Biotech Values

[DewDiligence]

Risperdal Consta Is a Waste of Money, Study Says

[Consta is JNJ’s fourth-biggest drug at $1.6B per year (#msg-59178027). It seems that nothing is going right for JNJ these days.]

http://www.bloomberg.com/news/2011-03-02/j-j-s-risperdal-consta-no-better-than-cheaper-drugs-study-says.html

›By Alex Nussbaum - Mar 2, 2011

Johnson & Johnson (JNJ)’s antipsychotic medicine Risperdal Consta, the company’s third-best-selling drug, did no better than cheaper treatments at keeping schizophrenia patients out of the hospital and led to more side effects, U.S. researchers said.

Patients on Risperdal Consta, a twice-monthly injection, ended up in the hospital 39 percent of the time during the three-year analysis, about the same as those who took other drugs as a daily pill, the study today in the New England Journal of Medicine said. People who received the J&J treatment also reported more headaches and muscle tremors among their side effects, scientists found.

Today’s findings undercut what has been the injection’s main selling point: that patients are more likely to stay on the medicine because it’s taken less often, said Robert Rosenheck, the study’s lead author. Researchers saw no better adherence after the initial two-week dose, he said. Risperdal Consta generated $1.5 billion in sales last year for New Brunswick, New Jersey-based J&J.

“This study gives no reason why the use of this treatment should be increased” over other drugs, said Rosenheck, a researcher with the U.S. Department of Veterans Affairs, which funded the study. “It may be effective for individual patients, but as a matter of policy, this is an expensive treatment and there’s no reason to aggressively promote it.”

$7,000 Price

A year of Risperdal Consta costs about $7,000 a patient, making it the most expensive of all antipsychotic drugs, said Rosenheck, lead investigator at the VA’s New England Mental Illness, Research Education and Clinical Center.

J&J is contending with product recalls and manufacturing shutdowns that cut sales by $900 million in 2010. The company retracted 40 consumer products last year, led by over-the- counter children’s medicines and Tylenol pain pills, along with artificial hips and contact lenses. U.K. regulators today said the company had also pulled four brands of sutures after faulty packaging threatened their sterile seals.

The study followed 369 patients with a history of hospitalization for the disease. J&J’s Ortho-McNeil Janssen unit, which sells Risperdal Consta, provided an unrestricted funding grant along with free medication.

Non-Inferior Testing

The study was designed to test whether switching to the injection was superior to continuing oral medications, said Kara Russell, a J&J spokeswoman, in an e-mailed statement. “It was not designed to show whether these treatments were non-inferior to each other, which requires different analytic assumptions and methods,” she said.

“We believe changes in the conduct and analysis of this study from the original study protocol significantly compromised meaningful interpretation of the results, especially those related to superiority or equivalence,” Russell said. In a telephone interview, she declined to specify those changes.

Schizophrenia is a mental disorder affecting about 1 in 100 Americans that makes it hard to distinguish reality, think logically and behave normally in social settings, according to the National Institutes of Health. Drug treatments help control severe symptoms, such as hearing voices or violent outbursts. They also can produce side effects such as weight gain, diabetes, and movement disorders.

Patients not taking Risperdal Consta were on a variety of alternative medications, among them Zyprexa, made by Indianapolis-based Eli Lilly & Co. (LLY), and J&J’s Risperdal, an older drug taken as daily pill. The seeming benefit of taking the Consta version only twice a month proved a disadvantage when it came to avoiding side effects, Rosenheck said.

No Control

“Patients on oral medication, when they start getting side effects they can cut back on the dose, whereas when you inject somebody with a chemical in their body, they have no control over it,” he said.

J&J sells another long-acting schizophrenia injection, Invega Sustenna, which is only taken once a month and doesn’t need to be refrigerated, Rosenheck said. The National Institutes of Health is funding another study to see whether that drug offers any advantages, he said.

Invega Sustenna, introduced in 2009, generated $183 million in sales last year and may reach $330 million this year, said Lawrence Biegelsen, a Wells Fargo Securities analyst in New York, in a note to clients yesterday.‹