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Noven Pharmaceuticals, Inc. press release : Noven completes acquisition of Daytrana® methylphenidate transdermal system (CII) from Shire



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http://www.hisamitsu.co.jp/english/pdf/noven_E_101001.pdf
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NOVEN COMPLETES ACQUISITION OF DAYTRANA®
METHYLPHENIDATE TRANSDERMAL SYSTEM (CII) FROM SHIRE


First and Only Patch for ADHD Now to be Marketed and Sold by Noven Therapeutics


Miami, FL, October 1, 2010 -- Noven Pharmaceuticals, Inc. today announced that it has
completed the acquisition of global rights to Daytrana® (methylphenidate transdermal system)
from Shire plc (“Shire”).


Daytrana was originally licensed globally to Shire by Noven in 2003 and was approved and
launched in the U.S. in 2006. The product is indicated for the treatment of Attention Deficit
Hyperactivity Disorder (“ADHD”) in patients 6 to 17 years old. Daytrana should be used as part
of a total treatment program for ADHD that may include counseling or other therapies. Shire’s
net sales of the product for the first half of 2010 were $34.7 million.


Daytrana will be marketed and sold by Noven Therapeutics, Noven’s specialty pharmaceuticals
marketing and sales unit. Noven Therapeutics currently promotes the oral prescription products
Pexeva®, Stavzor® and Lithobid® to psychiatrists and other appropriate physicians in the U.S.
Daytrana product availability will not be interrupted or otherwise affected by the acquisition or
by the transfer of the product to Noven.


Jeffrey Eisenberg, Noven’s President and Chief Executive Officer, said: “We are very pleased to
complete the acquisition and to add Daytrana − a product developed and manufactured by Noven
− to the portfolio of products that we market and sell through Noven Therapeutics. I extend my
thanks and appreciation to Shire for their partnership and support during the period of their
license of Daytrana, and to both the Noven and Shire teams who made the transaction happen.
Daytrana continues to represent an important therapeutic option in the treatment of ADHD. As
an organization, we’re excited to begin active promotion of the product, with the goal of
increasing awareness of Daytrana and helping patients, physicians and caregivers manage the
symptoms of ADHD.”


For further information, please contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
305-253-1916


About Daytrana


The Daytrana patch is a prescription central nervous system (brain) stimulant medicine used to
treat ADHD in children 6 to 17 years old. Daytrana may help increase attention and decrease
impulsive and hyperactive behavior. The Daytrana patch 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.


The Daytrana patch 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 the Daytrana patch 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 the Daytrana patch 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 the Daytrana patch.


Serious side effects such as seizures (this usually happens in children with a history of seizures),
slowing of growth (weight and height), eyesight changes or blurred vision have been reported
with the Daytrana patch. 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 medicine has been applied. Avoid exposing the Daytrana patch to direct external heat
sources such as hair dryers, heating pads, electric blankets, heated water beds, or other heat
sources while wearing the patch. Heating the patch 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 using the Daytrana
patch and your doctor may stop treatment if a problem is found during these check-ups.


Most common side effects seen while using the Daytrana patch 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 and Medication Guide for Daytrana, including the
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 Noven


Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research,
development, manufacturing, marketing and sale of prescription pharmaceutical products.
Noven’s business and operations are focused in three principal areas – transdermal drug delivery
and related manufacturing, the Novogyne joint venture, and Noven Therapeutics, Noven’s
specialty pharmaceutical unit. Noven is committed to developing and offering products and
technologies that meaningfully benefit patients, its customers and its industry partners.
Previously a publicly-traded company, Noven was acquired in August 2009 by Hisamitsu
Pharmaceutical Co., Inc., headquartered in Tosu, Saga and Tokyo. Noven is now a stand-alone
operating subsidiary of Hisamitsu, and is positioned to serve as Hisamitsu’s U.S. growth
platform in prescription pharmaceuticals. For more information about Noven, visit
www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english.


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