Shire Announces FDA Acceptance For Filing With Priority Review Of Supplemental New Drug Application (Snda) For Vyvanse® (Lisdexamfetamine Dimesylate) Capsules (CII) For Adults With Binge Eating Disorder

September 15, 2014

Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for filing with priority review a supplemental New Drug Application (sNDA) for Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) as a treatment for adults with binge eating disorder (BED). The FDA is expected to provide a decision in February 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.

“The decision from the FDA to accept our filing for priority review not only marks progress in the development of Vyvanse for adults with BED, but underscores this is an area of unmet medical need as there are currently no approved pharmacologic options for these patients,” said Phil Vickers, PhD, Head of Research and Development, Shire.

Vyvanse is a prescription medicine currently only approved for Attention-Deficit/Hyperactivity Disorder (ADHD).  Vyvanse should only be used to treat ADHD.

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.

Shire is seeking approval for Vyvanse as a treatment option for adults with BED based on the results of two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse versus placebo, previously announced in a press release dated November 5, 2013.1

About BED

BED is a distinct eating disorder now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5®).2 BED is characterized by recurring episodes of eating significantly larger amounts of food in a discrete period of time (eg, any two-hour period) than most people would eat in a similar period of time under similar circumstances.2 These episodes are associated with feelings of distress and lack of control (eg, the sense one cannot stop eating or control what or how much one is eating).

As described in DSM-5, a person with BED may eat much more rapidly than normal, eat until feeling uncomfortably full, eat large amounts of food when not feeling physically hungry, eat alone to hide the behavior due to embarrassment, or experience feelings of disgust, depression or guilt after a binge episode.2 In these individuals, binge eating occurs, on average, at least once a week for three months.2 Unlike bulimia nervosa and anorexia nervosa, BED is not associated with the recurrent use of inappropriate behaviors to compensate for binge eating (eg, purging, excessive exercise or fasting).2

About VYVANSE (lisdexamfetamine dimesylate)

Vyvanse is a prescription medicine currently only approved in the United States, Canada, Australia, several European countries (trade name: Elvanse®/Tyvense®) and Brazil (trade name: Venvanse™) for ADHD. Vyvanse should only be used to treat ADHD. Vyvanse should only be used in accordance with locally approved prescribing information.

INDICATION

Vyvanse is a prescription medicine for the treatment of ADHD in patients 6 years and above.

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 or your child:
    • is taking or has taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
    • is 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:
    1. 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 or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. The doctor should check your or your child’s blood pressure and heart rate regularly during treatment.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.

  1. Mental (psychiatric) problems including:
    • new or worse behavior and thought problems
  2. new or worse bipolar illness

In Children and Teenagers

  • 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 or your child has had, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking Vyvanse (lisdexamfetamine dimesylate).

  1. 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 or your child has any of these signs or symptoms or develops unexplained wounds on fingers or toes while taking Vyvanse.

  • Tell the doctor if you or your child is pregnant, breast-feeding, or plans to become pregnant or breast-feed.
  • Vyvanse may cause serious side effects, including:
  • slowing of growth (height and weight) in children. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.
  • The most common side effects reported in studies of Vyvanse were:
    • anxiety
    • decreased appetite
    • diarrhea
    • dizziness
    • dry mouth
    • irritability
    • loss of appetite
    • nausea
    • trouble sleeping
    • upper stomach pain
    • vomiting
    • weight loss

For additional safety information, click here for Prescribing Information and Medication Guide.

For further information please contact:

Investor Relations
Jeff Poulton
jpoulton@shire.com
+1 781 482 0945

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

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

Audrey Abernathy
aabernathy@shire.com
+1 484 595 2389

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.

www.shire.com

Click here for the PDF version of this press release.

THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:

  • and other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “Item 1A: Risk Factors” in Shire’s Annual Report on Form 10-K for the year ended December 31, 2013.
  • Shire’s products may not be a commercial success;
  • revenues from ADDERALL XR are subject to generic erosion and revenues from INTUNIV will become subject to generic competition starting in December 2014;
  • the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues, financial condition and results of operations;
  • Shire conducts its own manufacturing operations for certain of its Rare Diseases products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
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  • adverse outcomes in legal matters and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
  • Shire faces intense competition for highly qualified personnel from other companies, academic institutions, government entities and other organizations. Shire is undergoing a corporate reorganization and the consequent uncertainty could adversely impact Shire’s ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
  • failure to achieve Shire’s strategic objectives with respect to the acquisition of ViroPharma Incorporated may adversely affect Shire’s financial condition and results of operations;
  • the recommended combination with AbbVie Inc. ( “ AbbVie” ) is subject to a number of conditions, including approval by shareholders and regulators

and other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “Item 1A: Risk Factors” in Shire’s Annual Report on Form 10-K for the year ended December 31, 2013.

Vyvanse® is a registered trademark of Shire LLC.

1 Shire Pharmaceuticals, (2013, November 5). Positive Top-line Results Shown for Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) in Adults with Binge Eating Disorder [press release]. Retrieved from: .
2 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association; 2013.​