Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Novo Nordisk Agrees to Pay Fine But Denies "Wrongdoing"; i.e., Sales Reps Obscured Victoza's Risks

Novo Nordisk Agrees to Pay Fine But Denies "Wrongdoing"; i.e., Sales Reps Obscured Victoza's Risks | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Novo Nordisk will pay $58.65 million to the Justice Department to resolve allegations that it instructed some of its sales representatives to share information with physicians that downplayed safety risks for Victoza, its type-2 diabetes medication.

 

The FDA approved Victoza in 2010, on the condition that the company implement a Risk Evaluation and Mitigation Strategy (REMS) to warn physicians about the potential risk of patients developing a rare cancer called medullary thyroid carcinoma. The drug now has a black-box warning.

 

The allegations against Novo include that managers instructed reps to “sandwich” the risk information between promotional messages in order to minimize that information. Reps also reportedly told doctors that the risk of cancer is only associated with mice and rats; that all diabetes drugs have boxed warnings and Victoza was no different; and that this type of cancer is “easy to treat” if a patient was diagnosed.

 

Because the reps gave doctors a misleading impression about the risks cited in the FDA-mandated REMS program, some physicians who prescribed Victoza were unaware of those risks, the Justice Department alleged. A government survey conducted in 2011 found that half of primary-care doctors were unaware of the cancer risks associated with Victoza.

 

In a statement, the drugmaker said it disagreed with the government's “legal conclusions” and denied wrongdoing. “We're pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients,” Doug Langa, Novo Nordisk's president and EVP and head of North America operations, said in the statement.

 

Novo reported that Victoza – part of a class of drugs called GLP-1s, which includes Eli Lilly's Trulicity – brought in $3 billion in sales in 2016. In addition, the drugmaker has pursued new indications for the therapy. In 2015, a formulation of Victoza was approved as Saxenda, a treatment for weight loss. Earlier this year, the FDA approved Victoza as a treatment to lower the risk of cardiovascular events like heart attacks and strokes.

 

Novo spent $128 million on direct-to-consumer advertising for Victoza in 2016, according to Kantar Media.

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Novo Nordisk President Pledges to Limit List Prices of Drugs But Cannot Guarantee Market Price

Novo Nordisk President Pledges to Limit List Prices of Drugs But Cannot Guarantee Market Price | Pharmaguy's Insights Into Drug Industry News | Scoop.it

We hear from more and more people living with diabetes about the challenges they face affording healthcare, including the medicines we make. We take this issue seriously and have been thinking about what we can do to better support patients. This has become a responsibility that needs to be shared among all those involved in healthcare and we’re going to do our part. 


As a first step, we‘ve taken a position on affordability, outlining three tenets that will be our focus. One is creating more pricing predictability so customers like pharmacy benefit managers (PBMs) and payers can effectively anticipate and budget for our price increases. We will support that by limiting any potential future list price increases for our medicines to no more than single-digit percentages annually. This is one action we are taking immediately. 


A second area of focus is transforming the drug pricing system, which is incredibly complex and has resulted in a lot of confusion around what patients pay for medicines. News reports on drug prices have left the public with an impression that companies like ours realize all the profits from the “list price” increases we’ve made over the last decade. In other words, a list price increase by XX percent leads to an automatic XX percent profit for the drug maker. We believe that is misleading and here’s why: As the manufacturer, we do set the “list price” and have full accountability for those increases. However, after we set the list price, we negotiate with the companies that actually pay for the medicines, which we call payers. This is necessary in order for our medicines to stay on their preferred drug list or formulary. The price or profit we receive after rebates, fees and other price concessions we provide to the payer is the “net price.” The net price more closely reflects our actual profits.


In the graphic showing our insulin, NovoLog®, you’ll see the difference between list price, which increases a lot after 2010, and the net price. The list price increases after those negotiations translated year-over-year to mid-single digit price increases for all our insulins, even when you don’t account for inflation.  And when you do, those net prices were closer to the Consumer Price Index – Urban, a common measure of the average price of goods.

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Bernie Sanders Calls Lilly & Novo #pharma a"Greedy" for Raising Prices of Insulin Drugs

Bernie Sanders Calls Lilly & Novo #pharma a"Greedy" for Raising Prices of Insulin Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Despite his defeat in the primary, popular Vermont Senator Bernie Sanders continues to lend his star power to the principals of the political revolution, taking aim Tuesday at a pharmaceutical company that raised the price of a life-saving insulin drug—and Wall Street is taking notice.

Tuesday morning, Sanders criticized pharmaceutical company Eli Lilly, which raised the price of its insulin drug Homolog (sic) by 700 percent in 20 years when adjusted for inflation.

In a tweet to his 2.7 million Twitter followers, the Vermont Senator posted a Washington Post graph showing the cost of Homolog has risen from $21 to $255 since 1996. Sanders blamed “the drug industry’s greed” for profiting off those in need.

Pharma Guy's insight:

Is Bernie short-selling the stock of pharma companies he criticizes?

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Everywoman Betty and Everyman Freddy are Tresiba Ready! Until Side Effects in AD Pop Up!

Everywoman Betty and Everyman Freddy are Tresiba Ready! Until Side Effects in AD Pop Up! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After setting out to get their blood sugar under control and trim their A1C, Betty the waitress, Freddy the barber and Eddy the delivery man all decide that they're Tresiba-ready.

 

View the ad here and you too will get the refrain stuck in your head!

Pharma Guy's insight:

I hate the "Trisiba Ready" refrain sung in the background over and over again! I can't get it out of my head! Damn!

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Sanofi & Novo Nordisk Raise Diabetes Drug Prices in "Lockstep" With One Another

Sanofi & Novo Nordisk Raise Diabetes Drug Prices in "Lockstep" With One Another | Pharmaguy's Insights Into Drug Industry News | Scoop.it

On May 30 last year, the price for a vial of the blockbuster diabetes medication Lantus went up by 16.1 percent. On the next day, Lantus’s direct competitor, Levemir, also registered a price increase -- of 16.1 percent.


The pattern repeated itself six months later when Lantus, from French drugmaker Sanofi, was marked up 11.9 percent, and Levemir, made by Novo Nordisk A/S, matched again exactly.


In 13 instances since 2009, prices of Lantus and Levemir -- which dominate the global market for long-acting injectable insulin with $11 billion in combined sales -- have gone up in tandem in the U.S., according to SSR Health, a market researcher in Montclair, New Jersey.


Contrary to the consumer’s ideal in which bare-knuckled rivals cut prices to grab market share, competitors in branded pharmaceuticals often drive each other’s prices higher. This behavior, known as “shadow pricing,” is one reason U.S. drug costs are surging. Prescription spending rose 13 percent last year to $374 billion, according to IMS Health Holdings Inc.

Pharma Guy's insight:


I fail to see how this is "Patient Centric." It's a question I should ask Dr. Anne Beal, Chief Patient Officer (CPO), at Sanofi, who spoke about the "Chief Patient Officer of the Future" during a recent Pharma Marketing Talk podcast: http://bit.ly/PMT232 

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Letizia Affinito's curator insight, May 7, 2015 6:52 PM

As healthcare stakeholders keep using the word "patient-centric", one must be wondering, how can health communicators working in pharma support and facilitate patients’ desires for greater inclusion and authority in their care and still turn a profit?

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Team Novo Nordisk to compete in The Tour of Britain

Team Novo Nordisk to compete in The Tour of Britain | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The world's first all-diabetic professional cycling team will compete in The Tour of Britain from September 7, 2014.


Team Novo Nordisk is a global sports team made up of more than 100 triathletes, runners and cyclists, led by their professional cycling team. The unique team all have type 1 diabetes and manage their condition while training and competing in high endurance competitions.


Novo Nordisk said the team will be competing to encourage other patients to learn how to control their diabetes in order to be able to progress in their day-to-day lives.


Dr Rafael Castol, Team Novo Nordisk medical director, said: “Our experience working with Team Novo Nordisk riders demonstrates that all levels of physical exercise can play an important role in the management of people with both type 1 and type 2 diabetes.


“When supporting patients to step up levels of exercise, we would recommend that healthcare professionals consider the individual's personal commitment to achieving tight glycaemic control, their confidence level in monitoring blood glucose levels, and their ability to make appropriate adjustments to their medication.”


The team was formed in December 2012 by Novo Nordisk and Phil Southerland, co-founder and CEO of Team Novo Nordisk, as part of Nordisk's Changing Diabetes programme, which aims to create more opportunities to live well with diabetes and ensure better outcomes for more patients.

Pharma Guy's insight:


Novo Nordisk has a penchant for teaming up with athletes to help promote its diabetes franchise. You might recall that in the U.S. Novo Nordisk's Levemir insulin brand team sponsors Charlie Kimball, a racecar driver who has diabetes (see here). 

Auto racing and cycling are two sports that are heavily sponsored by corporations. Brand and company logos are plastered all over the machines and the uniforms worn by the athletes. Kimball is a Levemir-branded billboard that must comply with FDA regulations because he displays the Levemir logo and is known to use the drug to treat his diabetes. Therefore, the back of his uniform must include fair balance (seriously!).

Pharma companies, however, cannot sponsor branded ads in Europe. Consequently, the uniforms worn by the cyclists of Team Novo Nordisk only sport the corporate logo and the tag line "Changing Diabetes"

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Major #Pharma Companies Sued for Colluding to Raise Insulin Prices

Major #Pharma Companies Sued for Colluding to Raise Insulin Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The latest dustup over the rising price of insulin has found its way to a federal court, where several consumers are accusing the three biggest manufacturers — Sanofi, Eli Lilly, and Novo Nordisk — of running a coordinated scheme that has caused patients economic harm.

 

The lawsuit arrives two months after Senator Bernie Sanders (D-Vt.) and Representative Elijah Cummings (D-Md.) asked the Department of Justice and the Federal Trade Commission to investigate the companies for price collusion. They cited a pattern in which prices for insulin often rose in tandem over several years and expressed concern the drug makers conspired to raise prices and, as a result, drove up the cost for patients and taxpayers.

 

Indeed, the lawsuit makes similar allegations, charging the companies raised prices on their drugs by more than 150 percent and that, as a result, some consumers pay almost $900 each month. “Drugs that used to cost $25 per prescription now cost between $300 and $450 a month,” according to the lawsuit, which was filed in federal court in Boston and seeks class-action status.

 

The latest accusations follow months of reports about skyrocketing costs for insulin (read “Soaring Insulin Prices Impact Patients Every Day!”; http://sco.lt/7iQKZt ).

 

A study last year, for instance, in the Journal of the American Medical Association found the price for a milliliter of insulin climbed 197 percent from $4.34 per to $12.92 between 2002 and 2013. More than 29 million Americans, or 9.3 percent of the population, have some form of diabetes, according to the Centers for Disease Control and Prevention.

 

Pharma Guy's insight:

Also read “Sanofi & Novo Nordisk Raise Diabetes Drug Prices in "Lockstep" With One Another”; http://sco.lt/7sltK5  and “Why Is Insulin So Expensive In The U.S.?”; http://sco.lt/9K9FJJ  and “Soaring Insulin Prices Impact Patients Every Day!”; http://sco.lt/7iQKZt 

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Dear #Pharma: Do You Know Where Your Ads Are? Novo Nordisk Learns That Adwords is Politically Agnostic!

Dear #Pharma: Do You Know Where Your Ads Are? Novo Nordisk Learns That Adwords is Politically Agnostic! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The forthcoming Trump presidency may have buoyed biopharma stocks, but not all drug makers are happy with the new status quo. 

Diabetes giant Novo Nordisk recently pulled advertising from Breitbart News, the conservative site founded by Stephen Bannon, president-elect Donald Trump’s new chief strategist.

The Danish drug maker joins more than a dozen companies confirming that they’ve withdrawn advertising from Breitbart. 

Many companies are unaware that their ads show up on sites like Breitbart, because they buy into larger ad purveyors — like Google Ads — to market their wares. But AppNexus, one of the largest digital ad services, recently barred Breitbart for hate speech.

Pharma Guy's insight:

LOL! 

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Novo Nordisk and Indy Driver Charlie Kimball: Perhaps the Longest Lasting Celebrity-Pharma Partnership!

Novo Nordisk and Indy Driver Charlie Kimball: Perhaps the Longest Lasting Celebrity-Pharma Partnership! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Every racecar driver has sponsors. But not every driver depends on its car sponsor the way Charlie Kimball does: He has type 1 diabetes and uses Novo Nordisk ($NVO) meds daily. And not every sponsor gets the articulate marketing backup that Kimball provides.

 

Last weekend, Kimball finished his 100th race in the Novo Nordisk IndyCar with no signs of slowing down the successful partnership.

 

Kimball first met with Novo Nordisk in 2008, introduced by his endocrinologist a year after finding out at that he had Type 1 diabetes. He was already using Novo treatments, and so his doctor thought the pharma might be interested in the young race car driver's story. The company was. Novo Nordisk and Kimball struck a partnership in 2009, starting with the brand on his racing suit and a few speaking engagements.

 

Novo first signed on as Kimball's primary car sponsor in 2011 under the Chip Ganassi Racing team. While details of that deal aren't public, Bloomberg estimates that the cost of a primary Indy car sponsorship starts at $5 million to $9 million for the side pod, another $1 million to $2 million for the front wind and $300,000-$900,000 for the cockpit and tail.

 

But the team-up soon expanded beyond paint colors and car logos. Impressed with Kimball's combination of driving grit and genuine dedication to fans and diabetes awareness, Novo rolled out the “Race With Insulin” education campaign in 2013 [This is incorrect. Pharmaguy blogged about the @racewithinsulin campaign back in 2009. See here; http://bit.ly/3SM9wL Also, listen to this 2009 interview: “Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter”; http://sco.lt/8GXLJh ]. That same year, Kimball became the first driver with Type 1 diabetes to win a major IndyCar race.

 

Celebrity endorsements are not always so cohesive and effective. Brands can run into issues that cause celebs to disavow them, as Sarah Jessica Parker recently did with Mylan's EpiPen amid the company's pricing debacle. Other times, as Novo knows, celebrities' behavior can cause a rift: The Danish drugmaker faced negative publicity and a split with Paula Deen after she admitted to using racist language [read “Should Novo Nordisk Dump Deen?; http://bit.ly/10gwOFW - They did!].

 

Meanwhile, November is Diabetes Awareness Month, coming just after the season ends, and Kimball will spend the month traveling with Novo Nordisk and other ambassadors, including basketball player Dominque Wilkins, country music singer RaeLynn, actor Ben Vereen and rapper Rev Run, sharing their stories at speaking engagements and events.  

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Novo Nordisk Thanks #FDA for Forcing It to Prove Victoza Can Decrease CV Events

Novo Nordisk Thanks #FDA for Forcing It to Prove Victoza Can Decrease CV Events | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Researchers announced that Victoza, a diabetes drug sold by Danish drug giant Novo Nordisk , prevents heart attacks, strokes and cardiovascular deaths.

 

It is only the second diabetes drug ever to do so. The first, Jardiance, a pill sold by Eli Lilly and Boehringer Ingelheim , presented its positive results just last year. Researchers say that the new results could change the way that doctors treat diabetes, shifting the treatments doctors reach for after metformin, the tried-and-true first-line drug, which is generic.

 

“There’s a building momentum that maybe we do need to rethink the way diabetes is cared for in America,” says John Buse, the University of North Carolina, Chapel Hill researcher who led the study, which was funded by Novo Nordisk.

 

And doctors and Novo Nordisk itself give credit to the new diabetes data to a surprising source: Tougher regulations for diabetes drugs from the Food and Drug Administration, which many in industry had previously decried, saying it was keeping new drugs from the market and hurting patients.

 

“I can almost guarantee you that these trials would not have been done if it had not been for the FDA regulations,” says Buse, who has been a consultant to many companies for years. “Before the guidance I was constantly pushing on companies to do these trials.”

 

That fact – that companies and patients are likely to benefit from the FDA’s toughness – goes against one of the common narratives in the drug industry and among the FDA’s critics: that high regulations slow patients’ access. In some cases, its clear, they also create a bar for industry to leap over, and deliver billions of dollars in spoils to companies that actually manage to help patients, not just blood test results.

 

The Victoza result is exactly the kind of marketing claim that makes a drug company salivate: Novo Nordisk can now tell patients and their insurers that the alternative to its drug is an earlier death.

Pharma Guy's insight:

The research showed that 13% of patients on Victoza had a heart attack, stroke, or death, compared to 14.9% on placebo, a 13% decrease in risk. Reductions in cardiovascular death (22%) and death from any cause (15%) were also statistically significant.

 

Now, perhaps, Novo won't have to bribe so many physicians or promote the drug for weight loss. For more on that, read "Novo Nordisk’s Victoza Tops List of Drug Payments to Physicians"; http://sco.lt/9141vV "Public Citizen: Off-Label Uses Promoted in DTC Ads for Diabetes Drugs"; http://sco.lt/84lZtR

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Novo Nordisk’s Victoza Tops List of Drug Payments to Physicians. Better Investment Than Paula Deen!

Novo Nordisk’s Victoza Tops List of Drug Payments to Physicians. Better Investment Than Paula Deen! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Novo Nordisk paid more than $9 million to physicians for promotion of its diabetes drug Victoza in the last five months of 2013, topping the list of drugs that were responsible for the most physician payments during the first reporting period covered by the CMS Open Payments database.


The bulk of the drugs on the list are blood-thinners vying to replace Coumadin (warfarin), followed by antipsychotics and anti-inflammatory drugs.


Most are relatively new, having received FDA approval since 2010. The only older drug that made the list, Humira, was approved in 2002.

Following Victoza (liraglutide[rDNA origin] injection) at  $9.07 million; the rest of the list is as follows:


  • Bristol-Myers Squibb, $7.99 million for anticoagulant Eliquis (apixaban);
  • AstraZeneca, $7.71 million for the blood-thinner Brilinta (ticagrelor);
  • Johnson & Johnson, $7.16 million for its type 2 diabetes drug Invokana (canagliflozin);
  • Dainippon Sumitomo Pharma, $7.03 million for atypical antipsychotic Latuda (lurasidone) for schizophrenia;
  • Bayer, $6.93 million for blood-thinner Xarelto (rivaroxiban);
  • AbbVie, $5.58 million for anti-inflammatory Humira (adalimumab) for a number of autoimmune indications, including arthritis, Crohn’s disease and ankylosing spondylitis;
  • Forest, $5.31 million for Tudorza (aclidinium bromide inhalation powder) and $5.2 million for Daliresp (roflumilast), both for chronic obstructive pulmonary disease;
  • Otsuka, $5 million for Abilify Maintena (aripiprazole) for schizophrenia.
Pharma Guy's insight:


Impressive. But at least it probably had a much better ROI than the millions Novo paid Paul Deen et al to be a spokesperson. For more on that, read Paula Deen & Victoza: Brilliant or Dumb?

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