Neurogen has procured rights to Wyeth Pharmaceuticals’ failed Schizophrenia drug to be tested in Phase II trials in Parkinson’s disease and restless leg syndrome (RLS). Aplindore is a small molecule partial agonist for the D2 dopamine receptor. "We're very pleased to have in-licensed a Phase II compound with the excellent prospects of Aplindore, in a highly competitive environment for good in-licensing opportunities,” says William H. Koster, Ph.D., president and CEO of Neurogen. “While we possess an outstanding drug discovery platform here at Neurogen, we have also been looking for the right mid-stage clinical candidate to augment our internally discovered compounds.”
Neurogen believes that at doses lower than that tested by Wyeth for Schizophrenia, Aplindore may prove to be an attractive treatment for Parkinson's disease and RLS. Wyeth previously showed Aplindore to have excellent brain receptor occupancy and pharmacologic activity at low doses. When tested in six Phase I and Phase II trials, however, the drug proved inappropriate for the treatment of Schizophrenia at the dose range tested.
“The market for Parkinson's disease and RLS is continuing to grow significantly,” points out Dr. Koster, “and we believe there is need for improvement in dosing regimens and side-effect profiles that may be made possible by Aplindore." Dopamine agonists currently available for the treatment of Parkinson's disease and RLS are full agonists at D2 receptors. Neurogen believes that Aplindore may provide an improved side-effect profile and shorter dosing titration period in both diseases due to partial agonism of the D2 receptor.
Neurogen acquired worldwide development and commercialization to Aplindore for an initial license fee of $3 million, in an agreement signed November 21, 2006. The company will also pay Wyeth milestone payments upon the successful achievement of clinical development and regulatory events and royalties on worldwide sales. Neurogen expects to commence Phase II trials with Aplindore during 2007.