Pimavanserin to treat Parkinson’s disease psychosis soon to hit markets

New drug to treat Parkinson’s disease psychosis is completing clinical studies.

Named pimavanserin, the new drug against Parkinson’s disease psychosis is being jointly developed by Acadia Pharmaceuticals and Biovail Laboratories International SRL, a subsidiary of Biovail Corporation.

Pimavanserin is a selective 5-HT2A inverse agonist.The 5-HT2A receptor, a drug target that plays an important role in the treatment of various neuropsychiatric disorders. Pimavanserin is  currently in Phase III development as a treatment for Parkinson’s disease psychosis.

What’s Parkinson’s disease psychosis?

Parkinson’s disease psychosis affects up to 40 percent of patients with Parkinson’s disease. Parkinson’s disease psychosis  shows psychotic symptoms, commonly consisting of visual hallucinations and delusions.The development of psychosis in patients with Parkinson’s disease often disrupts their ability to perform many of the activities of daily living that keeps them independent and active. As a result, PDP is associated with increased caregiver burden, nursing home placement, and increased mortality. Currently there is no therapy in the United States approved to treat Parkinson’s disease psychosis. According to the National Parkinson Foundation, over 1.5 million people in the United States suffer from Parkinson’s disease.

Parkinson’s disease psychosis is slightly different from  Alzheimer’s disease psychosis (ADP). The criteria for diagnosing Alzheimer’s disease are mostly focused on cognitive deficits. It is the behavioral and neuropsychiatric symptoms that are often troublesome for caregivers and lead to poor quality of life for patients. Approximately 5.3 million people in the United States have Alzheimer’s disease. Between 25 and 50 percent of patients with Alzheimer’s disease may develop ADP, which is characterized by disturbing hallucinations and delusions, according to the Alzheimer’s Association. There currently is no therapy in the United States approved for the treatment of ADP. The presence of psychotic symptoms in patients with Alzheimer’s disease is associated with more rapid cognitive and functional decline and increased institutionalization.

“Our alliance with Biovail not only helps us to advance pimavanserin as a potential first-in-class therapy for Parkinson’s disease psychosis, but also enables us to broaden the pimavanserin development program to Alzheimer’s disease psychosis,” said Uli Hacksell, Ph D, Chief Executive Officer of Acadia.

The pimavanserin collaboration provides for the co-development and commercialization of pimavanserin for multiple neurological and psychiatric indications, including Parkinson’s disease psychosis (PDP) and Alzheimer’s disease psychosis (ADP).

Acadia will manage the ongoing Phase III trials for PDP. Biovail will lead other development, manufacturing, and commercialization efforts for pimavanserin, including activities directed at ADP and other potential indications.

Biovail is granted the right to develop, manufacture, and commercialize pimavanserin in the United States and Canada, while Acadia retains rights to pimavanserin in the rest of the world.

As per the term of pimavanserin collaboration, Acadia is entitled to receive aggregate payments, excluding royalties, of up to $395 million. These include an upfront cash payment of $30 million, up to $160 million in potential milestone payments associated with the successful completion of clinical trials, regulatory submissions and approvals of pimavanserin for PDP and ADP, up to $45 million in potential milestones should the parties pursue a third indication, and up to $160 million in potential milestones as certain sales thresholds are met.

Acadia also will be entitled to receive a 15 percent royalty on annual net sales of pimavanserin up to $100 million and a 20 percent royalty on annual net sales over $100 million. In addition to product royalties, Acadia has the option to co-promote pimavanserin in the United States. Biovail will be responsible for all future costs associated with the development, manufacturing, and commercialization of pimavanserin in all indications with the exception of specified ongoing PDP studies, which will continue to be funded by Acadia.

“This agreement provides Biovail with a late-stage NCE product with strong intellectual property protection that is directly on target with our specialty central nervous system focus,” said Bill Wells, Biovail’s Chief Executive Officer.

Acadia is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. Acadia’s  portfolio consists of five product candidates, including pimavanserin in Phase III for Parkinson’s disease psychosis, a product candidate in Phase II for chronic pain and a product candidate in Phase I for glaucoma, both in collaboration with Allergan, and two programs in IND-track development.

Biovail Corporation is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products.

Parkinson’s Disease: Stories from the archives

Aspirin, Ibuprofen regular use reduce Parkinson’s disease risk

Parkinson’s Disease new treatment to relieve symptoms Azilect

Parkinson Disease treatment triggers gambling in some

Advanced Parkinson’s disease transdermal system for treatment