21 Feb 2007
NOVEN RECEIVES $25 MILLION DAYTRANA™ SALES MILESTONE
21 Feb 2007 - Miami, FL – February 20, 2007 - Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that it has received from Shire plc the first of three possible $25 million milestone payments related to sales of Daytrana™ (methylphenidate transdermal system).
Daytrana™, licensed globally to Shire, was launched in June 2006. Payment of the first milestone was triggered upon Shire’s net sales of Daytrana™ exceeding $25 million in 2006.
Under the Daytrana™ transaction agreement, two additional payments of $25 million each are payable upon Shire’s achievement of $50 million and $75 million, respectively, in annual net sales of Daytrana™. For purposes of the sales milestones, Shire’s annual net sales are measured quarterly on a trailing 12-month basis. From an accounting standpoint, Noven expects to defer the sales milestones and recognize them as license revenues over time.
At September 30, 2006, Noven had an aggregate $139.2 million in cash and cash equivalents and short-term investments. Noven expects to announce full-year 2006 financial results in early March 2007.
Daytrana™, developed and manufactured by Noven, 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
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™.
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 irritation or allergic skin rash may occur.
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Noven’s prescription patches are approved in over 30 countries and include Vivelle-Dot™ (the most prescribed estrogen patch in the U.S.) and Daytrana™ (the first and only patch approved for the treatment of ADHD). A range of new patches is under development by Noven in collaboration with industry partners. Noven is committed to expanding the universe of available transdermal therapies for the benefit of patients, partners and shareholders. See www.noven.com for additional information. Daytrana™ and DOT Matrix™ are trademarks of Shire Pharmaceuticals Ireland Limited and Noven, respectively.
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 which are, in many instances, beyond Noven's control. These risks and uncertainties include: the risk of supply interruptions of methylphenidate, which is necessary for the production of Daytrana™, including uncertainties relating to future DEA awards of methylphenidate procurement quota, which interruptions could negatively affect production, facility utilization and Noven’s revenues and gross margin in future periods as well as market acceptance for Daytrana™; the risk that Noven may encounter production inefficiencies or other issues in the process of manufacturing commercial quantities of Daytrana™, which could adversely affect the success of the product and Noven’s results of operations; the risk that only limited prescription data is presently available for Daytrana™ and such data may not be representative of the future market for the product; the risk that past Daytrana™ results may not be indicative of future sales; risks related to competition (including from other ADHD products marketed or under development by Shire) and market acceptance of Daytrana™ that could adversely affect the commercial success of Daytrana™ and could, among other things, limit Noven’s ability to achieve the additional milestone payments under its agreement with Shire; and the possibility that the market for methylphenidate products may be negatively affected by the ongoing public debate in the United States regarding the appropriateness of using methylphenidate and other medications to treat children with ADHD, as well as the outcome of the FDA’s ongoing inquiry into the possible cardiac, psychiatric and other side effects of ADHD medications, and that the FDA’s inquiry could result in “black-box” warnings being added to the labeling for these medications. For additional information regarding these and other risks associated with Noven’s business, readers should refer to Noven’s Annual Report on Form 10-K for the year ended December 31, 2005 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