With investigators at Impax Pharmaceuticals ($IPXL) preparing to reap a final round of late-stage data for their Parkinson's drug IPX066, GlaxoSmithKline ($GSK) has stepped up to license marketing rights for the CNS drug. GSK is paying $11.5 million upfront and promising up to $175 million more in milestones in exchange for rights to the drug outside of the U.S. and Taiwan.
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.
Now investigators at the Hayward, CA-based generics drug company have harvested the first round of late-stage data from a study of IPX066 and plan to wrap a second Phase III trial next year, leaving the biotech prepared to file a marketing app in late 2011. Impax Pharmaceuticals is the branded drug division of Impax Laboratories.
"We are excited by the opportunity IPX066 represents to patients," said Atul Pande, senior vice president, Neurosciences Medicines Development Center, GSK. "There is a significant need for a therapy which can improve on clinical symptom management and control in Parkinson's disease."
- here's the Impax/GSK release
- read the story from Reuters