Novartis milestones be proud ! Management take a bow !

Quote
$18 million Novartis sale stalls amid lawsuit
Robert Brum 11:14 a.m. ET Feb. 24, 2017

SUFFERN - A firm poised to purchase the vacant Novartis campus for $18 million has filed a lawsuit claiming the deal has been stymied by pharmaceutical company's refusal to allow aggressive environmental testing.

A lawsuit filed Feb. 10 in state Supreme Court in New City by RS Old Mill LLC is seeking to force the Swiss drugmaker to allow the testing or return its $2.5 million deposit. The suit also seeks to prohibit Novartis from seeking other buyers.

Court papers identify RS Old Mill as “a foreign limited liability company" formed under Delaware state law, and which is now located in Mahwah, New Jersey. The complaint is signed by Yehuda Salamon, who is listed as the firm's manager.


RS Old Mill, which was formed to acquire the Novartis property, has filed for Chapter 11 protection, according to Douglas Pick, its bankruptcy attorney. That did not prevent it from obtaining outside funding to make the purchase, he said.

RS Old Mill wants to move its unspecified operations — identified as "a small group of family owned companies" —from Mahwah to the site of the former Novartis manufacturing plant at 25 Old Mill Road and claims the companies may be forced to close if it can't relocate, losing 80 jobs.

The lawsuit contains no mention of what RS Old Mill wants to do with the property. Modifying the building for a different purpose would be costly and anything besides an industrial use would require a zone change.

Novartis and RS Old Mill entered into a sale agreement on Nov. 28 for the property, which is mostly in Suffern but extends into Montebello, according to the lawsuit. The agreement contained a due-diligence period during which the buyer had the right to perform inspections and "invasive" tests on the property to make sure there were no environmental issues.

When the buyer inspected the premises and reviewed documents, “critical" environmental concerns were revealed warranting investigation, according to the lawsuit. The site once produced tablets, capsules, vials and inhalation products.

The issues cited in court papers include underground petroleum storage tanks, past reported petroleum spills, former drum burial and solid waste disposal areas. Other concerns include a stormwater detention pond that has “potential significant contamination” from acetone, possible undetected contamination of other wells, and vapor issues from chlorinated solvents and other hazardous materials.

Legoland amusement parks; and Intercos, an Italian cosmetics company with offices in Congers and West Nyack, expressed interest but subsequently backed out.
 






Novartis products suspended in South Korea as officials weigh 'tougher' measures: report
by Eric Sagonowsky |
Mar 1, 2017 9:30am

Already facing a fine and a three-month ban on certain products in South Korea, Novartis is likely to see "tougher" punishments when the Health Ministry hands down its own decisions this month, according to a local media report.

Novartis will soon discover just how much fallout it faces from last year’s kickbacks case in South Korea, local media says. Officials there levied one set of punishments and are weighing further options that are likely to be "tougher."

On top of punishments imposed by the Ministry of Food and Drug Safety—a small fine and suspensions for some medicines sold in the country—authorities are considering lowering the prices of Novartis drugs involved in the alleged kickbacks scheme, a Ministry of Health and Wellness source told South Korea’s The Investor.

Novartis itself disputes the details of The Investor's report. In a statement to FiercePharma, the Swiss drugmaker said it's not aware any decision is "imminent."

"The court case will continue for some months yet and a decision is expected from the MOHW in due course," a spokesperson said.

Early last year, prosecutors raided a Novartis office in Seoul, rounding up documents and account books. Later in the year, the government handed out indictments to a half-dozen Novartis execs, plus more than a dozen doctors and five heads of medical journals.

Prosecutors contend that Novartis staff offered payments to doctors who attended meetings set up by journals in order to boost sales.

South Korea’s Health Ministry is likely to hand out fines and a sales ban of up to half a year, according to The Investor’s source. The Ministry of Food and Drug Safety last week levied a $177,000 fine and a three-month ban on 12 drugs, the report states.

Novartis says three, not 12, of its brands are suspended for three months. Twelve "stock keeping units" received the suspension, meaning different formulations and dosages of the drugs had to be shelved. In acknowledging the recent MFDS decision, Novartis stressed that it doesn't "tolerate misconduct" and is "continuing to invest significant efforts to fully embed a culture of compliance throughout our Korean organization."

"We’ve previously acknowledged and expressed our regret that certain associates in Korea took actions in violation of our policies and inconsistent with our culture and the expectations society has for us and our industry," according to a spokesperson.

The unnamed official quoted by The Investor expects “tougher” penalties from the Health Ministry. Korea is Novartis’ tenth-largest market, according to the publication.

Previously, Novartis said “certain associates in Korea conducted small medical meetings and other scientific-related activities through trade journals.”

“Some associates supported travel to overseas congresses for some healthcare practitioners" in a way that didn't comply with domestic self-regulation standards, according to the company's previous statement.

Separately, Novartis ran into trouble in Japan back in 2015 with a high-profile data scandal. The Japanese government eventually suspended the company’s operations there for 15 days, and executives traveled to the country to apologize for its mistakes.

As industry watchers know, the Swiss drugmaker is far from alone in the Big Pharma world in working through kickbacks charges. GlaxoSmithKline notoriously paid nearly $489 million in 2014 to resolve its bribery case in China, and Teva Pharmaceutical recently reached a $520 million settlement with U.S. officials to resolve Foreign Corrupt Practices Act violations in a few countries.
 












Storm Clouds said:
April 18, 2016 2:36 pm

Clouds gather over Novartis as it battles series of setbacks
Andrew Ward in London and Ralph Atkins in Zurich

Joe Jimenez is facing a battle to restore investor confidence in Novartis after a series of setbacks which have sent shares in the Swiss pharmaceuticals group down more than a quarter in the past year.

By far the biggest peril is from a lawsuit being pursued by Preet Bharara, the formidable US attorney-general for the southern district of New York. He has accused Novartis of funnelling kickbacks to prescribers through as many as 80,0000 “sham” educational meetings where doctors were wined and dined.

Mr Bharara, has already secured a $390m settlement from Novartis in a separate case last year, and Andrew Baum, analyst at Citigroup, says there is a “high probability” of another fine that could be similar in scale to the record $3bn paid byGlaxoSmithKline to the US justice department in 2012.

Like GSK, Novartis might also have to commit to marketing reforms that would make it harder to aggressively push Entresto. Mr Baum said this could “severely impact” earnings and cast “a reputational shadow over the incumbent Novartis chairman [Joerg Reinhardt] and CEO”.

In an attempt to clean up, Novartis has appointed a chief ethics officer and is in the process of tightening its rules on relations with doctors.

For all the challenges, some analysts still see reasons for optimism. While Entresto has flopped so far, another new product, Cosentyx for psoriasis, has started strongly with forecasts of $2.5bn in annual sales by 2020. Michael Nawrath, analyst at Zürcher Kantonalbank, says Mr Jimenez could refresh the business with bolt-on deals. “It doesn’t have to be a mega merger, but there are smart asset swaps, collaborations, or purchases . . . which could convince shareholders that there is future growth.”
Click to expand...


So Joe meets Donald a couple weeks back, and the Madman of Manhattan gets fired for doing his job.



Preet Bharara, the Manhattan federal prosecutor who was asked by President Trump to remain in his post shortly after the election, was fired on Saturday after he refused an order to submit his resignation.

Mr. Bharara’s dismissal capped an extraordinary showdown in which a political appointee who was named by Mr. Trump’s predecessor, President Barack Obama, declined an order to submit a resignation.

“I did not resign. Moments ago I was fired. Being the US Attorney in SDNY will forever be the greatest honor of my professional life,” Mr. Bharara wrote on his personal Twitter feed, which he set up in the last two weeks.


https://www.nytimes.com/2017/03/11/us/politics/preet-bharara-us-attorney.html?
 






Novartis Breast Cancer Drug Just OK'd — And Already Losing?

Novartis' breast-cancer drug may already be at a disadvantage just a day after being approved.
Novartis' newly approved breast-cancer drug is at a disadvantage to Pfizer's Ibrance with a label warning of liver toxicity and requiring occasional heart-rhythm monitoring, an analyst said Tuesday.

Leerink analyst Seamus Fernandez expects Pfizer to keep 67% of the market with Novartis grabbing 20%. Novartis said late Monday that the FDA had approved its drug, Kisqali, to treat some forms of post-menopausal advanced breast cancer.

Kisqali's label warns of potential liver toxicity and fast or chaotic heartbeats known as QT prolongation. That means a patient must undergo electrocardiograms, electrolyte monitoring and liver function tests at various points in treatment.
 






Once scored as a potential blockbuster, Novartis’ serelaxin fizzles in critical cardio outcomes test

by john carroll
March 22, 2017 06:11 AM EDT
Updated: 07:52

You can scratch serelaxin off Novartis’ list of potential blockbusters in the late-stage pipeline.

This morning the pharma giant said that its 4-year study of the heart drug flubbed the primary endpoint, failing to significantly cut the rate of cardiovascular death or reduce worsening heart failure among patients with acute heart failure.

Novartis Chief Medical Officer Vas Narasimhan said that the pharma giant will continue to look over the data to determine next steps. But the R&D journey would appear to be over.

Despite winning one of the first breakthrough drug designations at the FDA for this program, an FDA panel wasn’t persuaded by the data that Novartis offered. The agency formally rejected the drug in the spring of 2014, looking for the outcomes data from the 6,600 patients recruited for RELAX-AHF-2.

The EU followed up soon after with a thumbs down as well.

Novartis execs had been convinced that serelaxin would be the next big thing in heart drugs, set on a course to blockbuster status. The data, however, wouldn’t cooperate with their plans.
 






Spain Probes Pharma Giants For Restricting Competition
By Matthew Perlman

New York (March 21, 2017, 3:28 PM EDT) -- Spain’s competition watchdog said Tuesday that it has opened proceedings against six pharmaceutical companies, including subsidiaries of Pfizer, Merck and Novartis, for possible anti-competitive behavior.
The National Competition and Markets Commission, or CNMC, said it is looking into the possible establishment of a dual-pricing distribution system among Pfizer SLU, Merck Sharp & Dohme de España SA, Novartis Farmacéutica SA, Lilly SA, Sanofi-Aventis SA and Johnson & Johnson unit Janssen-Cilag SA.
 






Not just Colombia: Novartis has charged more for some drugs in Mexico, too
ED SILVERMAN @Pharmalot

MARCH 28, 2017

As Novartis grapples with controversy over its pricing in Colombia, internal company data show the drug maker has also charged higher prices for some widely used medicines in other Latin American countries — notably, Mexico — than in many wealthy nations.

In 2014, the most recent year for which data was available, Novartis charged 29 percent to 548 percent more for 30 tablets of the Co-Diovan blood pressure pill in Mexico than in 20 other countries, including several high-income nations. For instance, the price was $63.06 for a pack of 30 compared with $35.51 in Germany, $30.04 in the UK, and $9.73 in Italy.
 






Kickbacks judge to Novartis: Hand over the info on those 79,000 'sham' events
by Tracy Staton |
Mar 30, 2017 11:53am
DOJ_0.jpg

Novartis must hand over info on more than 79,000 'sham' physicians dinner events.

A U.S. judge has ordered Novartis to do something it’s been trying for a year to avoid: Hand over documents on 79,236 educational events the company says it held with doctors.

Federal prosecutors claim those events were shams. They call them “kickbacks” instead. The government alleges that Novartis invited the same doctors to speaker events over and over, treating them to lavish dinners at Nobu and Smith & Wollensky—and gatherings at Hooters—in return for prescribing more Novartis meds.

In a legal drama on TV, this is when we would see a montage of photocopying and stacking, and a final shot of hand trucks delivering box upon box of documents. The whistleblower in the case, former Novartis sales rep Oswald Bilotta, might shake hands or high-five with the Justice Department lawyers accepting the delivery.

Lacking Hollywood license, Judge Paul Gardephe offers these comments in his Tuesday order (PDF) compelling Novartis to muster its paperwork.

Novartis must produce backup documentation on its events from a company database. The company also has to turn over records of its payments to doctors speaking at the events, educational PowerPoint presentations and reports on Novartis’ own investigations into complaints about its speaker programs.

Judge Gardephe denied a request that Novartis search electronic records kept by 363 additional sales staffers because the DOJ had agreed to limit those searches to 150 reps.

Novartis had argued that the DOJ also agreed to limit its demands for information to 6,600 events—rather than more than 80,000—and that gathering up documentation for the additional 70,000-plus would be too monumental a task.

The court didn’t buy it. Satisfying the demands for evidence wouldn’t be unduly burdensome, Gardephe wrote. And in any case, the stakes are high enough to warrant some sweat on Novartis’ part, the order states.

The government claims that “sham” events and honoraria, paid from 2002 through at least 2011, were essentially bribes to induce doctors to prescribe Novartis cardiovascular drugs, including the now-off-patent blood pressure med Diovan and the diabetes med Starlix.

According to the feds, the presentations were often cursory at best and sometimes didn't take place at all. The DOJ says they were essentially social occasions disguised as educational programs. Novartis held some events in noisy restaurants without private dining rooms where speakers might have set up slide presentations. Physicians repeatedly attended programs on the same topic, the government said.

To amount to kickbacks, though, these entertainments had to be linked to increased prescription numbers. The lawsuit claims attendees did boost their prescribing of the drugs involved—and doctors knew they wouldn’t be asked back if they didn’t.

According to Gardephe’s order, the prosecutors say Novartis paid “tens of thousands of doctors kickbacks,” and each of those doctors then “wrote many thousands of dollars’ worth of prescriptions” for Novartis drugs that were paid for by federal healthcare programs. That means the case “has the potential for broad public impact”—justifying the time and trouble necessary to produce those records, Gardephe wrote.
 






Exhibit A.

The consequences of focusing on financial performance as #1 priority.


http://www.fiercepharma.com/legal/greek-official-thousands-people-implicated-novartis-bribery-probe

The public drama surrounding an investigation into alleged bribes by Novartis to sell more drugs in Greece entered a new act today as the country’s justice minister told a state news agency the drugmaker likely bribed “thousands” of government officials and doctors to push its meds. The claims came a week after Greece’s top corruption prosecutor resigned citing backlash from her bribery probe into Novartis.

Greek Justice Minister Stavros Kontonis told ANA radio a “great number” of the country’s officials and doctors were involved in the scheme “to promote drugs in an illegal and anti-scientific manner,” according to Medical Xpress. From what he’s seen, Kontonis said, “it must be thousands who were directly bribed from Switzerland,” the report says.
 






Generics Successful at Invalidating Novartis Gilenya Patent
April 12, 2017Dennis Crouch


by Dennis Crouch

Novartis v. Torrent Pharma, Apotex, and Mylan (Fed. Cir. 2017)

At the conclusion of its Inter Partes Review (IPR) Trial, the Patent Trial & Appeal Board (PTAB) found all claims of Novartis U.S. Patent No. 8,324,283 invalid as obvious. The PTAB had allowed Novartis to include substitute claims as well, but found those also unpatentable as obvious. On appeal here, the Federal Circuit affirms.

The ‘283 patent covers a solid combination of a sphingosine-1 phosphate (S1P) receptor agonist (fingolimod) and a sugar alcohol (mannitol). The drug – sold under the trade name Gilenya – is used to treat multiple sclerosis. This is the first oral disease modifying MS drug approved by the FDA and is a big drug with billions in sales each year.

The particular ingredients were already known in the art, and the active ingredient – fingolimod – was already known as useful for treating autoimmune diseases such as MS. However, none of the references brought-together the entire combination in a “solid pharmaceutical composition” as required by the claims. However, the Board found that the combination of references would have led an ordinary skilled artisan to the invention claimed here.

On appeal, the Federal Circuit reviews the Board’s factual findings for substantial evidence – a liberal and forgiving standard that only requires “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” Conclusions of law, however, are reviewed de novo on appeal. In patent law, the ultimate question of obviousness is deemed a question of law. However, that ultimate conclusion must be based upon a set of predicate factual conclusions as outlined in Graham v. John Deere.

Perhaps of most relevance for many obviousness cases – the existence of a motivation-to-combine references is deemed a question of fact and thus deference is given to the PTO’s conclusion. Here, the court noted that the board considered the negative properties of using mannitol (teaching-away), but was not convinced, and sufficient evidence supported the Board’s decision. The patentee also focused on the fact that the Board’s written decision did not expressly consider all of the patentee’s teaching-away arguments. On appeal, the Federal Circuit rejected that argument – holding that “there is no requirement that the Board expressly discuss each and every negative and positive piece of evidence lurking in the record to evaluate a cursory argument.” On this point, the court recognized the tension with Medichem‘s holding that the disadvantages of a reference must be considered, but held that Medichem does not create a bright-line rule requiring express discussion of all disadvantages. Rather, the Board is “not require[d] . . . to address every argument raised by a party or explain every possible reason supporting its conclusion.” Synopsys, Inc. v. Mentor Graphics Corp., 814 F.3d 1309, 1322 (Fed. Cir. 2016).

Novartis also raised an APA challenge – arguing that the Board did not provide the required notice and an opportunity since the Board included a new reference (Sakai) in its final decision. Sakai was raised in the IPR petition, but institution was denied for the particular grounds raising Sakai. On appeal, the Federal Circuit sided with the PTAB holding that – although institution decision rejected Sakai as anticipatory or the primary obviousness reference – the Board did not exclude Sakai from consideration since it is clearly a relevant reference. “The Board’s discussion of Sakai in the Final Written Decision was not inconsistent with its review of Sakai in the Institution Decision.” With this explanation, the court was able to justify the PTAB approach and find that the agency did not “change theories in midstream without giving respondents reasonable notice of the change.” and ‘the opportunity to present argument under the new theory.” Rodale Press, Inc. v. FTC, 407 F.2d 1252, 1256–57 (D.C. Cir. 1968).

What next: I’ll note here that the ‘283 patent is only one of four patents listed in the Orange Book covering Gilenya, one of which is also currently being challenged at the PTAB.


https://patentlyo.com/patent/2017/04/generics-successful-invalidating.html
 






Novartis' Gilenya patent loss sets MS market up for battle with early generics
by Eric Sagonowsky |
Apr 13, 2017 10:51am

Novartis lost an appeal to protect a 2026 patent on multiple sclerosis blockbuster Gilenya, which brought in more than $3 billion last year.

Novartis' bid to fend off early Gilenya generics has failed in court. The Swiss drugmaker, attempting to salvage a 2026 patent, lost that fight at the U.S. Federal Circuit, leaving the multiple sclerosis blockbuster shielded from generics only through 2019.

The decision sets up an impending generic rush that stands to not only erode Gilenya's sales but upturn the market for MS pills in general. Other brands, including Biogen's Tecfidera, will be forced to compete with cheaper Gilenya knockoffs years before they expected that fight, analysts said.

The U.S. Court of Appeals for the Federal Circuit on Wednesday agreed with the U.S. Patent Trial and Appeals Board’s 2015 finding that Gilenya's 2026 formulation patent is invalid. In affirming the PTAB’s decision, the appeals court wrote that it “considered all of Novartis’ remaining arguments,” but concluded “that they are without merit.”

Now, Novartis has a patent term extension expiring in 2019 and a dose patent expiring in 2027, according to its recent 20-F filing with the Securities & Exchange Commission.

It’s a blow to Novartis, knocking several years of branded pricing power from a drug that brought in $3.1 billion last year. FDA-approved in 2010 as the first oral MS therapy, Gilenya remains a growth driver at the pharma giant; last year, it posted sales growth of 14%.

India’s Torrent Pharma brought the PTAB challenge to Gilenya’s intellectual property, while Mylan and Apotex filed a separate challenge. The mandatory Hatch-Waxman Act stay on generic approvals expires in March 2018, Novartis said in its filing.

In late 2015—when the PTAB invalidated the 2026 Novartis patent on grounds that it was “obvious"—Bernstein analyst Ronny Gal said the decision could reverberate through the entire MS market. Gal expected generic Gilenya and knockoffs of Teva’s big-selling injectable, Copaxone, to deliver dual blows to rival therapies.
 






MSBU Layoffs? said:
Novartis' Gilenya patent loss sets MS market up for battle with early generics
by Eric Sagonowsky |
Apr 13, 2017 10:51am

Novartis lost an appeal to protect a 2026 patent on multiple sclerosis blockbuster Gilenya, which brought in more than $3 billion last year.

Novartis' bid to fend off early Gilenya generics has failed in court. The Swiss drugmaker, attempting to salvage a 2026 patent, lost that fight at the U.S. Federal Circuit, leaving the multiple sclerosis blockbuster shielded from generics only through 2019.

The decision sets up an impending generic rush that stands to not only erode Gilenya's sales but upturn the market for MS pills in general. Other brands, including Biogen's Tecfidera, will be forced to compete with cheaper Gilenya knockoffs years before they expected that fight, analysts said.

The U.S. Court of Appeals for the Federal Circuit on Wednesday agreed with the U.S. Patent Trial and Appeals Board’s 2015 finding that Gilenya's 2026 formulation patent is invalid. In affirming the PTAB’s decision, the appeals court wrote that it “considered all of Novartis’ remaining arguments,” but concluded “that they are without merit.”

Now, Novartis has a patent term extension expiring in 2019 and a dose patent expiring in 2027, according to its recent 20-F filing with the Securities & Exchange Commission.

It’s a blow to Novartis, knocking several years of branded pricing power from a drug that brought in $3.1 billion last year. FDA-approved in 2010 as the first oral MS therapy, Gilenya remains a growth driver at the pharma giant; last year, it posted sales growth of 14%.

India’s Torrent Pharma brought the PTAB challenge to Gilenya’s intellectual property, while Mylan and Apotex filed a separate challenge. The mandatory Hatch-Waxman Act stay on generic approvals expires in March 2018, Novartis said in its filing.

In late 2015—when the PTAB invalidated the 2026 Novartis patent on grounds that it was “obvious"—Bernstein analyst Ronny Gal said the decision could reverberate through the entire MS market. Gal expected generic Gilenya and knockoffs of Teva’s big-selling injectable, Copaxone, to deliver dual blows to rival therapies.
Click to expand...


The good news is maybe Ed from Philly will be laid off and good luck finding another job little man
 






Add it to the never ending list of criminal wrongdoing

Novartis faces W55b fine, insurance coverage suspension over rebate
  • The Investor PUBLISHED :April 27, 2017 - 18:01
  • Swiss drug giant Novartis on April 27 was slapped with a 55.1 billion won (US$48.8 million) fine and suspension of health insurance reimbursement on nine drugs for paying illegal kickbacks to doctors in Korea.

    Out of the 42 rebate-related medications sold by Norvartis here, the Ministry of Health and Welfare will suspend the nine drugs from the list of national insurance coverage for six months and slap administrative fines on 33 drugs, in lieu of suspension.


    The punitive measures came as Novartis was found to indirectly offer bribes worth 2.59 billion won from 2011 to 2016 to doctors in exchange for recommending its drugs.

    Novartis said it will take immediate and decisive measures to strengthen ethical management.

    “We apologize to patients and the drug industry for disappointment caused by the incident,” a company official said.

    The drugs that will face the six-month coverage exclusion include Alzheimer’s drug Exelon and bone cancer therapy Zometa.

    Novartis is one of the top-selling foreign pharma companies in Korea, which is the tenth-largest market for the company in terms of sales.

    The company’s cancer treatment Gleevec, which patients feared would be suspended, was not subject to the punitive measures.

    Last week, Korean leukemia patients who takes Gleevec urged the government not to exclude the drug from the insurance coverage list as they have bear a big price increase or use other generic drugs. Some 6,000 patients are taking Gleevec in Korea.

    The Health Ministry’s sanctions are tougher than the measures announced by the Ministry of Food and Drug Safety, the country’s drug regulator, in February over the same charges.

    The MFDS fined the Swiss pharma firm 200 million won on 30 drug items and banned sales of 12 variations of three drug types including Alzheimer’s drug Exelon for three months.

    By Park Han-na (hnpark@heraldcorp.com)
 






Dear Oswald Bilotta,

You sue because you were a shady rep??? You are a pretty pathetic person.

But what's more pathetic is this lawsuits. You are blaming Novartis because you were unethical. It also states that there are shame programs not no one attended and then say that doctors were paid to write, which one is it?

Glad you moved out of LI you POS
 






Novartis takes a $200M hit to write off a flop as execs spell out a cautious R&D strategy

by john carroll
April 25, 2017 08:32 AM EDT
Updated: 08:41 AM


With its top line locked into a holding pattern as its sales teams struggle to expand franchise revenue, Novartis has outlined its near-term R&D strategy, taking a $200 million hit to write off the disappointing heart drug serelaxin (RLX030) while looking beyond a decision later in the year on its pioneering CAR-T drug as it shoots for new FDA filings.

Joe-Jimenez-LinkedIn.jpg

Joe Jimenez. Novartis

The pharma giant said recently that it has wrapped its initial FDA application for CTL019. And in a new note out from Biren Amin the Jefferies analyst predicts that we’ll be seeing the closely-watched followup data from the JULIET study at the International Conference on Malignant Lymphoma on June 14 in Lugano, Switzerland.

Following a hoped-for approval in CAR-T, Novartis revealed this morning that its discussions with regulators is encouraging the company to aim for a 2018 filing for SEG101 (crizanlizumab) for sickle cell pain crises after it wraps the PK/PD comparability study to final manufacturing process. Right alongside the pharma giant’s R&D team will angle for an FDA approval of BAF312 (siponimod) for relapsing multiple sclerosis.

What you shouldn’t look for: Any big M&A pacts. Like a number of its major league rivals, Novartis execs say that valuations in biotech have reached a forbidding high. Novartis CEO Joe Jimenez adds that the company’s BD team plans to move upstream, to earlier-stage assets and deals, as the company stays focused on what you can get in a $2 billion to $5 billion bolt-on.

“The price of some of these assets has increased to the point that we don’t feel like we can create value for Novartis shareholders,’’ Chief Executive Officer Joe Jimenez said on a conference call Tuesday, according to a report from Bloomberg.

Net income for Novartis slid 15% in the first quarter, which the company largely attributed to the $200 million charge on serelaxin. The write off for its one-time blockbuster hope can’t come as any kind of surprise. A month ago Novartis said that its 4-year study of the heart drug flubbed the primary endpoint, failing to significantly cut the rate of cardiovascular death or reduce worsening heart failure among patients with acute heart failure.

Novartis is left making slow progress with Entresto, which has been grappling with widespread payer resistance. In the meantime, its big flagship drug Gleevec is being hammered by generic competition.
 






anonymous said:
Dear Oswald Bilotta,

You sue because you were a shady rep??? You are a pretty pathetic person.

But what's more pathetic is this lawsuits. You are blaming Novartis because you were unethical. It also states that there are shame programs not no one attended and then say that doctors were paid to write, which one is it?

Glad you moved out of LI you POS
Click to expand...


You mean "future rich pos" . This guy is a hero
 






In the news:
Danish pharmaceutical giant Novo Nordisk is being accused of engaging in a "white coat marketing scheme" to entice doctors to prescribe three of its diabetes drugs — NovoLog, Levimir, and Victoza.

Together these three drugs made Novo Nordisk $6 billion in sales in 2013, comprising 10% of the company's worldwide sales for the year, according to the complaint.

Specifically, whistleblowers allege that the company illegally hired Certified Diabetes Educators (CDEs) and employed them as sales reps, and then sent them into doctors offices to promote the drug through its "Changing Life with Diabetes Program."

The suit claims that, because the company's sales reps were titled as CDEs, they got unprecedented access to doctors. However, "they were sales representatives in every way except title."

Once inside the CDE's allegedly educated doctors for free. Novo Nordisk, for its part, is a member of the powerful PhRMA lobby, which prohibits member companies from exchanging free medical education for prescriptions.

The government is jumping in because these drugs are all covered by federal health insurance programs — Medicaid, Medicare, and Tricare. And the suit could be a sign that, in an effort to reduce costs, the government is focusing on its reimbursement of drugs.

Novo Nordisk has responded to Business Insider's request for comment with the following statement:

“In February 2011, the U.S. Attorney’s Office for the District of Massachusetts served Novo Nordisk with a subpoena calling for the production of documents regarding potential civil and criminal offences relating to the company’s marketing and promotional practices for the following products: NovoLog®, Levemir® and Victoza®. This matter is being conducted by the US Attorney for the District of Columbia. We’ve reached an agreement in principle to settle certain claims related to this investigation, and the unsealing is a part of that process. The process is not finalized, and as such we can’t provide further comment to this matter at this time.”

If you wonder who may be next, talk to your PSL :rolleyes:
 






#PharmaScamsNeverEnd

EU Urged To Probe Gilead, Novartis, Roche, Aspen Pricing
By Dani Kass

New York (May 4, 2017, 2:17 PM EDT) -- European and Italian consumer organizations Wednesday urged the European Commission to investigate whether Gilead, Novartis, Roche and Aspen, four drug companies that Italy and the U.S. have accused of anticompetitive practices, are ripping off the European Union.
The commission is writing a report on various competition issues in the pharmaceutical industry, so the European organization, BEUC, and the Italian organization, Altroconsumo, asked them to specifically look into these four manufacturers. Italy had fined Aspen Pharma, Hoffmann-La Roche and Novartis AG and the U.S. is looking into Gilead Sciences Inc.

The actions of those companies "undermine consumers’ access to essential medicines and put profits before people health,” the letter states.

The Italian authority had fined Novartis and Roche in March 2014 for conspiring to block an eye medication that was cheaper than their competing product, the groups said. Roche had to pay €92 million and Novartis €90.5 million.

The two drugmakers sell Lucentis to treat age-related macular degeneration and other eye issues, which is 10 times more expensive than the drug they tried to get the country’s health agency to exclude, the letter states. Both drugs are equally effective and safe.

“The excerpts of correspondence between Roche and Novartis’ representatives clearly show that the two companies set up specific strategies to artificially distinguish the two products and to unduly influence the choice of doctors and healthcare systems,” the groups said.
 






Even they're embarrassed by them

GlaxoSmithKline Could Buy Out Partner Novartis
Tony Owusu
Follow
May 15, 2017 8:27 AM EDT
GlaxoSmithKline (GSK) is considering buying out partner Novartis' (NVS) stake in its consumer healthcare joint venture in a deal that could be worth about $10 billion as Glaxo looks to expand its consumer healthcare business, the Sunday Times reported.
Novartis' stake in the business is 36.5%. The Swiss drugmaker could use the funds from the sale to purchase rival Astrazeneca (AZN) , according to the Times.
 






Top Bottom
Back
Quote