Head-to-Head Study Demonstrates Focalin XR Offers Faster and Better Symptom Control than Concerta in Early Part of ADHD Patients' Day

- Focalin XR demonstrated better symptom control versus Concerta from 30 minutes to six hours post-dose in primary and secondary endpoints

EAST HANOVER, N.J., July 08, 2008 /PRNewswire/ -- A head-to-head study, published in the June Journal of Child and Adolescent Psychopharmacology, confirms that Focalin XR (dexmethylphenidate HCl) extended-release capsules offer greater improvements in managing symptoms of Attention Deficit/Hyperactivity Disorder compared with Concerta (d,l- methylphenidate HCl) extended-release tablets at two hours post-dose, the primary study endpoint.

Focalin XR 20 mg and 30 mg2 also demonstrated better symptom control versus Concerta 36 mg and 54 mg respectively, from 30 minutes to 6 hours. Symptom control was demonstrated as early as 30 minutes post-dose with Focalin XR 20 mg and 30 mg versus placebo. Neither dose of Concerta was effective versus placebo at 30 minutes. Novartis is seeking revised labeling to reflect the 30-minute onset of action.

"There are many things to consider when determining which treatment is best for a patient, including lifestyle implications," said Alice Mao, M.D., Associate Professor of Psychiatry at the . "The results of this study demonstrate the benefits of Focalin XR during the early part of the day, which may be better for children who need their medication to begin working before they leave for school and continue working throughout the day."

Attention Deficit/Hyperactivity Disorder affects approximately three to seven percent of children in the United States, and its symptoms -- inattention, hyperactivity and impulsivity -- can significantly impact a child's ability to focus and learn in an educational setting. The study included children between the ages of 6 and 12 and examined their response to Focalin XR compared to Concerta as well as placebo in a classroom setting.

Similar efficacy was observed between Focalin XR and Concerta at eight hours post-dose. Only at 10 to 12 hours and 11 to 12 hours post-dose did Concerta 36 mg and 54 mg demonstrate symptom improvement over Focalin XR 20 mg and 30 mg respectively.

"Focalin XR helps children with ADHD optimize their natural cycle of the day because its drug delivery system allows for a quick onset in the morning, effective symptom management during the day, and then tapers off in the evening," said Rafael Muniz, MD, Senior Medical Director, Novartis Pharmaceuticals Corporation.

Focalin XR uses the proprietary SODAS(R) (Spheroidal Oral Drug Absorption System) technology developed by Elan Corporation, where 50% of the dose is released immediately and the remaining 50% is released after approximately four hours, resulting in a maximum peak at about 1.5 hours and a second peak at about 6.5 hours. Concerta is formulated to release 22% of the drug initially, with the remainder released through a controlled osmotic process.

In addition, Focalin XR and Concerta have chemical differences. Focalin XR isolates the active d-isomer of d,l-methylphenidate. Therefore, only half the dose of methylphenidate is required. Concerta is a d,l-methylphenidate.

Study Results

The randomized, multi-center, double-blind, five-period, crossover study was conducted in 84 children with ADHD with 6-12 years of age, stabilized on methylphenidate and randomized to different treatment sequences for comparison. The study was conducted in a laboratory classroom setting over a 12 hour period. The crossover design exposed each child to five treatments: Focalin XR (20 mg/day and 30 mg/day), Concerta (36 mg/day and 54 mg/day) and placebo.

Primary efficacy was measured by the change from pre-dose in the Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale-Combined scores at two hours post-dose with Focalin XR 20 mg compared with Concerta 36 mg. The SKAMP rating scale is a standard assessment tool used in laboratory classroom clinical trials to evaluate attention and behavior.

Both doses of Focalin XR showed significantly greater improvement in SKAMP-Attention and -Deportment scores when compared with placebo at all measured time-points (30 minutes to 12 hours post-dose), except for 10-12 hours post-dose with 20 mg. Concerta 36 mg and 54 mg demonstrated efficacy at measured time-points 1-12 hours post-dose, but were no different to placebo at 30 minutes.

Because of the differences in release profiles, the investigators also studied overall efficacy during the 12 hour study period using an area under the curve analysis (AUC0-12) of the SKAMP combined scores. All doses of the active medication were significantly better than placebo. There was no difference between Focalin XR 20 mg and 30 mg when compared to both Concerta 36 mg and 54 mg, respectively, observed overall across the 12-hour day.

In general, both treatments were well tolerated and no patients discontinued or had a reduction in study drug dose due to an adverse event. A total of 81 children completed the study (three withdrew consent for reasons not related to study medications).

A previous head-to-head study comparing Focalin XR and Concerta published in the April 2008 Psychopharmacology Bulletin found similar efficacy and safety results to the present study.

About Focalin XR

Focalin XR (dexmethylphenidate HCl) extended-release capsules are indicated for the treatment of Attention Deficit/Hyperactivity Disorder (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, social) for patients with this syndrome.

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.

Please see full Prescribing Information for Focalin XR including Contraindications, Boxed Warning and Medication Guide at http://www.FocalinXR.com or call us at 1-888-NOW-NOVA.

For further information, please visit http://www.FocalinXR.com.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "suggests," "can," "is seeking," "may," or similar expressions, or by express or implied discussions regarding potential additional labeling or indications or potential future sales of Focalin XR. 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; 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 growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and 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 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

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(R) 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.

References

1. Concerta(R) is a registered trademark of ALZA Corporation.

2. The 30 mg dose of Focalin XR is not an FDA-approved dosage strength. The maximum approved dose is 20 mg once daily.

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Posted: July 2008

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