Global Insight Perspective | |
Significance | The U.S. FDA yesterday granted its first approval for a new treatment for schizophrenia since 1993, by giving the marketing green light for J&J's new atypical antipsychotic Invega extended-release. |
Implications | This represents a significant success for J&J, as Invega is crucial to the company's strategy of maintaining sales in its mental health franchise. The company will be hoping that it can switch patients who are currently using Invega's predecessor Risperdal, in order to stem the generic erosion of this older drug, which could occur as early as 2008. |
Outlook | J&J is likely to meet some cynicism from physicians over Invega because of its similarity to Risperdal. However, the company believes that the development process for Invega has created a compound with strong efficacy and safety/tolerability profiles, and that this should enable it to gain significant traction in the market. |
J&J Puts Heat Under Mental Health Franchise
The U.S .FDA has approved Johnson & Johnson's (J&J) new atypical antipsychotic Invega (paliperidone) extended-release tablets for the treatment of schizophrenia, the drug-maker confirmed yesterday. This represents an important achievement for J&J, as the commercial success of Invega is crucial to the company maintaining momentum in its mental health franchise; Invega's predecessor Risperdal (risperidone), which generated full-year sales of US$3.6 billion in 2005, could face generic competition in the United States as soon as 2008. In a press release, the company added that Invega will be marketed by Janssen LP and will be available in the key U.S. market in January 2007. According to a Dow Jones report, the company has thus far refused to be drawn on its prospective pricing for this new drug, but did indicate that it would be priced competitively with other newer antipsychotics on the market. As a guide, it is worth noting that currently the average monthly cost per patient for Risperdal is estimated at around US$474.
Key Feature: Efficacy and Safety/Tolerability
The effectiveness of Invega was established through three six-week, placebo-controlled trials involving 1,665 participants, with doses ranging from 3 mg to 15 mg per day. The drug proved to be more effective than placebo in the treatment of acute schizophrenia, but, interestingly, the company did not use placebo-controlled clinical trials to evaluate the efficacy of the drug for periods longer than six weeks. In a statement, a J&J representative added that treatment with the drug also led to improvements in measures of personal and social functioning, as well as having a similar tolerability profile to placebo at the 6 mg-per-day recommended dose.
Outlook and Implications:
It seems likely that J&J will encounter some cynicism about Invega, because of the similarity of its chemical structure to its predecessor Risperdal (paliperidone is a derivative of risperidone). In fact, a Bloomberg report suggests that many physicians believe Invega to hold quite modest advantages over its predecessor. However, the company believes that this new antipsychotic will bring a number of competitive and patient advantages to the market, as outlined below. This market was estimated at around US$16.2 billion in 2005, marking an expansion of 10.7% over the previous year. This impressive growth is expected to continue, and the market is anticipated to top US$18 billion by 2010.
J&J's press release on the approval of Invega once again took the opportunity to stress the impressive combination of a strong safety/tolerability profile and potentially market-leading efficacy that Invega holds. J&J believes that these characteristics should allow the drug to have a significant impact on the schizophrenia treatment market, and allow the company to move beyond Risperdal, as many of the current leading products are believed to be compromised, by either their lack of market-leading efficacy or their weak tolerability profiles. For example, sales of current market leader Zyprexa (olanzapine; Eli Lilly (U.S.)) have been dogged in recent years by continual reports linking the drug to potentially serious metabolic side-effects. Another major advantage that J&J sees for Invega is its once-daily extended-release formulation, which could ultimately turn physicians in its favour. If both of these advantages can be realised in a real-world setting and transformed into sales, Invega could achieve rapid growth; a Cowen & Co analyst cited by Bloomberg anticipates sales reaching the US$500 million mark in 2008..
Competitive Landscape of Market for Newer Antipsychotics | ||||
Drug | Company | Indication | FY2005 Sales (US$ mil.) | % Change; Y/Y |
Zyprexa | Eli Lilly | Schizophrenia; bipolar (acute monotherapy for acute, mixed or manic episodes of bipolar I disorder; maintenance monotherapy; combination therapy with lithium or valproate for short-term treatment of acute mixed or manic episodes); (psychomotor) agitation associated with schizophrenia and bipolar I mania | 4,202 | -5 |
Risperdal | Johnson & Johnson | Schizophrenia; acute monotherapy for acute, mixed or manic episodes of bipolar I disorder; combination therapy with lithium or valproate for short-term treatment of acute mixed or manic episodes | 3,552 | 16 |
Seroquel | AstraZeneca | Treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; short-term treatment of schizophrenia (close monitoring after six weeks) | 2,761 | 36 |
Abilify | Bristol-Myers Squibb | Treatment of schizophrenia; treatment of acute manic and mixed episodes associated with bipolar disorder | 912 | 53.8 |
Geodon | Pfizer | Schizophrenia; acute manic or mixed episodes associated with bipolar disorder; acute agitation in schizophrenic patients | 589 | 26.0 |
Source: Global Insight Research and Company Reports | ||||
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