8/11/2010 6:58:09 AM
MIAMI--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc. today announced that it has entered into a Product and Trademark Acquisition Agreement (the “Agreement”) with affiliates of Shire plc (“Shire”) pursuant to which Noven will acquire global rights to Daytrana® (methylphenidate transdermal system) from Shire.
Daytrana®, developed and manufactured by Noven, was originally licensed globally to Shire 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 a part of a total treatment program for ADHD that may include counseling or other therapies. Shire’s net sales of the product in 2009 were $71 million.
The Agreement provides that Noven will acquire substantially all rights and assets related to Daytrana®, including the product’s New Drug Application, and will assume certain related liabilities. Shire will continue to commercialize the product through closing of the transaction, scheduled for October 1, 2010.
Once transferred to Noven, Daytrana® will be marketed and sold by Noven Therapeutics, Noven’s specialty pharmaceuticals marketing and sales unit, with U.S. promotion of the product expected to begin in March 2011. Noven Therapeutics currently promotes the oral prescription products Pexeva®, Stavzor® and Lithobid® to psychiatrists and other target physicians in the U.S.
Jeffrey Eisenberg, Noven’s President and Chief Executive Officer, said: “We are excited to add Daytrana® to the product portfolio of Noven Therapeutics. Since 2006, Daytrana® has been an important therapeutic alternative for patients with ADHD and their physicians. Applying the focused strategies and resources of Noven Therapeutics, we believe Noven will be well-positioned to continue to raise awareness of Daytrana®, with the ultimate goal of helping patients manage their ADHD.”
Important Safety Information about Daytrana®
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 and prevent misuse or abuse. 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), a diagnosis or family history of seizures, a diagnosis or family history of Tourette’s syndrome; or 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; or 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 and 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.
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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