Novartis milestones be proud ! Management take a bow !

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Says Amgen LOL !! :D

Novartis sues Amgen over collaboration on migraine treatment Aimovig

Jonathan Stempel, Deena Beasley
4 MIN READ

NEW YORK/LOS ANGELES (Reuters) - Swiss drugmaker Novartis AG sued Amgen Inc on Thursday, accusing the U.S. biotechnology company of trying to wrongfully back out of agreements to jointly develop and market migraine prevention drug Aimovig, and keep the profits for itself.

The complaint filed in the U.S. District Court in Manhattan comes as drugmakers move to build share in the large market for new treatments to prevent migraine headaches.

Aimovig, which won U.S. and European approvals last year, belongs to a new class of medicines that also includes Eli Lilly and Co’s Emgality and Teva Pharmaceutical Industries Ltd’s Ajovy.

Novartis called Aimovig a “runaway success,” so far used by about 210,000 patients in the United States and 20,000 elsewhere.

Roughly 39 million Americans suffer from migraine headaches, according to the Migraine Research Foundation. Global drug sales to treat migraines could total $8.7 billion by 2026, according to the GlobalData analytics firm.

Amgen, in an emailed statement, said it is seeking to terminate the collaboration agreements with Novartis and obtain damages, but termination would not be effective until the litigation is resolved.

In its complaint, Novartis said it has spent at least $870 million on Aimovig since it began collaborating in August 2015 with Amgen, which previously controlled rights to the drug.

Novartis accused Amgen of trying to wrongfully back out of their collaboration agreements based on the pretext that the Swiss company’s Sandoz unit was working with Alder Biopharmaceuticals Inc on a possible Aimovig rival.

“The program about which Amgen has complained is being terminated,” Novartis said, and the lack of a breach means Amgen’s April 2 notice terminating the collaboration agreements should be deemed void.

“Having reaped” the benefits of the collaboration, “Amgen now wants to keep the Aimovig profits for itself and deprive Novartis Pharma of its contractual right to share in the product’s success and recoup its significant investments,” Novartis said.

The lawsuit seeks to enforce the companies’ collaboration agreements, and declare Amgen’s purported termination void.

Alder, which is seeking U.S. approval for an intravenous migraine treatment, has an agreement through 2023 for Sandoz to manufacture the drug, called eptinezumab, according to Alder Chief Executive Robert Azelby.

“Sandoz is a separate entity who does contract manufacturing for many companies who would compete with an Amgen or whatever,” Azelby told Reuters in a phone interview. “It is common for biopharmaceutical companies that partner in one area to compete in other areas.”

Azelby said Alder intends to keep all U.S. marketing rights for eptinezumab, but is looking for a partner to sell it in other parts of the world.


Novartis’ U.S.-listed shares were down $1.28, or 1.4 percent at $93.68, while Amgen shares were off $1.00, or 0.5 percent, at $191.42. Alder’s shares were down 61 cents, or 4.4 percent, at $13.40.

The case is Novartis Pharma AG v. Amgen Inc, U.S. District Court, Southern District of New York, No. 19-02993.
 
























April 3, 2019 In a ruling released earlier this week, a federal district judge decreed that the U.S. Department of Justice (DOJ) has presented sufficient evidence of a company-wide kickback scheme at Novartis AG (“Novartis”) to move the case forward to trial and to deny Novartis an early out through summary judgment.

Of particular interest to those in the pharmaceutical industry, the judge held that DOJ may proceed with allegations that Novartis “Lunch-n-Learn” and other activities and interactions with doctors that are alleged to have served an educational purpose are part of the “fraudulent program” that ultimately led to the alleged violations of the False Claims Act at Novartis. The complaint against Novartis, originally filed as a whistleblower suit by a former Novartis sales representative before the government intervened, alleged that a number of so-called educational events, including “Lunch-n-Learns,” were in fact nothing more than sham events meant to induce doctors to prescribe Novartis drugs. Along with stories of purportedly educational activities at wineries, golf clubs, sporting venues and interestingly, 75 events at Hooters, the complaint also includes the allegation that one physician was paid to speak at his own office eight times.

While the Novartis case makes its way toward trial, those in the pharmaceutical and health care industries should adduce a few lessons regarding compliance and “educational activities.” Events such as “lunch-n-learns” must actually have an educational component and providers of such activities should be able to provide proof of such. Items such as Power Point presentations, sign-in sheets, and printed materials should be provided to attendees and kept on file as proof of compliance. In addition, “canned” and recycled materials that are used over and over again without any change or update over long periods of time are to be avoided. In other words, the “education” portion of the event has to actually be demonstrably “educational.” Companies that engage in “Lunch-n-Learn” or similar educational activities, together with the more typical meals and entertainments, should undertake regular audits of these programs to ensure and maintain compliance with the requirements of the Anti-Kickback Statute and False Claims Act.
 






HEALTH NEWS
APRIL 19, 2019 / 8:29 PM / UPDATED 2 HOURS AGO
Second death in Novartis gene therapy trials under investigation

Deena Beasley

(Reuters) - Novartis AG, which this week announced positive interim trial results for its experimental gene therapy for spinal muscular atrophy, on Friday said investigation is underway into whether a second trial death could be related to the treatment.

Novartis has filed for U.S. Food and Drug Administration approval of the gene therapy, Zolgensma, and a decision is expected within weeks. The FDA submission was based on findings from a trial of 15 babies treated with Zolgensma.

But Novartis has expanded its clinical trial program - presenting on Tuesday at an Orlando, Florida meeting of the Muscular Dystrophy Association interim results for 22 babies with Type 1 SMA, the most serious form of the disease. The data showed that Zolgensma treatment resulted in encouraging progress in motor skills such as the ability to sit up. One patient died from respiratory failure, which was deemed by the investigator and an independent monitor to be unrelated to the gene therapy.

SMA, which can lead to paralysis, breathing difficulty and death, is the leading genetic cause of death in infants.

Novartis officials also disclosed that in addition to that death, a 6-month-old patient with Type 1 SMA had recently died after undergoing Zolgensma treatment in the company’s European trial.

“Preliminary findings indicate this occurred in the context of a severe respiratory infection followed by neurological complications in a symptomatic SMA Type 1 patient, and was deemed possibly related to treatment by the investigator,” Novartis spokesman Eric Althoff said in an emailed statement on Friday.

He said an autopsy has been performed and results are pending. Meanwhile, trial investigators and regulatory authorities have been informed.

Gene therapies use engineered viruses to carry healthy genetic material into a person’s cells to replace faulty or mutated genes that cause a disease or condition. Zolgensma


“As we learn more, we will provide further updates,” Althoff said.

Novartis estimates that without treatment, 50 percent of babies with SMA Type 1 will not survive or will need permanent breathing support by the time they are 10.5 months old.

The company has said its price for Zolgensma will be determined in negotiations with health plans, but it believes the gene therapy would be cost effective at $4 million to $5 million as a one-time treatment.

Reporting By Deena Beasley; Editing by Margu
 






FUNNY ADMISSION WITH A TRIAL LOOMING o_O


MAY 1, 2019 / 2:22 PM
CROSS-CULTURE: What finance can learn about compliance culture from Volkswagen, Novartis & Tenneco
Henry Engler


Chief compliance officers from the world’s largest carmaker, Volkswagen AG, Swiss pharmaceutical giant Novartis, and U.S.-based auto parts manufacturer, Tenneco, took part in the fourth such annual series on conduct and culture, moderated by Stein Berre, senior vice president for supervision at the Federal Reserve Bank of New York.

This time, the focus was to examine what the financial sector might learn from companies outside the industry, all of whom have endured their own share of past problems, and who are working to find innovative ways of limiting bad behavior while also giving employees a sense of purpose in their companies.

Among the insights and themes that resonated for the audience, comprised largely of financial compliance and risk professionals, was the necessity for senior management to admit when failure occurs – a trait that even after numerous scandals is rarely seen today among leaders of global financial firms.

“I believe it`s important to start by acknowledging that we have not lived up to the expectations of society and that is simply a fact,” said Klaus Moosmayer, chief compliance officer at Novartis, a company with nearly 130,00 thousand employees, and products sold in 155 countries, according to its 2018 annual report.

“You can debate over whether it’s perceived correctly or not, but you have to acknowledge that there is a trust issue,” he added. “This acknowledgement has to be there first. If you are only in a defensive position, that is not a good start.”

The willingness to acknowledge wrongdoing or misconduct when things go wrong is a problem that has plagued many large firms. The tendency among executives is still to characterize such behavior as one-off occurrences, often driven by “rogue” employees in remote corners of the institution. The typical public message is that we want to “get the matter behind us” as quickly as possible.
 






white trailer trash clueless bioch - sound familiar? YES!! worse ever mgr by huge margin - kg-entresto cv2 palm bch fl abl, she is a micromanager, shows up late & drunk for ride alongs, is an ugly fatso bad breath dumb, tells her (nvs & pdi) reps to train offc employees to falsify medicare prior auth forms in order to get phony rxs, she recently got dumped by her hubby for his gym buddy hottie pawg lol, karma always finds you doesnt kg fat ugly skank
 






FDA Raises Concerns With Novartis in Clinical Inspection
Zachary Brennan

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As part of Novartis’ new drug application for its recently approved multiple sclerosis drug Mayzent (siponimod), the US Food and Drug Administration (FDA) questioned the drugmaker’s data practices during a clinical inspection.

“During the sponsor inspection, significant data reliability concerns were identified,” FDA said, citing the company with an Official Action Indicated (OAI).

FDA explained how in one study protocol, blinding “was not adequately maintained as specified in the protocol throughout the course of the trial at 62 (21%) of 294 sites. Study personnel were given inappropriate access to the first dose and main databases affecting 285 (17%) out of 1651 total study subjects.”

The agency found that tracking user activities in two databases, such as which users accessed databases and when, as well as what data were viewed, was limited because of a lack of system access audit trails.

FDA also noted that “Novartis did not have sufficient procedures outlined in their monitoring plan for granting and revoking access as well as detecting inappropriate access to databases that contained study information that could be potentially unblinding. Novartis CRAs [clinical research associates] did not properly grant study personnel (e.g., study coordinators, investigators, and EDSS raters) access to the databases used in the trial. In addition, the CRAs failed to identify cases where inappropriate database access was granted to site personnel.”

But FDA could not say whether this inappropriate access to certain information led to bias.

However, the agency also said it could not rule out the introduction of bias in terms of the reliability of the study data, “specifically for 163 of the 285 subjects who had study assessments performed by main database users and EDSS raters (i.e., blinded study personnel) who were granted inappropriate access to the first dose and/or main databases.”

In an email last December, FDA called on Novartis to conduct a sensitivity analysis, excluding in the per-protocol analysis subjects who may have been impacted, including 62 subjects who were potentially affected by the 11 EDSS raters who had inappropriate access to the first dose or main databases and 101 subjects who were potentially affected by the 32 users of the main database who had inappropriate access to the first dose database.

Novartis did not respond to a request for comment.

Mayzent (siponimod)
 






More trouble in paradise for sandoz division of "ethical" Novartis

BUSINESS NEWS
Drugmakers allegedly inflated prices over 1,000% and 44 states are now suing
PUBLISHED SAT, MAY 11 2019 3:47 PM EDTUPDATED SAT, MAY 11 2019 3:55 PM EDT
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U.S. states filed a lawsuit accusing Teva Pharmaceuticals USA of orchestrating a sweeping scheme with 19 other drug companies to inflate drug prices — sometimes by more than 1,000% — and stifle competition for generic drugs, state prosecutors said on Saturday.

Soaring drug prices from both branded and generic manufacturers have sparked outrage and investigations in the United States. The criticism has come from across the political spectrum, from President Donald Trump, a Republican, to progressive Democrats including U.S. Senator Elizabeth Warren, who is running for president.

The 20 drug companies engaged in illegal conspiracies to divide up the market for drugs to avoid competing and, in some cases, conspired to either prevent prices from dropping or to raise them, according to the complaint by 44 U.S. states, filed on Friday in the U.S. District Court in Connecticut.

A representative of Teva USA, a unit of Israeli company Teva Pharmaceutical Industries, said it will fight the lawsuit.

“The allegations in this new complaint, and in the litigation more generally, are just that — allegations,” it said in a statement. “Teva continues to review the issue internally and has not engaged in any conduct that would lead to civil or criminal liability.”

The 500-page lawsuit accuses the generic drug industry, which mainly sells medicines that are off patent and should be less expensive, of a long history of discreet agreements to ensure that companies that are supposedly competitors each get a “fair share.”

The situation worsened in 2012, the complaint said.

“Apparently unsatisfied with the status quo of ‘fair share’ and the mere avoidance of price erosion, Teva and its co-conspirators embarked on one of the most egregious and damaging price-fixing conspiracies in the history of the United States,” the complaint said.

With Teva at the center of the conspiracy, the drug companies colluded to significantly raise prices on 86 medicines between July 2013 and January 2015, the complaint said.

Representatives of Sandoz, another company named in the lawsuit, did not immediately respond to a request for comment.

The drugs included everything from tablets and capsules to creams and ointments to treat conditions including diabetes, high cholesterol, high blood pressure, cancer, epilepsy and more, they said. In some instances, the coordinated price increases were more than 1,000 percent, the lawsuit said.

The lawsuit also names 15 individuals as defendants who it said carried out the schemes on a day-to-day basis.

“The level of corporate greed alleged in this multistate lawsuit is heartless and unconscionable,” Nevada Governor Steve Sisolak said in a statement.

According to New Jersey Attorney General Gurbir Grewal, more than half of the corporate defendants are based in New Jersey, and five of the individual defendants live in the state.

The lawsuit seeks damages, civil penalties and actions by the court to restore competition to the generic drug market.

Generic drugs can save drug buyers and taxpayers tens of billions of dollars a year because they are a lower-priced alternative to brand-name drugs.

“Generic drugs were one of the few ‘bargains’ in the United States healthcare system,” the lawsuit said.

However, it added, “Prices for hundreds of generic drugs have risen — while some have skyrocketed, without explanation, sparking outrage from politicians, payers and consumers across the country whose costs have doubled, tripled, or even increased 1,000% or more.”

As a result of the drug companies’ conspiracies, it said, consumers and states paid “substantially inflated and anticompetitive prices for numerous generic pharmaceutical drugs” while the drug companies profited.

The lawsuit filed on Friday is parallel to an action brought in December 2016 by the attorneys general of 45 states and the District of Columbia. That case was later expanded to include more than a dozen drugmakers.

 






Novartis could settle for $1B as part of federal kickback lawsuit: report
by Kyle Blankenship |
May 16, 2019 10:43am
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Novartis could be approaching a $1 billion settlement in a long-running kickback scheme lawsuit in federal court. (Novartis)

Six years after federal prosecutors first targeted Novartis for an alleged kickback scheme involving $10,000 dinners and fishing trips for doctors, signs pointed to the Swiss drugmaker finally having its day in court. Now it looks like that may not happen.


Novartis could be approaching a billion-dollar settlement with the U.S. government as part of a whistleblower lawsuit accusing the company of bribing doctors to boost subscriptions of its drugs, sources told STAT. Novartis declined to comment Thursday on the possible settlement.

In early April, U.S. District Judge Paul Gardephe cleared the way for the lawsuit to reach a jury trial after Novartis requested the suit be tossed based on a lack of evidence of a “nationwide kickback scheme” and a clear quid pro quo between the company and doctors allegedly on its payroll.

The most eye-popping claims in the lawsuit read like corporate corruption out of the world of fiction, with Novartis allegedly treating doctors to $10,000 dinners at Nobu, a chic New York seafood restaurant, and wild nights out at Hooters. In one instance, whistleblowers said the company held a sham promotional speaker event on a fishing boat.

RELATED: Did Novartis hand out kickbacks or host educational dinners? A jury may decide

Gardephe said those incidents were just a few of some 79,000 events admissible as trial evidence after federal prosecutors alleged a “companywide scheme” to boost scripts that defrauded the U.S. government of millions in Medicare and Medicaid billing over the span of nearly a decade.

Novartis spokesman Eric Althoff said in early April the promotional events were not opportunities to bribe doctors but instead part of the company’s educational program to inform physicians on the company’s drugs.

“Novartis strongly believes in the importance of peer-to-peer education,” he said. “Through these speaker programs, we provide information to healthcare professionals regarding the benefits and appropriate use of our medicines to help ensure that any prescription decisions are in the best interest of patients.”

RELATED: Novartis bribery investigation craters after Greek prosecutors clear 4 officials

A settlement in the Manhattan federal suit could wind down a second major investigation into Novartis’ business practices after four Greek government officials were cleared in April as part of a wide-ranging bribery probe alleging payments between the company and 10 politicians.

Corruption investigators returned a report to the Greek Parliament listing only former health minister Andreas Loverdos’ name as part of the probe, but Kathimerini reported investigators found no evidence Loverdos ever received a bribe.

However, other investigations into Novartis have gained more traction in recent years, including a $390 million civil settlement with the feds in 2015 on claims it worked with specialty pharmacies to push two of its drugs in exchange for paying rebates.

In addition, Novartis was flagged in former U.S. Special Counsel Robert Mueller's Russian collusion investigation in November 2017 after Michael Cohen, former personal attorney for President Donald Trump, acknowledged receiving $1.2 million from the company. NBC News reported a senior Novartis official said the payments followed Cohen pledging access to the Trump administration after his inauguration.
 






Novartis & GSK ‘misled’ consumers, says Federal Court of Australia
Novartis & GSK found to have misled consumers with the packaging and pricing of their osteoarthritis pain treatment.

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The Federal Court of Australia has found that the subsidiaries of pharmaceutical companies Swiss drug manufacturer Novartis and GlaxoSmithKline (GSK) breached Australian Consumer Law by promoting false claims or misleading assertions about their pain-relief products.

The Australian Competition and Consumer Commission (ACCC) held an investigation from January 2012 to March 2017 into the products. It found that Voltaren Osteo Gel claimed to be a more effective treatment against osteoarthritis-induced pain and inflammation than Voltaren Emugel, despite the two products having the same active ingredients.

The findings also showed that Voltaren Osteo Gel was sold at a higher price than Voltaren Emugel.


Sarah Court, Commissioner of the ACCC, said that “Novartis and GSK misled osteoarthritis sufferers into buying the more expensive Osteo Gel thinking that it was more effective than Emugel for treating their symptoms when this is not the case.”

GSK has since corrected the packaging of the Osteo Gel to include the wording: “Same effective formula as Volarten Emugel.”

GSK has stated that they are ‘pleased’ with the outcome and that the actions taken by the ACCC provide “greater clarity around the expectations of companies marketing medicinal products.”

The ACCC has stated that a separate hearing at a later date will take place to determine penalties.
 






Advertising executive testifies in Novartis bribery case
IOANNA MANDROU
The owner of an advertising agency gave his testimony to a corruption prosecutor in Athens as part of the Novartis probe on Wednesday, during which he argued that he had never paid any bribes to politicians accused of allegedly taking bribes from the Swiss pharmaceutical firm in exchange for preferential treatment.

The executive, who stands accused of laundering the bribe money, said that over the course of five years he had given a specific Novartis executive round 400,000 euros from money his advertising agency had initially received from the pharmaceutical firm as payment for ads. He said the Novartis executive was not Constantinos Frouzis, the former general manager of the firm's Greek branch.

Sources said the witness also denied over-charging Novartis or issuing fake invoices.

Another four suspects who were members of committees responsible for pricing medicines in the Greek market appeared before the same prosecutor on Wednesday. Their testimonies did not produce evidence incriminating politicians.

Ten politicians have been accused by three unnamed witnesses for taking bribes from Novartis, though several months of investigations have failed to turn up any evidence to back these claims.

Judicial sources have told Kathimerini that the cases against former conservative prime minister Antonis Samaras and former finance minister Yannis Stournaras, currently the governor of the Bank of Greece, have been dropped, though no official announcements have been made yet.
 






Conatus wields ax as Novartis-partnered NASH drug fails again
by Nick Paul Taylor |
Jun 25, 2019
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In spite of several challenges, Conatus thinks it can end 2019 with up to $15 million.

A phase 2b trial of Conatus Pharmaceuticals’ emricasan in nonalcoholic steatohepatitis (NASH) has missed its primary endpoint. The latest setback prompted Novartis-partnered Conatus to lay off40% of its staff and begin looking for strategic alternatives.

Novartis catapulted Conatus into the limelight in 2016 when it paid $50 million for an option on oral pan-caspase inhibitor emricasan. Since then, emricasan has advanced through a series of readouts that have suggested it poses little threat to the other companies pursuing NASH, culminating in the delivery of data from the phase 2b ENCORE-LF trial.

Neither dose of emricasan outperformed placebo against a primary endpoint that looked at whether patients died, suffered new decompensation events or experienced liver disease progression. There were “no clear trends indicating a potential treatment effect,” Conatus said in a statement.

To compound the failure, Conatus revealed a 24-week extension to one of its four midphase flops also missed the mark. Conatus said the data from the extension were consistent with results from the original 24-week study, which found emricasan was no better than placebo at improving mean hepatic venous pressure gradient in compensated NASH cirrhosis patients.

As it navigated the series of setbacks, Conatus highlighted positives and looked to future trials to generate stronger evidence. But the biotech has now come to the end of the road, with CEO Steven Mento accepting the trials “provided a fair evaluation of emricasan’s lack of efficacy.”

With multiple failed trials to its name, Conatus is set to lay off 40% of its staff, suspend development of preclinical-stage caspase-1 inhibitor CTS-2090 and engage Oppenheimer & Co. to look into strategic alternatives that enable its beleaguered investors to make some money back. Through the changes, Conatus thinks it can end 2019 with up to $15 million in cash, equivalents and marketable securities, buying it the time to search for a way out of its current predicament.

The repeat failures of emricasan have left Conatus with little to offer a potential buyer. Beyond its Nasdaq listing, Conatus’ main asset is CTS-2090. Mento talked up the drug in a release to disclose the reorganization.

“We remain excited by the potential of CTS-2090 as a uniquely positioned inflammasome disease compound,” Mento said. “Although we are halting development activities for CTS-2090, we plan to continue to explore a variety of opportunities to advance this compound.”
 












Southern District of New York (S.D.N.Y.) marketing practices investigation and litigation

In 2013, the US government filed a civil complaint in intervention to an individual qui tam action against Novartis Pharmaceuticals Corporation (NPC) in the United States District Court for the S.D.N.Y. The complaint, as subsequently amended, asserts federal False Claims Act and common law claims with respect to speaker programs and other promotional activities for certain NPC cardiovascular
medications (including Lotrel, Starlix and Valturna) allegedly serving as mechanisms to provide kickbacks to healthcare professionals from 2002 to 2011. It seeks damages and disgorgement of Novartis profits from the alleged unlawful conduct which, based on the government’s calculation, with trebling and penalties could exceed USD 1 billion. Also in 2013, New York State filed a civil complaint in intervention asserting similar claims. Neither government complaint in intervention adopted the individual relator’s claims with respect to off-label promotion of Valturna, which were subsequently dismissed with prejudice by the court. The individual relator continues to litigate the kickback claims on behalf of other states and municipalities. Novartis is engaged in settlement discussions to resolve the above-described claims and has recorded a provision in the amount of USD 0.7 billion in Q2 2019.
 






Novartis Sets Aside $700 Million to Settle Bribery Allegations
Swiss drugmaker raises full-year guidance despite provision
By Denise Roland
July 18, 2019 7:03 am ET


Novartis AG NVS 4.47% set aside $700 million to settle a long-running lawsuit alleging the drugmaker treated U.S. doctors to lavish dinners and other events in return for boosting prescriptions.

The case centers on 80,000 events Novartis held between 2002 and 2011 that federal prosecutors allege amounted to kickbacks masquerading as educational meetings. Those included fishing trips off the Florida coast, expensive meals at high-end restaurants like Nobu in Manhattan, and trips to Hooters locations across the country, according to court documents.

Novartis, which has denied wrongdoing, is currently in negotiations with prosecutors to reach a settlement. Chief Executive Vas Narasimhan said settling the matter was “consistent with our efforts to resolve legacy compliance issues.”

The case is the highest-profile of a number of allegations of wrongdoing by the company in recent years, as Dr. Narasimhan, who took the helm in early 2018, seeks to overhaul the drug giant.
 






HEALTH NEWS
JULY 29, 2019 / 3:25 AM / UPDATED 5 HOURS AGO
Novartis heart drug fails trial, curbing growth prospects

John Revill, John Miller

ZURICH (Reuters) - Novartis’s heart failure drug Entresto failed a trial in a new use, the Swiss drugmaker said on Monday, calling into question billions of dollars in potential revenue and taking the shine off one of the company’s biggest growth prospects.

The drug, already approved for reduced fraction heart failure, “narrowly missed” its objectives when tested on patients with preserved ejection fraction type of heart disease which affects 13 million globally, roughly half of all heart failure patients, the company said in a statement.

Twice-a-day Entresto has the potential for more than $3 billion annual sales for the current indication in patients whose heart muscles do not contract effectively, Novartis has said.

With a possible new indication in heart failure patients in whom the heart muscle contracts normally but the ventricles do not relax as they should, the Basel-based drugmaker saw total annual sales rising to as much as $5 billion. The failure in this trial in 4,822 patients puts the increased sales at risk. (reut.rs/2yixDVd)

“The trial narrowly missed statistical significance for its
composite primary endpoint of reducing cardiovascular death and total heart failure hospitalizations,” Novartis said.

The Paragon HF trial compared Entresto against the older medicine valsartan, which Novartis sells under the brand name Diovan.

Entresto started out slow following its 2015 approval but has recently picked up momentum, with revenue rising about 80% in the first half of 2019 to $778 million globally as doctors shifted treatment from older medicines.

Novartis said it would present the result of the trial at the European Society of Cardiology in September, and discuss next steps with clinical experts and regulators.

The company’s shares shed 1.4% to 91.20 Swiss francs ($91.90) in early trading in Zurich following the news.

Analyst Michael Nawrath at Zuercher Kantonalbank said the likelihood of a positive outcome in the study had been low, since efforts to tackle this form of heart failure have yet to bear results. There are currently no approved treatments for preserved ejection fraction heart failure.

“The milder the disease the higher the hurdle,” he said. “It would have been very good for the momentum of Novartis, whose shares would have passed the 100 franc per share mark, on a positive outcome.

“Despite the relatively low expectations, we are talking about a negative but not sustained price reaction.”
 






:eek::eek::eek::eek::eek:

FDA threatens criminal action against Novartis over faulty data used in application for $2.1 million gene therapy
PUBLISHED AN HOUR AGO UPDATED 16 MIN AGO

Berkeley Lovelace Jr.@BERKELEYJR

  • The FDA is threatening to take criminal action against Novartis, saying the drugmaker used data it knew was inaccurate in its application for a $2.1 million gene therapy.
  • The agency says the gene therapy should remain on the market, even while it’s still assessing the situation.
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Arnd Wiegmann | Reuters

The Food and Drug Administration is threatening to take criminal action against Novartis, saying Tuesday the drugmaker used data it knew was inaccurate in its application for a $2.1 million gene therapy that was approved in May.

“On June 28, following the FDA’s approval of the product, the agency was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application and reviewed by the FDA,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement.


AveXis is the gene therapy subsidiary of Novartis. The FDA said the gene therapy for spinal muscular atrophy should remain on the market, even while it’s still assessing the situation.

“The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties,” Mark added.

Novartis didn’t immediately respond to a request for comment.

U.S.-traded shares of the Swiss drugmaker tumbled 3.6% in early afternoon trading. Biogen, which also produces a spinal muscular atrophy treatment, was up about 1%.

In May, the FDA approved Novartis’ gene therapy, making it the world’s most expensive drug. The therapy, Zolgensma, is a one-time treatment for spinal muscular atrophy, a muscle-wasting disease and leading genetic cause of infant mortality that affects one in every 11,000 births.


At the time, Acting FDA Commissioner Ned Sharpless lauded the approval, saying that it marked “another milestone in the transformational power of gene and cell therapies to treat a wide range of diseases.”

In a tweet Tuesday, Sharpless said the agency relies “on truthful scientific data to make regulatory decisions, and we take the issue of data integrity very seriously.”
 






Warning signs were always there for Novartis’s Avexis deal
High-profile departures at Avexis raise more questions about Novartis’s acquisition, but there were plenty of red flags before the deal was sealed.

Last week Novartis was rocked by revelations of data manipulation with its SMA gene therapy Zolgensma. And yesterday it emerged that the group had phased out top scientists from Avexis, the originator of Zolgensma, three months ago, raising more questions about conduct at the subsidiary.

The news last week took the markets by surprise, but the warning signs over Avexis were there to see for anyone looking hard enough. Indeed, these stopped one fund from investing in Avexis well before Novartis sealed its $8.7bn deal in 2018.

Dmitry Kuzmin, managing partner at 4Bio Capital, told Vantage that the UK-based group, which invests solely in companies developing innovative projects such as gene therapies, steered clear of Avexis because of some “large red flags”, including allegations involving several of Avexis’s founders.

Exiting

One of people no longer with Novartis is Brian Kaspar, Avexis’s erstwhile chief scientific officer. Novartis yesterday said his involvement with company, and that of his brother, Allan Kaspar, former vice-president of R&D, had ended in early May.

Novartis did not disclose whether either brother had been involved in the data manipulation scandal that surfaced last week, but the latest move is not exactly a vote of confidence in the ex-Avexis execs.

And this is not the first time that Mr Kaspar has raised eyebrows among investors. While working for Avexis he was also a researcher at the Nationwide Children's Hospital (NCH) in Ohio, where Zolgensma, then known as AVXS-101, was originally developed.

This spurred concerns about a potential conflict of interest, as did the fact that the NCH stood to gain from Zolgensma’s success, in the form of milestones and royalties should the project get approved.

Any unease around potential conflicts of interest would not have been allayed by fact that the phase I study of Zolgensma, called Start, which was led by Dr Jerry Mendell of the NCH, was carried out solely at this hospital. Investors could rightly worry about the rigour of single-centre trials; added to this, there have also been questions about whether some patients in the study in fact had the most severe form of SMA. Any misclassification of patients might have flattered the results seen with Zolgensma versus historical controls.

True, the claims of misconduct in the Start trial come from a short seller, and an ongoing multicentre phase III trial of Zolgensma, called Str1ve, has since yielded decent data.

But the FDA’s decision to give Zolgensma the nod partly based on a single-centre, uncontrolled trial could be seen as unwise, particularly after the agency attracted criticism for its reliance on another controversial NCH study; namely, the phase II trial of Sarepta’s Duchenne muscular dystrophy therapy Exondys 51, which was also led by Dr Mendell, and paved the way for that product's approval in 2016.

Robert Califf, the FDA commissioner at the time, famously questioned the conduct in the Sarepta study, calling for a retraction of the original publication of the results.

Lawsuits

While any concerns about Mr Kaspar are so far largely circumstantial, two other Avexis co-founders, John Carbona and David Genecov, have much more colourful backstories.

Mr Carbona, who was Avexis’s chief executive until 2015, was found to have committed fraud when his previous company, CH Industries, was acquired by Mediq after allegations that he misrepresented the pre-sale state of the group to inflate his own bonus.

Meanwhile, Mr Genecov’s former company, a hospital chain called Forest Park Medical Center, was embroiled in claims that it paid kickbacks to doctors and one of its co-founders, Richard Toussaint, was found guilty of fraud.

Mr Genecov himself was never indicted and, like Mr Carbona, had left Avexis long before Novartis made its move. Still, recent developments have raised fresh questions about the culture at Avexis, and the history of the company will do nothing to reassure Novartis investors on this score.

Warning signs were always there for Novartis’s Avexis deal
 






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