Impax Laboratories ($IPXL) is on a roll. The Hayward, CA-based developer announced Monday evening that the Parkinson's drug it in-licensed from GlaxoSmithKline last year--its second attempt at an extended release version of caribidopa-levadopa--handily beat out the standard of care for controlling a key symptom of the disease in a late-stage study. And investors cheered the biiopharma company on to the regulatory finish line by pumping up the company's stock by 12 percent, adding to a months-long surge in the price.
The primary endpoint of the IPX066 trial was the percentage of "off time"--when patients' medication effect has worn off and there is a return of Parkinson's symptoms--during waking hours. IPX066 demonstrated a 37 percent improvement from baseline compared to a 17 percent improvement from baseline for the standard treatment.
"Consistent with our Phase II findings, these data show IPX066 provides a robust level of efficacy across a range of PD clinical and QOL measures, which represents a potentially significant improvement over existing treatment options," said Impax CSO Dr. Suneel Gupta. "With the successful completion of this ADVANCE-PD trial and the APEX-PD trial in patients with early PD, we have completed the two required Phase III trials for a New Drug Application as agreed with the Food and Drug Administration. We are working diligently to file an NDA in the fourth quarter of 2011."
Just three months ago GlaxoSmithKline stepped in with a $186 million licensing deal for the program, snagging ex-U.S. rights with an $11.5 million upfront payment and a promise of $175 million in milestones. IPX066 is Impax's latest try for an extended release carbidopa-levodopa product, which is designed to help ease symptoms of the disease. The FDA rejected a similar product from Impax, Vadova, back in early 2008. A few months after that setback the company announced plans to launch a new development program to create a next-gen carbidopa-levodopa therapy that could leverage the experience it had gained trying to get an approval for Vadova.
- here's the Impax release