GSK abandons Parkinson’s drug
GlaxoSmithKline has terminated its three-year old agreement with Impax Pharmaceuticals to develop investigational Parkinson’s disease drug IPX066.
“The decision has been reached because of delays in the anticipated regulatory approval and launch dates in countries in which GSK has rights to commercialise the product,” a statement from Impax said.
The extended-release capsule formulation of carbidopa-levodopa is intended for the symptomatic treatment of adults with idiopathic Parkinson’s, but GSK has clearly tired of waiting.
IPX066, known as Rytary in the US, is not approved anywhere in the world and GSK’s right to develop and commercialise it outside the US and Taiwan will transfer back to Impax at the end of July this year.
It is another disappointment for Impax, which in March was hit by the news that a second FDA inspection of its troubled manufacturing facility in Hayward, California, still uncovered compliance issues.
The problems there have been a factor in delaying FDA approval of Rytary, which is the company’s lead branded candidate and therefore an important growth prospect.
Impax has tried to sidestep the issue by removing the plant as a secondary production unit in its New Drug Application for Rytary, and has said it still hopes to launch the drug in 2014.
“While we had made progress in our remediation efforts, we still had more work to do, as evidenced by the receipt of a new Form 483, following the FDA’s re-inspection,” explained Impax chief executive Larry Hsu.
It is not known how GSK’s decision may affect the timeline, but Impax certainly wants to find someone else to help with efforts to get the drug on the market.
The California-based firm, formed in 1999, says it: “Intends to initiate activities to find a partner or partners for markets outside the US looking to grow their non-US neurology franchise”.
IPX066 has been evaluated in two Phase III studies (ADVANCE-PD and ASCEND-PD Part 1) in patients with advanced Parkinson’s, with results suggesting that it improves control of the disease’s motor symptoms.
The extended-release formulation is also designed to make it more convenient for patients, enabling a reduced dosing frequency.
Impax’s pipeline also contains IPX159 for moderate-to-severe restless legs syndrome and IPX056, an extended-release baclofen product for spasticity in patients with multiple sclerosis.
The company also has a generics business, and in February received $48 million in a legal settlement from Shire to end a long-running action over supply of an authorised version of Adderall XR.