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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Regeneron CEO Len Schleifer vs Allergan Chief Brent Saunders re Controversial Native American Tribe Patent Deal

Regeneron CEO Len Schleifer vs Allergan Chief Brent Saunders re Controversial Native American Tribe Patent Deal | Pharmaguy's Insights Into Drug Industry News | Scoop.it

One of the drug industry’s most persistent critics happens to be one of its most famous faces. And Dr. Leonard Schleifer, founder and CEO of Regeneron Pharmaceuticals, didn’t disappoint in his latest performance.

 

“It’s nuts,” Schleifer said Thursday of Allergan’s controversial move to protect patents by transferring them to a Native American tribe. Brent Saunders, Allergan’s CEO, made waves and headlines alike last year with a promise to do right by society. To Schleifer, the patent deal violates Saunders’s vaunted social contract and, plainly, “makes your company look bad.”

 

The debate, which took place at Forbes’ annual health care conference, was classic Schleifer, whose schtick routinely breaks up the monotony of drug industry panels that tend to feature wealthy white men agreeing with one another before a live audience.

 

But some analysts caution that Schleifer’s tell-it-like-is persona might have a downside — that he, like Saunders, may one day find his bold words used against him.

 

Further Reading:

  • “Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics”; http://sco.lt/7spJWD
  • “Regeneron CEO Len Schleifer vs Pfizer CEO Ian Read on Drug Prices Redux”; http://sco.lt/8kHMET
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Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics

Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In an unprecedented move, leading global pharmaceutical company Allergan appears to have handed its Orange Book-listed US patents covering its blockbuster dry eye drug Restasis to the Native American St. Regis Mohawk Tribe in Northern New York.  

The Tribe has granted exclusive licenses in the patents back to Allergan.  The deal will provide the Tribe, which has a population of around 13,000, with $13.75 million up-front and annual royalties of up to $15 million, (crucially, in this case) provided the patents remain valid.

Allergan may have made the move in an attempt to evade challenges from competitors at the Patent Trial and Appeal Board (PTAB) – an administrative court created in 2011 that can cancel patents – in a somewhat controversial, post-issuance review process called "inter partes review" (IPR).

IPRs against the Allergan patents were launched on behalf of generics companies Mylan, Teva, and Akorn Pharmaceuticals. They were expected to reach a result this December. 

Although the deal creates what may seem like a significant yearly dent in Allergan’s accounts, annual sales of Restasis stand at approximately $1.5 billion – second only to Allergan’s biggest-selling, wrinkle treatment product, Botox – and are expected to increase.  With the patents covering Restasis not due to expire until 2024, this multi-million dollar outlay in exchange for extra protection could turn out to be a shrewd piece of business by Allergan’s decision makers.

IPRs were authorised by the 2011 America Invents Act and have arguably revolutionised the way and regularity in which patents are challenged in the USA.  While invalidating a patent via litigation in federal court typically costs millions of dollars, invalidating a patent through the IPR process costs the challenger the relative bargain of a few hundred thousand dollars.  This is similar to the European post-grant opposition process.

The Tribe is, in theory, able to file a motion to dismiss the ongoing IPRs against the granted Restasis patents on account of its “sovereign immunity” status. 

IPRs were designed to improve the US patent system, and quickly and efficiently settle patent validity disputes on novelty and obviousness.  Statistics have shown that fewer IPR petitions are brought against biotech and pharma patents, and there is a lower rate of invalidation of these compared to all technical fields combined, but Allergan have seemingly gone on the defensive early doors. 

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Allergan's Promotion of New Rosacea Drug: Is It False or Misleading Advertising?

Allergan's Promotion of New Rosacea Drug: Is It False or Misleading Advertising? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Allergan told investors it plans to increase its promotional efforts for its new rosacea drug, Rhofade, now that it has secured access on CVS Health's formulary. Rhofade is a treatment for erythema, or redness of the face, a common symptom of rosacea.

 

The FDA in January approved the drug, which works by constricting blood vessels in the face. Persistent facial redness is often treated with laser therapy. Rhofade, however, is a topical cream.

 

The company began advertising on Facebook last week and will ramp up other aspects of its consumer-advertising program, Bill Meury, Allergan's chief commercial officer, told investors during an earnings call on Thursday.

 

Allergan CEO Brent Saunders further discussed the company's promotional strategy, saying, “as you get formulary coverage, that gives you the ability to advertise more broadly. I liken it back to my consumer days: You don't run a lot of advertising until your product is on the shelf, and that's akin to having formulary coverage. So the team's really focused on access, and they're doing a great job. And as that continues to build, you'll see us continue to ramp up promotion.”

 

Allergan kicked off marketing efforts for Rhofade in May with Less Red More You, an awareness campaign featuring singer and actress Kristin Chenoweth, who suffers from rosacea. Allergan has frequently leaned on celebrities to market its dermatology, women's health, and aesthetics portfolios. In the past two years, the company developed partnerships with actors Lea Michele, Kate Bosworth, and reality-TV personality Khloé Kardashian. Michele worked with Allergan for its women's health campaign, Actually She Can, while Kardashian kicked off the Live Chin Up campaign for Kybella, a chin-fat injection. Bosworth helped promote acne treatment, Aczone.

 

Further Reading:

  • “Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?”; http://sco.lt/5CPdfl
Pharma Guy's insight:

Allergan again resorts to side-by-side "before and after” images to prove that this product works. This is the same technique the company used  to promote Kybella for double chin syndrome.

 

In that case, I analyzed the figures and suspected foul play; i.e., the after image was just a retouched version of the before image (see "Further Reading" link). The ad, however, claimed they were “unretouched photos.”

 

Despite some anonymous commentator to my blog post claiming he/she “worked on this campaign and I saw first hand that not one photo in the treatment area was retouched,” I don’t buy it.

 

But I will point out that the photos in this ad for Rhofade are definitely not retouched versions of the same photo. The ad, however, says “Illustration only.” Which means this is not a real case study of a real person’s response to the drug.

 

Perhaps that commentator learned from my blog to be more careful about its before-and-after imagery.

 

Whatever! Allergan is again practicing misleading and/or false advertising, IMHO!

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Pharma Payments to HCPs Topped $8 Billion in 2016. Allergan & Celgene Paid Out the Most!

Pharma Payments to HCPs Topped $8 Billion in 2016. Allergan & Celgene Paid Out the Most! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Payments from drug and device companies to physicians and teaching hospitals hit more than $8 billion in 2016 according to Open Payments data recently released by CMS.

All told, nearly 631,000 physicians and approximately 1,146 teaching hospitals received $8.18 billion in payments and ownership and investment interests in 2016, according to tallies compiled by the CMS. Last year's total was $7.52 billion.

About half of the overall payments were for research and $2.7 billion were in payments not related to research. A little more than $1 billion stemmed from ownership or investment interests.

Of the largest pharmaceutical companies, Allergan paid out the most in 2016 with $66 million in total payments. Dr. George Patrick Maxwell, a plastic surgeon in Nashville, is listed as the highest payment recipient from Allergan, with $4.6 million.

Celgene was the second-highest spender with a total of $54 million in payments last year. Of its recipients, Boston oncologist Dr. Kenneth C. Anderson a took in the most, with $1.9 million.

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Much More Kybella TV DTC Advertising on the Way

Much More Kybella TV DTC Advertising on the Way | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Allergan plans to increase its investment in DTC for its chin-fat reducing injection, Kybella, to “an even higher level,” after the drug's sales [took it on the chin] at the end of 2016.

 

In the last three months of 2016 Allergan reported that Kybella saw sales of $12 million, compared to $14 million in the three-month period before that. The drugmaker acquired Kybella in its deal to buy Kythera Biopharmaceuticals in 2015. The drug was also approved in 2015.

 

Bill Meury, Allergan's chief commercial officer, on Wednesday told investors that the company plans to focus on training clinicians on how to use the product, identifying patients, and managing patients' expectations. “We're building a market,” he explained. “Our goal in 2017 is to drive utilization.”

 

Allergan's consumer-oriented promotional efforts for Kybella included a live event in March with Khloé Kardashian (read “Khloé Kardashian Shills for Kybella at Dermatologists' Offices & Soon on TV”; http://sco.lt/6TW6qX). The company also launched two DTC ad spots in August: one called Ancestors, in which a man laments the double chin he inherited from his otherwise distinguished ancestors (read “Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?”; http://sco.lt/5CPdfl), and Adra's Portrait in Action, which tells a near-identical story, but with a woman narrating.

 

Brent Saunders, the company's CEO, affirmed the company's confidence in direct-to-consumer advertising during the same investor call, “We spend the second most on DTC,” he said. For the data on that, see here: http://sco.lt/95gSRt

Pharma Guy's insight:

Further Reading:

  • “New Drug Kybella Zaps Double Chin: Facetious FAQ”; http://sco.lt/7MZwpN
  • “Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face”; http://sco.lt/8osXGD
  • “Allergen Seeks to Own Women's "Lower Face" with New Indication for Kybella. DTC to Follow.”; http://sco.lt/8Objqz
  • “A Social Media Unmet Medical Need: Fear of ‘Submental Fullness’ Invented by Kybella Marketers”; http://sco.lt/4jse3N
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Donald Trump as President Doesn’t Change the Debate on Drug Pricing, Says Allergan CEO

Donald Trump as President Doesn’t Change the Debate on Drug Pricing, Says Allergan CEO | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Like many Americans, the results of the 2016 U.S. Presidential election surprised me. Many fully expected a Hillary Clinton victory. With that expectation was the belief that drug pricing would remain a key focus of the political debate. 

With the election of Donald Trump as our next President, is the focus off drug prices? Will things go back to business as usual? Will changes to the Affordable Care Act, the economy, jobs and immigration consume all of the political oxygen in the room leaving no room for anything else? 

My answer to those questions: No. 

Let’s not fool ourselves. The outcome on November 8 didn’t change the fact that many Americans are angry about the rising cost of healthcare and their medicines. This anger will fuel the discussion about affordability well into the future.  

The biopharmaceutical industry does amazing things to help people and is an American treasure. As an industry, we discover and advance inventions that improve health. We fund research by universities, academic institutions and startup biotech companies. We deliver new medicines, vaccines and devices that help millions of people  live longer, healthier lives. And, we employ hundreds of thousands of people in good paying jobs who are committed to doing good things every day.

But our industry has a social contract.  Patients understand that making new medicines requires significant investment. Companies doing the hard, long and risky work of bringing new medicines to market have generally understood that they have to price medicines in a way that makes them accessible to patients while providing sufficient profit to encourage future investment. Everybody wins when it works the way it should.

But some have violated this social contract, and the whole industry is under attack. The election results don't change that debate. 

Pharma Guy's insight:

Related article: “Allergan's Brent Saunders' Manifesto on Drug Prices & Access”; http://sco.lt/6WN0AT

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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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LA Times Columnist Not Drinking Kool-Aid Served Up by Allergan CEO Saunders

LA Times Columnist Not Drinking Kool-Aid Served Up by Allergan CEO Saunders | Pharmaguy's Insights Into Drug Industry News | Scoop.it

So it’s come to this: The chief executive of a major drug company is a hero because he won’t rip off customers any more (read“Allergan's Brent Sauders' ‘Manifesto’ on Drug Prices & Access”; http://sco.lt/6WN0AT)

 

Brent Saunders, CEO of Allergan, the company best known for making Botox, made headlines this week after posting an announcement on his company’s website that future price hikes will be limited to single digits and he’ll no longer jack up prices to crazy levels right before a patent expires.

 

“While we have participated in this industry practice in the past, we will stop this practice going forward,” Saunders said.

Excuse me for not drinking the Kool-Aid, but how is this different from a schoolyard bully patting himself on the back for saying he won’t beat you up any more? What about all the past beatings? Forgive and forget?

 

If Saunders deserves points for anything, it’s being the first CEO of a top pharmaceutical company to try to get out in front of scandalously high drug prices before lawmakers, riding a wave of public outrage, lower the boom with some hard-and-fast regulations.

 

“I don’t like what is happening,” he said in his blog post, adding that “it is hard to speak out publicly on this.”

 

Deep breath. Just tell us how you feel.

 

“The healthcare industry has had a long-standing unwritten social contract with patients, physicians, policy makers and the public at large,” Saunders said. “Those who have taken aggressive or predatory price increases have violated this social contract!”

 

And even though Allergan once exhibited the same shoddy behavior, the company has seen the light. Saunders committed himself to a renewed social contract.

He said the company’s focus now is on pricing its drugs “commensurate with, or lower than, the value they create.” I’m not sure what that means exactly. How is such value determined?

 

 

Allergan sells 30 capsules of its Alzheimer’s drug Namenda XR for about $440, according to the price-comparison site GoodRX. The price was boosted by about 10% at the beginning of the year.

Twice as many tablets of the generic, older version of Namenda cost about $20. Is their value really that different?

 

Saunders, who received nearly $22 million in compensation last year, vowed that “we will not engage in price gouging or predatory pricing.” Um, thanks?

 

He said Allergan will limit annual price hikes “to single-digit percentage increases.”

 

That, I suppose, is an impressive commitment in light of the triple-digit increases that are becoming the industry norm. But consider this: The current U.S. inflation rate is 0.8%, so a price increase of, say, 5% represents a significant markup over living costs. Moreover, wages for many workers haven’t risen in years.

 

“You don’t see anything else going up 7%, 8%, 9% a year,” said Janet Schwartz, an assistant professor of marketing at Tulane University who specializes in healthcare. “Pharmaceuticals are far outpacing the rate of inflation.”

 

Pharma Guy's insight:

These are exactly the points I was thinking of making but I didn't want to be the pharmaguy that always sees the pit in the cherry!

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Allergan's Brent Saunders' "Manifesto" on Drug Prices & Access

Allergan's Brent Saunders' "Manifesto" on Drug Prices & Access | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Access & Pricing

We commit to making these branded therapeutic treatments accessible and affordable to patients while also ensuring that we can continue to meet our ‘invest and innovate’ obligations outlined in Principle 1.

Providing our treatments to patients is not a straightforward exercise.  We have to go through many decision makers and intermediaries to make sure that our products are available to the patients who need them.  That means government payers, regulators, private insurers, and PBMs to name a few.  We commit to working with decision makers and intermediaries to make our products accessible to all people who need them.  This often includes giving discounts and paying rebates.  The current pricing environment is highly competitive with large payers making decisions that may limit patient access to our medicines in favor of a competitor based on the latter’s willingness to pay more rebates.  In order to ensure that patients and physicians have access to a full array of medical options, we believe that these intermediaries should have open access to formularies whenever possible. 

We commit to these responsible pricing ideals for our branded therapeutics.

  • We will price our products in a way that is commensurate with, or lower than, the value they create by mitigating or avoiding the need for other treatment modalities or providing better quality of life to those patients without other treatment options.
  • We will enhance access to patients.  This means that Allergan will enhance our patient assistance programs in 2017 to match the current industry leader(s).
  • We will work with policy makers and payers to facilitate better access to our medicines.
  • We will not engage in price gouging actions or predatory pricing.
  • We will limit price increases.  Where we increase price on our branded therapeutic medicines, we will take price increases no more than once per year and, when we do, they will be limited to single-digit percentage increases.  Our expectation is that the overall cost of our drugs, net of rebates and discounts, will not increase by more than low-to-mid single digits percentages per year, slightly above the current annual rate of inflation. 
  • We will not engage in the practice of taking major price increases without corresponding cost increases as our products near patent expiration. While we have participated in this industry practice in the past, we will stop this practice going forward.  Where new regulatory requirements impose added costs, we will seek to reflect those costs in our pricing.
  • We commit to providing an aggregate view of the net impact of price on our business at least annually.



Pharma Guy's insight:

I can't help but think there's a lot that can be read between the lines in this manifesto. Any comments?

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Allergen Seeks to Own Women's "Lower Face" with New Indication for Kybella. DTC to Follow.

Allergen Seeks to Own Women's "Lower Face" with New Indication for Kybella. DTC to Follow. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Allergan thinks facial injectable Kybella has the potential to one day bank Botox-level sales. And the company is starting up a couple new studies to help it get there.

 

The Dublin drugmaker is initiating trials of the med in bra-line fat and fat around the knees and ankles, Bernstein analyst Ronny Gal wrote in a recent note to clients. And it’s hoping those will eventually help it add some new indications to the mix, on top of Kybella’s current approval for busting chin fat [read “New Drug Kybella Zaps Double Chin: Facetious FAQ”; http://sco.lt/7MZwpN].

 

The way CEO Brent Saunders describes it, Allergan’s aesthetic strategy is “owning the face” [read, for example, “Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face”; http://sco.lt/8osXGD ]--and Allergan expects Kybella to “serve as a gateway to the lower face,” commercial chief Bill Meury told investors on the company’s Q2 conference call. It expects that strategy to open up a new market of consumers--including males.

 

Next up? “We are creating awareness and demand among consumers, which will be boosted by our DTC campaign beginning this month,” he said.

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Khloé Kardashian Shills for Kybella at Dermatologists' Offices & Soon on TV

Khloé Kardashian Shills for Kybella at Dermatologists' Offices & Soon on TV | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Kybella, Allergan’s med for excess chin fat, is already in the middle of a successful launch. But the company is by no means stopping there, execs said Tuesday.

 

So far, the Dublin drugmaker has trained more than 4,000 providers to inject the drug--in other words, nearly half the product’s potential user base, commercial chief Bill Meury told investors on the company’s Q1 conference call. And of those trainees, 3,000 have already placed orders for the fat-fighter.

 

But Allergan knows it’s up to its own marketing ranks to lay “the groundwork in the creation and development of this new market for injectables,” Meury said--and so it plans to keep the push going strong. Later this year, the company will roll out a DTC campaign for Kybella, which will follow up on marketing activities that have included a partnership with Khloé Kardashian.

Pharma Guy's insight:

I knew a Kardashian was going to shill for Allergans "chin" buster drug (read "Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face"; http://sco.lt/8osXGD). But I thought it would be Kim and her fat ass as in this Kybella FAQ:

 

Could the drug help destroy fat cells in other areas of the body?

Like Kim Kardashian's ass?

 

BTW, Khloé easily competes with her sister ass-size-wise!

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An Open Letter to Mr Ian Read: Chairman & CEO @Pfizer

An Open Letter to Mr Ian Read: Chairman & CEO @Pfizer | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Anyone who sincerely cares about innovation in healthcare & the creation of true patient value will take some forbidding pleasure from the collapse of Pfizer’s proposed merger with Allergan. Mr Ian Read, Pfizer doesn’t need yet another M&A; instead, it needs nonconformity.

You’ve got all the key ingredients to succeed without another “Blockbuster M&A”


 Last year, I read your LinkedIn post, arguing why this merger will “bring greater resources to invest in productive R&D and manufacturing, deliver greater value to our shareholders, and most importantly, make more medicines available to more people around the world”. I agree with your "MBA answer" of why the merger is good, but I and others sincerely, think you're better off without it. A good read is a commentary in Nature: The impact of mergers on pharmaceutical R&D. You’ve got all the key ingredients (scientific talent & leadership, resources and entrepreneurship) to succeed without yet another “Blockbuster M&A”.

These mega M&As have essentially no long-term value to the ultimate customer, the patient!


Since 2000, Pfizer has been the most active blue-chip drug maker with a series of high profile acquisitions (Warner-Lambert, Pharmacia, Wyeth, and so forth... including the multiple unsuccessful attempted deals). There is ample precedence from these past "successful" M&A’s that this deal wouldn’t change the rate at which you’d bring new molecules to market as you suggest. These mega mergers have essentially no long-term value to the patient, key subject from some of the US presidential candidates.

...when 4/5 prescriptions written are for off-patent products, then you've got an even bigger problem than another failed deal.

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Sanders to Pfizer and Allergan: "I Don't Want Your Damn Merger!"

Sanders to Pfizer and Allergan: "I Don't Want Your Damn Merger!" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sanders has asked the Treasury to try to undermine the deal by removing some of the tax strategies, including "hopscotch loans" that companies use after a so-called tax inversion like this one to return offshore profits to shareholders, according to his letter to the department.

"Blocking this inversion would not only be sound fiscal policy, it would also act as a strong deterrent to other companies that are contemplating similar tax scams," Sanders, the ranking member of the Senate Budget Committee, said in his letter.

He pointed to estimates from a tax fairness group stating that stopping the merger would save the U.S. about $35 billion in lost taxes, although some economists have questioned that estimate.

The Treasury, which already has twice made rule changes in an effort to make such deals less palatable, acknowledged receiving the letter and said the department would respond "in due course," The Washington Post reported.

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An “Army” of Allergan Sales Reps is Being Recruited to Storm OB-GYNs Across the U.S. DTC Ads Too, Of Course!

An “Army” of Allergan Sales Reps is Being Recruited to Storm OB-GYNs Across the U.S. DTC Ads Too, Of Course! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

From where Allergan’s sitting, forthcoming uterine fibroid treatment Esmya could become a flagship product. But the company knows that getting it there won’t be easy—or cheap.

 

For one, there’s going to be “a lot of education required” to make Esmya successful, company commercial chief Bill Meury said in an interview. Currently, there are no FDA-approved treatments for uterine fibroids, and Allergan’s research suggests that many women living with the condition aren’t aware of treatment options.

 

“They’re employing various coping strategies, or just normalizing symptoms,” Meury said.

 

Allergan, though, is up for the task. The product is going to get “a great deal of investment,” starting with backing from a women’s health field force of roughly 300 representatives—an army Meury said is one of, if not the, largest in the industry. They’ll call on 20,000 OB-GYNs nationwide, and that’s where Allergan things its “excellent relationships” with OB-GYNs around the country will come into play.

 

“They know us and we know them,” thanks to oral contraceptive Lo Loestrin and estrogen replacement product Estrace, Meury said. “Esmya will fit right into that group.”

 

The company is also plotting a branded DTC campaign that will put Esmya “front and center,” Meury said, and that effort will include TV, print and social media components.

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Botox - the Duct Tape/Swiss Army Knife of Drugs - Approved for Forehead Lines

Botox - the Duct Tape/Swiss Army Knife of Drugs - Approved for Forehead Lines | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Allergan’s Botox, which the company has called a “pipeline in a drug,” has delivered again.

On Tuesday, the FDA approved the blockbuster product to temporarily improve the appearance of certain forehead lines in adults. The green light marked the med’s third cosmetic indication—it also bears go-aheads to treat crow’s feet and glabellar lines—and makes it the only neurotoxin that can boast approvals in three separate facial treatment areas.

The approval presents another opportunity for Allergan in an aesthetics market that company CEO Brent Saunders has called the best market in the world.

“It's high-quality, it's cash-pay, it's global,” he said on this summer’s second-quarter earnings call. “We are just at the initial stages of market development in the U.S. and almost every market in the world. So we have very high conviction around the sustainability,” he added.

 

Further Reading:

  • “Allergan CEO Brent Saunders is Not Just a Botox Fan, He's Also a Botox User!”: http://sco.lt/4jUjmD
  • Botox, the Swiss Army Knife of Drugs, Featured on Cover of Time Magazine”; http://sco.lt/56XOfB
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Allergan CEO Talks Anti-Lip Enhancement For Teens, But Will Docs Listen?

Allergan CEO Talks Anti-Lip Enhancement For Teens, But Will Docs Listen? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Allergan is targeting some newer, fast-growing markets with its aesthetic drugs portfolio—but the under-18 crowd isn’t one of them.

 

In a Wednesday blog post, CEO Brent Saunders laid out the reasons he struggles with the idea of using some of his company’s own treatments in minors—and asked others in the field to share their opinions.

 

“As the father of two high-school-age girls, I am sensitive to the societal pressures they face—to look a certain way or meet a certain standard,” Saunders begins. When that world intersects the world of medical aesthetic tech—through the “inappropriate use of medical aesthetic procedures among minors—it is time to speak up,” he added.

 

With his blog post, Saunders is wading into a debate larger than his own business, addressing the tough-to-achieve markers of beauty that pop stars, actors, models and fashionistas set for young girls and women, consciously or not. The way he sees it, “emotional maturity is critical to the decision-making process involved to fully understand treatment options and their potential implications,” and “many teenagers lack that level of maturity.”

 

Prettifying injections and treatments generally are used off-label in teens. Allergan's in particular—which include blockbuster toxin Botox and filler Juvederm, aren't FDA-approved for minors, Saunders points out. "To be clear, Allergan’s medical aesthetic products are approved for adults," he writes.

 

The post, which he titled “Building a Consensus on Medical Aesthetic Treatment for Minors,” comes as interest in aesthetic treatments grows among younger patients. Saunders cites the lip injection trend that’s taken off among teens, and points out that girls are increasingly using soft tissue and hyaluronic acid dermal fillers, too.

 

“With each passing year, the rates of inappropriate use of aesthetic treatments among this teenage population are likely to increase,” he wrote.

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Allergan CEO Saunders Says Martin Shkreli is a "Mentor"

Allergan CEO Saunders Says Martin Shkreli is a "Mentor" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sarah Hassan was new to the hedge fund world in 2010 when a longtime friend of her father suggested she meet a “rising star” in the industry: Martin Shkreli.

The friend, Brent Saunders, the chief executive of pharmaceutical giant Allergan, said he had had “some phenomenal returns” by investing in one of Shkreli’s funds, Hassan told a federal jury in Brooklyn this week. “Mr. Saunders had suggested we meet up because I was trying to learn about the hedge fund world. He thought Martin could be mentor,” she said.

Hassan eventually met Shkreli for lunch at a Manhattan restaurant, during which he recommended some books to read and gave general advice about wading into hedge fund investing. Hassan would go on to invest $300,000 in one of Shkreli’s hedge funds, MSMB Capital.

So marked the start of business relationship that produced a handsome windfall but would eventually lead to Hassan testifying this week against Shkreli as he stands trial for defrauding investors and committing securities fraud. Hassan’s dealings with the Wall Street bad boy offered a window into the workings of the lucrative hedge fund world, and illustrated the tension at the heart of the prosecution’s case: the victims ultimately made money.

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Allergan Rings in New Year with 9.0% to 9.5% Price Hike for Nine Drugs

Allergan Rings in New Year with 9.0% to 9.5% Price Hike for Nine Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A bunch of specialty pharma companies just boosted prices on key therapies for the year ahead, with Allergan among the most notable after CEO Brent Saunders in September publicly condemned companies in the sector for aggressive or predatory price increases (read “Allergan's Brent Saunders' ‘Manifesto’ on Drug Prices & Access”; http://sco.lt/6WN0AT).  

 

The pricing on nine Allergan products effectively increased on Jan. 1, but the company did remain within its promise to limit price increases to a single-digit percentage as promised in the fall. Pricing on each of the products will be increased by either 9% or 9.5%, according to a Jefferies report on Tuesday that notes a lag of several weeks is typical before new pricing is reflected.

 

Allergan's "social contract with patients" was revealed in a September blog post by the chief executive in the wake of public outcry around drugmakers such as Mylan for its anticompetitive measures to boost rates for its EpiPen used to save the lives of individuals suffering an allergic reaction.

 

"The price increases are the first since the Social Contract was introduced in September 2016 and they are consistent with its commitments," Allergan spokesman Mark Marmur wrote in an email Tuesday morning, adding that this will be the only increase in 2017 for these brands.

 

The basket of key brands victim to price increases at Allergan this year include Bystolic, Delzicol, Estrace, Lo Loestrin Fe, Lumigan, Minastrin, Linzess, Namenda XR and Restasis.

 

Further Reading:

  • “LA Times Columnist Not Drinking Kool-Aid Served Up by Allergan CEO Saunders”; http://sco.lt/72uFt3
Pharma Guy's insight:

If Allergan keeps raising the prices of these drugs by 9.5% each year, the price of each drug will have doubled after the 7th or 8th year.

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Allergan See's Shire's Aniston and Raises Tomei to Promote Restasis

Allergan See's Shire's Aniston and Raises Tomei to Promote Restasis | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Is there an Oscar for best dry eye awareness performance in pharma? Actress Marisa Tomei is speaking up about the disease as Allergan's spokesperson for its branded Restasis marketing, while Shire has tapped actress Jennifer Aniston to front its disease awareness TV campaign (read “Jennifer Aniston is Shilling for Shire!”; http://sco.lt/5G686T). Tomei signed on as an ambassador for Restasis in July, talking to news and TV media outlets about her own experience with the disease, and Aniston joined Shire's unbranded effort in August.

 

Tomei also teamed up with Guide Dogs for the Blind and will contribute $1 for every person who takes the Restasis dry eye quiz on its website through the end of the year. So far, more than 40,000 people have done so. Traffic to the Restasis website has also increased by 50% since the campaign began, Herm Cukier, senior vice president for U.S. eye care at Allergan, told FiercePharma.

 

Restasis is the market share leader in dry eye prescription treatments, launched first in 2003. But it recently got its first category competition with Shire’s launch of Xiidra. To promote the newer drug, Shire is running two ad campaigns, the unbranded dry eye disease awareness campaign featuring Aniston, and another branded Xiidra campaign that began in September.

 

While the two compete in the dry eye treatment market, they have different indications. Xiidra is approved for dry eye disease, while Restasis’ indication is for increasing tear production. A Bernstein analyst noted recently that while Shire has the full dry eye label advantage, Allergan “enjoys the power of incumbency,” including contracts, sales and an established patient pool.

Pharma Guy's insight:

I just added Tomei to my gallery of  “Celebrities Who Shill for #Pharma”; http://sco.lt/5mzajZ

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Xiidra DTC Ad Campaign Relies on Hokey Double ii’s – Get It?

Xiidra DTC Ad Campaign Relies on Hokey Double ii’s – Get It? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The first work for the dry eye disease treatment uses the "ii" in the drug’s name to create visual plays on words. The campaign subs the double i for single i in print, digital and social media ads--asking, "how's iit going?"--as well as in marketing materials for eyecare professionals.

 

The trend continues throughout the work; the professionals' intro kit, for example, reads, "Niice to meet you." There's a drug helpline called "ask iiris," as well as a copay card named the "Xiidra iinsider." And the campaign--created by Shire's agency of record, Digitas Health--also includes a video game app called Bliip, a Pong-like game available in the iTunes store.

 

“From the get-go we wanted to create a consumer brand that cut across both audiences, not just a brand for eyecare professionals and then another brand for consumers. We wanted to create a consumer brand with one voice that connects with those customers,” Victoria Noble, head of marketing for opthamalics at Shire, told FiercePharmaMarketing in an interview.

 

Collette Douaihy, senior vice president and group creative director at Digitas Health, said the opportunity to play off the double i in the name Xiidra makes for a fun, personal and memorable introduction to the brand.

 

“It’s the theme that keeps giving,” she said. “There are so many opportunities to message out and play with the double i’s and get to a very personal level with our target audiences.”

 

“We’re the challenger in this space, so in order for us to make those connections, we needed to break through and be different and engage. We weren’t going to do that by being typical pharma,” Noble said.

Pharma Guy's insight:

But don’t forget - Jennifer Aniston is Shilling for Shire! http://sco.lt/5G686T So will the ii’s or will Jennifer tip the scales in favor of Xiidra? I must admit that Aniston is better looking than that real “spooky” eye doctor used in Allergan’s ads, even though “Allergan's Persistent, Repetitive, Spooky & Annoying DTC Advertising Pays Off!”; http://sco.lt/5UsAGf

 

Also read “Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements?”; http://sco.lt/5xPB5t

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Four Lessons #Pharma PR Flacks Can Learn from Allergan's Blog Post

Four Lessons #Pharma PR Flacks Can Learn from Allergan's Blog Post | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Here are four lessons you need to learn from one of the most unlikely blog posts on the Internet today.

You have to have something significant to say. I’ll admit I struggled a bit as I waded through the first few paragraphs of corporate-speak about “commitment to innovation, access and responsible pricing ideals” before I got to “we will limit price increases.” But then I was hooked.

You have to be candid. Check this out. Not only does Saunders vow that, “We will not engage in the practice of taking major price increases without corresponding cost increases as our products near patent expiration,” but he accentuates the point by admitting they have done just that in the past. “While we have participated in this industry practice in the past, we will stop this practice going forward.” That’s gold, Jerry! GOLD!

It helps to speak from the heart. I’m sure Saunders’ post had to get cleared by Legal, but it still contains the language of a man who is being honest. One small example: “I don’t like what is happening, and despite the fact that it is hard to speak out publicly on this, now is the time to take action to spell out what this social contract means to me.” 

Deliver a call to action. A good blog post inspires. A great one directs people to act. And Saunders does just that. “For our industry to remain a vibrant and important part of the healthcare ecosystem, Allergan commits to this social contract and I encourage others to formulate their own self-policing actions.”

Pharma Guy's insight:

Find the blog post here: http://sco.lt/6WN0AT 

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Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements?

Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

I read with interest today's email missive from Bob Ehrlich, Chairman of DTC Perspectives. He was talking about the "Dry Eye DTC Battle" between Allergan's Restasis and the new kid on the bloc: Shire's Xiidra (two i's - get it? aka two "eyes").

 

Ehrlich pointed out that Shire enlisting Jennifer Aniston is a "big get. Getting a movie star to promote the dry eye condition must have cost Shire a lot in talent fees," said Ehrlich.

 

"Obviously they think she is worth it. Her ad just went on air under the 'myeyelove' title" (read "Jennifer Aniston is Shilling for Shire!").

 

Ehrlich noted that Aniston is getting "lots of commercial endorsements these days. She is touting skin care brand Aveeno and plugging the comforts of Emirate Airways. I am sure Shire considered whether we at a Jennifer saturation point. My feeling is we can take a couple more campaigns before she gets overused."

 

My view is that celebs are being overused by pharma marketers these days. Why? Find out here...

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Women A-List Celebs Hold a Special Place in Allergan's Multi-Channel Marketing Strategy

Women A-List Celebs Hold a Special Place in Allergan's Multi-Channel Marketing Strategy | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As it looks for new ways to connect consumers with its dermatology, women's health, and aesthetics portfolios, Allergan is increasingly calling on celebrity heavyweights to promote its products. In the past year alone, the drugmaker has partnered with TV and stage star Lea Michele, movie star Kate Bosworth, and reality-TV personality Khloé Kardashian.

Allergan, which estimates that 62% of its customers are women, sees the celebrity involvement as a way to create authenticity and draw attention to its brands.“It's part of a multi-channel strategy,” said Jag Dosanjh, SVP, medical dermatology for Allergan, who developed the partnership with Kate Bosworth for its acne treatment Aczone. “People consume their media in many ways, they look for different sources. Whether it's in their Facebook feeds or anything else, having other ways to connect with consumers — so they can understand the issues — is important for us to look at.”

Celebrity partnerships are an important part of the media mix for Allergan because they help break down stigmas around certain disorders, Dosanjh added. 

Last July, Allergan launched #ActuallySheCan, a campaign that was directed at millennial women (read“Allergan's #ActuallySheCan Campaign: Brand Promotion Disguised as Social Media”; http://sco.lt/684Xhp). That initiative drew on a network of female celebrities, including Michele, to foster a discussion among women. Other popular celebrities, like Emmy Rossum (“Shameless”) and model Miranda Kerr, posted content with the hashtag in support of the campaign. While an unbranded initiative, ActuallySheCan's website featured product information for the company's birth control pill Lo Loestrin Fe.

Kardashian, for her part, helped kicked off the Live Chin Up campaign in March for Kybella, a chin fat reducing injection, at a New York event (read“Khloé Kardashian Shills for Kybella at Dermatologists' Offices & Soon on TV”; http://sco.lt/6TW6qX). There, she moderated a panel, which also featured a dermatologist and a patient, who discussed her experiences with submental fullness — commonly referred to as a double chin.

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Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face

Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Stand down flaccid penis, the next fat profit center in the pharmaceutical industry may be the double chin.


Allergan Plc is beginning an aggressive sales blitz for Kybella, the first injectable treatment for what the medical industry terms “submental fat” and you probably think of as the junk inside of jowls. “It’s a disruptive technology,” said Philippe Schaison, president of Allergan’s U.S. medical business. “It’s working great, and there’s nothing like it.”


Scientists at Kythera Biopharmaceuticals Inc. worked on Kybella for roughly a decade. Soon after the Food and Drug Administration approved the chin treatment, in April 2015, Allergan moved to buy Kythera for $2.1 billion in cash.

 

Allergan is putting together an advertising blitz, including a number of television commercials, that will flood televisions in September.


The active ingredient in Kybella, deoxycholic acid, is a form of bile that destroys fat cells in the digestive tract. It turns out that the stuff does the same in the chin. The treatment involves 20 to 30 tiny injections by a doctor, with care to avoid the nerves and major blood vessels running under the jawline.


Each session costs about $1,500, and most patients require two to four, according to Dr. Anne Chapas, a dermatologist in Manhattan. Her practice, Union Square Laser Dermatology, now performs a few Kybella treatments a week. “We’ve been hearing about this for over 10 years, so we were absolutely excited about it,” Dr. Chapas said. “We know there’s huge potential.”


That broad potential has made it difficult for analysts to forecast the drug’s sales. Allergan believes Kybella could eventually become a $1 billion business, roughly half the company’s current Botox revenue. Krutoholow is forecasting $500 million in annual sales, and Sanford Bernstein expects the treatment to garner $306 million a year by 2020.


Of course, even a billion-dollar chin business would be fairly tiny next to erectile-dysfunction pills, which garnered $4.3 billion in sales around the world last year. But Kybella should quickly blow past Prozac (depression), Propecia (hair loss), and Prilosec (heartburn). And why stop at the bottom of your face? Allergan is already testing whether Kybella might be safe and effective in arms, knees, and love handles.

 

“We own the face,” said Allergan’s Philippe Schaison.

Pharma Guy's insight:

What is the treatment and how does it work?

It's a needle! It dissolves fat! Watch out -- hope none of it crosses the blood-brain barrier because then you are toast!

 

Why is it needed?

Because "80% of people with double chins are concerned about it"? Is that a good enough reason? This is the real world "HAVITOL" drug (see here for the reference: http://sco.lt/5jzlBJ).

 

What results should you expect?

Some people may get up to 50 injections in a single treatment. Whaaaa?

 

Can it help tighten a saggy chin?

"Some people did notice a tightening effect." -- especially people who are told they may notice a tightening effect.

 

What are the potential side effects?

"A possible serious side effect is an injury to the marginal mandibular nerve, which helps control facial expressions, causing an off-balance smile." I didn't make that one up.

 

Could the drug help destroy fat cells in other areas of the body?

Like Kim Kardashian's ass?

 

What will it cost?

An arm and a chin. Badda Bing!

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Obama Knocks Pfizer HQ Out of Ireland Back Into the USA - Yay!

Obama Knocks Pfizer HQ Out of Ireland Back Into the USA - Yay! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pfizer said it would walk away from its planned $150 billion takeover of Allergan, after the Obama administration took aim at the deal that would have moved the biggest drug company in the U.S. to Ireland to lower its taxes. 

 

The Wall Street Journal reported Tuesday that Pfizer's board had voted to halt the combination and the New York-based pharmaceutical company then notified Dublin-based Allergan. Pfizer will pay Allergan a breakup fee of $150 million. 

 

The decision to walk away is the latest setback in Pfizer's long-running efforts to overcome what Chief Executive Ian Read has said was the company's competitive disadvantage with foreign rivals that faced significantly lower tax bills.


The apparent decision comes after the U.S. Treasury Department issued rules to make such "tax inversion" deals less profitable and after President Obama had harsh words for such moves.

Analysts said the unexpectedly aggressive tax law changes issued late Monday, and their timing, were aimed squarely at preventing New York-based Pfizer, the biggest U.S.-based drug maker from completing its proposed $160 billion Allergan acquisition and inversion in the second half of the year.

"The Obama administration isn't just sending a message to Pfizer, it's sending a message to all U.S. companies contemplating inversions, and that message is 'Don't,"' said analyst Steve Brozak, president of WBB Securities LLC.

Pharma Guy's insight:

Yay!

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5Marissa Kinne's comment, October 11, 2016 10:54 PM
the role shown here is Chief guardian of economy. I didn't realize this company was the largest drug business in the US. I agree with Obama's decision because if the companies taxes are lower if they were to move out of the US, they could keep their prices the same or raise them to make more money for themselves instead of benefiting the country.
6AidanKeller's curator insight, October 12, 2016 2:37 PM
A. Chief executive
B. I did not know that you could move a company over seas just to get a tax cut. Very Smart
C. I agree with this method. I believe you should be able to do whatever you want to do with your money/company.