Pharmaguy's Insights Into Drug Industry News

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.

Once seen as a disorder affecting mainly children and young adults, attention deficit hyperactivity disorder is increasingly understood to last throughout one’s lifetime.

In 2012, in one of the only epidemiological studies done on A.D.H.D. in older adults, a large Dutch population study found the condition in close to 3 percent of people over 60.

Yet we know little about how A.D.H.D. affects older people, or even who has it.

“We hardly have any literature,” said Dr. Thomas Brown, associate director of the Yale Clinic for Attention and Related Disorders at the Yale School of Medicine. Almost none of the clinical trials and epidemiological studies on A.D.H.D. have included people over 50. “But I see quite a few people turning up in my office with these complaints. It’s reasonable to assume that a lot of elderly people have A.D.H.D.”

Heightened awareness of A.D.H.D. is bringing increased referrals of elderly adults to specialty clinics. “A child had been treated, then a parent, then everyone started looking at Grandpa, and saying, ‘Oh my gosh,’ and they would bring him in,” said Dr. Martin Wetzel, associate clinical professor of psychiatry at the University of Nebraska Medical Center.

Yet many general practitioners and mental health experts mistake symptoms like impaired short-term memory or an inability to stay focused on a task as something else.

“We do a horrible job of training health care professionals about adult A.D.H.D.,” Dr. Wetzel said.

After writing yesterday's blog post about Monica Seles helping Shire promote Vyvanse for Binge Eating Disorder (B.E.D.), which is a new indication for the ADHD drug, I wondered if this would make it easier for young people to obtain prescriptions for Vyvanse, which is a Schedule II controlled substance with a high potential for abuse.

Like overweight college students, I too could use a little "pick me up" pill from time to time.

Since there is no lab test to confirm a B.E.D. diagnosis, all I have to do to get a prescription for Vyvanse is convince a doctor that I meet all of the DSM-5® diagnostic criteria for binge eating disorder, which Shire provides here on the BingeEatingDisorder.com website.

Anyone can use Shire's handy "Binge Eating Disorder (B.E.D.) Symptom Checklist," which you can find on the "Talking With Your Doctor" page where "Starting the Conversation Is Key." 

It's easy to use the Checklist and get a printout (pdf file) to bring to your doctor. Here's how I filled in the Checklist and the advice I got from Shire on "starting the conversation" with my doctor - a surefire way of getting a prescription for Vyvanse and the boost I need during my busy day.

More...

Shire will present new research on Binge Eating Disorder (B.E.D.) and Attention-Deficit/Hyperactivity Disorder (ADHD) at the upcoming 169th Annual Meeting of the American Psychiatric Association (APA) in Atlanta, GA, demonstrating its ongoing commitment to furthering the understanding and management of psychiatric disorders.

“The data being presented this year at APA will address several important topics within the adult psychiatry therapeutic area, including the characterization of eating behaviors in adults with binge eating disorder, as well as patterns of prescription medication use in two psychiatric disorders,” said Barry K. Herman, MD, MMM, DLFAPA, Global Medical Team Lead, Senior Medical Director for Shire. “These presentations underscore our long-standing commitment to furthering knowledge of psychiatric conditions and advancing research into the unmet needs of people with B.E.D. and ADHD.”

Posters presented during the conference will include:

Poster Number P6-048; Monday, May 16, 2:00pm EDT: The Use and Value of the 7-Item Binge Eating Disorder Screener in Clinical Practice; Presented by Barry K. Herman, MD, MMM, DLFAPA

“Continued research on binge eating disorder in adults is crucial to expanding our understanding of the disorder,” said Cynthia Bulik, PhD, FAED, Distinguished Professor of Eating Disorders, Department of Psychiatry, University of North Carolina at Chapel Hill, and co-author of P6-136. “We value our collaboration with Shire to enhance efforts to educate health care professionals who evaluate adults living with B.E.D.”

Shire's ADHD treatment Vyvanse won a label expansion into treating moderatetosevere bingeeating disorder BED Friday. One analyst says that disease awareness and detailing efforts are crucial to the drugs commercial plans in the category.

Jefferies analyst David Steinberg wrote in an investor note Monday morning that he estimates the US patient population for BED at 2.8 million and that unmet need in the category is substantial. He added that the drug's success largely hinges on Shire's ability to spread awareness of the disorder and its patient and physician education efforts.

Steinberg expects the Dublin-based drugmaker's commercial strategy to focus on “physician and patient education with substantial early efforts focused on disease awareness, unmet patient and physician detailing.” He noted that the second step in Shire's marketing plan is likely a DTC campaign.

Steinberg also expressed some confidence that Shire will be able to make this expansion a commercially successful one. “While this market will largely need to be ‘built' from the group up, Shire has a strong track record in this regard—as evidenced by its key role in establishing the ADHD (Adderall and Vyvanse franchises) category,” he explained, estimating sales of $24 million in 2015 and $73 million in 2016.

OMG! Is there nothing old athletes won't do for money?

Remember Monica Seles who was famously stabbed on the tennis court in 1993? No? OK, whatever. She's celebrity enough to hawk for Shire, which recently won PRIORITY approval from the FDA for a new indication for Vyvanse, it's ADHD drug:

Binge Eating Disorder or B.E.D.

According to Seles & Shire, which is hosting the website BingeEatingDisorder.com ("A Resource for Understanding B.E.D. in Adults"):

"Binge Eating Disorder (B.E.D.) is not just overeating. It is a real medical condition [my emphasis] that was formally recognized in 2013. B.E.D. is the most common eating disorder among US adults."

How many times have you heard the phrase "It is a real medical condition" before? Aside from Seles & Shire, who says B.E.D. is a real medical condition? Who "formally recognized" it in 2013 (just in time for Shire to ask for FDA approval)?

To find out, read more here.

Shire Plc, which is in the process of being acquired by AbbVie Inc, has agreed to pay $56.5 million (34.5 million pounds) to resolve allegations of making false claims in themarketing of its ADHD drug Adderall XR and other medicines, the U.S. Justice Department said on Wednesday.

The settlement involved charges that Ireland-based Shire, between January 2004 and December 2007, promoted its extended release Adderall with claims of superiority over rival medicines that were not supported by clinical data, the Justice Department said.

The company was also accused of promoting the drug for unapproved uses and of making other false claims not supported by data, such as that Adderall XR would prevent poor academic performance, loss of employment, criminal behaviour, traffic accidents, and sexually transmitted disease.