Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announces that seven posters highlighting scientific data and clinical research will be presented at the upcoming American Psychiatric Association (APA) 167th Annual Meeting in New York City, May 3 to May 7, 2014. These data represent Shire’s ongoing commitment to clinical research and to understanding the unmet needs of patients.
“Improving the diagnosis and care of people living with mental health disorders is a priority for Shire” said Phil Vickers, Global Head of Research and Development for Shire. “For example, the research Shire is presenting at APA exemplifies our commitment to better understanding binge eating disorder and the needs of the adult patients who suffer from it.”
Scientific Poster Presentations:
The titles and dates of the APA scientific presentations are noted below. Specific information about the data contained in these scientific presentations is embargoed until the start of the meeting.
- (Poster Number NR3-107; Sunday May 4, 10:30am EDT): Characteristics of Patients with BED Compared to Patients with EDNOS and Patients Without an Eating Disorder; Presented by Brandon Bellows, Pharm. D
- (Poster Number NR6-990; Monday May 5, 2:30pm EDT):Lisdexamfetamine Dimesylate Effects on Cytochrome P450 Substrate Pharmacokinetics in Healthy Adults in an Open-Label, Randomized, Crossover Study; Presented by James Ermer, MS
- (Poster Number NR6-97; Monday May 5, 2:30pm EDT):Prevalence and Frequency of Residual Symptoms of Depression in US Adults; Presented by Bryan Dirks, MD
- (Poster Number NR8-44; Tuesday May 6, 2:30pm EDT):Estimating the Prevalence of Binge Eating Disorder in a Community Sample, Comparing DSM-IV-TR and DSM-5 Criteria; Presented by Nicole Cossrow, Ph.D, MPH
- (Poster Number NR8-55; Tuesday May 6, 2:30pm EDT):Survey of Binge Eating Disorder Recognition, Diagnosis, Treatment and Referral in US Physician Practices; Presented by Dylan Supina, Ph.D
- (Poster Number NR8-53; Tuesday May 6, 2:30pm EDT):Binge Eating Disorder Patient Characteristics and Barriers to Treatment: A Qualitative Study; Presented by Barry K. Herman MD, MMM
- (Poster Number NR8-54; Tuesday May 6, 2:30pm EDT):Randomized Controlled Safety and Efficacy Trials of Lisdexamfetamine Dimesylate for Adults With Moderate to Severe Binge Eating Disorder; Presented by Susan McElroy, MD
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 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.
2. Mental (psychiatric) problems including:
- new or worse behavior and thought problems
- 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.
3. 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:
- decreased appetite
- dry mouth
- loss of appetite
- trouble sleeping
- upper stomach pain
- weight loss
For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.
For further information please contact:
+1 781 482 0945
+44 1256 894157
+1 484 595 9836
+1 484 343 4616
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 provide treatments in Neuroscience, Rare Diseases, Gastrointestinal and Internal Medicine, and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.
Click here for the PDF version of this press release.
FORWARD - LOOKING STATEMENTS - "SAFEHARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements. 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:
- 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 contractors 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.
- the development, approval and manufacturing of Shire’s products is subject to extensive oversight by various regulatory agencies and regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely impact Shire’s revenues, financial conditions or results of operations;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in the distraction of senior management, significant legal costs and the payment of substantial compensation or fines;
- 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;
and other risks and uncertainties detailed from time to time in Shire’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
Vyvanse® is a registered trademark of Shire LLC.