04 Aug 2008
Noven Announces Triggering of $25million DAYTRANA® Sales Milestone
04 Aug 2008 - Miami, FL – August 4, 2008 - Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that it has been advised by Shire Limited that Shire’s net sales of Daytrana® (methylphenidate transdermal system) have triggered the third and final $25 million sales milestone due to be paid to Noven.
Daytrana®, licensed globally to Shire, was launched in June 2006. Payment of the milestone announced today was triggered upon Shire’s net sales of Daytrana® exceeding $75 million in the 12-months preceding June 30, 2008. Under Noven’s agreement with Shire, the $25 million milestone is due to be paid in the third quarter of 2008. As with prior Daytrana® sales milestones, Noven expects to defer recognition of the latest sales milestone and recognize it as license revenues over time.
Daytrana® is the first and only transdermal medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). It is approved for children aged six to twelve years with ADHD. The product combines the active ingredient methylphenidate with Noven’s patented DOT Matrix® transdermal technology.
Important Safety Information for Daytrana®
Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.
Daytrana® should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana®; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette’s syndrome.
Tell your doctor before using Daytrana® if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana®.
In clinical studies, side effects were generally mild to moderate. The most common side effects reported with Daytrana® were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using Daytrana®.
Note: Abuse of Daytrana® can lead to dependence.
Daytrana® should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin redness or itching is common with Daytrana®. Allergic skin rash may occur.
About Noven Pharmaceuticals
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. Noven’s business and operations are focused in three principal areas – transdermal drug delivery, the Novogyne joint venture, and Noven Therapeutics, Noven’s specialty pharmaceutical unit. For more information about Noven Pharmaceuticals, visit www.noven.com.
Safe Harbor Statement under the Private Litigation Securities Reform Act of 1995
Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. When used in this press release, the word “expect” and similar expressions identify certain of such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven and are subject to a number of risks and uncertainties that are subject to change based on factors that are, in many instances, beyond Noven's control. For information regarding the risks associated with Noven’s business, readers should refer to Noven’s Annual Report on Form 10-K for the year ended December 31, 2007 as well as other reports filed from time to time by Noven with the Securities and Exchange Commission.
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.