GlaxoSmithKline (GSK) recently presented positive top-line data on its Parkinson’s disease candidate, IPX066, from a phase III study. Results from the ADVANCE-Parkinson’s Disease (ADVANCE-PD) study showed a 37% decrease in “off-time” in the IPX066 arm compared to a 17% decrease in the immediate-release (IR) carbidopa-levodopa (CD-LD) arm. IPX066 is an extended release (ER) version of CD-LD.
The primary endpoint of the study was the percentage of “off time” during waking hours. The “off time” indicates the state when the effect of the Parkinson’s disease medicine wears off and the disease symptoms return.
IPX066 Being Developed in Collaboration with Impax
Glaxo has a development and commercialization agreement with Impax Laboratories, Inc. (IPXL) for IPX066. While Glaxo has an exclusive license for the development and commercialization of IPX066 outside the US and Taiwan, Impax is responsible for completing the phase III program for IPX066, including the ADVANCE-PD study.
The phase III program for IPX066 consists of three studies – ADVANCE-PD, APEX-PD and ASCEND-PD. Impax had reported positive top-line results from the APEX-PD study (early Parkinson’s disease) in November 2010.
The ASCEND-PD study, which will compare IPX066 with carbidopa-levodopa and entacapone, is currently ongoing. Besides this, an open label extension study with patients from the ADVANCE-PD and APEX-PD studies is also ongoing.
We are pleased with the positive results on the Parkinson’s disease candidate. Impax should be in a position to file for US approval later this year. Approval could come in 2012. The Parkinson’s disease market presents significant commercial potential with about 3 million people being affected in the US, Europe and Japan.
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