Shire Agrees to Divest Daytrana(R) (Methylphenidate Transdermal System) CII to Noven Pharmaceuticals, Inc.; Shire's 2010 Earnings Outlook Unchanged
By Shire Plc, PRNEMonday, August 9, 2010
DUBLIN, August 10, 2010 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announced the divestiture of Daytrana(R)
(methylphenidate transdermal system) to Noven Pharmaceuticals, Inc. Daytrana,
which is approved and marketed in the US for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) in children and adolescents, will
continue to be available for patients through Noven.
Shire's divestiture agreement grants Noven global marketing rights for
Daytrana and is effective October 1, 2010. The book value of the assets to be
disposed is approximately $95 million (or a gross, pre-amortization value of
approximately $150 million). Shire's 2010 outlook of Non GAAP earnings
trending towards $4.00 per ADS which was recently announced in its second
quarter earnings press release is unchanged.
Noven developed and manufactures Daytrana, and Noven licensed Daytrana to
Shire in 2003. The US Food and Drug Administration (FDA) approved Daytrana as
a treatment for ADHD in children and adolescents in April 2006 and June 2010,
respectively.
Indication
Daytrana is a prescription central nervous system (brain)
stimulant medicine used to treat ADHD in people 6 to 17 years old. Daytrana
may help increase attention and decrease impulsive and hyperactive behavior.
Daytrana should be used as a part of a total treatment program for ADHD that
may include counseling or other therapies.
Important Safety Information
IMPORTANT:
Daytrana is a controlled substance (CII) because it can be
abused or lead to dependence. Keep Daytrana in a safe place to protect it
from theft. Selling or giving away Daytrana may harm others and is against
the law.
Tell the prescribing doctor if your child has ever abused or been
dependent on alcohol, prescription medicines or street drugs.
Daytrana should not be used if your child is very anxious,
tense, or agitated; has an eye problem called glaucoma; has tics (repeated
movements or sounds that cannot be controlled) has a diagnosis or family
history of seizures or has a diagnosis or family history of Tourette's
syndrome; or have had an abnormal brain wave test (EEG); is taking a
monoamine oxidase inhibitor (MAOI) medicine or has discontinued an MAOI
medicine in the last 2 weeks; is pregnant or breastfeeding; is allergic to
methylphenidate or any other ingredients of Daytrana.
Serious heart problems have been reported with Daytrana or
other stimulant medicines including:
- sudden death in people with heart problems or heart defects - stroke and heart attack in adults - increased blood pressure and heart rate
Tell the doctor if your child or a family member has any heart
problems, heart defects, or increased blood pressure and heart rate. Remove
the Daytrana patch and call the doctor right away if your child has any signs
of heart problems such as chest pain, shortness of breath, or fainting while
using Daytrana.
Serious mental (psychiatric) problems have been reported with
Daytrana or other stimulant medicines including:
- new or worse aggressive behavior, hostility, anger or irritability - new or worse bipolar illness or mania (an extreme increase in activity or talking) - new or worse psychosis (hearing or seeing things that are not real, being suspicious, or distrustful, believing things that are not true) - other unusual or extreme changes in behavior or mood
Tell the doctor about any mental problems your child or family
members have including suicide or depression, bipolar illness, mania, or
psychosis. Call the doctor right away if your child has any new or worsening
mental symptoms or problems while using Daytrana.
Serious side effects such as seizures (this usually happens in people
with a history of seizures), slowing of growth (weight and height), eyesight
changes or blurred vision have been reported with Daytrana. Allergic skin
rash may occur. Stop using Daytrana and see the doctor right away if
swelling, bumps, or blisters happen at or around where the patch is applied.
If the patch is worn longer than 9 hours in a day, or if more than 1
patch is worn at a time, too much Daytrana has been used. Your child should
not use hair dryers, heating pads, electric blankets, heated water beds or
other heat sources while wearing a Daytrana patch. This could cause too much
medicine to pass into your child's body and cause serious side effects.
Your child should have his or her height and weight checked often while
taking Daytrana and your doctor may stop treatment if a problem is found
during these check-ups.
Most common side effects seen with Daytrana include skin problems
(redness, small bumps, itching) where the patch is applied, poor appetite,
nausea, vomiting, stomach pain, weight loss, tics, trouble sleeping, mood
swings, and dizziness.
Please see Full Prescribing Information (
www.daytrana.com/prescribing-information/) and Medication Guide
(www.daytrana.com/medication-guide/) including Warning regarding abuse
and dependence.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
About ADHD
ADHD is one of the most common psychiatric disorders in children and
adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent
(with large variability), according to a comprehensive systematic review of
this topic published in 2007 in the American Journal of Psychiatry. In the
United States, approximately 7.8 percent of all school-aged children, or
about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD
at some point in their lives, according to the Centers for Disease Control
and Prevention (CDC).
ADHD is a psychiatric behavioral 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. The specific etiology of ADHD is unknown and there is no
single diagnostic test for this disorder. Adequate diagnosis requires the
use of medical and special psychological, educational and social resources,
utilizing diagnostic criteria such as Diagnostic and Statistical Manual of
Mental Disorders-IV (DSM-IV(R)) or International Classification of Diseases
10 (ICD-10).
Although there is no cure for ADHD, there are accepted treatments that
specifically target its symptoms. Standard treatments include educational
approaches, psychological or behavioral modification, and/or medication.
SHIRE PLC
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 hyperactivity
disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases as well as opportunities in other therapeutic areas to the extent
they arise through acquisitions. Shire's in-licensing, merger and acquisition
efforts are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire believes that a
carefully selected and balanced portfolio of products with strategically
aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:
www.shire.com.
"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, the Company's results could be
materially adversely affected. The risks and uncertainties include, but are
not limited to, risks associated with: the inherent uncertainty of research,
development, approval, reimbursement, manufacturing and commercialization of
the Company's Specialty Pharmaceutical and Human Genetic Therapies products,
as well as the ability to secure and integrate new products for
commercialization and/or development; government regulation of the Company's
products; the Company's ability to manufacture its products in sufficient
quantities to meet demand; the impact of competitive therapies on the
Company's products; the Company's ability to register, maintain and enforce
patents and other intellectual property rights relating to its products; the
Company's ability to obtain and maintain government and other third-party
reimbursement for its products; and other risks and uncertainties detailed
from time to time in the Company's filings with the Securities and Exchange
Commission.
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey
JE4 8PX
For further information please contact: Investor Relations Eric Rojas erojas@shire.com +1-781-482-0999 Media Jessica Mann jmann@shire.com +44-1256-894-280 Matthew Cabrey mcabrey@shire.com +1-484-595-8248
www.shire.com
For further information please contact: Investor Relations, Eric Rojas, erojas at shire.com, +1-781-482-0999. Media, Jessica Mann, jmann at shire.com, +44-1256-894-280. Matthew Cabrey, mcabrey at shire.com, +1-484-595-8248
Tags: August 10, Dublin, Shire Plc, United Kingdom