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Studies Show Pharmacoeconomic Benefits with Trileptal®

Treatment Found to Reduce Adverse Events and Lower Healthcare-Related Costs Compared to Carbamazepine

BASEL, SWITZERLAND -- October 11, 2002 -- According to two studies presented at the 5^th European Congress on Epileptology, the anti-epileptic drug Trileptal® (oxcarbazepine) was associated with fewer treatment-related adverse events and lower healthcare-related costs than carbamazepine.

The studies directly compared the costs associated with the incidence of adverse events and healthcare utilization. Results from one study showed that by reducing adverse events, costs of hospitalizations were expected to be reduced by an average of 11 percent. In the other study, when additional medication costs were factored in, Trileptal treatment saved an average of USD 222 per patient per year.

"The results of these studies suggest that treatment with Trileptal is a good option, in terms of both tolerability and cost effectiveness," said Michael T. Halpern, MD, PhD, MPH, principal scientist at Exponent, Inc. and author of one of the studies.

Study design and results

The first study, presented by Dr. Halpern, evaluated the incidence and impact of adverse events (AEs) with Trileptal and carbamazepine over a three-month review period. Data was derived from the United States Food and Drug Administration's Adverse Event Reporting System (AERS), and all events in which Trileptal or carbamazepine were specified as the primary or concomitant treatment were included in the study. During the review period, researchers identified 43 events associated with Trileptal and 307 with carbamazepine. The hospitalization rate for adverse events associated with Trileptal was 74.4 percent compared to 76.2 percent for the carbamazepine group. In addition, associated hospital stays were projected to be 0.6 days shorter for Trileptal patients, on average. The mean cost of hospitalization for patients in the Trileptal group was expected to be 11 percent lower than the carbamazepine group, resulting in cost savings per adverse event of USD 600.

The second study, presented by Luke Boulanger, MA, Boston Health Economics, Inc., compared healthcare utilization and costs for patients in a managed care setting treated with Trileptal or carbamazepine. Researchers reviewed administrative claims data to determine costs associated with patients using seizure-related healthcare. Costs were assessed on a descriptive basis in terms of net change over a 12-month period. It was found that compared to the carbamazepine-treated group the Trileptal group had a smaller increase in physician visits (2.5 percent vs. 6.7 percent). While emergency department visits and hospitalizations were reduced in both groups, the decreases were greater in the Trileptal group than the carbamazepine group (15.4 percent vs. 7.3 percent) and 7.7 percent vs. 0.2 percent respectively). In addition, over the 12 month study period mean medical costs were USD 484 lower in the Trileptal group. When costs of medication were factored in, the Trileptal group realized an average savings per person of USD 222.

About Trileptal

Trileptal is an antiepileptic drug with proven efficacy either as a monotherapy or in combination therapy in the treatment of partial seizures (including seizure subtypes of simple, complex, and partial seizures evolving to secondarily generalized seizures) in adults and children with epilepsy.

Trileptal has a favorable safety profile. There is no black box warning and it is not associated with aplastic anemia, agranulocytosis, hepatotoxicity or pancreatitis. In addition, no monitoring of liver functions and blood counts is required. Trileptal has limited interactions with other AEDs. However, when Trileptal at doses greater than 1200 mg per day is added to phenytoin, a decrease in the dose of phenytoin may be required. As monotherapy in adults, Trileptal is well tolerated, with discontinuation rates comparable to placebo.

Trileptal is not generally associated with weight gain or cosmetic side effects. As monotherapy or adjunctive therapy in adults previously treated with AEDs, the most common (>5 percent) adverse events occurring substantially more frequently than in placebo patients were dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, and abnormal gait-these were typically mild to moderate in severity. As add-on therapy in pediatric patients, adverse events with Trileptal were similar to adults.

Clinically significant hyponatremia (sodium <125 mmol/L) has been observed in 2.5 percent of Trileptal-treated patients in controlled clinical trials. Measurement of serum sodium levels should be considered for patients at risk of hyponatremia.

Of patients who have had hypersensitivity to carbamazepine, 25 percent to 30 percent will experience a reaction to Trileptal. Caution should be exercised when prescribing Trileptal for patients with a history of hypersensitivity to carbamazepine. (Please see Warnings section of complete prescribing information.)

The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "suggest(s)", "reduce adverse events and lower healthcare-related costs", "may be a good option" or similar expressions. Such forward looking 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 Trileptal could be affected by amongst other things, 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 AG is a world leader in pharmaceuticals and consumer health. In 2001, the 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 74 000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

SOURCE: Novartis AG

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