BASINGSTOKE, United Kingdom, and PHILADELPHIA, May 19 /PRNewswire/ --
Shire plc (LSE: SHP; Nasdaq: SHPGY; TSX: SHQ) announced today that it has
received an approvable letter from the U.S. Food and Drug Administration
(FDA) for SPD465 (triple-bead mixed amphetamine salts [MAS], an
investigational oral stimulant intended to provide symptom control of ADHD
in adults for up to 16 hours with one daily dose. Following receipt of this
approvable letter, Shire is evaluating its options related to SPD465.
Shire submitted a New Drug Application for SPD465 on July 21, 2006.(1)
If approved, SPD465 will be a treatment option for adults with ADHD and
part of Shire's overall ADHD portfolio.
Approximately 7.8 percent of all school-age children, or about 4.4
million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at
some point in their lives, according to the CDC.(2) ADHD is one of the most
common psychiatric disorders in children and adolescents.(3) The disorder
is also estimated to affect approximately 9.8 million adults across the
U.S. based on a retrospective survey of adults aged 18 to 34, projected to
the full U.S. adult population.(4,5) ADHD is a neurobiological psychiatric
disorder that manifests as a persistent pattern of inattention and/or
hyperactivity- impulsivity that is more frequent and severe than is
typically observed in individuals at a comparable level of development.(6)
To be properly diagnosed with ADHD, a child needs to demonstrate at least
six of nine symptoms of inattention; and/or at least six of nine symptoms
of hyperactivity/impulsivity; the onset of which appears before age 7
years; that some impairment from the symptoms is present in two or more
settings (e.g., at school and home); that the symptoms continue for at
least six months; and that there is clinically significant impairment in
social, academic or occupational functioning and the symptoms cannot be
better explained by another psychiatric disorder.(6)
Although there is no "cure" for ADHD, there are accepted treatments
that specifically target its symptoms. The most common standard treatments
include educational approaches, psychological or behavioral modification,
For further information on ADHD please visit www.adhdsupport.com.
Shire ADHD Portfolio
In addition to SPD465, Shire's portfolio of ADHD treatments includes
VYVANSE(TM) (lisdexamfetamine dimesylate), the first prodrug stimulant,
which is planned to launch 2Q 2007, DAYTRANA(TM) (methylphenidate
transdermal system), the first and only ADHD patch, and ADDERALL XR(R)
(mixed salts of a single-entity amphetamine product), a long-acting
formulated stimulant. SPD503 (guanfacine HCl extended release) is currently
under review with FDA.
SPD465, a single entity formulation of mixed amphetamine salts, was
designed to provide extended release of medication with symptom control for
up to 16 hours, is being studied for the treatment of ADHD in adults. The
most common adverse events reported include insomnia, decreased appetite,
dry mouth, headache and weight decrease.
About VYVANSE and ADDERALL XR
Tell your doctor about any heart conditions, including structural
abnormalities, that you, your child, or a family member, may have. Inform
your doctor immediately if you or your child develops symptoms that suggest
heart problems, such as chest pain or fainting.
VYVANSE or Adderall XR should not be taken by patients who have
advanced disease of the blood vessels (arteriosclerosis); symptomatic heart
disease; moderate to severe high blood pressure; overactive thyroid gland
(hyperthyroidism); known allergy or unusual reactions to drugs called
sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma;
a history of problems with alcohol or drugs; agitated states; taken a
monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell your doctor before using, VYVANSE or Adderall XR if you or your
child are being treated for or have symptoms of depression (sadness,
worthlessness, or hopelessness) or bipolar disorder; have abnormal thoughts
or visions, hear abnormal sounds, or have been diagnosed with psychosis;
have had seizures or abnormal EEGs; have or have had high blood pressure;
exhibit aggressive behavior or hostility. Tell your doctor immediately if
any of these conditions or symptoms develop while using VYVANSE or Adderall
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events. These events
have also been reported rarely with amphetamine use.
VYVANSE and Adderall XR were generally well tolerated in clinical
studies. The most common side effects in studies of Vyvanse included:
children - difficulty falling asleep, stomachache, and irritability. The
most common side effects in studies of Adderall XR included: children -
decreased appetite, difficulty falling asleep, stomachache, and emotional
lability; adolescents - loss of appetite, difficulty falling asleep,
stomachache, and weight loss; adults - dry mouth, loss of appetite,
difficulty falling asleep, headache, and weight loss.
Aggression, new abnormal thoughts/behaviors, mania, growth suppression,
worsening of motion or verbal tics and Tourette's syndrome have been
associated with use of drugs of this type. Tell your doctor if you or your
child have blurred vision while taking VYVANSE or Adderall XR.
DAYTRANA should not be used in patients with allergy to methylphenidate
or patch components; marked anxiety, tension and agitation; glaucoma; tics,
diagnosis or a family history of Tourette's syndrome; seizures; or during
or within 14 days after treatment with monoamine oxidase inhibitors
Sudden death has been reported in association with CNS stimulant
treatment at usual doses in children and adolescents with structural
cardiac abnormalities or other serious heart problems. Sudden deaths,
stroke, and myocardial infarction have been reported in adults taking
stimulant drugs at usual doses in ADHD. Physicians should take a careful
patient history, including family history, and physical exam, to assess the
presence of cardiac disease. Patients who report symptoms of cardiac
disease such as exertional chest pain and unexplained syncope should be
promptly evaluated. Use with caution in patients whose underlying medical
condition might be affected by increases in blood pressure or heart rate.
New psychosis, mania, aggression, growth suppression, and visual
disturbances have been associated with the use of stimulants. Use with
caution in patients with a history of: psychosis; EEG abnormalities;
bipolar disorder; depression. Growth and hematologic monitoring is advised
during prolonged treatment. Patients should avoid applying external heat to
the DAYTRANA patch. Skin irritation or contact sensitization may occur.
DAYTRANA should be given cautiously to patients with a history of drug
dependence and alcoholism. Chronic abuse can lead to marked tolerance and
psychological dependence. Frank psychotic episodes can occur, especially
with parenteral abuse. Careful supervision is required during withdrawal
abusive use, since severe depression may occur. Withdrawal following
chronic therapeutic use may unmask symptoms of the underlying disorder.
Common adverse events reported by patients who received DAYTRANA in
clinical trials were decreased appetite, insomnia, nausea, vomiting,
decreased weight, tics, affect lability, and anorexia, consistent with
adverse events commonly associated with the use of methylphenidate.
For further product information related to Shire's portfolio of ADHD
treatments, please go to Vyvanse.com, AdderallXR.com and Daytrana.com.
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire focuses its business on attention deficit and
hyperactivity disorder (ADHD), human genetic therapies (HGT),
gastrointestinal (GI) and renal diseases. The structure is sufficiently
flexible to allow Shire to target new therapeutic areas to the extent
opportunities arise through acquisitions. Shire believes that a carefully
selected portfolio of products with a strategically aligned and relatively
small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for
specialty physicians. Shire's in-licensing, merger and acquisition efforts
are focused on products in niche markets with strong intellectual property
protection either in the US or Europe.
For further information on Shire, please visit the Company's website:
"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 affected. The risks and uncertainties include, but are not
limited to, risks associated with: the inherent uncertainty of
pharmaceutical research, product development, manufacturing and
commercialization; the impact of competitive products, including, but not
limited to the impact of those on Shire's Attention Deficit and
Hyperactivity Disorder ("ADHD") franchise; patents, including but not
limited to, legal challenges relating to Shire's ADHD franchise; government
regulation and approval, including but not limited to the expected product
approval dates of SPD503 (guanfacine extended release) (ADHD) and SPD465
(extended release triple-bead mixed amphetamine salts) (ADHD); Shire's
ability to secure new products for commercialization and/or development;
Shire's ability to benefit from its acquisition of New River
Pharmaceuticals Inc.; and other risks and uncertainties detailed from time
to time in Shire plc's filings with the Securities and Exchange Commission,
particularly Shire plc's Annual Report on Form 10-K for the year ended
December 31, 2006.
(1) Shire Pharmaceuticals Group. Basingstoke: Shire; [updated 2006 Oct.
20; cited 2006 Oct. 19]. Shire Announces Filing Of Spd465 For The Treatment
Of Adult ADHD. Available from
(2) Mental health in the United States: Prevalence of diagnosis and
medication treatment for attention-deficit/hyperactivity disorder, United
States, 2003. MMWR, September 2, 2005;54(34):842-847. Available at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5434a2.htm. Accessed September
(3) "Introduction," Diagnosis and Treatment of Attention Deficit
Hyperactivity Disorder. NIH Consensus Statement 1998 Nov 16-18; 16(2):
1-37. Available at:
http://consensus.nih.gov/cons/110/110_statement.htm#0_Abstract. Accessed on
June 8, 2005.
(4) Kessler RC, et al. "The Prevalence and Correlates of Adult ADHD in
the United States: Results from the National Comorbidity Survey
Replication." The American Journal of Psychiatry. 2006;163:716-723., US
Census 2005. Data
extrapolated from survey data in adults 18-44 years old, projected to
the total adult population in the US.
(5) "Annual Estimates of the Population by Selected Age Groups and Sex
for the United States: April 1, 2000 to July 1, 2005 (NC-EST2005-02)." U.S.
Census Bureau. Available at:
http://www.census.gov/popest/national/asrh/NC-EST2005-sa.html. Accessed May
(6) Diagnostic and Statistical Manual of Mental Disorders: Fourth
Edition, Text Revision. DSM-TR-IV(R). Washington, DC: American Psychiatric
Association; 2000: 85.
(7) Baumgartel A, et al. Practice guideline for the diagnosis and
management of attention deficit hyperactivity disorder. Ambulatory Child
SOURCE Shire plc