ACADIA Pharmaceuticals (NASDAQ:ACAD) outlined commercial expansion plans for its marketed therapies, DAYBUE and NUPLAZID, while highlighting upcoming clinical data for remlifanserin in Alzheimer’s disease psychosis during a discussion hosted by Canaccord Genuity.
Thomas Garner, Acadia’s chief commercial officer, said the company’s commercial strategy has centered on disease education, targeted outreach to healthcare providers and focused execution in both Parkinson’s disease psychosis and Rett syndrome.
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The company has focused on raising awareness that hallucinations and delusions can occur during the course of Parkinson’s disease, while also educating healthcare providers about treatment options. Garner said Acadia estimates that about 1 million people in the U.S. are living with Parkinson’s disease and that roughly half may experience hallucinations and delusions during their disease course.
Acadia’s “More to Parkinson’s” awareness campaign, involving actor Ryan Reynolds, has contributed to a threefold increase in awareness of Parkinson’s disease psychosis among people living with Parkinson’s disease over the past two to three years, according to Garner.
To expand NUPLAZID’s reach, Acadia increased its sales force by roughly 40% earlier this year. The expansion increased the number of healthcare providers targeted by the company from approximately 5,000 to 6,000 to roughly 10,000 to 10,500, Garner said.
Garner said new treatments entering the broader Parkinson’s disease market could help improve disease awareness and diagnosis, potentially supporting demand for therapies addressing psychosis.
DAYBUE Formulation and Persistence
DAYBUE, Acadia’s treatment for Rett syndrome, launched in 2023 and is the first and only approved treatment for the condition, according to Garner. Acadia estimates that about 6,000 people in the U.S., primarily young girls, are living with Rett syndrome.
Long-term patient persistence remains a central commercial focus. Garner said 12-month persistence is above 50% to 55%, while approximately 50% of patients remain on treatment at 18 months. He added that 70% of current DAYBUE patients have been receiving therapy for more than 12 months.
The company recently introduced DAYBUE STIX, a powder formulation that can be mixed with a non-dairy liquid. Garner said the formulation removes certain excipients contained in the earlier oral-solution version and may help Acadia reach treatment-naive patients as well as patients who previously discontinued DAYBUE.
In the second quarter, 60% of DAYBUE business came from the oral solution and 40% came from STIX. In June alone, however, 60% of prescriptions were for STIX, suggesting the newer formulation could become the leading form of the franchise over time, Garner said. He noted that some patients may remain on the oral solution because of the complexity of Rett syndrome and caregiver preferences.
Acadia also sees an opportunity to reengage approximately 1,000 Rett syndrome patients who previously tried and later stopped DAYBUE.
European and Japanese Expansion
Garner said Acadia recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for DAYBUE and is preparing for a European Commission decision. The company plans to launch first in Germany after an EC decision and to submit pricing and reimbursement dossiers in additional priority markets.
Acadia estimates there are between 8,000 and 12,000 people living with Rett syndrome in the European Union, compared with about 6,000 in the U.S. Garner said the European opportunity is larger in patient numbers, though pricing and access conditions will vary by country.
The company is also conducting a DAYBUE trial in Japan. Garner said Acadia is evaluating a partnership-based approach to bringing the treatment to Japanese patients.
Pipeline and Business Development
Acadia expects Phase II data for remlifanserin in Alzheimer’s disease psychosis in the September-to-October timeframe. Garner described the indication as a large commercial opportunity, estimating that 30% of the 7 million to 7.5 million people currently living with Alzheimer’s disease in the U.S. may develop psychosis.
He said Acadia believes remlifanserin could be differentiated by a profile suited to elderly patients with complex medical needs, though he emphasized that the company must first see how the data develop.
Al Kildani, Acadia’s senior vice president of investor relations and corporate communications, said the company also has a Phase II trial of remlifanserin in Lewy body dementia underway and expects Phase II data for ACP-211 in major depressive disorder in the latter part of next year.
Garner said Acadia has close to $1 billion in cash and is evaluating business-development opportunities ranging from near-term commercial assets to additions that could strengthen its mid-stage pipeline. He said the company is not required to pursue a transaction and intends to be selective about potential deals.
About ACADIA Pharmaceuticals (NASDAQ:ACAD)
ACADIA Pharmaceuticals Inc is a biopharmaceutical company focused on the development and commercialization of innovative therapies for central nervous system (CNS) disorders. Established in 1993 and headquartered in San Diego, California, ACADIA’s research centers concentrate on conditions with significant unmet medical needs, including Parkinson’s disease psychosis, Alzheimer’s disease psychosis, and schizophrenia. The company utilizes a range of scientific platforms, including selective receptor modulation and precision-targeted compounds, to advance its portfolio of small-molecule therapeutics.
The company’s flagship product, NUPLAZID® (pimavanserin), received U.S.
