Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) Becomes First and Only Treatment Approved by the FDA for Adults with Moderate to Severe Binge Eating Disorder

Lexington, Massachusetts (ots/PRNewswire) -

Shire plc announced today that the U.S. Food and Drug
Administration (FDA) approved Vyvanse(R) (lisdexamfetamine
dimesylate) Capsules (CII), the first and only medication for the
treatment of moderate to severe binge eating disorder (B.E.D.) in
adults, shown to significantly reduce the mean number of binge days
per week. Vyvanse is not indicated or recommended for weight loss or
the treatment of obesity. Other sympathomimetic drugs used for weight
loss have been associated with serious cardiovascular reactions.

"Binge eating disorder is the most common adult eating disorder in
the United States, and we are excited to provide the first
FDA-approved treatment for moderate to severe B.E.D. in adults," said
Philip J. Vickers, Ph.D., Global Head of Research and Development at
Shire. "This new indication for Vyvanse is a critical milestone in
the treatment of this condition and reflects our ongoing commitment
to address the needs of patients."

"The management of B.E.D. is continuously being studied, and
though advancements have been made to increase awareness and
understanding of this real disorder, rates of diagnosis remain low,"
said Susan L. McElroy, M.D., Professor of Psychiatry and Behavioral
Neuroscience, University of Cincinnati College of Medicine; and
principal investigator of the B.E.D. clinical trials. "The
development of new treatment options for adults with B.E.D. is
important to the patients who continue to live with this complex
disorder."

The efficacy of Vyvanse in the treatment of B.E.D. was
demonstrated in two 12-week randomized, double-blind, multi-center,
parallel-group, placebo-controlled, dose-optimization studies in
adults aged 18 to 55 years (Study 1: N=374, Study 2: N=350) with
protocol-defined moderate to severe B.E.D. (severity was defined as
having at least 3 binge days per week for 2 weeks prior to the
baseline visit and a Clinical Global Impression Severity score of
greater than or equal to4 at baseline). The primary efficacy outcome
for the two studies was defined as the change from baseline at week
12 in the number of binge days per week. Baseline is defined as the
weekly average of the number of binge days per week for the 14 days
prior to the baseline visit.

Subjects from both studies on Vyvanse had a statistically
significant greater reduction from baseline in mean number of binge
days per week at Week 12. In study 1, Vyvanse reduced the mean number
of binge days per week from 4.79 at baseline to 0.78 at study
endpoint compared with 4.60 to 2.22 for placebo. The least squares
mean change from baseline in binge days per week was -3.87 and -2.51
for Vyvanse and placebo, respectively. Similar results were seen in
study 2.

Vyvanse is a federally controlled substance (CII) because it can
be abused or lead to dependence. Keep in a safe place to prevent
misuse and abuse. Selling or sharing Vyvanse may harm others and is
illegal.

Greater improvement across key secondary outcomes was also
observed in subjects treated with Vyvanse as compared to placebo,
including a higher proportion of subjects rated improved on the
Clinical Global Impressions-Improvement (CGI-I) rating scale, higher
proportion of subjects with 4-week binge cessation, and greater
reduction in the Yale-Brown Obsessive Compulsive Scale Modified for
Binge Eating (Y-BOCS-BE) total score in both studies.

Patients with current anorexia or bulimia nervosa; current
comorbid psychiatric disorder; and cardiovascular risk factors other
than obesity and smoking were excluded from the studies. In both
studies, there were 4 patients each in the Vyvanse and placebo
treated groups who reported serious adverse events (SAEs). There were
no deaths in either of the studies. Of patients treated with Vyvanse,
5.1% (19/373) discontinued due to adverse reactions compared with
2.4% (9/372) of placebo-treated patients. The most common adverse
reactions (incidence greater than or equal to 5% and at least twice
placebo) reported in adults with moderate to severe B.E.D. were dry
mouth, insomnia, decreased appetite, increased heart rate,
constipation, feeling jittery, and anxiety.

About B.E.D.

Binge eating disorder, now recognized as a distinct disorder, is
defined as recurring episodes (greater than or equal to once weekly,
for at least 3 months) of consuming a large amount of food in a short
time, compared with others. Patients feel a lack of control during a
binge eating episode and marked distress over their eating. They
typically experience shame and guilt, among other symptoms, about
their binge eating, and may conceal the symptoms. Unlike people with
other eating disorders, adults with B.E.D. don't routinely try to
"undo" their excessive eating with extreme actions like purging or
over-exercising.

B.E.D. is the most common eating disorder in the United States,
affecting an estimated 2.8 million adults, according to a national
survey. B.E.D. occurs in both men and women, and is more common than
anorexia and bulimia combined. B.E.D. can occur in normal weight,

overweight, and obese adults, and is seen across racial and ethnic
groups. Medication is not appropriate for all adults with B.E.D.

More About Vyvanse (lisdexamfetamine dimesylate) B.E.D. Clinical
Trials

In the two 12-week studies, patients were confirmed with a
diagnosis of B.E.D. using DSM-IV-TR(R) criteria for B.E.D. For both
studies, a binge day was defined as a day with at least 1 binge
episode, as determined from the subject's daily binge diary and
confirmed by the clinician.

About VYVANSE (lisdexamfetamine dimesylate)

INDICATION

Vyvanse is a prescription medicine for the treatment of moderate
to severe binge eating disorder (B.E.D.) in adults.

Vyvanse is not for weight loss. It is not known if Vyvanse is safe
and effective for the treatment of obesity.

IMPORTANT SAFETY INFORMATION

Vyvanse is a federally controlled substance (CII) because it can
be abused or lead to dependence. Keep in a safe place to prevent
misuse and abuse. Selling or sharing Vyvanse may harm others and is
illegal.

- Do not take Vyvanse if you:
- are taking or have taken within the past 14 days an anti-depression
medicine called a monoamine oxidase inhibitor or MAOI
- are sensitive to, allergic to, or had a reaction to other stimulant
medicines

- Some people have had the following problems when taking stimulant
medicines, such as Vyvanse:
- Heart-related problems including:
- sudden death in people who have heart problems or heart defects
- sudden death, stroke and heart attack in adults
- increased blood pressure and heart rate

Tell your doctor if you have any heart problems, heart defects,
high blood pressure, or a family history of these problems. The
doctor should check your blood pressure and heart rate regularly
during treatment. Call your doctor right away if you have any signs
of heart problems such as chest pain, shortness of breath, or
fainting while taking Vyvanse.

- Mental (psychiatric) problems including:
- new or worse behavior and thought problems
- new or worse bipolar illness
- new psychotic symptoms such as:
- seeing things or hearing voices that are not real
- believing things that are not true
- being suspicious
- new manic symptoms

Tell your doctor about any drug abuse, alcohol abuse or mental
problems that you have had, or about a family history of suicide,
bipolar illness, or depression. Call your doctor right away if you
have any new or worsening mental symptoms or problems while taking
Vyvanse.

- Circulation problems in fingers and toes [Peripheral vasculopathy,
including Raynaud's phenomenon]:
- Fingers or toes may feel numb, cool, painful, sensitive to temperature
and/or change color from pale, to blue, to red

Call your doctor right away if you have any of these signs or
symptoms or develop unexplained wounds on fingers or toes while
taking Vyvanse.

- Tell the doctor if you are pregnant, breast-feeding, or plan to become
pregnant or breast-feed.

For additional safety information, click here for Prescribing
Information [http://pi.shirecontent.com/PI/PDFs/Vyvanse_USA_ENG.pdf ]
and Medication Guide [http://medguide.shirecontent.com/MEDGUIDE/PDFs/
MG_Vyvanse_USA_ENG.pdf ] and discuss with your doctor.

Shire is committed to helping patients get the Shire medicines
their physician has prescribed and is developing various programs to
extend this commitment to adults with moderate to severe B.E.D. For
more information, please visit http://www.shire.com.

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better
lives.

Our strategy is to focus on developing and marketing innovative
specialty medicines to meet significant unmet patient needs.

We focus on providing treatments in Neuroscience, Rare Diseases,
and Gastrointestinal and Internal Medicine and are developing
treatments for symptomatic conditions treated by specialist
physicians in other targeted therapeutic areas, such as
Ophthalmology.

http://www.shire.com

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Vyvanse(R) (lisdexamfetamine dimesylate) is a registered trademark
of Shire LLC. Vyvanse is available in 10, 20, 30, 40, 50, 60 and 70
mg capsules.

DSM-5(R) is a registered trademark of the American Psychiatric
Association.

For further information please contact:

Investor Relations
Sarah Elton-Farr seltonfarr@shire.com +44-1256-894157

Media
Gwen Fisher gfisher@shire.com +1-484-595-9836

ots Originaltext: Shire Pharmaceuticals Group Plc
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