Johnson & Johnson Push Ahead With Invega Franchise
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm files response to “complete response” letter for once-monthly version and tries for new indication for once-daily paliperidone.
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Johnson & Johnson's attempts to establish Invega (paliperidone) as the successor to its Risperdal (risperidone) atypical antipsychotic franchise haven't been successful yet, but the company is giving it another go with the resubmission of the long-acting injectable paliperidone palmitate and with an sNDA for a new indication for the original Invega formulation. Following well-established pharmaceutical industry practice, J&J introduced Invega in December 2006, with the intent of establishing it as the brand of choice in advance of Risperdal's patent expiration in June 2008. But Invega sales have not performed up to expectations, and the once-monthly long-acting paliperidone palmitate version - the one true point of distinction from Risperdal - hit a snag at FDA (1 (Also see "J&J Cautious On Paliperidone Palmitate" - Pink Sheet, 15 Jul, 2008.)). Paliperidone palmitate received a "complete response" letter in August 2008, with FDA requesting a re-analysis of a subset of data. The company predicted the launch would be pushed back to 2010, pending its resubmission to FDA and an anticipated six-month review (2 (Also see "Paliperidone Palmitate Launch Unlikely Until 2010, J&J Says" - Pink Sheet, 14 Oct, 2008.)). The paliperidone palmitate resubmission also included new dosing information. J&J recently released data from a new 13-week, placebo-controlled Phase III study supporting a higher initiation dose (150 mg equivalent) for treatment of schizophrenia ( 3 Pharmaceutical Approvals Monthly, December 2008 , In Brief). The company also started a head-to-head trial of the higher initiation dose of paliperidone palmitate versus Risperdal Consta , with results expected this year. For now, J&J may be focusing on Risperdal Consta as an answer to the disappointing Invega; Consta sales grew slightly more than 8 percent both for the quarter to $117 million and for the year to $465 million. The company did not split out sales figures for Invega in its 2008 earnings release (usually not a good sign). On the heels of the delay for paliperidone palmitate, J&J announced it had filed for a once-monthly version of Risperdal Consta - an injectable currently administered every two weeks - in April with FDA for treatment of bipolar maintenance. Indication for schizoaffective disorder sought Yet the company still is pushing ahead with Invega, trying to add a new, unique indication. In conjunction with the paliperidone palmitate response, J&J announced the submission of two supplemental NDAs for the once-daily tablet formulation for treatment of schizoaffective disorder as monotherapy and for use in combination with antidepressants and/or mood stabilizers. There currently are no approved drugs for schizoaffective disorder. J&J also had been seeking a bipolar indication (after schizophrenia, the most popular market for atypicals) for once-daily Invega, but in December the firm withdrew the EU application after receiving feedback that data were not sufficient to support approval ( 4 Pharmaceutical Approvals Monthly, December 2008 , In Brief). The company would not comment on the status of a U.S. application for a bipolar claim for Invega. J&J has had a busy few weeks in terms of regulatory filings. In addition to the Invega submissions, J&J's Tibotec submitted an application Feb. 6 to convert the accelerated approval of the HIV therapy Intelence (etravirine) to a full approval, and J&J's Centocor submitted the response to the "complete response" letter for the psoriasis biologic ustekinumab (5 (Also see "FDA To Centocor: Show Me The REMS" - Pink Sheet, 22 Dec, 2008.)). -Becky Jungbauer ([email protected]) |