals Inc., now known as Kavod Pharmaceuticals, which settled U.S. charges in December, as well as unnamed companies based in New York, Michigan and Pennsylvania.

 

[anonymous]

this is about the only silver lining NVS can take out of the current situation.

F.D.A. Halts Overseas Inspections of Drugs and Devices, Citing Coronavirus

F.D.A. Halts Overseas Inspections of Drugs and Devices, Citing Coronavirus

 

[D E S P E R A T I O N]

Novartis launches programme to buy back up to 10% of shares
CONTRIBUTOR
Michael Shields Reuters
PUBLISHED
MAR 10, 2020 2:20AM EDT

Novartis AG plans to buy back up to 10% of its stock over the next three years with an eye to cancel the shares it repurchases, the Swiss drugmaker said on Tuesday.
ZURICH, March 10 (Reuters) - Novartis AG NOVN.S plans to buy back up to 10% of its stock over the next three years with an eye to cancel the shares it repurchases, the Swiss drugmaker said on Tuesday.

UBS Group UBSG.S is managing the buyback via a separate trading line on the SIX Swiss Exchange.

(Reporting by Michael Shields Editing by Riham Alkousaa)

((zurich.newsroom@thomsonreuters.com; +41 58 306 7336)