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FDA Approves 30-Minute Onset of Action for Focalin XR

Data indicate Focalin XR provides rapid and significant improvements in attention, behavior and academic productivity at 30 minutes post-dose

EAST HANOVER, N.J., November 12, 2008 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved a 30-minute onset of action for Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), bringing potential benefits for young patients and their families during the important morning period when they are preparing for school.

"The morning is a critical time for families," said Alice Mao, MD, Associate Professor of Psychiatry at the . "The early onset of Focalin XR provides symptom control which may help families and children living with ADHD get through their morning routine."

The new labeling is based on clinical study data. The most recent study, involving 86 children with ADHD between the ages of six and 12, showed that Focalin XR provided significant improvements at 30 minutes post-dose compared to placebo in measures of attention, deportment, and academic productivity.

ADHD affects approximately three to six percent of children in the United States, and its symptoms - inattention, hyperactivity and impulsivity - can significantly impact a child's ability to focus and behave in school.

A 2007 Harris survey of 1,001 caregivers of young ADHD patients revealed that caregivers were significantly more likely to report that their child's or adolescent's behavior was negatively affected in the morning compared to other periods through the day in 12 out of 16 common behaviors. These negative behaviors included lack of concentration, messiness, interrupting others, failure to complete tasks and speaking out of turn.

"The 30-minute onset of action can help children with ADHD improve their morning academic productivity in school. Focalin XR also allows them to effectively manage their symptoms for up to 12 hours getting them through school and homework time," said Rafael Muniz, MD, Senior Medical Director, Novartis Pharmaceuticals Corporation.

Study Results

The data for 30-minute post-dose labeling includes a study by Brams et al. recently published in CNS Drugs. The study was a randomized, multi-center, double-blind crossover study in which participants received 20 mg of Focalin XR or placebo for seven days, with the final dose administrated in a laboratory classroom setting on the last day of each treatment period.

Primary efficacy was measured by the change from pre-dose in the Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale-Combined score at 0.5 hours, with additional secondary assessments at 1, 2, 4, 6 and 8 hours post-dose. The SKAMP rating scale is a standard assessment tool used in laboratory classroom clinical trials to evaluate attention and behavior.

Secondary efficacy was measured by the change from pre-dose at all time points in SKAMP-Attention and -Deportment, Math test-Attempted and -Correct scores, and change from baseline on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P).

The overall rate of adverse events (AEs) was similar between groups (17.4% Focalin XR vs. 22.1% placebo). The most common AEs (>/= 2% patients during double-blind treatment) were abdominal pain, headache, increased appetite, and viral gastroenteritis. Most AEs were reported as mild (15% Focalin XR; 17% placebo) or moderate (1% Focalin XR; 5% placebo) in severity. One patient experienced a headache reported as severe while receiving Focalin XR. There were no serious AEs reported or discontinuations due to AEs.

Focalin XR (dexmethylphenidate HCl) extended-release capsules are indicated for the treatment of ADHD in adults, adolescents and children six years and older. Focalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (e.g., psychological, educational and social).

Important Safety Information

The most common adverse events seen with Focalin XR were dyspepsia, decreased appetite, headache and anxiety in pediatric studies; and dry mouth, dyspepsia, feeling jittery, dizziness, headache and anxiety in adult studies.

Focalin XR is contraindicated in patients with marked anxiety, tension and agitation since the drug may aggravate these symptoms; in patients known to be hypersensitive to methylphenidate or other components of the product; in patients with glaucoma; in patients with motor tics or with a family history or diagnosis of Tourette's syndrome; and during or following treatment with monoamine oxidase inhibitors.

Stimulants should generally not be used in children, adolescents or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart-rhythm abnormalities or other serious cardiac problems. Use with caution in treating patients with underlying medical conditions that might be compromised by increases in blood pressure or heart rate, such as those with pre-existing hypertension, heart failure, recent myocardial infarction or ventricular arrhythmia. Before initiating treatment, patients should have careful history and physical exam to assess for presence of cardiac disease.

Use with caution in psychosis or bipolar disorder. Discontinuation of treatment may be appropriate in the presence of treatment-emergent psychotic or manic symptoms. While aggressive behavior is often observed in children or adolescents with ADHD, patients beginning treatment should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Suppression of growth has been reported with long-term use of stimulants. Stimulants should be used with caution in patients with a prior history of seizures or EEG abnormalities. Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (See WARNINGS.)

Focalin XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "potential," "may," "potentially," "can," or similar expressions, or by express or implied discussions regarding potential additional labeling or indications or potential future sales of Focalin XR. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Focalin XR will be approved for any additional labeling or indications in any country. Nor can there be any guarantee that Focalin XR will reach any particular sales levels. In particular, management's expectations regarding Focalin XR could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data, and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 full-time associates and operate in over 140 countries around the world.

Novartis Partnerships

Celgene Corporation of Summit, New Jersey granted Novartis Pharma AG an exclusive worldwide (excluding Canada) license covering its intellectual property rights associated with Focalin XR. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets Focalin XR in the U.S.

Focalin XR was developed with SODAS technology (spheroidal oral drug absorption system), a multiparticulate drug delivery system of Elan Corporation, plc . Focalin XR is being supplied to Novartis under an exclusive worldwide (except Canada) royalty and manufacturing agreement between Elan Corporation, plc, and Novartis Pharma AG.

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Posted: November 2008

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