FDA Grants Marketing Clearance for Ritalin LA, A Once-Daily Formulation of Ritalin For ADHD That Lasts Through the Entire School Day.

Business/Technology Editors & Health/Medical Writers

EAST HANOVER, N.J., DUBLIN, Ireland & WARREN, N.J.--(BW HealthWire)--June 6, 2002-- Novartis Pharmaceuticals Corporation (NYSE: NVS), Elan Corporation, plc (NYSE: ELN) ("Elan"), and Celgene Corporation (Nasdaq: CELG) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for Ritalin(R) LA (methylphenidate HCl) extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Ritalin LA, a new once-daily formulation of Ritalin(R) (methylphenidate HCl), eliminates the need for a mid-day dose during school. Ritalin LA uses SODAS(TM) technology(1), a proprietary drug delivery technology of Elan. The medication is available in 20, 30 and 40 mg beaded capsules for oral administration.

"Ritalin LA represents an important advance in the treatment of ADHD," said Thomas Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School and Assistant Director of the Pediatric Psychopharmacology Research Program at Massachusetts General Hospital. "It provides the rapid onset, and the proven safety and efficacy of Ritalin in one, single morning dose. Ritalin LA is effective in treating ADHD symptoms throughout the school day, eliminating the need for children to take their medication while in school."

Each bead-filled capsule of Ritalin LA provides an immediate release of Ritalin for rapid onset of action, and a second release of the medication approximately four hours after administration. The bimodal release formulation of Ritalin LA provides two peak concentrations of medication, mimicking twice-daily administration of Ritalin, but with less fluctuation. Ritalin LA provides the same rapid onset as Ritalin and its efficacy lasts throughout the school day. Ritalin LA may be swallowed as whole capsules, or, for children who have difficulty swallowing, it may be administered by sprinkling the beaded contents on applesauce.

A double-blind, placebo-controlled study involving 134 patients, aged 6 to 12 years, demonstrated Ritalin LA to be effective in treating ADHD symptoms. In this study, in which efficacy was evaluated by examining presence of ADHD symptoms in home and school settings, Ritalin LA was administered once-daily at individually titrated doses ranging from 10-40 mg/day for up to two weeks. Efficacy was measured by the change from baseline in the Conners ADHD/DSM-IV total subscale for teachers (CADS-T), a validated tool for the assessment of ADHD symptoms by teachers. Results of the analysis demonstrated that Ritalin LA was statistically superior to placebo in managing ADHD symptoms, including symptoms of inattention and hyperactivity.

Ritalin LA was proven to be safe and well tolerated. In a placebo controlled, double-blind, parallel group study with 134 children, adverse events were reported in 25% of treated patients compared with 24% in the placebo group. The most commonly reported adverse events included anorexia, insomnia, sore throat, headache and vomiting. Overall discontinuation rates were 1.5% for Ritalin LA and 0% for placebo.

Ritalin LA is contraindicated in patients known to be hypersensitive to the drug or to Ritalin, in patients with glaucoma, in patients with motor tics, and in patients with a family history or diagnosis of Tourette's syndrome. In addition, Ritalin LA is contraindicated during treatment with monoamine oxidase inhibitors and should not be taken until at least 14 days after discontinuation of a monoamine oxidase inhibitor. Ritalin LA should be given cautiously to patients with a history of drug dependence or alcoholism.

ADHD is a neurobiologic disorder that interferes with an individual's ability to regulate activity level and behavior, and sustain focus in developmentally appropriate ways. It is the most studied childhood psychiatric disorder and is supported by a substantial body of scientific evidence. Scientific research indicates that ADHD may be related to disturbances in certain neurotransmitters in the brain. Novartis supports only the proper diagnosis and treatment of ADHD. Recognizing that no single treatment is perfect for everyone, Ritalin LA is recommended as part of a comprehensive treatment regimen including behavior modification and counseling.

Ritalin LA was developed by Elan's drug delivery division and will be supplied to Novartis under an exclusive worldwide royalty and manufacturing agreement between the companies. Novartis Pharmaceuticals Corporation has commercialization rights to Ritalin LA in the U.S.

Ritalin LA joins the Novartis ADHD product portfolio, which includes Ritalin, Ritalin SR, and Focalin(TM) (dexmethylphenidate HCl). Celgene Corporation of Warren, New Jersey granted Novartis Pharma AG an exclusive worldwide (excluding Canada) license covering its intellectual property rights associated with Ritalin LA as well as Focalin. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets Focalin in the U.S.

The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology such as, "new", "important advance", "to offer" or similar expressions. Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectation regarding the commercialization of Ritalin LA could be affected by amongst other things, results from future clinical trials, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20F filed with the 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 described herein anticipated, believed, estimated or expected.

Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. 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 (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Novartis Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 71,000 people and operate in over 140 countries around the world. For further information please consult http://www.pharma.us.novartis.com/ or http://www.novartis.com.

Elan is a leading worldwide, fully integrated biopharmaceutical company headquartered in Ireland, with its principal research, development, manufacturing and marketing facilities located in Ireland and in the U.S. Elan is focused on the marketing of therapeutic products and services in neurology, pain management, infectious disease, dermatology, oncology and the development and commercialization of products using its extensive range of proprietary drug delivery technologies. Elan shares trade on the New York, London and Dublin Stock Exchanges. For further information, please feel free to visit the Company's Web site at http://www.elan.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 http://www.celgene.com.

(1)SODAS(TM) is a trademark of Elan Corporation, plc.

For complete prescribing information, please contact Gina Moran or Denise Brashear of Novartis Pharmaceuticals at 973-781-8300.