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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How DTC Made Restasis a Blockbuster in the U.S. Even Though Its Efficacy Is Unproven In The Rest of the World

How DTC Made Restasis a Blockbuster in the U.S. Even Though Its Efficacy Is Unproven In The Rest of the World | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Rich Meyer of DTC Marketing Blog Meyer says: "I’m having a hard time understanding how anyone with a conscience could work for a company like Allergan. Transferring patents, rights to a native American tribe (Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics) to try and circumvent the law and using DTC to market a drug that did nothing, according to JAMA but increase health care costs."

 

According to the JAMA article:

 

Restasis is not approved in the European Union, Australia, or New Zealand, where in 2001 registration applications were “withdrawn prior to approval due to insufficient evidence of efficacy. But Americans pay for Restasis—a lot: $8.8 billion in US sales between 2009 and 2015, including over $2.9 billion in public monies through Medicare Part D.

 

An important reason may be the extensive marketing campaign to sell a disease—chronic dry eyes—and its treatment. From 2007 to 2016, Allergan spent $645 million on television, magazine, and electronic ads including its mydryeyes.com website.

 

The website recasts ordinary unpleasant life experiences as disease: “those who experience stinging, burning, and watering eyes might attribute these symptoms to the weather, allergies, contacts or even their eye makeup, when in fact they may be suffering from Chronic Dry Eye (CDE) disease.” Mydryeyes.com invites people to take a quiz. The results come with a warning: “Don’t wait; over time, CDE disease may get worse and may have potential health consequences for your eyes, including damage to the front surface of the eye, an increased risk of eye infection, and effects on your vision.”

 

Based on the evidence, why should consumers, private insurers, and the federal government spend billions of dollars on a marginally effective drug for a condition that many would not consider to be a disease? Restasis might never have reached blockbuster status if payers, clinicians, and consumers had easy access to independent drug information.

 

Further Reading:

Pharma Guy's insight:

An Allergan spokesperson told PMLIVE that "the success of the [Restasis DTC] campaign can primarily be attributed to the fact that the team took a deeper dive into the patient's journey and experience, bringing to life the moment when a patient realises she doesn't just have dry eyes, she has a disease called chronic dry eye." All this hubbub about "a deeper dive into the patient's journey and experience" is secondary to the age-old advertising formula of "reach and frequency." $645 million buys a LOT of TV and magazine ads!

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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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Allergan's Persistent, Repetitive, Spooky & Annoying DTC Advertising Pays Off!

Allergan's Persistent, Repetitive, Spooky & Annoying DTC Advertising Pays Off! | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Allergan executives attributed strong sales of branded products to recent investments in directtoconsumer advertising.


Throughout the company's second-quarter earnings call, Allergan executives attributed strong sales of Juvederm Voluma, Botox, Restasis and Bystolic to the company's recent efforts in DTC.


The drugmaker's facial-aesthetics business grew 13.5% compared to the same period a year ago, according to Philippe Schaison, EVP and president of Allergan Medical, who noted that this growth—particularly for Juvederm Voluma and Botox—is “linked to very strong advertising.”


Bill Meury, EVP, branded pharmaceuticals, also said that the response for its latest DTC campaign for chronic idiopathic constipation drug Linzess is “exceeding industry norms.”


For Restasis, the company is focused on gaining market share in the artificial-tear market, according to Meury, who said Allergan hopes to continue to drive sales through in-office screenings for dry eye and bolstering primary-care education efforts.

Pharma Guy's insight:

I absolutely hate those Restasis ads! Can't they find another eye doctor with dry eyes? And those belly knotted intestine ads - TMI!

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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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Jennifer Aniston is Shilling for Shire!

Jennifer Aniston is Shilling for Shire! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Shire is expected to unveil a new disease awareness campaign Thursday featuring actress Jennifer Aniston as it prepares to introduce its new dry-eye drug to the U.S. market.

 

The drugmaker expects the multi-channel initiative to lay its foundation in the ophthalmology market, following the approval in July of its chronic dry eye drug, Xiidra. The campaign will also set the stage for Shire to compete with the current market leader, Allergan's Restasis. Xiidra is expected to be available in pharmacies later this month.

 

This is the rare-disease maker's first move into the eye care market and its CEO Flemming Ørnskov told investors during the company's earnings call earlier this month that he considers the launch of Xiidra to be the company's biggest to date. Xiidra represents a new venture from a drugmaker that bills itself as a global biotech focused on rare diseases — given the many millions of people affected by dry-eye disease.

 

“Shire is making a big entry into the eye care space at a time when there's a little bit of churn within the leadership [of the category],” said Vic Noble, head of marketing, ophthalmics, for Shire. “This is what market leaders, and want-to-be market leaders, do — they show a big commitment to health.”

 

The company is indeed making a big commitment, pulling in TV and movie star Jennifer Aniston as the face of the campaign. She will be featured in TV spots for eyelove and will also be involved in consumer PR outreach. Shire hired Digitas Health LifeBrands as the creative agency for campaign, and Edelman is leading social media, experiential events, and consumer PR.

 

“We picked up a magazine and there was a story about Jennifer [Aniston] and she mentioned that she's addicted to eye drops,” Noble said. A few phone calls later and she was on board, Noble noted, adding that “this is an issue she's been dealing with for a while.”

 

Allergan has been preparing for the competition. Its chief commercial officer, Bill Meury, said during an earnings call in August that they expect growth for Restasis to “moderate” with the introduction of Xiidra, as well as the fact that “Shire is going to, of course, be sampling the product heavily.”

Pharma Guy's insight:

Why do drug marketers always claim that they read about celebrities with exactly the health problem their drug treats BEFORE they hire them to shill for the product? Also, you might think disease awareness ads will help the market leader (Restasis) more than Shire's product, but the secret is "heavy" sampling - Free stuff!

NOTE: “Allergan See's Shire's Aniston and Raises Tomei to Promote Restasis”; http://sco.lt/8r5bxB

 

Shire enlisting Jennifer Aniston is a big get, according to Bob Ehrlich, Chairman of DTC Perspectives. "Getting a movie star to promote the dry eye condition must have cost Shire a lot in talent fees. Obviously they think she is worth it. Her ad just went on air under the "myeyelove" title."

"Jennifer Aniston is getting lots of commercial endorsements these days," Said Ehrlich. "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 feeling is that I'm at the saturation popint viz-a-viz celebrity pharma endorsements. And the fact that Aniston is plugging other products only goes to prove my point that her people probably approached Shire rather than Shire just stumbling upon a story about her dry eyes in a magazine - in fact I bet that story was an "audition" for the part!

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