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Neurogen In-licenses Aplindore for Phase II Trial


Posted on 2006-11-28 07:37:00



Neurogen Corporation  has acquired worldwide development and commercialization rights to Aplindore, a small molecule partial agonist for the D2 dopamine receptor. Neurogen expects to commence Phase II trials in Parkinson's disease and restless legs syndrome (RLS) with Aplindore during 2007, following the manufacture of clinical supplies. Aplindore was developed by Wyeth Pharmaceuticals.

Aplindore was initially developed by Wyeth for schizophrenia and has been studied in six Phase I and Phase II clinical trials involving over 100 healthy volunteers and over 100 schizophrenic patients. The drug demonstrated excellent brain receptor occupancy and pharmacologic activity at low doses, but proved inappropriate for the treatment of this disease at the dose range tested. Neurogen believes that at doses significantly lower than those used in previous trials, Aplindore may prove to be an attractive treatment for Parkinson's disease and RLS.

Neurogen acquired worldwide rights to Aplindore for an initial license fee payment of $3 million, in an agreement signed November 21, 2006. Neurogen will also pay Wyeth milestone payments upon the successful achievement of clinical development and regulatory events, and royalties on worldwide sales.

William H. Koster, PhD, President and CEO of Neurogen, said, "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. 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. The market for Parkinson's disease and RLS is continuing to grow significantly 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 and require a long titration period--up to seven weeks in Parkinson's disease and four weeks in RLS. Titration is the process of establishing the appropriate dose of a drug for a particular patient by increasing doses incrementally over a period of time. Currently available dopamine agonist treatments for Parkinson's disease produce side effects in many patients that include daytime somnolence or drowsiness, dyskinesias (sudden episodes of abnormal involuntary movements), and hallucinations. While dopamine agonists have proved effective in the treatment of RLS, many patients still suffer side effects of augmentation (a worsening of symptoms), nausea, constipation, and hypotension. Neurogen believes that Aplindore may provide an improved side-effect profile and shorter dosing titration period in Parkinson's disease and RLS due to partial agonism of the D2 receptor, as compared with the full agonist drugs currently in use.



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