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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AbbVie Must Pay $150 Million for Misleading AndroGel Marketing, But Not to DOJ!

AbbVie Must Pay $150 Million for Misleading AndroGel Marketing, But Not to DOJ! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a split decision, a federal jury in Chicago ordered AbbVie to pay $150 million in punitive damages for fraudulently misrepresenting the risks of its AndroGel testosterone replacement drug. But at the same time, the jury decided the drug maker was not liable for a heart attack that the plaintiff, Jesse Mitchell, suffered after taking the medication.

 

The trial was the first in an estimated 6,000 lawsuits that the drug maker faces over its controversial marketing, which warned that low testosterone can interfere with sex drive, moods, and energy levels. However, the increased usage was accompanied by dueling medical studies — and subsequent debate — over the extent to which AndroGel and other such drugs could increase cardiovascular risks.

 

AndroGel was approved by regulators to treat hypogonadism, a condition in which the body does not produce enough testosterone and is supposed to be prescribed due to illness or injury. However, the consumer marketing campaign, which was dubbed “Low T,” also suggested that AndroGel could be used to treat typical signs of aging, such as low energy, low sex drive, and moodiness.

 

Moreover, the lawsuits also allege that AbbVie either hid or downplayed the risk of heart attacks. Two years ago, after sustained scrutiny, the Food and Drug Administration required drug makers to add information on their product labeling about the possible increased risk of heart attacks and strokes associated with low testosterone treatments.

 

In the case decided on Monday, Jesse Mitchell, a 54-year-old laundry manager from Fairview, Ore., alleged AbbVie misled him and his doctor about the possibility that AndroGel could cause blood clots, which can lead to fatal heart attacks. Mitchell suffered a heart attack in 2012 after taking AndroGel for four years, according to court documents.

 

However, the jury did not find that AbbVie was negligent and so did not award anything to Mitchell for his heart attack. As a result, he was not awarded any compensatory damages; the $150 million award is only for punitive damages. An AbbVie spokeswoman wrote us that “the jury found that Androgel did not cause any damage. We expect the punitive damage award will not stand.”

 

Further Reading:

  • “Insurers ‘Duped’ by Deceptive Low-T #Pharma Marketing”; http://sco.lt/5iII89
  • “Too Many Healthy Men Receive ‘Low-T’ Treatment & Are at Risk for Major Adverse Cardiovascular Events”; http://sco.lt/7UBZq5
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AbbVie is 3rd Pharma Company to Vow to Keep Drug Price Increases Below 10% - for 2017 At Least!

AbbVie is 3rd Pharma Company to Vow to Keep Drug Price Increases Below 10% - for 2017 At Least! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AbbVie Inc Chief Executive Richard Gonzalez on Wednesday promised to keep all drug price increases in 2017 under 10 percent, becoming the third global drugmaker to publicly make that pledge.

 

Speaking at the annual JP Morgan Healthcare Conference in San Francisco, Gonzalez said his company would raise prices just once this year, and the percentage increases would not exceed single digits.

 

AbbVie, whose rheumatoid arthritis treatment Humira is the world's biggest-selling drug, joins Allergan and Danish diabetes company Novo Nordisk as the first major drugmakers promising such a limit on price increases.

 

"There's a strong debate going on right now about pricing," Gonzalez told investors. "We need to make sure we are operating in an appropriate way ... and demonstrating the value of the products that we have."

 

Further Reading:

  • “Enbrel and Humira Prices Mysteriously Rise in Tandem. What Could be the Bizarre Reason?”; http://sco.lt/964qbh
  • “Abbie on a Humira TV Ad Spending Spree in Anticipation of Biosimilar Competition”; http://sco.lt/7X1n3x
  • “Novo Nordisk President Pledges to Limit List Prices of Drugs But Cannot Guarantee Market Price”; http://sco.lt/7vRFzt
  • “Allergan's Brent Saunders' "Manifesto" on Drug Prices & Access”; http://sco.lt/6630V7
Pharma Guy's insight:

What about 2018, 2019, 2020? I guess the pledge lasts only as long as the public maintains the heat!

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The Dog-Eat-Dog-Eat-Dog World of Biosimilars!

The Dog-Eat-Dog-Eat-Dog World of Biosimilars! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amgen took one step closer to approval for its biosimilar of the world’s biggest-selling drug last night, but analysts don’t see it hitting the market this side of 2020 as a bitter patent battle continues.

 

The FDA advisory voted 26-0 that its version of AbbVie’s ($ABBV) Humira (adalimumab), currently known as ABP 501, should be approved along the same lines as the original drug--which includes licenses for rheumatoid arthritis and plaque psoriasis, as well as Crohn's disease and ulcerative colitis (UC).

 

Humira makes around $14 billion (with $8.4 billion made in the U.S.) a year and depending on how Amgen decides to price its copy (typically in Europe biosims are around 25% cheaper than the original), it could be set to eventually take a fair chunk of that away.

 

So, champagne corks popping at Amgen? Not quite, as even if, as expected, it gains full approval for all indications this year, it will likely not be launching its drug until 2022 if AbbVie has anything to do with it.

 

That’s because the two have locked horns in an increasingly bitter patent war, as AbbVie believes it has another 6 years of legal protection before anyone can release a biosimilar version. The dispute is still ongoing in the courts.

 

But in a reverse of fortune, Amgen is in fact today playing the role of AbbVie as the FDA panel turns its attentions to a biosimilar version of its blockbuster drug Enbrel (etanercept), which is indicated for rheumatoid arthritis and other chronic autoimmune conditions.

 

Novartis is seeking an approval for its Enbrel copy GP2015, which FDA staffers have already said in documents posted on the agency’s site this week is “highly similar” to its reference product, and the five licenses Enbrel has. The panel will meet today to discuss whether it too should recommend approval.

 

But guess what? In a familiar sounding scenario, Amgen is suing Novartis’ generic and biosimilar unit Sandoz on the grounds that its biosimilar infringes several of Enbrel's patents, so any launch could also be delayed.

 

And Amgen was in fact the first to succumb to biological copies in the U.S. when, just over a year ago, the FDA approved its first biosim in the form of Zarxio (filgrastim-sndz) from Sandoz--a biosimilar of Amgen's chemotherapy side effects drug Neupogen (filgrastim).

 

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Disaster! Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition

Disaster! Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Real fans (of intense fights over drug pricing) don't leave the stands early. The most fascinating pharma battle in recent years has been over new drugs that can rapidly cure hepatitis C (HCV). This fight has everything: Sky-high prices, congressional hearings, concerns about patient access, lawsuits, and a price war. Oh, and a mere $38 billion in combined sales since the first of these drugs launched in late 2013.  

 

In April, Gilead, the leader in this space, reported the first-ever year-over-year sales decline of its lead HCV drug. That prompted some observers to assume the frenzy had peaked -- these drugs are cures, so patient numbers should decline over time. But there are still plenty of patients who need treatment, according to a new analysis by Bloomberg Intelligence analyst Asthika Goonewardene. And a new generation of potentially quicker and more broadly effective drugs means more price wars and market-share brawls may lie ahead for Gilead and competitors such as AbbVie and Merck.

 

This status quo won't last. All three firms are working on more potent drug cocktails that could cut treatment time and work for more types of patients. As these drugs start to arrive over the next few years, things will start to get interesting.

 

BI's model takes a look at how much just one company's pricing decision on one drug -- in this case AbbVie's -- could shift billions in revenue (see chart above).

 

Scenario 1: AbbVie prices its next-generation drug at a big premium to Viekira Pak, keeping prices high across the board.

 

Scenario 2: In a second scenario, it makes that premium a little smaller.

 

Scenario 3: In a third (and probably less-likely) scenario, AbbVie prices the new drug extra-low to grab market share. A big AbbVie price cut could force Gilead to cut its own prices, and its sales could drop to $14 billion by 2018. [DISASTER!]

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AbbVie Has Room to Cut Its $203 Million Humira Ad Budget, Say Analysts. But Why Bother?

AbbVie Has Room to Cut Its $203 Million Humira Ad Budget, Say Analysts. But Why Bother? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

With biosimilars makers eager to grab a piece ofHumira's $12.5 billion-plus revenue, copies of AbbVie's ($ABBV) blockbuster are on their way. What analysts disagree on, though, is when they'll arrive and how long it'll take them to make their presence known--and a pair of UBS analysts, for one, thinks the Illinois pharma has some marketing maneuvers up its sleeve to minimize their impact.


According to UBS analysts Marc Goodman and Ami Fadia, should the entry of Humira biosimilars put branded sales on a serious downswing, AbbVie has some room to pare down costs. Right now, it ranks as the No. 2 ad spender in Big Pharma, and last year it shelled out 56% of its budget--$203.2 million--on advertising the drug.

Pharma Guy's insight:


File this one under "You don't need an analyst to know which way the wind is blowing." But I guess $200 Million is not a lot considering Humira sales are about $8 BILLION annually. Thus, the marketing budget is less than 3% of sales! Even if Humira lost 50% market share, which often happens when generics hit the market, AbbVie can still spend $200 Million on adverting and that would be just 5% of sales!

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AbbVie aims to truck ahead with hep C testing promo campaign

AbbVie aims to truck ahead with hep C testing promo campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AbbVie's  waiting for FDA approval on a hepatitis C combo therapy. OraSure makes a rapid test to detect the virus. And professional truck drivers in the U.S. are more than 5 times as likely as other Americans to have it.


Put it all together, and you've got the makings for a brand-new marketing campaign, "Truckers Rolling Against Hepatitis C." Together, AbbVie and OraSure--parties to a copromotion agreement focused on testing individuals with the latter's OraQuick HCV Test--have teamed with the Healthy Trucking Association of America to educate drivers about HCV and encourage them to get tested.


The campaign will kick off at--where else?--The Great American Trucking Show, coming up later this week in Dallas. From there, the companies will keep it going with local HCV testing events across the country.

Pharma Guy's insight:


#1: I did not know truckers were 5X as likely to have Hep C. Keep on Truckin' indeed!


#2: Just because there will be competition to Sovaldi doesn't mean that prices for these treatments will drop:


From: Don't worry about a hep C pricing war, analysts tell Gilead-watchers


No price war on hepatitis C drugs? That would be a disappointment to payers worried about the cost of treating millions of patients with super-expensive, yet highly effective drugs. But to investors, that reassurance sounds really good.


As Barron's points out today, Bernstein analysts issued a report to assuage fears of an all-out pricing competition when Gilead Sciences' Sovaldi is joined on the market by new treatments from AbbVie, Bristol-Myers, and Merck.


"One of the near-term bear arguments is the expected approval of a competitive all-oral HCV regimen from AbbVie, and the potential for aggressive pricing tactics by AbbVie," Bernstein's Geoffrey Porges and Wen Shi wrote in a note to investors.


Obviously, major undercutting of Sovaldi's notorious $84,000-per-treatment-course price could either force Gilead to slash the cost of its own meds, or relinquish market share to AbbVie. And as the analysts point out, payers are encouraging AbbVie and its fellows to do just that.


"However, we believe the risk of a price war hurting Gilead's HCV revenue in the next 1-2 years is overblown," they wrote.


For three reasons, basically. Even if AbbVie's regimen is cheaper, payers have "limited tools" to use to restrict access to Gilead's therapy, which will probably include a new combo pill by year's end. AbbVie has said--and recently--that it's not interested in a price war. That sort of competition isn't necessarily a good move in the hep C market, where awareness is growing and diagnosis is expected to increase, which means the entire pie is bigger for everyone.


And besides, if Gilead were to face lower-priced rivals, the company "has counter strategies to mitigate the impact of any potential price war by AbbVie on a payer-by-payer basis," the analysts write. Behind-closed-doors negotiations, maybe?

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Top 10 Pharma Companies with Best Reputations as Determined by Their "Friends"

Top 10 Pharma Companies with Best Reputations as Determined by Their "Friends" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Reputation Institute named AbbVie the most reputable pharmaceutical company in today’s release of its annual Global Pharma RepTrak®. The study is based on over 16,500 reputation ratings collected during January and February 2017 among the general public in 8 key markets: Brazil, Canada, France, Italy, Germany, Spain, UK and US.

 

The reputation of the pharmaceutical industry is improving and is now at a strong level with the general public. Overall, the industry earned a strong RepTrak® score of 71.8, up from 68.2 in 2016. 44% of respondents viewed the industry as having an excellent reputation with a 7% point increase compared to 2016, while 26% perceived it as weak or poor, down from 35% in 2016. “The strong reputation results come as a surprise to many, who expect the general public to be very negative towards the pharmaceutical companies. However, the reputation data tells a different story,” says Kasper Ulf Nielsen, Executive Partner of Reputation Institute. “We see that the general public actually has strong positive feelings about the individual pharmaceutical companies which they see as delivering on core expectations within products and services, innovation, and leadership. This does not match the media coverage, which is very negative, but serves as a good reminder that media coverage does not equal reputation. Reputation is the perception people have, and that is what is captured in the RepTrak® study.”

 

The Pharma RepTrak® measures the perception of 17 pharmaceutical companies on overall reputation as well as the seven rational dimensions of reputation: products / services, innovation, workplace, governance, citizenship, leadership and performance. Each company is measured by the general public who are somewhat or very familiar with the company.

 

The top 10 companies in the 2017 Global Pharma RepTrak® are:

  1. AbbVie
  2. Novo Nordisk
  3. Takeda
  4. Roche
  5. Janssen Pharmaceuticals
  6. Gilead Sciences
  7. Bayer
  8. MSD / Merck & Co
  9. Sanofi
  10. Eli Lilly

 

Further Reading:

Pharma Guy's insight:

While 80% of the general public feels that the pharma industry puts profits ahead of people (see Edelman study), this study says 42% of the "friendly" public - i.e., public who are somewhat or very familiar with the company - says that pharma sets prices "fairly." Of course, we are not comparing apples to apples here, but surveys of the public who are familiar with pharma companies are not very indicative of the voting public, IMHO. And the voting public is the audience pharma should be most concerned about instead of patting themselves on the back based on this study.

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Dermatologists Accepted $34 Million from Pharma Companies

Dermatologists Accepted $34 Million from Pharma Companies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Dermatologists received more than $34 million from industry in 2014, and most of that money came from pharmaceutical companies, according to a new study published in JAMA Dermatology.

Researchers in the study mined the Centers for Medicare and Medicaid Services Sunshine Act Open Payment database, which lists payments that dermatologists receive from companies making products that are reimbursed by a government-run health program. In 2014, the database’s first full year of financial data, 8,333 dermatologists received more than 208,000 payments. The top 10% of dermatologists received 90% of the total payments.

“At the center of all this is [the patient’s] concern about dishonesty and selfishness,” says says Dr. Hao Feng, the study’s first author and a dermatology resident at NYU Langone Medical Center.

Most of the payments were for food and beverage, but that’s not where the big money was spent. Speaker fees, consulting fees and payments for research represented 70% of the total money spent. The top 15 companies were all pharmaceutical manufacturers. Studies on other branches of medicine reveal that receiving industry payments and meals was linked to increased prescribing of brand-name medications, the authors write.

Pharma Guy's insight:

Hmmm... Allergan sure paid for a lot of "research" compared to Abbie, which paid for "speaking" junkets! Surprising. I wonder how different pharma companies categorize their payments to physicians. Who confirms that this process is the same at each company?

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Abbie on a Humira TV Ad Spending Spree in Anticipation of Biosimilar Competition

Abbie on a Humira TV Ad Spending Spree in Anticipation of Biosimilar Competition | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amid projections and prognostications of overall pharma ad spending increases for 2016, iSpot.tv’s ad tracking numbers for May bear that out, with AbbVie’s ($ABBV) Humira leading the charge. AbbVie spent more than $25 million on Humira TV ads in May, bringing the drug’s TV spending total to $118 million for the year. That means AbbVie has already topped its full-year 2015 TV ad spending of $98.6 million.

Humira has been running nine ads since January, spread thematically across its three FDA-approved indications for arthritis, psoriasis, and ulcerative colitis and Crohn’s disease, with the most, a total of $60.9 million, spent on placing its 5 TV ads for arthritis, according to iSpot.tv data.

The TV spend reflects Humira’s importance to AbbVie; it brought in $8.4 billion in sales last year and accounted for 62% of the company’s total revenue. Humira revenue for the first quarter of 2016 was $2.2 billion. The Wall Street Journal recently reported that AbbVie raised the price of Humira 8 times in the past three years, increasing its price 73% to about $49,000 a year before discounts.

Pending competition for Humira may also be spurring TV advertising, with AbbVie estimating its first biologic competitors coming to market in Europe in 2018.

Pharma Guy's insight:

2016 is shaping up to be even a better banner year for DTC than 2015! For updated 2015 spending numbers, read  “Pharma Drug Ads: A Glass Half Empty is a Glass Half Full”; http://sco.lt/8jF4Qj 

 

Also read: “Big Pharma Spending on TV Ads Like a Drunken Sailor”; http://sco.lt/8epI6z

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How to Improve Patient Engagement by Partnering with #Pharma Legal Overlords

How to Improve Patient Engagement by Partnering with #Pharma Legal Overlords | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Jutta Ulbrich, Head of Patient Engagement, and Kristin Buetecke, Head of Legal, for AbbVie Germany, presented a case study at the recent Barcelona 2016 conference. The study detailed efforts that the German affiliate had embarked on to help translate the concept of patient centricity into reality. As they explained, “Employees often haven’t been as patient-centric as they’d like to be because they worry that by trying to help, they might end up inadvertently over-stepping the mark.”

The realization that employees were often deterred from engaging with patients out of fear that they might act inappropriately motivated the Patient Engagement Team to seek a solution. They decided to partner with the legal department to create a guidebook for patient interactions. The digital manual that has been produced provides a comprehensive framework of information that can be used daily by all staff, and offers guidelines for many of their interfaces with patients. The intention was not to create another policy but to develop a ‘one-stop’ digital manual where all policies, legal requirements, applicable codices, and rules were referenced, as well as putting procedures and various templates into one document.

As Ulbrich states, “Legal teams may occasionally be seen as a bottle-neck for pharma companies, but when you’re talking about the healthcare of people, the support from the legal department and compliance are of key importance, as are the Codes of Conduct.” By allowing the legal department to become an enabler, the manual has actually increased the number of patient-centric projects that the AbbVie German affiliate has been able to embark on. As Buetecke says, “Staff now know exactly where to look to have their questions answered and where to access company guidelines for most situations that face them, so are more willing and able to make decisions that will ultimately benefit the patient.”

To date, the usage figures have been extremely encouraging. “People really seem to have accepted this as a tool for their daily use,” says Ulbrich.  She feels that this success can be attributed to the intention behind the manual, which was to be helpful in providing answers to everyday questions and situations. Given the enthusiastic response to the document since its launch, she believes it would be useful to any pharma company wishing to improve its patient centricity by providing an enabling manual that provides clear guidelines for all customer interactions.

There have already been many requests from other companies in Europe for assistance in putting together a similar document, and Buetecke says the team is happy to share the basic framework. However, she cautions that content needs to be company specific, with examples taken from a company’s daily practice in order for a manual to be relevant to the business. Ultimately, she believes that the manual AbbVie has produced provides an easily accessible framework that documents a wide-range of daily challenges to all staff and the steps that should be taken in each situation. Having convenient access to this knowledge assists employees in their patient centricity by allowing them to act confidently and within the boundaries of compliance.

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Male Lifestyle Drug Marketers Think FDA's Proposed Study on Spousal DTC Influence is Bogus!

Male Lifestyle Drug Marketers Think FDA's Proposed Study on Spousal DTC Influence is Bogus! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Back in December, 2014, I reported in Pharma Marketing News that the FDA was planning to study "Spousal Influence On Consumer Understanding Of And Response To Direct-To-Consumer Prescription Drug Advertisements" (see "Does Your Spouse Influence Your DTC Viewing Experience?").

At about the same time, the new ad for Viagra, which featured a sexy woman (no man), aired on TV (read "Oh Yeah, Baby! Show Me More!... Viagra TV Ads Like This. But Don't Let My FDA See It!").

Of course, I thought the FDA should study how wives (or significant other spousal equivalent) might influence their spouses' (i.e., husbands') response to THAT ad.

But, no, the FDA will be using asthma drug ads in their study. Huh?!

It appears, however, that the FDA is using a benign drug category to get results that it may use against Viagra and other male/female enhancement drug ads. AbbVie and Eli Lilly -- two marketers of lifestyle-enhancing drugs for men -- recognize this ploy and have submitted comments to the FDA in an attempt to shoot down the study.

What's their beef? Read more here: http://bit.ly/1HH9bIl 

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