GlaxoSmithKline (GSK) recently presented positive top-line data on its Parkinson’s disease candidate, IPX066, from a phase III study. Results from the ASCEND-Parkinson’s Disease (ASCEND -PD) study showed a 33.5% decrease in "off-time" in the IPX066 arm compared to a 10% decrease in the carbidopa-levodopa plus entacapone (CLE) arm. IPX066 is an extended release (ER) version of carbidopa-levodopa (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. Glaxo has an exclusive license for the development and commercialization of IPX066 outside the US and Taiwan.
The phase III program for IPX066 included three studies – ADVANCE-PD, APEX-PD and ASCEND-PD. Impax had reported positive results from the APEX-PD study (early Parkinson’s disease) as well as the ADVANCE-PD (advanced PD) earlier this year.
Currently, an open label extension study with patients from the ADVANCE-PD and APEX-PD studies are 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 in the fourth quarter of 2011. Approval could come in 2012. Meanwhile, Glaxo intends to file for EU approval in 2012. The Parkinson’s disease market presents significant commercial potential with more than 3 million people being affected in the US, Europe and Japan.
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