Firm to continue pimavanserin PDP program but postpones trials in AD psychosis and schizophrenia.

The Valeant Pharmaceuticals subsidiary Biovail Laboratories is paying Acadia $8.7 million as part of a deal through which the latter will regain all rights to its Phase III-stage CNS candidate, pimavanserin. Biovail and Acadia had previously been collaborating on development of the 5-HT2A receptor blocker in the U.S. and Canada, primarily for the treatment of Parkinson disease psychosis (PDP). However, following the recent merger of Biovail with Valeant, neither the drug nor the broad development strategy underpinning the pimavanserin collaboration fit in with the combined company’s strategic focus, Acadia states. The $8.75 million pay-off received by Acadia to end the collaboration will cover costs associated with ongoing clinical trials of pimavanserin.

Acadia says it will carry on with the ongoing Phase III PDP program. However, for now it will have to hold off starting the previously planned clinical trials in patients with Alzheimer disease psychosis or schizophrenia. The firm says the payment from Biovail means it will have enough cash to fund its operations through to mid-2012.

Pimavanserin is an orally bioavailable NCE discovered by Acadia. In July the firm announced the start of a third pimavanserin Phase III trial in patients with PDP. The placebo-controlled -020 study will enroll about 200 patients in North America and evaluate pimavanserin in combination with their existing dopamine-replacement therapies.

In addition to the -020 study, ACADIA is continuing to conduct an open-label safety extension study (the -015 study) in patients who had previously completed either of two earlier Phase III PDP studies. Patients who complete the -020 study also will have the opportunity to enroll in the -015 trial, the firm points out. It says that National Parkinson Foundation estimates suggest that up to 40% of the 1.5 million U.S. Parkinson disease patients suffer from PDP, but there is currently no approved therapy for the condition.

Acadia is using its drug delivery platform to develop a pipeline of drugs for CNS disorders, headed by lead candidate pimavanserin. The firm has two additional candidates in clinical development through its partnership with Allergan. AGN XX/YY is the first candidate in a class of small molecule candidates for the treatment of chronic pain, which is being taken through Phase II studies by Allergan. AC-262271 is a small molecule product candidate for the treatment of glaucoma, which was discovered by Acadia but is being partnered with Allergan. Currently in Phase I trials, AC-262271 is a selective muscarinic receptor agonist designed to impact on the control of intraocular pressure.

Acadia’s preclinical program includes AM-831, a small molecule product candidate for the treatment of schizophrenia and related disorders, which was discovered and is being developed in collaboration with Meiji Seika Kaisha. Currently in development prior to IND filing, AM-831 was selected from a series of compounds that could represent a new class of procognitive antipsychotic drugs, the firm claims. The compounds combine muscarinic m1 agonist with activity on both dopamine and serotonin receptors.

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