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Pharmaceutical industry

Biovail and ACADIA Pharmaceuticals Reaffirm Commitment to Pimavanserin despite Disappointing Parkinson's Disease Psychosis Trial Results

Strategic Insights

— 1 min read

Biovail Corporation and ACADIA Pharmaceuticals have announced an update on their Phase III program with pimavanserin for Parkinson's disease psychosis (PDP), which they are pursuing in collaboration. Despite disappointing top-line results from the first Phase III PDP trial, the parties remain committed to the successful development of pimavanserin and have established a development strategy that they believe will strengthen the PDP program. They also intend to pursue adjunctive therapy with pimavanserin for schizophrenia as a third indication in the collaboration.

Key Takeaways:

  • The parties have agreed on a development strategy for PDP that involves using findings from the first Phase III trial, which did not meet its primary endpoint, together with those from the second ongoing Phase III trial, to arrive at an enhanced study design that may be used in new Phase III trials.
  • The ongoing second Phase III trial (-014 Study) will be concluded at its current enrollment level (about 120 patients) to allow for the analysis of data as soon as practicable.
  • A new Phase III PDP trial using a 40 mg dose of pimavanserin is expected to start in the first half of 2010, with Biovail being responsible for the cost of this third Phase III trial.
  • ACADIA will continue its ongoing open-label safety extension studies in patients with PDP.
  • Biovail intends to pursue adjunctive therapy with pimavanserin for schizophrenia as a third indication in the collaboration.
  • Alzheimer's disease psychosis (ADP) remains the second indication provided for in the collaboration.

Statistics:

  • Over 1.5 million people in the United States suffer from Parkinson's disease (National Parkinson Foundation).
  • Up to 40 percent of patients with Parkinson's disease may develop psychotic symptoms, commonly consisting of visual hallucinations and delusions.
  • Currently, there is no therapy in the United States approved to treat PDP.
  • Biovail Corporation is a specialty pharmaceutical company focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system (CNS) markets.

Sources:

  • Biovail Corporation press release (no date or timestamp provided)
  • ACADIA Pharmaceuticals press release (no date or timestamp provided)
  • National Parkinson Foundation: "Parkinson's Disease: Basics on Parkinson's Disease" (no date or timestamp provided)
  • Biovail Corporation website: www.biovail.com (accessed [no date or timestamp provided])
  • ACADIA Pharmaceuticals website: www.acadia-pharm.com (accessed [no date or timestamp provided])

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