Anyone who had expected clear-cut guidance from a major, federally financed study on big-selling schizophrenia drugs will be sorely disappointed. That's because the study raises more questions than answers, according to Alexandra Hauber, an analyst at Bear Stearns. The Clinical Antipsychotic Trials of Intervention Effectiveness, or CATIE, recently examined four Big Pharma drugs and one generic drug. Doctors were hoping to gain insight in to the drugs' effectiveness and side effects. Analysts were looking to determine when and if these drugs could help their developers' stock prices. Instead, they got a mixture of uncertainty and conflicting information for several $1-billion-plus drugs from companies such as Eli Lilly ( LLY) and AstraZeneca ( AZN). "We're not expecting any revenue impact in the third quarter or the fourth quarter," says Albert L. Rauch of A.G. Edwards, referring to the study sponsored by the National Institute of Mental Health. If the CATIE study prompts any changes in product sales, it will be next year, he says. The biggest surprise, on a cost-benefit basis, was that the 40-year-old generic drug perphenazine was as good as the more expensive brand-name drugs. Relatively few patients stayed with the same drug during the 18 months of study, highlighting the challenge to doctors. "How clinicians, patients, families and policymakers evaluate the trade-offs between efficacy and side effects will determine future patterns of use," say authors of the study, which was published recently in The New England Journal of Medicine. Such comments prompted Hauber to worry that CATIE might lead to a slowdown in sales of newer drugs, known as atypical antipsychotics. Generic perphenazine cost about one-tenth the price of a brand-name drug. Even though Rauch says there weren't "real clear definitions of what works best," he doubts doctors will revert to older drugs, preferring instead the atypical antipsychotics. Generic companies lack the money or incentive to run updated clinical trials on old drugs, leaving the freshest research to newer drugs.
Rauch adds that doctors tend to keep someone on a certain drug as long as the patient is stabilized and doesn't suffer from severe side effects. Thus, it will take time for physicians to change their practice patterns. The earliest indicator for investors will be changes in new prescriptions. If a clear pattern emerges, then investors can look to changes in revenue. According to the National Alliance on Mental Illness, a nonprofit advocacy group, about 2.2 million American adults have schizophrenia.
But Zyprexa patients had greater weight gains, increases in blood sugar levels and other side effects vs. people taking competing medications. Patients lost weight with perphenazine and Geodon.