Focalin™ Receives FDA Approval

East Hanover, NJ and Warren, NJ - November 16, 2001

Novartis Pharmaceuticals Corporation and Celgene Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Focalin™ (dexmethylphenidate HCl) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

Focalin™, a refined formulation of Ritalin® (d,l-methylphenidate HCl), contains only the more active isomer, which is responsible for the effective management of the symptoms of ADHD. Focalin™ is an advance in single-isomer technology and is formulated by isolating the active d-isomer of Ritalin, which contains both the d and l isomers of methylphenidate.

Focalin™ is available in 2.5, 5 and 10 mg tablets for oral administration and may be administered with or without food. The recommended starting dose for new patients is 2.5 mg twice daily. For patients who are switched from Ritalin or other brands of short-acting methylphenidate, the recommended dose of dexmethylphenidate is half the dose of Ritalin.

"Focalin is a unique formulation that is designed specifically to benefit those patients who need the flexibility of a rapid-onset methylphenidate," said Scott West, M.D., CNS Healthcare, Florida and clinical investigator in the Focalin pivotal trials.

Focalin was proven to be efficacious, safe and well-tolerated in six clinical trials that included a total of 684 ADHD patients, aged 6-17 years, and in 12 healthy adult subjects. Efficacy was confirmed with parents, teachers, physicians and patients using validated, qualitative and objective scales. Two double-blind, placebo-controlled studies involving 221 patients, aged 6 to 17, demonstrated Focalin to be effective in improving performance and behavioral symptoms of ADHD. Symptoms of ADHD in both studies were evaluated using the SNAP-ADHD rating scale (a standard behavioral assessment tool used in clinical trials). Focalin was significantly more effective than placebo in lowering scores on the Teacher SNAP-ADHD rating scale (p is less than 0.0001 vs. placebo), signifying an improvement in the clinical status of the children. Parent SNAP-ADHD assessments supported the teacher SNAP findings. In addition, Focalin significantly improved Math Test and Clinical Global Impression of Improvement (CGI-I) scores.

Overall, there was a low incidence of adverse events with the majority being of mild severity. In double-blind, placebo-controlled trials there were no discontinuations due to adverse events. In long-term extension studies, only 7 %, or 50 of 684, of children and adults treated with Focalin experienced an adverse event that resulted in discontinuation.

Like most drugs approved for the treatment of ADHD, and like Ritalin, Focalin is contraindicated in patients known to be hypersensitive to the drug or to Ritalin, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome. It is also contraindicated during treatment with monoamine oxidase inhibitors and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result). In addition, like most drugs approved for the treatment of ADHD, Focalin is a schedule II drug.

"We are very pleased that the FDA has approved Focalin and believe it will be a valuable addition to existing medications for ADHD. Now patients with ADHD may receive the efficacy they need with Focalin, which contains only the effective isomer of Ritalin," said Larry Perlow, M.D., Senior Vice President and General Manager, Commercial Operations, Novartis Pharmaceuticals Corporation. "As the manufacturers of Ritalin, a medication which has helped ADHD patients and their families for more than 40 years, Novartis is committed to developing innovative treatments that will afford new options for tailored, flexible care for people with this condition."

Novartis Pharma AG licensed the worldwide (excluding Canada) marketing rights to Focalin and all related intellectual property and patents from Celgene Corporation (Nasdaq: CELG) of Warren, New Jersey. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation will market Focalin in the U.S.

"We are proud to have developed Focalin, as it represents an advance in single-isomer therapy," said Sol J. Barer, Ph.D., President and Chief Operating Officer, Celgene Corporation. "Focalin is a refined form of methylphenidate that affords patients an important new treatment option."

ADHD is a neurobiologic disorder that interferes with an individual's ability to regulate activity level and behavior and sustain focus on tasks in developmentally appropriate ways. Scientific research indicates that ADHD may be related to disturbances in certain neurotransmitters in the brain. ADHD is the most common childhood psychiatric disorder. It has been well studied for more than 40 years and is supported by a substantial body of scientific evidence.

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including mental health. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

In keeping with this mission, Novartis Pharmaceuticals Corporation has a long history of supporting patient education and mental health programs from organizations such as the National Council on Patient Information and Education; the National Alliance for the Mentally Ill; Children and Adults with Attention-Deficit/Hyperactivity Disorder; and the Lab School of Washington. In an effort to continue to provide innovative solutions to patient information and education, the company has recently partnered with Oscar-winning producer Ann Michaels in the production of Listen to the Children, a documentary film focused on children's mental health within the United States.

The Novartis Group is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 70,000 people and operates in over 140 countries around the world. For further information please consult www.pharma.us.novartis.com.

Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company engaged primarily in the discovery, development and commercialization of orally administered small molecule drugs for the treatment of cancer and inflammatory diseases through gene regulation. Please feel free to visit the Company's Web site at www.celgene.com.