1. - Conference call and webcast to be held today at 8:00 a.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA issued a CRL to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form.

    Despite prior agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design targeting a broad DRP patient population analyzed…

    - Conference call and webcast to be held today at 8:00 a.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA issued a CRL to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form.

    Despite prior agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design targeting a broad DRP patient population analyzed as a single group, the Division, in the CRL, cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval.

    The DRP pivotal HARMONY study met its prespecified primary and secondary endpoints with robust and persuasive clinical and statistical superiority of pimavanserin over placebo, which was a prospectively agreed prerequisite for the DRP indication. Statistical separation by dementia subgroups and certain minimum numbers of patients with specific subtypes were not among the prespecified requirements.

    "Acadia stands behind the robustly positive results from the pivotal Phase 3 HARMONY study and the prospectively agreed trial design and criteria for establishing efficacy in DRP. Over the entire course of the review, the Division did not raise any concerns regarding the agreed upon study design, including the issues raised in the CRL," said Steve Davis, Chief Executive Officer of Acadia. "We will immediately request a Type A meeting to work with the FDA to address the CRL and determine an expeditious path forward for the approval of pimavanserin in DRP."

    The Division also stated in the CRL that it considers the Phase 2 Alzheimer's disease psychosis study -019, a supportive study in the sNDA filing, to not be adequate and well controlled, citing that it was a single center study with no type I error control of secondary endpoints in which certain protocol deviations occurred. The Company believes these observations impact neither the positive results on the study's primary endpoint, nor the study's overall conclusions of efficacy.

    There were no safety issues or concerns raised in the CRL.

    sNDA Submission for Dementia-Related Psychosis

    The sNDA submission of pimavanserin for the treatment of hallucinations and delusions associated with DRP was supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023). Pimavanserin also met the key secondary endpoint in the study, significantly reducing the risk of discontinuation for any reason by 2.2 fold compared to placebo (hazard ratio = 0.452, one-sided p=0.0024). The sNDA also included positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints: the Phase 2 (-019) study in patients with Alzheimer's disease psychosis and the Phase 3 (-020) study in patients with Parkinson's disease psychosis. In addition, the sNDA included a large safety database from completed and ongoing studies representing over 1,500 patients with neurodegenerative disease.

    Conference Call and Webcast Information

    Acadia management will discuss today's announcement via conference call and webcast at 8:00 a.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6894834). A telephone replay of the conference call may be accessed through April 19, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6894834). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there through May 3, 2021.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature. In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, including hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions. These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality.

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID® (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

    NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.

     

    Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.

     

    Warnings and Precautions: QT Interval Prolongation

    °

    NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.

    °

    NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.

     

    Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

     

    Drug Interactions:

    °

    Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.

    °

    Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

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  2. - Conference call and webcast to be held today at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company's supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

    The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to work with the FDA…

    - Conference call and webcast to be held today at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company's supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

    The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them. In July 2020, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2021 for completion of its review of the sNDA.

    Conference Call and Webcast Information

    Acadia management will discuss today's announcement via conference call and webcast at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4153316). A telephone replay of the conference call may be accessed through March 15, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4153316). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there through April 8, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID® (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

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  3. - Full year 2020 net sales grew to $441.8 million, a 30% increase over 2019

    - Upcoming PDUFA action date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2020.

    "Acadia delivered strong financial results in the fourth quarter and full year 2020, driven by robust sales of NUPLAZID in Parkinson's disease psychosis. Additionally, we made significant advancements in two Phase 3 programs and further expanded our pipeline in pain and neuropsychiatry through strategic business development," said Steve…

    - Full year 2020 net sales grew to $441.8 million, a 30% increase over 2019

    - Upcoming PDUFA action date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2020.

    "Acadia delivered strong financial results in the fourth quarter and full year 2020, driven by robust sales of NUPLAZID in Parkinson's disease psychosis. Additionally, we made significant advancements in two Phase 3 programs and further expanded our pipeline in pain and neuropsychiatry through strategic business development," said Steve Davis, Chief Executive Officer. "In 2021, we are focused on delivering continued growth of NUPLAZID, the upcoming potential approval and launch of pimavanserin for dementia-related psychosis and advancing our business development strategy."

    Company Highlights

    • Upcoming PDUFA (Prescription Drug User Fee Act) date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis.
    • Top-line results from Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome expected in the fourth quarter of 2021.
    • Two Phase 2 clinical studies evaluating ACP-044, a novel, first-in-class, orally administered, non-opioid analgesic, in acute and chronic pain to commence in first half of 2021. A bunionectomy study is expected to initiate in the first quarter of 2021 and an osteoarthritis study is expected to initiate in the second quarter of 2021.
    • In November 2020, the FDA approved a label update to allow the NUPLAZID capsule to be sprinkled on certain foods. This is an important feature for patients who take oral medications and may have difficulty swallowing; a potential issue for Parkinson's disease patients and in the elderly in general.
    • Kathie Bishop, Ph.D., joined Acadia as Senior Vice President, Head of Rare Disease and Diann Potestio joined Acadia as Senior Vice President, Market Access, Reimbursement and Channel Strategy.

    Financial Results

    Revenue

    Net sales of NUPLAZID® (pimavanserin) were $121.0 million for the fourth quarter of 2020, an increase of 23% as compared to $98.3 million reported for the fourth quarter of 2019. For the years ended December 31, 2020 and 2019, Acadia reported net product sales of $441.8 million and $339.1 million, respectively, an increase of 30% year-over-year.

    Research and Development

    Research and development expenses for the fourth quarter of 2020 were $62.1 million, compared to $57.5 million for the same period of 2019. For the years ended December 31, 2020 and 2019, research and development expenses were $319.1 million and $240.4 million, respectively. The increase in full year 2020 was primarily due to the upfront expenses of $52.8 million related to the acquisition of CerSci Therapeutics and a $10.0 million upfront payment to Vanderbilt University related to the license agreement and collaboration for novel therapeutic programs targeting muscarinic M1 receptors.

    Selling, General and Administrative

    Selling, general and administrative expenses for the fourth quarter of 2020 were $120.8 million, compared to $91.9 million for the same period of 2019. For the years ended December 31, 2020 and 2019, selling, general and administrative expenses were $388.7 million and $325.6 million, respectively. This increase during the 2020 period as compared to 2019 was primarily due to increased advertising and promotional costs, dementia-related psychosis launch preparation expenses, as well as an increase in personnel and related costs.

    Net Loss

    For the fourth quarter of 2020, Acadia reported a net loss of $66.8 million, or $0.42 per common share, compared to a net loss of $53.0 million, or $0.34 per common share, for the same period in 2019. The net losses for the fourth quarters of 2020 and 2019 included $21.2 million and $19.8 million, respectively, of non-cash stock-based compensation expense. For the year ended December 31, 2020, Acadia reported a net loss of $281.6 million, or $1.79 per common share, compared to a net loss of $235.3 million, or $1.60 per common share, for the same period in 2019. The net losses for the years ended December 31, 2020 and 2019 included $84.4 million and $82.3 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At December 31, 2020, Acadia's cash, cash equivalents, and investment securities totaled $632.0 million, compared to $697.4 million at December 31, 2019.

    2021 Financial Guidance

    • Net sales guidance for NUPLAZID in Parkinson's disease psychosis (PDP) of $510 to $550 million. As this is the potential launch year for dementia-related psychosis (DRP), the Company is not including revenue projections for DRP in 2021 net sales guidance.
    • GAAP R&D guidance of $300 to $320 million reflects the progression of candidates in five clinical indications this year. This guidance includes approximately $30 million of share-based compensation expense.
    • GAAP SG&A guidance of $560 to $590 million reflects a similar level of investment to 2020 in PDP activities, together with additional investments associated with a potential DRP launch. This guidance includes approximately $60 million of share-based compensation expense.

    Conference Call and Webcast Information

    Acadia management will review its fourth quarter and full year 2020 financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9576845). A telephone replay of the conference call may be accessed through March 10, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9576845). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there through March 24, 2021.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for dementia-related psychosis, schizophrenia, major depressive disorder, or depressive symptoms in patients with Parkinson's disease. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino-terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2021 NUPLAZID net sales for Parkinson's disease psychosis only and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2021, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2019 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

    Three Months Ended December 31,

     

     

    Years Ended December 31,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenues

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    121,007

     

     

    $

    98,326

     

     

    $

    441,755

     

     

    $

    339,076

     

    Total revenues

     

     

    121,007

     

     

     

    98,326

     

     

     

    441,755

     

     

     

    339,076

     

    Operating expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

     

    5,301

     

     

     

    5,334

     

     

     

    20,550

     

     

     

    19,598

     

    Research and development (1)

     

     

    62,116

     

     

     

    57,520

     

     

     

    319,130

     

     

     

    240,385

     

    Selling, general and administrative (1)

     

     

    120,752

     

     

     

    91,871

     

     

     

    388,661

     

     

     

    325,638

     

    Total operating expenses

     

     

    188,169

     

     

     

    154,725

     

     

     

    728,341

     

     

     

    585,621

     

    Loss from operations

     

     

    (67,162

    )

     

     

    (56,399

    )

     

     

    (286,586

    )

     

     

    (246,545

    )

    Interest income, net

     

     

    554

     

     

     

    3,272

     

     

     

    6,610

     

     

     

    11,165

     

    Other income (expense)

     

     

    265

     

     

     

    491

     

     

     

    (997

    )

     

     

    997

     

    Loss before income taxes

     

     

    (66,343

    )

     

     

    (52,636

    )

     

     

    (280,973

    )

     

     

    (234,383

    )

    Income tax (benefit) expense

     

     

    417

     

     

     

    400

     

     

     

    611

     

     

     

    876

     

    Net loss

     

    $

    (66,760

    )

     

    $

    (53,036

    )

     

    $

    (281,584

    )

     

    $

    (235,259

    )

    Net loss per common share, basic and diluted

     

    $

    (0.42

    )

     

    $

    (0.34

    )

     

    $

    (1.79

    )

     

    $

    (1.60

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    159,263

     

     

     

    154,492

     

     

     

    157,331

     

     

     

    147,199

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following share-based compensation expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

     

    $

    545

     

     

    $

    592

     

     

    $

    2,632

     

     

    $

    2,936

     

    Research and development

     

    $

    7,669

     

     

    $

    8,072

     

     

    $

    31,314

     

     

    $

    32,533

     

    Selling, general and administrative

    $

    12,981

     

    $

    11,099

     

    $

    50,476

     

    $

    46,796

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

     

    December 31,

    2020

     

     

    December 31,

    2019

     

     

     

    (unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and investment securities

     

    $

    631,958

     

     

    $

    697,429

     

    Accounts receivable, net

     

     

    48,247

     

     

     

    35,781

     

    Interest and other receivables

     

     

    2,035

     

     

     

    2,093

     

    Inventory

     

     

    9,682

     

     

     

    6,341

     

    Prepaid expenses

     

     

    25,694

     

     

     

    18,606

     

    Total current assets

     

     

    717,616

     

     

     

    760,250

     

    Property and equipment, net

     

     

    9,161

     

     

     

    3,180

     

    Operating lease right-of-use assets

     

     

    47,283

     

     

     

    9,524

     

    Intangible assets, net

     

     

    1,108

     

     

     

    2,585

     

    Restricted cash

     

     

    5,770

     

     

     

    4,787

     

    Other assets

     

     

    1,678

     

     

     

    2,857

     

    Total assets

     

    $

    782,616

     

     

    $

    783,183

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    8,493

     

     

    $

    7,222

     

    Accrued liabilities

     

     

    97,474

     

     

     

    67,604

     

    Total current liabilities

     

     

    105,967

     

     

     

    74,826

     

    Operating lease liabilities

     

     

    44,460

     

     

     

    6,361

     

    Long-term liabilities

     

     

    5,180

     

     

     

    2,861

     

    Total liabilities

     

     

    155,607

     

     

     

    84,048

     

    Total stockholders' equity

     

     

    627,009

     

     

     

    699,135

     

    Total liabilities and stockholders' equity

     

    $

    782,616

     

     

    $

    783,183

     

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  4. -  Educational resources help caregivers of the estimated 2.4 million people living with dementia-related hallucinations and delusions identify and discuss symptoms

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the launch of MoreThanMemoryLoss.com, a new website with educational resources designed to help caregivers and people living with dementia to learn more about dementia-related hallucinations and delusions.

    "As a leading, national caregiver organization, we hear from dementia caregivers every day about the challenges they experience caring for loved ones with behavioral symptoms of dementia. This new resource provides information and support to address these symptoms that can have a devastating impact on families," said…

    -  Educational resources help caregivers of the estimated 2.4 million people living with dementia-related hallucinations and delusions identify and discuss symptoms

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the launch of MoreThanMemoryLoss.com, a new website with educational resources designed to help caregivers and people living with dementia to learn more about dementia-related hallucinations and delusions.

    "As a leading, national caregiver organization, we hear from dementia caregivers every day about the challenges they experience caring for loved ones with behavioral symptoms of dementia. This new resource provides information and support to address these symptoms that can have a devastating impact on families," said John Schall, Chief Executive Officer, Caregiver Action Network.

    MoreThanMemoryLoss.com was developed following extensive caregiver research and input from advocacy organizations. The site offers educational and actionable resources for visitors, including a doctor discussion guide, a dementia-related hallucinations and delusions fact sheet and an adapted personal story from a caregiver coping with a loved one's experience of these symptoms.

    Dementia affects 8 million people in the U.S. and its prevalence is expected to increase as the population ages.1-4 Approximately 30 percent, or 2.4 million people in the U.S., experience dementia-related psychosis and only half of them, or 1.2 million, are diagnosed.1,5 Symptoms of dementia-related psychosis include hallucinations, when someone experiences things that are not there, such as seeing or hearing things that others do not and delusions, when someone believes things that are not true, such as people are talking about you (paranoia), or fear that someone is stealing from you. These symptoms are also very distressing for family and caregivers and may be associated with increased risk of aggressive behavior in dementia patients.6 Hallucinations and delusions can cause a person to lose touch with reality, and their loved ones to lose touch with them.

    "Caregivers often believe their job is to protect the image of their loved one and to hide the symptoms of dementia-related psychosis from others," said Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer, at Acadia Pharmaceuticals. "MoreThanMemoryLoss.com is an educational resource dedicated to providing caregivers with information and tools needed to start important conversations about dementia-related hallucinations and delusions with their loved one's healthcare providers."

    Visit https://www.morethanmemoryloss.com to learn more, and sign up for additional educational resources.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature.7 In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, including hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions. These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, progression of dementia, and increased risk of morbidity and mortality.8

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    References

    1Plassman BL, Langa KM, Fisher GG, et al. Prevalence of dementia in the United States: the aging, demographics, and memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    2Goodman RA, Lochner KA, Thambisetty M, et al. Prevalence of dementia subtypes in United States Medicare fee—for—service beneficiaries, 2011—2013. Alzheimers Dement. 2017;13(1):28—37.

    3Hebert LE, Weuve J, Scherr PA, et al. Alzheimer disease in the United States (2010-2050) estimated using the 2010 census. Neurology. 2013;80(19):1778-1783.

    4Alzheimer's Association. 2020 Alzheimer's disease facts and figures. Alzheimer's Dement. 2020;16(3):391-485

    52017 Alzheimer's Disease Facts and Figures and Acadia market research.

    6Lopez O, et al. Psychiatric symptoms vary with the severity of dementia in probable Alzheimer's disease. J Neuropsychiatry Clin Neurosci. 2003;153:346-353.

    7Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

    8Connors MH et al. Am J Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry 2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11). Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al. Neurology 1994;44(12).

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  5. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    10th Annual SVB Leerink Global Healthcare Conference
    Fireside Chat Presentation: Friday, February 26, 2021 at 10:40 a.m. Eastern Time

    Cowen 41st Annual Health Care Conference
    Fireside Chat Presentation: Monday, March 1, 2021 at 12:20 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals
    Acadia is trailblazing breakthroughs in neuroscience to…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    10th Annual SVB Leerink Global Healthcare Conference

    Fireside Chat Presentation: Friday, February 26, 2021 at 10:40 a.m. Eastern Time

    Cowen 41st Annual Health Care Conference

    Fireside Chat Presentation: Monday, March 1, 2021 at 12:20 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  6. Company to host conference call and webcast on Wednesday, February 24, 2021, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report fourth quarter and full year 2020 financial results on Wednesday, February 24, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on February 24, 2021, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9576845). A telephone replay of the conference call may be accessed through March 10, 2021 by dialing…

    Company to host conference call and webcast on Wednesday, February 24, 2021, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report fourth quarter and full year 2020 financial results on Wednesday, February 24, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on February 24, 2021, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9576845). A telephone replay of the conference call may be accessed through March 10, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9576845). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until March 24, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2019 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  7. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that Michael Yang, Executive Vice President and Chief Commercial Officer, will be leaving the organization effective January 29, 2021 to assume the role of chief executive officer at another healthcare company. Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer and Amanda Morgan, Senior Vice President, Chief Revenue and Customer Officer, will lead the commercial organization.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210127005903/en/

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer (Photo: Business Wire)

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer (Photo: Business Wire)

    "On behalf of the entire management…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that Michael Yang, Executive Vice President and Chief Commercial Officer, will be leaving the organization effective January 29, 2021 to assume the role of chief executive officer at another healthcare company. Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer and Amanda Morgan, Senior Vice President, Chief Revenue and Customer Officer, will lead the commercial organization.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210127005903/en/

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer (Photo: Business Wire)

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer (Photo: Business Wire)

    "On behalf of the entire management team and our employees, I want to thank Michael for his significant contributions and we wish him well in his future endeavors," said Steve Davis, Chief Executive Officer. "Amanda and Charmaine have been the foundation of our commercial success and I look forward to their continued leadership."

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer

    Charmaine Lykins is Senior Vice President, Global Product Planning and Chief Marketing Officer and leads Acadia's healthcare professional and consumer marketing, marketing operations and new product planning functions. She joined the company in 2018 as Vice President, Marketing and in 2019 was promoted to Senior Vice President and became a member of the company's Executive Management Committee.

    Ms. Lykins has over 25 years of global experience commercializing healthcare brands, including 10 product launches representing first-in-class therapies for central nervous system disorders. She led the U.S. launch teams for REXULTI® in depression and schizophrenia, prelaunch readiness for ABILIFY MAINTENA® in bipolar disorder, and ZIPSOR® for acute pain. Ms. Lykins also led commercial launch strategies for LATUDA® in bipolar depression and schizophrenia, CYMBALTA® for depression and diabetic neuropathic pain, and ZYPREXA® for bipolar depression and treatment resistant depression in combination with fluoxetine.

    Prior to joining Acadia, Ms. Lykins served as Global Vice President of Marketing at Lundbeck. Prior to Lundbeck she held global marketing leadership roles at Sunovion and U.S. marketing and sales leadership roles at Eli Lilly. Her career experience includes strategic commercialization roles in Europe, Asia, and the Middle East, as well as in research and development.

    Ms. Lykins has an MBA with an emphasis in international business from the Darla Moore School of Business at University of South Carolina, and bachelor's degrees in chemistry and honors humanities from Ball State University.

    Amanda Morgan, Senior Vice President, Chief Revenue and Customer Officer

    Amanda Morgan is Senior Vice President, Chief Revenue and Customer Officer and leads Acadia's neuroscience, long-term care, national accounts, and health systems. She joined the company in 2017 as Vice President, Sales and Market Access and in 2019 was promoted to Senior Vice President and became a member of the company's Executive Management Committee.

    Ms. Morgan has over 20 years of experience in developing high-performing cultures and teams in the healthcare industry. Prior to joining Acadia, she was the U.S. Head of Patient Services at Baxalta where she was responsible for launching the patient services organization that supported more than $6 billion dollars in revenue. Prior to Baxalta, she was U.S. Area Vice President at Baxter leading the hospital and healthcare sales teams overseeing market expansion, supplemental indications, and new product launch strategies.

    Throughout her career, Ms. Morgan has held leadership roles with increasing responsibility in marketing, sales, market access, patient services and operations in multiple therapeutic areas. She has a strong track record of executing commercial strategies in neuroscience, immunology, hematology, and oncology, as well as in rare diseases.

    Ms. Morgan earned her Bachelor of Science degree in Business Administration, Marketing from The University of Iowa.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  8. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 2:00 p.m. Eastern Time, followed by a question and answer session.

    The conference will be held virtually. A live audio-only webcast of Acadia's presentation and question and answer session, along with accompanying slides, will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through February 12, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 2:00 p.m. Eastern Time, followed by a question and answer session.

    The conference will be held virtually. A live audio-only webcast of Acadia's presentation and question and answer session, along with accompanying slides, will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through February 12, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  9. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020, at 3:20 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of Acadia's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through December 15, 2020.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020, at 3:20 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of Acadia's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through December 15, 2020.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  10. - 3Q20 Net Sales of $120.6 Million, a 27% Increase Over 3Q19

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the third quarter ended September 30, 2020.

    "This quarter we drove strong performance through the continued growth of new prescribers with more patients benefitting from NUPLAZID® treatment for their Parkinson's disease psychosis and remain on-track with our supplemental NDA for the treatment of dementia-related psychosis with a PDUFA date of April 3, 2021," said Steve Davis, Acadia's Chief Executive Officer. "We continue to advance…

    - 3Q20 Net Sales of $120.6 Million, a 27% Increase Over 3Q19

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the third quarter ended September 30, 2020.

    "This quarter we drove strong performance through the continued growth of new prescribers with more patients benefitting from NUPLAZID® treatment for their Parkinson's disease psychosis and remain on-track with our supplemental NDA for the treatment of dementia-related psychosis with a PDUFA date of April 3, 2021," said Steve Davis, Acadia's Chief Executive Officer. "We continue to advance our late-stage programs and invest in new opportunities through business development, highlighted by our recent acquisition of CerSci Therapeutics which expands our clinical pipeline with an innovative first-in-class, non-opioid, acute and chronic pain program."

    Company Updates

    • New clinical analyses across multiple studies of pimavanserin are being presented at this week's 13th Clinical Trials on Alzheimer's Disease (CTAD) meeting, including:
      • Oral presentation by Dr. Clive Ballard, University of Exeter Medical School: "Impact of Pimavanserin on Cognitive Measures in Patients with Neurodegenerative Disease: Results from 4 Placebo-Controlled Clinical Studies."
      • Poster presentation by Dr. Daniel Weintraub, Perelman School of Medicine at the University of Pennsylvania: "Impact of Pimavanserin Treatment on Motor Function in Patients with Neurodegenerative Disease: Results from 3 Clinical Studies."
    • In October, Acadia announced a partnership with The Lewy Body Dementia Association (LBDA) on the release of a disease education adaptation of the new documentary Robin's Wish©. The film is titled, "SPARK - Robin Williams and his Battle with Lewy Body Dementia©," and will be available to academic research institutions and universities as part of educational programming for healthcare professionals.
    • In October, Acadia presented a poster titled "Healthcare Resource Utilization and Associated Costs for Dementia Patients with Psychosis: A Medicare Database Study," at the Academy of Managed Care Pharmacy's (AMCP) Nexus conference, and received a Silver ribbon based on its relevance, originality, quality, bias and clarity of results.
    • In August, Acadia acquired CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. Acadia plans to initiate a Phase 2 program with the lead compound, ACP-044, in the first half of 2021.
    • Appointed Dr. Gudarz Davar as Executive Vice President and Head of Research and Development, reporting to Serge Stankovic, M.D., M.S.P.H., President of Acadia.
    • Elizabeth (Betsy) Garofalo, M.D. was appointed to the Acadia Board of Directors.

    Financial Results

    Revenue

    Net sales of NUPLAZID (pimavanserin) were $120.6 million for the three months ended September 30, 2020, an increase of 27% as compared to $94.6 million reported for the three months ended September 30, 2019. For the nine months ended September 30, 2020 and 2019, Acadia reported net product sales of $320.7 million and $240.8 million, respectively.

    Research and Development

    Research and development expenses for the three months ended September 30, 2020 were $120.1 million, compared to $62.6 million for the same period of 2019. This increase was primarily due to $52.8 million in upfront consideration and transaction expenses related to the acquisition of CerSci Therapeutics. For the nine months ended September 30, 2020 and 2019, research and development expenses were $257.0 million and $182.9 million, respectively. This increase was primarily due to the acquisition of CerSci Therapeutics and the upfront payment to Vanderbilt University for the M1 PAM program.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended September 30, 2020 were $81.6 million, compared to $72.7 million for the same period of 2019. For the nine months ended September 30, 2020 and 2019, selling, general and administrative expenses were $267.9 million and $233.8 million, respectively. This increase was primarily due to increased advertising and promotional costs as well as an increase in personnel and related costs.

    Net Loss

    For the three months ended September 30, 2020, Acadia reported a net loss of $84.7 million, or $0.54 per common share, compared to a net loss of $42.0 million, or $0.29 per common share, for the same period in 2019. The net losses for the three months ended September 30, 2020 and 2019 included $21.4 million and $22.0 million, respectively, of non-cash stock-based compensation expense. For the nine months ended September 30, 2020, Acadia reported a net loss of $214.8 million, or $1.37 per common share, compared to a net loss of $182.2 million, or $1.26 per common share, for the same period in 2019. The net losses for the nine months ended September 30, 2020 and 2019 included $63.2 million and $62.5 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At September 30, 2020, Acadia's cash, cash equivalents, and investment securities totaled $644.4 million, compared to $697.4 million at December 31, 2019.

    2020 Financial Guidance

    • Acadia reiterates its NUPLAZID net sales guidance of $430 to $450 million.
    • GAAP R&D guidance is increased to $325 to $340 million from the previous range of $265 to $280 million, primarily as a result of the $52.8 million upfront and transaction expenses associated with the acquisition of CerSci Therapeutics.
    • GAAP SG&A guidance is decreased to $385 to $400 million from the previous range of $400 to $420 million.
    • Non-cash stock-based compensation expense guidance is decreased to $80 to $90 million from the previous range of $90 to $100 million.
    • 2020 year-end cash, cash equivalents, and investment securities guidance of $570 to $590 million is unchanged.

    Conference Call and Webcast Information

    Acadia management will review its third quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6266016). A telephone replay of the conference call may be accessed through November 18, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6266016). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com, under the investors section and will be archived there until December 2, 2020.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for any other neuropsychiatric disorders. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino-terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide, ACP-044 and the M1 PAM program; unanticipated impacts of COVID-19 on Acadia's business, including its commercial sales operations, current and planned clinical trials, supply chain, and guidance for full-year 2020 NUPLAZID net sales and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2020, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2019 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Copyright 2020 by Tiburon Sunrise, LLC

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

    $

    120,577

     

    $

    94,586

     

    $

    320,748

     

    $

    240,750

     

    Total revenues

     

    120,577

     

     

    94,586

     

     

    320,748

     

     

    240,750

     

    Operating expenses

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

    4,801

     

     

    4,689

     

     

    15,249

     

     

    14,264

     

    Research and development (1)

     

    120,083

     

     

    62,622

     

     

    257,014

     

     

    182,865

     

    Selling, general and administrative (1)

     

    81,592

     

     

    72,696

     

     

    267,909

     

     

    233,767

     

    Total operating expenses

     

    206,476

     

     

    140,007

     

     

    540,172

     

     

    430,896

     

    Loss from operations

     

    (85,899

    )

     

    (45,421

    )

     

    (219,424

    )

     

    (190,146

    )

    Interest income, net

     

    1,242

     

     

    2,432

     

     

    6,056

     

     

    7,893

     

    Other (expense) income

     

    (202

    )

     

    747

     

     

    (1,262

    )

     

    506

     

    Loss before income taxes

     

    (84,859

    )

     

    (42,242

    )

     

    (214,630

    )

     

    (181,747

    )

    Income tax expense

     

    (199

    )

     

    (264

    )

     

    194

     

     

    476

     

    Net loss

    $

    (84,660

    )

    $

    (41,978

    )

    $

    (214,824

    )

    $

    (182,223

    )

    Net loss per common share, basic and diluted

    $

    (0.54

    )

    $

    (0.29

    )

    $

    (1.37

    )

    $

    (1.26

    )

    Weighted average common shares outstanding, basic and diluted

     

    158,129

     

     

    145,906

     

     

    156,683

     

     

    144,741

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

    $

    495

     

    $

    372

     

    $

    2,087

     

    $

    2,344

     

    Research and development

    $

    7,953

     

    $

    8,680

     

    $

    23,645

     

    $

    24,461

     

    Selling, general and administrative

    $

    12,924

     

    $

    12,971

     

    $

    37,495

     

    $

    35,697

     

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

     

    September 30,

    2020

     

    December 31,

    2019

     

     

    (unaudited)

     

     

     

    Assets

     

     

     

     

    Cash, cash equivalents and investment securities

    $

    644,441

    $

    697,429

    Accounts receivable, net

     

    46,344

     

    35,781

    Interest and other receivables

     

    1,440

     

    2,093

    Inventory

     

    7,979

     

    6,341

    Prepaid expenses

     

    30,009

     

    18,606

    Total current assets

     

    730,213

     

    760,250

    Property and equipment, net

     

    8,427

     

    3,180

    Operating lease right-of-use assets

     

    48,232

     

    9,524

    Intangible assets, net

     

    1,477

     

    2,585

    Restricted cash

     

    5,770

     

    4,787

    Other assets

     

    1,545

     

    2,857

    Total assets

    $

    795,664

    $

    783,183

    Liabilities and stockholders' equity

     

     

     

     

    Accounts payable

    $

    3,471

    $

    7,222

    Accrued liabilities

     

    88,385

     

    67,604

    Total current liabilities

     

    91,856

     

    74,826

    Operating lease liabilities

     

    45,343

     

    6,361

    Other long-term liabilities

     

    3,598

     

    2,861

    Total liabilities

     

    140,797

     

    84,048

    Total stockholders' equity

     

    654,867

     

    699,135

    Total liabilities and stockholders' equity

    $

    795,664

    $

    783,183

     

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  11. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that scientific presentations highlighting new analyses of pimavanserin clinical study data in dementia-related psychosis and neurodegenerative diseases will be shared at the 13th Clinical Trials on Alzheimer's Disease Conference (CTAD), being held virtually November 4-7, 2020.

    Scientific presentations include those investigating pimavanserin treatment and its impact on cognition and motor function in patients with neuropsychiatric symptoms related to neurodegenerative diseases, including dementia-related psychosis. Other presentations include a comprehensive literature review of current use of antipsychotic treatment for dementia-related psychosis, an analysis of mortality risk and…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that scientific presentations highlighting new analyses of pimavanserin clinical study data in dementia-related psychosis and neurodegenerative diseases will be shared at the 13th Clinical Trials on Alzheimer's Disease Conference (CTAD), being held virtually November 4-7, 2020.

    Scientific presentations include those investigating pimavanserin treatment and its impact on cognition and motor function in patients with neuropsychiatric symptoms related to neurodegenerative diseases, including dementia-related psychosis. Other presentations include a comprehensive literature review of current use of antipsychotic treatment for dementia-related psychosis, an analysis of mortality risk and need for long-term care for patients with dementia-related psychosis versus patients with dementia only, and assessments of efficacy and safety of pimavanserin in dementia-related psychosis.

    CTAD Accepted Scientific Presentations include:

    Oral Presentations:

    • Oral Presentation (OC31): Impact of Pimavanserin on Cognitive Measures in Patients with Neurodegenerative Disease: Results from 4 Placebo-Controlled Clinical Studies on Friday, November 6, 10:45 – 11:00 a.m. ET. Presenting author: Clive Ballard, MBChB, University of Exeter Medical School, Exeter, United Kingdom.
    • Oral Presentation (OC17): Relationship Between Pimavanserin Exposure and Psychosis Relapse in Patients with Dementia-Related Psychosis: Clinical Results and Modeling Analysis from the Phase 3 HARMONY Study on Thursday, November 5, 10:30 – 10:45 a.m. ET. Presenting author: Mona Darwish, Acadia Pharmaceuticals Inc.

    Poster Presentations:

    • Poster Presentation (P75): Impact of Pimavanserin Treatment on Motor Function in Patients with Neurodegenerative Disease: Results from 3 Clinical Studies. Presenting author: Daniel Weintraub, M.D., Departments of Psychiatry and Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
    • Poster Presentation (P21): Frequency of Antipsychotic-Associated Adverse Events with Pimavanserin Treatment in Patients with Dementia-Related Psychosis. Presenting author: George Demos, M.D., Acadia Pharmaceuticals Inc.
    • Poster Presentation (P71): Comparative Efficacy, Safety, Tolerability, and Effectiveness of Antipsychotics in the Treatment of Dementia Related Psychosis (DRP): A Systematic Literature Review. Presenting author: Ismaeel Yunusa, An-L-lt-Iks, Inc.
    • Poster Presentation (P69): Mortality Risk and Use of Long-Term Custodial Care for Patients With Dementia and Psychosis Versus Patients With Dementia Only: A Longitudinal, Matched Cohort Analysis of Medicare Claims Data. Presenting author: Nazia Rashid, Acadia Pharmaceuticals Inc.

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. Acadia submitted a supplemental new drug application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis on June 3, 2020. The FDA has accepted for filing the sNDA for DRP with a PDUFA date of April 3, 2021. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialize the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

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  12. Acadia to Host Conference Call and Webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report third quarter financial results on Wednesday, November 4, 2020, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6266016). A telephone replay of the conference call may be accessed through November 18, 2020 by dialing 855-859-2056…

    Acadia to Host Conference Call and Webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report third quarter financial results on Wednesday, November 4, 2020, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6266016). A telephone replay of the conference call may be accessed through November 18, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6266016). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com, under the investors section and will be archived there until December 2, 2020.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialize the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2019 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  13. The Lewy Body Dementia Association (LBDA) and Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today an exclusive partnership on the production and release of a disease education adaptation of the new film Robin's Wish©, a documentary detailing the late actor Robin Williams' courageous battle with the neurodegenerative disorder, Lewy body dementia (LBD).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201014005922/en/

    The film, SPARK - Robin Williams and his Battle with Lewy Body Dementia©, will go beyond describing LBD through the lens of Williams' personal experience and delve into the neurobiology of the disease and associated symptoms to help educate the medical community on…

    The Lewy Body Dementia Association (LBDA) and Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today an exclusive partnership on the production and release of a disease education adaptation of the new film Robin's Wish©, a documentary detailing the late actor Robin Williams' courageous battle with the neurodegenerative disorder, Lewy body dementia (LBD).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201014005922/en/

    The film, SPARK - Robin Williams and his Battle with Lewy Body Dementia©, will go beyond describing LBD through the lens of Williams' personal experience and delve into the neurobiology of the disease and associated symptoms to help educate the medical community on the second most common form of degenerative dementia. Lewy body dementia is also the most misdiagnosed dementia, and healthcare provider education is needed to enable early recognition, diagnosis and treatment.

    While the full-length film is available on demand and via digital channels, the adaptation, will be available to major academic research institutions and universities as part of educational programming and outreach to the healthcare professionals, the LBD community and general public. The film will be available starting in late October.

    "Robin Williams unknowingly battled LBD and unfortunately, he is not alone. This version of the documentary will not only raise awareness of Lewy body dementia, but reinforce the importance of early symptom recognition, diagnosis and effective management of this devastating disease, and can serve as a key element in our educational offering," said Todd Graham, Executive Director, Lewy Body Dementia Association.

    Approximately 8 million people in the United States are living with dementia, although only half are diagnosed with the condition.1,2,3 In addition to cognitive decline, neuropsychiatric symptoms, including hallucinations, delusions and changes in behavior, are also common. Lewy body dementia affects approximately 1.4 million people and their families in the United States alone.4

    "The use of scientific storytelling is an important opportunity to increase knowledge within the medical community on the need for better diagnostic and disease management solutions. Our goal is to ensure people struggling with LBD get the comprehensive support they need," said Ponni Subbiah, M.D., M.P.H., Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer at Acadia. "We are honored to partner with the LBDA and share a commitment to shine a light on the challenges that people with Lewy body dementia and their caregivers face."

    About Lewy Body Dementia Association

    The Lewy Body Dementia Association (LBDA) is the nation's leading authority on Lewy body dementias (LBD) and is dedicated to continuous outreach, education, research, and support for those affected with LBD and their families. LBD is a progressive brain disease that affects thinking, movement, behavior, and impacts 1.4 million people in the United States.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialize the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    References

    1 Plassman, BL Langa KM, Fisher GG, et al. Prevalence of dementia in the United States: the aging, demographics, and memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    2 Goodman RA, Lochner KA, Thambisetty M, Wingo TS, Posner SF, Ling SM. Prevalence of dementia subtypes in United States Medicare fee-for-service beneficiaries, 2011-2013. Alzheimers Dement. 2017;13(1):28-37.

    3 Hebert LE, Weuve J, Scherr PA, Evans DA. Alzheimer disease in the United States (2010-2050) estimated using the 2010 census. Neurology. 2013;80(19):1778-1783.

    4 Lewy Body Dementia Association www.lbda.org.

    Copyright 2020 by Tiburon Sunrise, LLC

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  14. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Elizabeth (Betsy) Garofalo, M.D. to its Board of Directors. Dr. Garofalo is a biopharma executive with more than 25 years of experience in global clinical development and regulatory affairs.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201001005364/en/

    Dr. Elizabeth Garofalo (Photo: Business Wire)

    Dr. Elizabeth Garofalo (Photo: Business Wire)

    "Dr. Garofalo is a highly-regarded business leader and innovator with invaluable clinical development experience," said Stephen R. Biggar, M.D., Ph.D., Chairman of Acadia's Board of Directors. "We are excited to welcome her to the Board of Directors and look forward to leveraging her significant CNS research and…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Elizabeth (Betsy) Garofalo, M.D. to its Board of Directors. Dr. Garofalo is a biopharma executive with more than 25 years of experience in global clinical development and regulatory affairs.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201001005364/en/

    Dr. Elizabeth Garofalo (Photo: Business Wire)

    Dr. Elizabeth Garofalo (Photo: Business Wire)

    "Dr. Garofalo is a highly-regarded business leader and innovator with invaluable clinical development experience," said Stephen R. Biggar, M.D., Ph.D., Chairman of Acadia's Board of Directors. "We are excited to welcome her to the Board of Directors and look forward to leveraging her significant CNS research and development expertise, particularly as the company advances its innovative late stage and growing early stage pipeline."

    "I look forward to working with the talented Acadia management team as they continue to seek breakthroughs in the field of CNS, pioneering new research and developing innovative new therapies to address unmet needs," said Dr. Garofalo.

    Since 2016, Dr. Garofalo has served as the Principal for EAG Pharma Consulting LLC. Prior to that, Dr. Garofalo served in numerous leadership roles including as the Global Head of Clinical Development and member of the Novartis Global Development Leadership Team, Chair of the Novartis Portfolio Stewardship Board, Co-Head of the Novartis Neuroscience Franchise, Head of the Neuroscience Therapy Area at Astellas, Ann Arbor Site Head of Worldwide Regulatory Affairs at Pfizer, and Ann Arbor Site Head of Neuroscience at Pfizer.

    Dr. Garofalo currently serves on the board for the Institute for Advanced Clinical Trials in Children and is the Chair of the Business Advisory Board for the Epilepsy Foundation of America. She earned her M.D. from the Indiana University School of Medicine and completed fellowships in pediatric neurology and epilepsy at the University of Michigan Medical School.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialize the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  15. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following upcoming virtual investor conferences:

    Citi 15th Annual BioPharma Virtual Conference
    Date: Wednesday, September 9, 2020
    Panel: Emerging Therapies for Psychiatric Disorders at 1:30 p.m. Eastern Time

    Morgan Stanley 18th Annual Global Healthcare Conference
    Date: Monday, September 14, 2020
    Fireside chat presentation: 3:45 p.m. Eastern Time

    Cantor Virtual Global Healthcare Conference
    Date: Wednesday, September 16, 2020
    Fireside chat presentation: 11:20 a.m. Eastern Time

    These conferences will all be held virtually. Live webcasts of the panel and presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following upcoming virtual investor conferences:

    Citi 15th Annual BioPharma Virtual Conference

    Date: Wednesday, September 9, 2020

    Panel: Emerging Therapies for Psychiatric Disorders at 1:30 p.m. Eastern Time

    Morgan Stanley 18th Annual Global Healthcare Conference

    Date: Monday, September 14, 2020

    Fireside chat presentation: 3:45 p.m. Eastern Time

    Cantor Virtual Global Healthcare Conference

    Date: Wednesday, September 16, 2020

    Fireside chat presentation: 11:20 a.m. Eastern Time

    These conferences will all be held virtually. Live webcasts of the panel and presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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  16. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Dr. Gudarz Davar as Executive Vice President and Head of Research and Development. Dr. Davar will be responsible for leading research and development activities at ACADIA and will serve as a member of the company's Executive Management Committee. In this role, he will report to Serge Stankovic, M.D., M.S.P.H., President of ACADIA. Dr. Stankovic will continue to oversee research and development, regulatory, medical affairs, external innovation and pharmacovigilance functions for the company.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200831005180/en/

    Gudarz Davar, M.D., Executive Vice President and Head of Research and Development (Photo: Business Wire)

    Gudarz Davar, M.D., Executive Vice President and Head…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Dr. Gudarz Davar as Executive Vice President and Head of Research and Development. Dr. Davar will be responsible for leading research and development activities at ACADIA and will serve as a member of the company's Executive Management Committee. In this role, he will report to Serge Stankovic, M.D., M.S.P.H., President of ACADIA. Dr. Stankovic will continue to oversee research and development, regulatory, medical affairs, external innovation and pharmacovigilance functions for the company.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200831005180/en/

    Gudarz Davar, M.D., Executive Vice President and Head of Research and Development (Photo: Business Wire)

    Gudarz Davar, M.D., Executive Vice President and Head of Research and Development (Photo: Business Wire)

    "We are thrilled to welcome Gudarz to ACADIA's executive team as a senior neurologist and neuroscientist with strong scientific, academic and corporate leadership experience," said Steve Davis, ACADIA's Chief Executive Officer. "As we prepare for the potential approval and launch in the U.S. of our second indication for pimavanserin, the treatment of hallucinations and delusions associated with dementia-related psychosis, we continue to focus on developing innovative new treatments to address unmet needs. Gudarz will be a valuable addition to our executive team as we execute and grow our pipeline to drive long-term growth."

    "I share ACADIA's passion for improving the lives of patients with central nervous system disorders and am particularly excited to use my experience to strengthen the breadth and depth of ACADIA's pipeline," said Dr. Davar.

    Dr. Davar joins ACADIA from Eli Lilly where he was Vice President, Head of Global Neurology Clinical Development, the senior leadership role responsible for the global development of all neuroscience and core Lilly biomedicines assets through clinical testing and life of the product. Under his leadership were the recent global approvals of Emgality® for migraine prevention and U.S. approval for the treatment of cluster headache, as well as the U.S. approval of REYVOW® as a first-in-class, novel, acute treatment for migraine.

    Prior to Eli Lilly, he served in senior leadership roles in neurology and clinical development at Allergan, Biogen Idec and Amgen. At Allergan, he led a global research and development and commercialization partnership focused on cognitive impairment and neurobehavioral symptoms in Alzheimer's disease.

    Dr. Davar received his medical degree from Dalhousie University in Halifax, Nova Scotia. He completed residency at University of Michigan Hospitals, Ann Arbor, Michigan and is board certified in Neurology.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  17. - First-in-class, non-opioid, mechanism interrupts pain pathways

    - Phase 2 initiation planned for the first half of 2021

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the acquisition of CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. The lead development program is a unique Reactive Species Decomposition Accelerant (RSDAx), a first-in-class mechanism focused on interrupting pathways that sensitize neurons to pain. The portfolio contains additional preclinical stage molecules, including brain penetrant molecules, with potential for symptomatic and disease modifying treatment…

    - First-in-class, non-opioid, mechanism interrupts pain pathways

    - Phase 2 initiation planned for the first half of 2021

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the acquisition of CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. The lead development program is a unique Reactive Species Decomposition Accelerant (RSDAx), a first-in-class mechanism focused on interrupting pathways that sensitize neurons to pain. The portfolio contains additional preclinical stage molecules, including brain penetrant molecules, with potential for symptomatic and disease modifying treatment utility in neurodegenerative diseases.

    This acquisition strengthens ACADIA's clinical pipeline to include non-opioid pain therapies that have potential non-addictive properties and reduced side effects typically seen with current opioid treatments. The lead molecule, ACP-044, has shown promising efficacy and safety results in animal models evaluating incisional, inflammatory, and neuropathic pain, as well as favorable tolerability and pharmacokinetic properties in Phase 1 trials. The novel RSDAx mechanism of action is thought to interfere with multiple pain pathways treating pain simultaneously. ACADIA plans to initiate a Phase 2 clinical study in the first half of 2021.

    "There is an urgent need for new approaches to treat pain without causing addiction," said Steve Davis, ACADIA's Chief Executive Officer. "We are excited by the potential clinical utility of this program across multiple pain modalities due to its novel non-opioid mechanism of action. By acquiring CerSci, ACADIA is further strengthening our development pipeline for long-term growth in central nervous system disorders."

    "For too long, the options for patients with acute and chronic pain have been very limited," said Lucas Rodriguez, CEO and co-founder of CerSci. "I am highly confident that ACADIA, with its proven development and commercialization capabilities, can advance CerSci's program and ultimately deliver a new generation of medicines to treat acute post-operative as well as chronic pain conditions."

    Under the terms of the agreement, ACADIA acquired all of the outstanding shares of CerSci for $52.5 million, primarily in ACADIA stock. The transaction closed on August 24, 2020. CerSci shareholders may also receive up to $887 million in development, commercialization, and sales milestones in addition to tiered royalties in the mid-single digits based on annual net sales.

    BofA Securities is serving as financial advisor and Paul Hastings, LLP is serving as legal advisor to ACADIA. Evercore is serving as financial advisor and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor to CerSci. CerSci's major investors include JDH Investment Management, LLC, Hiawatha Education Foundation, Lennox Capital Partners, LP and West Summit Investments, LP.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. ACADIA submitted a supplemental new drug application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis on June 3, 2020. The FDA has accepted for filing the sNDA for DRP with a PDUFA date of April 3, 2021. Pimavanserin is not approved for dementia-related psychosis. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the discovery, development and commercialization of any compounds from the above described acquisition, the clinical potential of and therapeutic opportunity for products based on such compounds and other statements that are not historical facts. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  18. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at The JMP Securities CNS Forum on Wednesday, August 19, 2020, at 11:00 a.m. Eastern Time.

    The conference will be held virtually. A live webcast of ACADIA's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through September 19, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at The JMP Securities CNS Forum on Wednesday, August 19, 2020, at 11:00 a.m. Eastern Time.

    The conference will be held virtually. A live webcast of ACADIA's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through September 19, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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  19. - 2Q20 Net Sales of $110.1 Million, a 32% Increase Over 2Q19

    - FDA filed the supplemental NDA for pimavanserin for the treatment of dementia-related psychosis with a PDUFA action date set for April 3, 2021

    - Initiated ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2020.

    "In the first half of 2020 we drove robust growth of NUPLAZID®. With the FDA filing of our sNDA for dementia-related psychosis…

    - 2Q20 Net Sales of $110.1 Million, a 32% Increase Over 2Q19

    - FDA filed the supplemental NDA for pimavanserin for the treatment of dementia-related psychosis with a PDUFA action date set for April 3, 2021

    - Initiated ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2020.

    "In the first half of 2020 we drove robust growth of NUPLAZID®. With the FDA filing of our sNDA for dementia-related psychosis we are one step closer to potentially delivering the first and only approved treatment for this devastating condition," said Steve Davis, ACADIA's Chief Executive Officer. "Building upon the successful development of our PDP and DRP programs, our clinical team is focused on advancing our innovative early- and late-stage pipeline."

    Company Updates

    • The U.S. Food and Drug Administration (FDA) filed the supplemental NDA for pimavanserin for the treatment of the hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA has assigned a PDUFA (Prescription Drug User Fee Act) action date of April 3, 2021.
    • ACADIA announced top-line results from the Phase 3 CLARITY study of pimavanserin for adjunctive treatment in patients with major depressive disorder. The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.
    • ACADIA initiated its second pivotal study, ADVANCE-2, a 26-week, placebo-controlled, 386 patient Phase 3 study designed to evaluate the efficacy and safety of the 34 mg dose of pimavanserin for the treatment of the negative symptoms of schizophrenia.
    • ACADIA presented important clinical data at recent virtual medical congresses:
      • In May, at the 2020 American Society of Clinical Psychopharmacology virtual annual meeting, ACADIA presented six posters and an oral presentation on the positive pivotal ADVANCE study results, titled ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients with Negative Symptoms of Schizophrenia.
      • In July, at the 2020 Alzheimer's Association International Conference virtual event, ACADIA presented nine posters and an oral presentation on the positive findings from the open-label portion of the HARMONY study, titled HARMONY: Response to Pimavanserin in the 12-Week, Open-label Treatment Phase.
    • ACADIA appointed Mark Schneyer as Senior Vice President, Business Development and Chief Business Officer and appointed Spyros Papapetropoulos, M.D., Ph.D., as Senior Vice President, Head of Clinical Development.

    Financial Results

    Revenue

    Net sales of NUPLAZID (pimavanserin) were $110.1 million for the three months ended June 30, 2020, an increase of 32% as compared to $83.2 million reported for the three months ended June 30, 2019. For the six months ended June 30, 2020 and 2019, ACADIA reported net product sales of $200.2 million and $146.2 million, respectively.

    Research and Development

    Research and development expenses for the three months ended June 30, 2020 were $64.3 million, compared to $67.3 million for the same period of 2019. The decrease in the three month period ending June 2020 compared to June 2019 was primarily due to lower development costs for pimavanserin in schizophrenia and DRP. For the six months ended June 30, 2020 and 2019, research and development expenses were $136.9 million and $120.2 million, respectively. The increase during the six month period ending June 2020 compared to June 2019 was primarily due to an upfront payment of $10.0 million to Vanderbilt University for the M1 PAM program and increased development costs associated with trofinetide, offset by decreased development costs for pimavanserin in schizophrenia and DRP.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended June 30, 2020 were $84.3 million, compared to $68.0 million for the same period of 2019. For the six months ended June 30, 2020 and 2019, selling, general and administrative expenses were $186.3 million and $161.1 million, respectively. The increase during the 2020 periods as compared to 2019 was primarily due to increased advertising and promotional costs as well as an increase in personnel and related costs.

    Net Loss

    For the three months ended June 30, 2020, ACADIA reported a net loss of $42.1 million, or $0.27 per common share, compared to a net loss of $54.9 million, or $0.38 per common share, for the same period in 2019. The net losses for the three months ended June 30, 2020 and 2019 included $19.5 million and $20.4 million, respectively, of non-cash stock-based compensation expense. For the six months ended June 30, 2020, ACADIA reported a net loss of $130.2 million, or $0.83 per common share, compared to a net loss of $140.2 million, or $0.97 per common share, for the same period in 2019. The net losses for the six months ended June 30, 2020 and 2019 included $41.9 million and $40.3 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At June 30, 2020, ACADIA's cash, cash equivalents, and investment securities totaled $658.6 million, compared to $697.4 million at December 31, 2019.

    2020 Financial Guidance

    • NUPLAZID net sales guidance is updated to $430 to $450 million from the previous range of $420 to $450 million.
    • GAAP R&D guidance is decreased to $265 to $280 million from the previous range of $270 to $285 million.
    • GAAP SG&A guidance is decreased to $400 to $420 million from the previous range of $425 to $445 million.
    • Non-cash stock-based compensation expense guidance of $90 to $100 million is unchanged compared to prior guidance.
    • 2020 year-end cash, cash equivalents, and investment securities is expected to be $570 to $590 million from a previous range of $470 to $500 million.

    Conference Call and Webcast Information

    ACADIA management will review its second quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9828845). A telephone replay of the conference call may be accessed through August 19, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9828845). The conference call also will be webcast live on ACADIA's website, www.acadia-pharm.com, under the investors section and will be archived there until September 2, 2020.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for any other neuropsychiatric disorders. ACADIA discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; unanticipated impacts of COVID-19 on ACADIA's business, including its commercial sales operations, current and planned clinical trials, supply chain, and guidance for full-year 2020 NUPLAZID net sales and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2020, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    110,103

     

     

    $

    83,205

     

     

    $

    200,171

     

     

    $

    146,164

     

    Total revenues

     

     

    110,103

     

     

     

    83,205

     

     

     

    200,171

     

     

     

    146,164

     

    Operating expenses

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

     

    5,474

     

     

     

    4,995

     

     

     

    10,448

     

     

     

    9,575

     

    Research and development (1)

     

     

    64,295

     

     

     

    67,320

     

     

     

    136,931

     

     

     

    120,243

     

    Selling, general and administrative (1)

     

     

    84,344

     

     

     

    67,981

     

     

     

    186,317

     

     

     

    161,071

     

    Total operating expenses

     

     

    154,113

     

     

     

    140,296

     

     

     

    333,696

     

     

     

    290,889

     

    Loss from operations

     

     

    (44,010

    )

     

     

    (57,091

    )

     

     

    (133,525

    )

     

     

    (144,725

    )

    Interest income, net

     

     

    1,825

     

     

     

    2,527

     

     

     

    4,814

     

     

     

    5,461

     

    Other income (expense)

     

     

    437

     

     

     

    (12

    )

     

     

    (1,060

    )

     

     

    (241

    )

    Loss before income taxes

     

     

    (41,748

    )

     

     

    (54,576

    )

     

     

    (129,771

    )

     

     

    (139,505

    )

    Income tax expense

     

     

    393

     

     

     

    365

     

     

     

    393

     

     

     

    740

     

    Net loss

     

    $

    (42,141

    )

     

    $

    (54,941

    )

     

    $

    (130,164

    )

     

    $

    (140,245

    )

    Net loss per common share, basic and diluted

     

    $

    (0.27

    )

     

    $

    (0.38

    )

     

    $

    (0.83

    )

     

    $

    (0.97

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    156,535

     

     

     

    144,314

     

     

     

    155,951

     

     

     

    144,148

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

     

    $

    743

     

     

    $

    803

     

     

    $

    1,592

     

     

    $

    1,798

     

    Research and development

     

    $

    7,235

     

     

    $

    7,901

     

     

    $

    15,692

     

     

    $

    15,781

     

    Selling, general and administrative

     

    $

    11,529

     

     

    $

    11,718

     

     

    $

    24,571

     

     

    $

    22,726

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

     

    June 30,

    2020

     

    December 31,

    2019

     

     

    (unaudited)

     

     

    Assets

     

     

     

     

    Cash, cash equivalents and investment securities

     

    $

    658,551

     

    $

    697,429

    Accounts receivable, net

     

     

    43,785

     

     

    35,781

    Interest and other receivables

     

     

    2,343

     

     

    2,093

    Inventory

     

     

    6,210

     

     

    6,341

    Prepaid expenses

     

     

    24,846

     

     

    18,606

    Total current assets

     

     

    735,735

     

     

    760,250

    Property and equipment, net

     

     

    6,687

     

     

    3,180

    Operating lease right-of-use assets

     

     

    7,880

     

     

    9,524

    Intangible assets, net

     

     

    1,846

     

     

    2,585

    Restricted cash

     

     

    5,770

     

     

    4,787

    Other assets

     

     

    1,731

     

     

    2,857

    Total assets

     

    $

    759,649

     

    $

    783,183

    Liabilities and stockholders' equity

     

     

     

     

    Accounts payable

     

    $

    6,466

     

    $

    7,222

    Accrued liabilities

     

     

    79,956

     

     

    67,604

    Total current liabilities

     

     

    86,422

     

     

    74,826

    Operating lease liabilities

     

     

    5,669

     

     

    6,361

    Other long-term liabilities

     

     

    4,545

     

     

    2,861

    Total liabilities

     

     

    96,636

     

     

    84,048

    Total stockholders' equity

     

     

    663,013

     

     

    699,135

    Total liabilities and stockholders' equity

     

    $

    759,649

     

    $

    783,183

     

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  20. - Key findings presented at AAIC 2020 include: a need to improve patients' symptoms and ability to know what is real versus what is not real

    - When asked to rank the impact on their own life, patients reported that visual hallucinations were the most impactful symptom

    - Care partners reported paranoid delusions/false beliefs as most impactful

    UsAgainstAlzheimer's, the Lewy Body Dementia Association and ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the results of a qualitative and quantitative survey that explored the impact of dementia-related psychosis on more than 200 patients to better understand the patient-centered experience of symptoms and unmet treatment needs. Both patients and caregivers responded to the survey…

    - Key findings presented at AAIC 2020 include: a need to improve patients' symptoms and ability to know what is real versus what is not real

    - When asked to rank the impact on their own life, patients reported that visual hallucinations were the most impactful symptom

    - Care partners reported paranoid delusions/false beliefs as most impactful

    UsAgainstAlzheimer's, the Lewy Body Dementia Association and ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the results of a qualitative and quantitative survey that explored the impact of dementia-related psychosis on more than 200 patients to better understand the patient-centered experience of symptoms and unmet treatment needs. Both patients and caregivers responded to the survey. These data were presented today in two posters during the Alzheimer's Association International Conference® (AAIC) virtual event, convening July 27-31, 2020.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200729005275/en/

    Key findings of the quantitative portion of the survey noted the most common symptoms of dementia-related psychosis reported by patients were visual hallucinations, auditory hallucinations, and distortion of senses. Care partners reported paranoid delusions/false beliefs as most impactful and that the symptoms of dementia-related psychosis make it difficult for their loved ones to know what is real and what is not real, increase anxiety, and impact their personal relationships. During the qualitative survey, the majority of participants reported that symptoms such as visual hallucinations, auditory hallucinations, and persecutory delusions have an impact on activities of daily living, sleep, family life, and safety concerns.

    "The symptoms of dementia-related psychosis can cause fear and anxiety, disrupting the lives of people living with dementia and their families," said Virginia Biggar, Senior Director of Communities, UsAgainstAlzheimer's. "The survey results show that many patients with dementia-related psychosis are unaware of what's happening or how to communicate what they are experiencing. The findings highlight the need for caregivers and healthcare providers to be able to better recognize, report, and manage these symptoms," added Terry Frangiosa, Lead Investigator, UsAgainstAlzheimer's A-LIST Insight Series.

    "There is an immense need to find better treatment and management strategies for hallucinations and delusions as a way to improve the lives of those living with dementia," said Angela Taylor, Senior Director of Research and Advocacy, Lewy Body Dementia Association. "We look forward to continuing efforts with ACADIA and our partner organizations on this project to increase awareness of neuropsychiatric symptoms of dementia in order to drive more comprehensive care and alleviate the distress these symptoms bring to those with dementia, their families and caregivers."

    "The data shows people with dementia-related psychosis experience hallucinations and delusions that have a substantial burden on their lives," said Teresa Brandt, Executive Director of Regulatory Affairs, ACADIA Pharmaceuticals. "We are pleased to be a part of this patient-focused study as it is critical for the treatment triad of patients, caregivers and healthcare providers to better identify and understand these symptoms, and to incorporate the patient's voice in drug development and evaluation."

    Survey Results

    The survey followed the approach as outlined in the FDA's 21st Century Cures Act – Patient Focused Drug Development. This observational, non-interventional, prospective study analyzed interviews with persons or their care partners who have a clinical diagnosis of all-cause dementia with psychotic symptoms. The online survey was completed by 26 people living with self-reported dementia-related psychosis and 186 care partners who responded on behalf of patients, identified through UsAgainstAlzheimer's and the Lewy Body Dementia Association.

    Survey results included the following key findings:

    • Most common symptoms of dementia-related psychosis reported by patients (n=26) were visual hallucinations (89 percent), auditory hallucinations (54 percent), and distortion of senses (54 percent).
    • Of patients who reported recent visual hallucinations, 61 percent indicated they occurred at least weekly.
    • Care partners surveyed about their loved ones with dementia-related psychosis (n=186) identified paranoid delusions (76 percent), visual hallucinations (75 percent), and lack of trust for loved ones (52 percent) as the most common symptoms.
    • The majority of care partners (77 percent) reported paranoid delusions as occurring at least weekly.

    Full survey results are available here.

    About UsAgainstAlzheimer's

    UsAgainstAlzheimer's (UsA2) is a disruptive advocacy and research-focused organization that is pushing for expanding treatments and accelerating towards a cure for Alzheimer's disease. UsA2's transformative programming is laser-focused on proactive brain health across the lifespan and understanding what matters most across the lived experiences of those affected by Alzheimer's in the service of preventing, treating and curing this disease. We are working to ensure that all communities have their voices heard and get a chance to be brain healthy from the earliest years while building resistance against possible cognitive decline.

    About the Lewy Body Dementia Association

    The Lewy Body Dementia Association (LBDA) is the nation's leading authority on Lewy body dementias (LBD) and is dedicated to continuous outreach, education, research, and support for those affected with LBD and their families. LBD is a progressive brain disease that affects thinking, movement, behavior, and impacts 1.4 million people in the United States.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, schizophrenia-negative symptoms, Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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  21. ACADIA to Host Conference Call and Webcast on Wednesday, August 5, 2020, at 4:30 p.m. Eastern Time

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report second quarter financial results on Wednesday, August 5, 2020, after the close of the U.S. financial markets. ACADIA's management team will also host a conference call and webcast on Wednesday, August 5, 2020, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9828845). A telephone replay of the conference call may be accessed through August 19, 2020 by dialing 855-859-2056 for…

    ACADIA to Host Conference Call and Webcast on Wednesday, August 5, 2020, at 4:30 p.m. Eastern Time

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report second quarter financial results on Wednesday, August 5, 2020, after the close of the U.S. financial markets. ACADIA's management team will also host a conference call and webcast on Wednesday, August 5, 2020, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9828845). A telephone replay of the conference call may be accessed through August 19, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9828845). The conference call also will be webcast live on ACADIA's website, www.acadia-pharm.com under the investors section and will be archived there until September 2, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  22. - If approved, NUPLAZID would be the first and only treatment indicated for dementia-related psychosis

    - Prescription Drug User Fee Act (PDUFA) date set for April 3, 2021

    - Conference call and webcast to be held today at 4:30 p.m. Eastern Time

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).

    "We are pleased that the FDA has accepted our sNDA for filing and we will be working closely with the FDA to facilitate completion of the review in a timely manner," said Steve Davis, ACADIA's Chief…

    - If approved, NUPLAZID would be the first and only treatment indicated for dementia-related psychosis

    - Prescription Drug User Fee Act (PDUFA) date set for April 3, 2021

    - Conference call and webcast to be held today at 4:30 p.m. Eastern Time

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).

    "We are pleased that the FDA has accepted our sNDA for filing and we will be working closely with the FDA to facilitate completion of the review in a timely manner," said Steve Davis, ACADIA's Chief Executive Officer. "If approved, NUPLAZID would be the first therapy indicated for the treatment of hallucinations and delusions associated with dementia-related psychosis. We look forward to potentially bringing this important treatment advancement to patients, caregivers and physicians."

    The FDA has assigned a standard review with a PDUFA (Prescription Drug User Fee Act) action date of April 3, 2021. The FDA has also informed the company that it has not identified any potential review issues at this point in their evaluation and at this time they are not planning to hold an Advisory Committee meeting.

    Dementia is highly prevalent, affecting approximately 8 million people in the U.S., and is expected to grow as the population ages. Approximately 30 percent, or 2.4 million people, experience dementia-related psychosis and only half of them, or 1.2 million, are diagnosed and treated1,2.

    The sNDA is supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023). The sNDA also includes positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints: the Phase 2 (-019) study in patients with Alzheimer's disease psychosis and the Phase 3 (-020) study in patients with Parkinson's disease psychosis. The sNDA includes a large safety database from completed and ongoing studies representing over 1500 patients with neurodegenerative disease.

    NUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinson's disease psychosis. Pimavanserin was granted Breakthrough Therapy Designation by the FDA for the treatment of hallucinations and delusions associated with DRP in October 2017.

    Conference Call and Webcast Information

    ACADIA will provide a corporate update via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call can be accessed by dialing 855-638-4820 for participants in the U.S. or Canada and 443-877-4067 for international callers (reference passcode 1486597). A telephone replay of the conference call may be accessed through July 27, 2020 by dialing 855- 859-2056 for callers in the U.S. or Canada and 404-537-3406 for international callers (reference passcode 1486597). The conference call will also be webcast live on ACADIA's website, www.acadia-pharm.com, in the investors section and will be archived there until August 20, 2020.

    About HARMONY

    HARMONY was a Phase 3 study designed to evaluate the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis across a broad population of patients with the most common clinically diagnosed subtypes of dementia including: Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia spectrum disorders. A total of 392 patients were enrolled in the study, with an average age of 74.5 years and a mean Mini-Mental State Examination (MMSE) score of 16.7. The primary endpoint in the study was time to relapse in the double-blind period as represented by the Kaplan-Meier curve and the hazard ratio. Top-line results were presented at the Clinical Trials on Alzheimer's Disease (CTAD) Meeting in December 2019.

    The HARMONY study included a 12-week open-label stabilization period during which patients with dementia-related psychosis began treatment with pimavanserin 34 mg once daily. In the open-label period, a significant majority (61.8%) of eligible subjects (N=351) met the sustained treatment response criteria at Week 8 and Week 12 and entered the double-blind period. Following the open-label period, patients who met pre-specified criteria for treatment response were then randomized into the double-blind period of the study to continue their pimavanserin dose (34 mg or 20 mg per day) or switched to placebo and followed for up to 26 weeks or until a relapse of psychosis occurred. Pimavanserin met its primary endpoint and was stopped at the pre-planned interim analysis for positive efficacy, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023).

    Pimavanserin was well-tolerated over the entire nine-month study duration, and pimavanserin treatment was not associated with a decline in cognition, as measured by the MMSE score, or the onset or worsening of extrapyramidal symptoms, as measured by the Extrapyramidal Symptom Rating Scale A (ESRS-A) score, compared to placebo. In the double-blind period, low rates of adverse events were observed, 41.0% of patients on pimavanserin and 36.6% on placebo. Discontinuations in the double-blind period due to adverse events were low, 2.9% for pimavanserin and 3.6% for placebo. Rates of serious adverse events were also low, 4.8% in the pimavanserin group and 3.6% in the placebo group. One death was reported in the open-label period and one death was reported in the pimavanserin group during the double-blind period. Investigators determined neither death was related to the study drug.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature.3 In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, including hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions.1,2 These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality.4

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. ACADIA submitted a supplemental new drug application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis on June 3, 2020. The FDA has accepted for filing the sNDA for DRP with a PDUFA date of April 3, 2021. NUPLAZID is not approved for dementia-related psychosis. In addition, ACADIA is developing pimavanserin in other neuropsychiatric conditions.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to pimavanserin as a potential treatment for the hallucinations and delusions associated with dementia-related psychosis, the expected growth in patients with dementia and other statements that are not historical facts. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

    References

    1Plassman BL, et al. Prevalence of dementia in the United States: The Aging Demographics, and Memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    22017 Alzheimer's Disease Facts and Figures and ACADIA market research.

    3Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

    4Connors MH et al. Am J Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry 2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11). Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al. Neurology 1994;44(12).

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  23. - The study did not achieve statistical significance on the primary endpoint

    - Conference call and webcast to be held today at 4:30 p.m. Eastern Time

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced top-line results from its 298 patient Phase 3 CLARITY study which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder (MDD). The combined efficacy and safety analysis was pre-specified prior to data unblinding following feedback from the FDA.

    The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score change…

    - The study did not achieve statistical significance on the primary endpoint

    - Conference call and webcast to be held today at 4:30 p.m. Eastern Time

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced top-line results from its 298 patient Phase 3 CLARITY study which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder (MDD). The combined efficacy and safety analysis was pre-specified prior to data unblinding following feedback from the FDA.

    The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score change from baseline to week 5. Pimavanserin 34 mg, given once-daily as an adjunctive treatment to standard antidepressant therapy was associated with a mean reduction of 9.0 in HAMD-17 total score compared to 8.1 for placebo as an adjunctive treatment (p=0.296).

    Positive results were observed on the key secondary endpoint, the Clinical Global Impression – Severity (CGI-S) score, a clinician assessment of a patient's severity of depression (nominal p=0.042).

    "We observed a consistent improvement of depressive symptoms over time with pimavanserin but, unfortunately, the robust positive results from our CLARITY-1 study were not replicated," said Serge Stankovic, ACADIA's President. "While these results do not support the product profile to pursue an additional Phase 3 study in adjunctive MDD, we will continue to analyze the data and the findings from our earlier positive depression studies as we assess next steps. All of us at ACADIA thank the patients, their families and the investigators who participated in the Phase 3 CLARITY study."

    In the study, pimavanserin was generally well-tolerated when added to existing antidepressant therapy, and similar rates of adverse events were observed between pimavanserin (58.1%) and placebo (54.7%).

    About the Phase 3 CLARITY Study

    The Phase 3 CLARITY study is a combination of CLARITY-2 and CLARITY-3, which were both 6-week, parallel-designed, randomized, double-blind, placebo-controlled, multi-center studies designed to evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with MDD who have an inadequate response to standard antidepressant therapy with either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). A total of 298 patients were randomized to receive six weeks of oral treatment with either 34 mg of pimavanserin or placebo, once daily, in addition to their ongoing antidepressant. The primary endpoint was change from baseline on the HAMD-17 total score.

    Phase 3 CLARITY Study Results:

    Efficacy Analysis

    • Statistical significance not achieved on the primary endpoint: HAMD-17 (p=0.296).
    • Positive results observed on key secondary endpoint: CGI-S (nominal p=0.042).
    • Positive results observed on Karolinska Sleepiness Scale (KSS) score (nominal p=0.005).
    • Clinically meaningful separation was not achieved on the other secondary endpoints.

    Safety and Tolerability

    • Similar rates of adverse events were observed between pimavanserin (58.1%) and placebo (54.7%).
    • Adverse events reported in greater than 5% of patients on pimavanserin and greater than placebo were diarrhea, dry mouth and headache.
    • Discontinuations due to adverse events were 2.7% for both pimavanserin and placebo.
    • Two subjects in each of the pimavanserin and placebo groups reported serious adverse events (SAEs). These SAEs were deemed not to be related to the study drug by the investigators.
    • The adjunctive use of pimavanserin did not result in clinically significant differences in vital signs, metabolic parameters or extrapyramidal symptoms compared to placebo.

    ACADIA previously announced plans to combine its CLARITY-2 and CLARITY-3 Phase 3 studies evaluating pimavanserin for the adjunctive treatment of MDD with a pre-specified statistical analysis plan. The two Phase 3 studies concluded with slightly more than 50% enrollment.

    Patients who completed the Phase 3 study were eligible to participate in the ongoing 52-week open-label extension study to evaluate the long-term safety and tolerability of pimavanserin as adjunctive treatment to standard antidepressants in MDD.

    About the CLARITY-1 Study

    CLARITY-1 was a Phase 2, 10-week, randomized, double-blind, placebo-controlled, multi-center, 2-stage sequential parallel comparison design (SPCD) study that evaluated the safety, tolerability, and efficacy of pimavanserin (34 mg once daily) as an adjunctive treatment in patients with MDD who had an inadequate response to a stable dose of standard antidepressant therapy with either a SSRI or a SNRI. The study was conducted in collaboration with the Massachusetts General Hospital Clinical Trials Network & Institute and randomized 207 patients across 27 clinical research centers in the U.S. and was completed in 2018.

    In the trial, pimavanserin met the primary endpoint by significantly reducing the HAMD-17 total score compared to placebo (p=0.039). On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004). Positive results were also observed for seven other secondary endpoints including the CGI-S score (p=0.008) and the KSS score (p=0.021).

    In the parallel design portion (Stage 1) of this SPCD study, adding pimavanserin to SSRI or SNRI therapy also significantly reduced HAMD-17 scores compared to placebo (p=0.0003). On the key secondary endpoint, pimavanserin also demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004).

    About the Open-Label Comorbid Parkinson's Disease and Depression Study

    This was an 8-week, open-label, single-arm Phase 2 study evaluating the efficacy and safety of pimavanserin as an adjunct to a SSRI or a SNRI or as a monotherapy in adults with both Parkinson's disease and depression (n=47) and was completed in 2019. In the study, patients treated with pimavanserin had significant improvement on the primary endpoint, the HAMD-17 total score change in baseline to week 8 (p<0.0001), with significant improvement seen as early as week 2 (p<0.0001). Improvement of ≥50% on the HAMD-17 total score was observed in 60.0% of patients at week 8, with 44.4% of patients reaching remission (HAMD-17 ≤7).

    Additional results from this study showed that Parkinson's disease patients treated with pimavanserin for depression also demonstrated improvement on multiple secondary endpoints compared to baseline, including the CGI-S score (p<0.0001) and the SCOPA-Global Sleep Quality scale (p<0.0001).

    Conference Call and Webcast Information

    ACADIA will provide a corporate update via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call can be accessed by dialing 855-638-4820 for participants in the U.S. or Canada and 443-877-4067 for international callers (reference passcode 1486597). A telephone replay of the conference call may be accessed through July 27, 2020 by dialing 855-859-2056 for callers in the U.S. or Canada and 404-537-3406 for international callers (reference passcode 1486597). The conference call will also be webcast live on ACADIA's website, www.acadia-pharm.com, in the investors section and will be archived there until August 20, 2020.

    About Major Depressive Disorder

    According to the National Institute of Mental Health, MDD affects approximately 17 million adults in the U.S.1, with approximately 2.5 million adults treated with adjunctive therapy.2,3 MDD is a condition characterized by depressive symptoms such as a depressed mood or a loss of interest or pleasure in daily activities for more than two weeks, as well as impaired social, occupational, or other important functioning. Continuing depression has been consistently linked with greater economic burden, with higher rate of healthcare utilization and reduced work productivity.4 The majority of people who suffer from MDD do not respond adequately to initial antidepressant therapy or discontinue due to side effects or safety concerns.5,6

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. The serotonin system is thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. ACADIA submitted a supplemental new drug application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis on June 3, 2020. The FDA has accepted for filing the sNDA for DRP with a PDUFA date of April 3, 2021. NUPLAZID is not approved for dementia-related psychosis. In addition, ACADIA is developing pimavanserin in other neuropsychiatric conditions.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to the potential benefits of pimavanserin as adjunctive treatment for major depressive disorder or other central nervous system disorders as well as the potential results of clinical trials of pimavanserin in other indications. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

    References

    1National Institute of Mental Health. (2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml

    2IMS NSP, NPA, NDTI MAT-24 month data through Aug 2017.

    3PLOS One, Characterization of Treatment Resistant Depression Episodes in a Cohort of Patients from a US Commercial Claims Database, Oct 2013, Vol 8, Issue 10.

    4Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of adults with major depressive disorder in the United States (2005 and 2010). J Clin Psych. 2015;76(2):155-162. doi: 10.4088/JCP.14m09298.

    5Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

    6Sansone RA, Sansone LA. Antidepressant adherence: are patients taking their medications? Innov Clin Neurosci. 2012;9(5-6):41-46.

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  24. - Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 fold reduction in the risk of relapse of psychosis

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to support a potential new indication for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.

    "This is an important step forward for the approximately 2.4 million people in the U.S. who…

    - Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 fold reduction in the risk of relapse of psychosis

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to support a potential new indication for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.

    "This is an important step forward for the approximately 2.4 million people in the U.S. who suffer from dementia-related hallucinations and delusions, representing a large unmet need with currently no approved treatment options," said Steve Davis, ACADIA's Chief Executive Officer. "Our pivotal HARMONY study showed a meaningful reduction of the symptoms and stabilization of psychosis and a nearly three-fold reduction in the risk of relapse of psychosis for patients continuing treatment on pimavanserin compared to placebo. We look forward to working with the FDA as it reviews our submission."

    The sNDA is supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023). The sNDA also includes positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints: The Phase 2 (-019) study in patients with Alzheimer's disease psychosis and the Phase 3 (-020) study in patients with Parkinson's disease psychosis. The sNDA includes a large safety and tolerability database from completed and ongoing studies representing over 1500 patients with neurodegenerative disease.

    Dementia is highly prevalent, affecting approximately 8 million people in the U.S., and is only expected to grow as the population ages. Approximately 30 percent, or 2.4 million people, experience dementia-related psychosis and only half, or 1.2 million, are diagnosed and treated1,2.

    NUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinson's disease psychosis. If approved by the FDA, NUPLAZID would be the first drug approved to treat the hallucinations and delusions associated with dementia-related psychosis and would be the second indication for NUPLAZID.

    About HARMONY

    HARMONY was a Phase 3 study designed to evaluate the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis across a broad population of patients with the most common clinically diagnosed subtypes of dementia including: Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia spectrum disorders. A total of 392 patients were enrolled in the study, with an average age of 74.5 years and a mean Mini-Mental State Examination (MMSE) score of 16.7. The primary endpoint in the study was time to relapse in the double-blind period as represented by the Kaplan-Meier curve and the hazard ratio. Top-line results were presented at the 2019 Clinical Trials on Alzheimer's Disease (CTAD) Meeting in December 2019.

    The HARMONY study included a 12-week open-label stabilization period during which patients with dementia-related psychosis began treatment with pimavanserin 34 mg once daily. In the open-label period, a significant majority (61.8%) of eligible subjects (N=351) met the sustained treatment response criteria at Week 8 and Week 12 and entered the double-blind period. Following the open-label period, patients who met pre-specified criteria for treatment response were then randomized into the double-blind period of the study to continue their pimavanserin dose (34 mg or 20 mg per day) or switched to placebo and followed for up to 26 weeks or until a relapse of psychosis occurred. Pimavanserin met its primary endpoint and was stopped at the pre-planned interim analysis for positive efficacy, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023).

    Pimavanserin was well-tolerated over the entire nine-month study duration, and pimavanserin treatment was not associated with a decline in cognition, as measured by the MMSE score, or the onset or worsening of extrapyramidal symptoms, as measured by the Extrapyramidal Symptom Rating Scale A (ESRS-A) score, compared to placebo. In the double-blind period, low rates of adverse events were observed, 41.0% of patients on pimavanserin and 36.6% on placebo. Discontinuations in the double-blind period due to adverse events were low, 2.9% for pimavanserin and 3.6% for placebo. Rates of serious adverse events were also low, 4.8% in the pimavanserin group and 3.6% in the placebo group. One death was reported in the open-label period and one death was reported in the pimavanserin group during the double-blind period. Investigators determined neither death was related to the study drug.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature.3 In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, including hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions1,2. These symptoms may be frequent and severe and may recur over time. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality4.

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in psychosis, schizophrenia, depression and other neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. ACADIA is evaluating pimavanserin in an extensive clinical development program in multiple indications with significant unmet need, including dementia-related psychosis, major depressive disorder, and negative symptoms of schizophrenia. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for dementia-related psychosis, schizophrenia or major depressive disorder.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, the negative symptoms of schizophrenia, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to pimavanserin as a potential treatment for the hallucinations and delusions associated with dementia-related psychosis and other statements that are not historical facts. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, and approval and commercialization. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

    References

    1Plassman BL, et al. Prevalence of dementia in the United States: the Aging Demographics, and Memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    22017 Alzheimer's Disease Facts and Figures and ACADIA market research.

    3Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

    4Connors MH et al. Am J Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry 2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11). Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al. Neurology 1994;44(12).

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  25. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference on Tuesday, June 9, 2020, at 4:40 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of ACADIA's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through July 9, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference on Tuesday, June 9, 2020, at 4:40 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of ACADIA's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through July 9, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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  26. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today announced that Mark Schneyer has been appointed to the newly created position of Senior Vice President, Business Development and Chief Business Officer. Mr. Schneyer will be responsible for sourcing and executing business development opportunities and serve as a member of the company's Executive Management Committee. He will report to Steve Davis, Chief Executive Officer.

    "I am very excited to welcome Mark to ACADIA as his extensive experience in the biopharmaceutical industry will be a valuable addition as we continue to expand our pipeline through business development," said Mr. Davis. "We remain focused on leveraging our research and development and commercial expertise as we advance…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today announced that Mark Schneyer has been appointed to the newly created position of Senior Vice President, Business Development and Chief Business Officer. Mr. Schneyer will be responsible for sourcing and executing business development opportunities and serve as a member of the company's Executive Management Committee. He will report to Steve Davis, Chief Executive Officer.

    "I am very excited to welcome Mark to ACADIA as his extensive experience in the biopharmaceutical industry will be a valuable addition as we continue to expand our pipeline through business development," said Mr. Davis. "We remain focused on leveraging our research and development and commercial expertise as we advance our business development strategies to position ACADIA for long-term growth."

    Mr. Schneyer joins ACADIA from Pfizer Inc. where he most recently was Vice President, Business Development, for the Upjohn division. Mr. Schneyer joined Pfizer's Worldwide Business Development organization in 2011 and served in various business development positions of increasing responsibility overseeing strategic transactions spanning licensing agreements, product acquisitions and divestitures, strategic collaborations and company acquisitions. Prior to Pfizer, he was an investment banker at Lazard and advised boards of directors and senior management teams in the healthcare sector. Mr. Schneyer earned a Bachelor of Science in economics with a concentration in finance from the Wharton School of the University of Pennsylvania.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  27. - Top-line results expected in 3Q20

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that following positive feedback from the U.S. Food and Drug Administration the company plans to combine its CLARITY-2 and CLARITY-3 Phase 3 studies evaluating pimavanserin for the adjunctive treatment of major depressive disorder (MDD) into one study with a pre-specified statistical analysis plan. As a result, no new patients will be enrolled in the two identically designed Phase 3 studies, each of which will be concluded with slightly more than 50% enrollment. Top-line results from the combined study are expected in the third quarter of 2020.

    If positive, the results from the combined study, along with the positive results from the previously…

    - Top-line results expected in 3Q20

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that following positive feedback from the U.S. Food and Drug Administration the company plans to combine its CLARITY-2 and CLARITY-3 Phase 3 studies evaluating pimavanserin for the adjunctive treatment of major depressive disorder (MDD) into one study with a pre-specified statistical analysis plan. As a result, no new patients will be enrolled in the two identically designed Phase 3 studies, each of which will be concluded with slightly more than 50% enrollment. Top-line results from the combined study are expected in the third quarter of 2020.

    If positive, the results from the combined study, along with the positive results from the previously announced pivotal CLARITY study, would form the basis for a supplemental new drug application for pimavanserin in the adjunctive treatment of MDD.

    About CLARITY-2 and CLARITY-3

    CLARITY-2 and CLARITY-3 are both 6-week, parallel-designed, randomized, double-blind, placebo-controlled, multi-center studies designed to evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with MDD who have an inadequate response to standard antidepressant therapy with either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). Patients in both studies were randomized to receive six weeks of oral treatment with either 34 mg of pimavanserin or placebo, once daily, in addition to their ongoing antidepressant. The primary endpoint in both studies is the change from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.

    Patients who completed the Phase 3 studies were eligible to participate in the ongoing 52-week open-label extension study to evaluate the long-term safety and tolerability of pimavanserin in MDD. The open-label extension study is continuing as planned.

    About CLARITY

    CLARITY was a Phase 2, 10-week, randomized, double-blind, placebo-controlled, multi-center, 2-stage sequential parallel comparison design (SPCD) study that evaluated the safety, tolerability, and efficacy of pimavanserin (34 mg once daily) as an adjunctive treatment in patients with MDD who had an inadequate response to a stable dose of standard antidepressant therapy with either a SSRI or a SNRI. The study was conducted in collaboration with the Massachusetts General Hospital Clinical Trials Network & Institute and randomized 207 patients across 27 clinical research centers in the U.S.

    In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing the HAMD-17 total score compared to placebo (p=0.039). On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004). Positive results were also observed for seven other secondary endpoints including the Karolinska Sleepiness Scale (p=0.0205) and the Massachusetts General Hospital Sexual Functioning Index (p=0.0003).

    In the parallel design portion (Stage 1) of this SPCD study, adding pimavanserin to first-line SSRI or SNRI therapy also significantly reduced HAMD-17 scores compared to placebo (p=0.0003). On the key secondary endpoint, pimavanserin also demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004).

    About Major Depressive Disorder

    According to the National Institute of Mental Health, MDD affects approximately 17 million adults in the U.S.1, with approximately 2.5 million adults treated with adjunctive therapy.2,3 MDD is a condition characterized by depressive symptoms such as a depressed mood or a loss of interest or pleasure in daily activities for more than two weeks, as well as impaired social, occupational, or other important functioning. The majority of people who suffer from MDD do not respond adequately to initial antidepressant therapy.4

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in psychosis, schizophrenia, depression and other neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. ACADIA is evaluating pimavanserin in an extensive clinical development program across multiple indications with significant unmet need including dementia-related psychosis, adjunctive major depressive disorder, and the negative symptoms of schizophrenia. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for dementia-related psychosis, schizophrenia or major depressive disorder.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to the potential benefits of pimavanserin as adjunctive treatment for major depressive disorder or other central nervous system disorders as well as the potential results of clinical trials of pimavanserin in other indications. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • QT Interval Prolongation: NUPLAZID prolongs the QT interval.
      • The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Indication: NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Dosage and Administration: Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please see the full Prescribing Information including Boxed WARNING for NUPLAZID.

    References:

    1National Institute of Mental Health. (2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml

    2IMS NSP, NPA, NDTI MAT-24 month data through Aug 2017.

    3PLOS One, Characterization of Treatment Resistant Depression Episodes in a Cohort of Patients from a US Commercial Claims Database, Oct 2013, Vol 8, Issue 10.

    4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

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  28. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that multiple scientific presentations and abstracts evaluating pimavanserin in clinical studies for the treatment of various central nervous system (CNS) disorders will be highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting on May 29-30, 2020.

    "Our research presentations at ASCP underscore the potential clinical utility of pimavanserin in serious CNS disorders," said Serge Stankovic, M.D., M.S.P.H., ACADIA's President. "We look forward to sharing data from our pivotal studies in negative symptoms of schizophrenia and major depressive disorder where pimavanserin has demonstrated the potential to be an important treatment option for…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that multiple scientific presentations and abstracts evaluating pimavanserin in clinical studies for the treatment of various central nervous system (CNS) disorders will be highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting on May 29-30, 2020.

    "Our research presentations at ASCP underscore the potential clinical utility of pimavanserin in serious CNS disorders," said Serge Stankovic, M.D., M.S.P.H., ACADIA's President. "We look forward to sharing data from our pivotal studies in negative symptoms of schizophrenia and major depressive disorder where pimavanserin has demonstrated the potential to be an important treatment option for patients, as well as new long-term safety and tolerability data of NUPLAZID® in Parkinson's disease psychosis."

    ASCP Accepted Scientific Presentations include:

    Negative Symptoms of Schizophrenia

    • Pharmaceutical Pipeline Oral Presentation: ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients with Negative Symptoms of Schizophrenia on Saturday, May 30, 2020, 4:55 p.m. - 5:05 p.m. Eastern Time.
    • Poster Presentation: ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients with Negative Symptoms of Schizophrenia on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.

    Depression

    • Poster Presentation: Effect of Adjunctive Pimavanserin on Suicidality in Patients with Major Depressive Disorder: Secondary Analysis from CLARITY on Friday, May 29, 2020, 12:30 p.m. - 2:00 p.m. Eastern Time.
    • Poster Presentation: Effect of Adjunctive Pimavanserin on Insomnia and Function in Patients with Major Depressive Disorder: Secondary Analysis from CLARITY on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.
    • Poster Presentation: Pimavanserin for the Treatment of Comorbid Depression in Patients with Parkinson's Disease on Friday, May 29, 2020, 12:30 p.m. - 2:00 p.m. Eastern Time.

    Parkinson's Disease Psychosis

    • Poster Presentation: Long-Term Evaluation of Open-Label Pimavanserin Safety and Tolerability in Parkinson's Disease Psychosis on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.
    • Poster Presentation: Improvement and Durability in SAPS-PD Assessment over 10 Weeks of Pimavanserin Treatment for Parkinson's Disease Psychosis on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in psychosis, schizophrenia, depression and other neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. ACADIA is evaluating pimavanserin in an extensive clinical development program across multiple indications with significant unmet need including dementia-related psychosis, adjunctive major depressive disorder, and the negative symptoms of schizophrenia. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for dementia-related psychosis, schizophrenia, major depressive disorder or depression in patients with Parkinson's disease.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential benefits of pimavanserin as adjunctive treatment for major depressive disorder, the negative symptoms of schizophrenia or other central nervous system disorders as well as the potential results of clinical trials of pimavanserin in other indications. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • QT Interval Prolongation: NUPLAZID prolongs the QT interval.
      • The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Indication: NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Dosage and Administration: Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please see the full Prescribing Information including Boxed WARNING for NUPLAZID.

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  29. - 1Q20 Net Sales of $90.1 Million, a 43% Increase Over 1Q19

    - On-track to submit supplemental NDA for pimavanserin for the treatment of dementia-related psychosis (DRP) this summer

    - Announced worldwide license agreement and collaboration with Vanderbilt University for new central nervous system (CNS) therapeutic program

    - 2020 revenue guidance reduced by approximately 5% due to currently anticipated COVID-19 impact

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the quarter ended March 31, 2020.

    "ACADIA entered 2020 with positive…

    - 1Q20 Net Sales of $90.1 Million, a 43% Increase Over 1Q19

    - On-track to submit supplemental NDA for pimavanserin for the treatment of dementia-related psychosis (DRP) this summer

    - Announced worldwide license agreement and collaboration with Vanderbilt University for new central nervous system (CNS) therapeutic program

    - 2020 revenue guidance reduced by approximately 5% due to currently anticipated COVID-19 impact

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the quarter ended March 31, 2020.

    "ACADIA entered 2020 with positive momentum. Successful execution of our commercial efforts led to continued strong performance of NUPLAZID® for Parkinson's disease psychosis and our plans remain on track for delivering a potential second indication with pimavanserin for the treatment of DRP. We also continue to invest in our late-stage pipeline and business development opportunities to shape our mid and long-term growth strategy," said Steve Davis, ACADIA's Chief Executive Officer. "Our results this quarter reflect the dedication of our employees and I am proud of our team's commitment to the patients we serve while adapting to the challenges of the global COVID-19 pandemic."

    Company Updates

    • ACADIA completed a pre-sNDA meeting with the U.S. Food and Drug Administration and is on-track to submit a supplemental NDA this summer for pimavanserin as a potential breakthrough therapy for DRP.
    • The FDA granted Rare Pediatric Disease designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder.
    • ACADIA entered into an exclusive worldwide license agreement and research collaboration with Vanderbilt University, adding an early clinical stage program focused on positive allosteric modulators (PAMs) of the M1 receptor to potentially treat a range of CNS disorders.

    Financial Results

    Revenue

    Net sales of NUPLAZID (pimavanserin) were $90.1 million for the three months ended March 31, 2020, an increase of 43% as compared to $63.0 million reported for the three months ended March 31, 2019.

    Research and Development

    Research and development expenses for the three months ended March 31, 2020 were $72.6 million, compared to $52.9 million for the same period of 2019. The increase was primarily due to an upfront payment of $10.0 million to Vanderbilt University for the M1 PAM program and increased development costs associated with trofinetide.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended March 31, 2020 were $102.0 million, compared to $93.1 million for the same period of 2019. The increase was largely due to increased personnel and medical affairs costs.

    Net Loss

    For the three months ended March 31, 2020, ACADIA reported a net loss of $88.0 million, or $0.57 per common share, compared to a net loss of $85.3 million, or $0.59 per common share, for the same period in 2019. The net losses for the three months ended March 31, 2020 and 2019 included $22.3 million and $19.9 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At March 31, 2020, ACADIA's cash, cash equivalents, and investment securities totaled $651.4 million, compared to $697.4 million at December 31, 2019.

    2020 Financial Guidance

    ACADIA is revising 2020 net sales and expense guidance to reflect the currently anticipated impact of the COVID-19 pandemic. ACADIA's 2020 net sales guidance reflects annual revenue growth of approximately 28% for NUPLAZID, at the mid-point of the range.

    • NUPLAZID net sales guidance is decreased to $420 to $450 million from the previous range of $440 to $470 million.
    • GAAP R&D guidance of $270 to $285 million is unchanged from prior guidance.
    • GAAP SG&A guidance is decreased to $425 to $445 million from the previous range of $440 to $460 million.
    • Non-cash stock-based compensation expense guidance of $90 to $100 million is unchanged compared to prior guidance.
    • 2020 year-end cash, cash equivalents, and investment securities of $470 to $500 million is unchanged compared to prior guidance.

    Conference Call and Webcast Information

    ACADIA management will review its first quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 1974276). A telephone replay of the conference call may be accessed through May 21, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 1974276). The conference call also will be webcast live on ACADIA's website, www.acadia-pharm.com, under the investors section and will be archived there until June 4, 2020.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for dementia-related psychosis, schizophrenia, major depressive disorder, or depressive symptoms in patients with Parkinson's disease. ACADIA discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; unanticipated impacts of COVID-19 on ACADIA's business, including its commercial sales operations, current and planned clinical trials, supply chain, and guidance for full-year 2020 NUPLAZID net sales and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2020, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

             

     

    Three Months Ended March 31,

     

     

    2020

       

    2019

     

    Revenues

     

     

       

     

     

     

    Product sales, net

    $

    90,068

       

    $

    62,959

     

    Total revenues

     

    90,068

       

     

    62,959

     

    Operating expenses

     

     

       

     

     

     

    Cost of product sales, license fees and royalties (1)

     

    4,974

       

     

    4,580

     

    Research and development (1)

     

    72,636

       

     

    52,923

     

    Selling, general and administrative (1)

     

    101,973

       

     

    93,090

     

    Total operating expenses

     

    179,583

       

     

    150,593

     

    Loss from operations

    (89,515

    )

    (87,634

    Interest income, net

     

    2,989

       

     

    2,934

     

    Other expense

    (1,497

    )

     

    (229

    )

    Loss before income taxes

     

    (88,023

    )

     

     

    (84,929

    )

    Income tax expense

     

       

     

    375

     

    Net loss

    $

    (88,023

    )

     

    $

    (85,304

    )

    Net loss per common share, basic and diluted

    $

    (0.57

    )

     

    $

    (0.59

    )

    Weighted average common shares outstanding, basic and diluted

     

    155,368

       

     

    143,981

     

     

     

     

       

     

     

     

     

     

     

       

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

       

     

     

     

     

     

     

       

     

     

     

    Cost of product sales, license fees and royalties

    $

    849

       

    $

    995

     

    Research and development

    $

    8,457

       

    $

    7,880

     

    Selling, general and administrative

    $

    13,042

       

    $

    11,008

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

     

    March 31,

    2020

     

     

    December 31,

    2019

     

     

     

    (unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and investment securities

     

    $

     

    651,406

     

     

    $

     

    697,429

     

    Accounts receivable, net

     

     

    41,636

     

     

     

    35,781

     

    Interest and other receivables

     

     

    2,935

     

     

     

    2,093

     

    Inventory

     

     

    6,318

     

     

     

    6,341

     

    Prepaid expenses

     

     

    22,126

     

     

     

    18,606

     

    Total current assets

     

     

    724,421

     

     

     

    760,250

     

    Property and equipment, net

     

     

    5,089

     

     

     

    3,180

     

    Operating lease right-of-use assets

     

     

    8,613

     

     

     

    9,524

     

    Intangible assets, net

     

     

    2,215

     

     

     

    2,585

     

    Restricted cash

     

     

    5,770

     

     

     

    4,787

     

    Other assets

     

     

    1,342

     

     

     

    2,857

     

    Total assets

     

    $

     

    747,450

     

     

    $

     

    783,183

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

     

    6,623

     

     

    $

     

    7,222

     

    Accrued liabilities

     

     

    93,118

     

     

     

    67,604

     

    Total current liabilities

     

     

    99,741

     

     

     

    74,826

     

    Operating lease liabilities

     

     

    6,090

     

     

     

    6,361

     

    Other long-term liabilities

     

     

    3,237

     

     

     

    2,861

     

    Total liabilities

     

     

    109,068

     

     

     

    84,048

     

    Total stockholders' equity

     

     

    638,382

     

     

     

    699,135

     

    Total liabilities and stockholders' equity

     

    $

     

    747,450

     

     

    $

     

    783,183

     

     

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  30. - ACADIA acquires exclusive worldwide rights to a novel therapeutic program targeting muscarinic M1 receptors

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) and Vanderbilt University today announced an exclusive worldwide license agreement to develop and commercialize novel drug candidates targeting the muscarinic M1 receptor with the potential to treat a range of central nervous system (CNS) disorders. The collaboration will focus on positive allosteric modulators (PAMs) of the M1 receptor.

    "ACADIA's collaboration with Vanderbilt University and its Warren Center for Neuroscience Drug Discovery (WCNDD), a leading academic center focused on discovering new drug candidates, complements our innovative late-stage pipeline," said Steve Davis, ACADIA's…

    - ACADIA acquires exclusive worldwide rights to a novel therapeutic program targeting muscarinic M1 receptors

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) and Vanderbilt University today announced an exclusive worldwide license agreement to develop and commercialize novel drug candidates targeting the muscarinic M1 receptor with the potential to treat a range of central nervous system (CNS) disorders. The collaboration will focus on positive allosteric modulators (PAMs) of the M1 receptor.

    "ACADIA's collaboration with Vanderbilt University and its Warren Center for Neuroscience Drug Discovery (WCNDD), a leading academic center focused on discovering new drug candidates, complements our innovative late-stage pipeline," said Steve Davis, ACADIA's Chief Executive Officer. "While the study of muscarinic modulators has been an area of high interest in the treatment of CNS disorders, it has proved difficult to separate efficacy from unwanted effects. WCNDD's approach represents a compelling opportunity for ACADIA to advance new potential therapies to treat disorders such as Alzheimer's disease and schizophrenia."

    "We are thrilled to be collaborating with ACADIA to further develop these novel compounds harnessing muscarinic receptors," said P. Jeffrey Conn, Ph.D., WCNDD director. "With ACADIA's proven development and commercialization capabilities in neuropsychiatric disorders, in combination with WCNDD's discovery expertise, we hope to develop differentiated treatment modalities that could address cognition and other neuropsychiatric symptoms that represent some of the largest unmet needs in CNS disorders today."

    The WCNDD has been developing highly selective PAMs of the M1 subtype of muscarinic acetylcholine receptor, which may represent a novel approach for improving cognitive function and other neuropsychiatric symptoms in patients suffering from CNS disorders. The agreement includes a lead compound currently in Phase 1 testing, as well as compounds currently in preclinical development and compounds generated in an ongoing discovery program. Under the terms of the License and Collaboration Agreement, Vanderbilt University will receive $10 million upfront and is eligible for potential milestone payments of up to $515 million and tiered royalties.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, the negative symptoms of schizophrenia, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    About the Warren Center for Neuroscience Drug Discovery at Vanderbilt University

    The Warren Center for Neuroscience Drug Discovery extends traditional academic pursuits in basic science to take the most exciting advances in our understanding of human disease and drug targets to a point where these breakthroughs can directly impact patient care. By incorporating the highest level of drug discovery into academic research, the WCNDD propels scientific breakthroughs beyond the lab and toward the development of patentable and marketable drugs suited for clinical studies. The center is staffed by dozens of scientists, most of whom bring industry experience to this collaborative, academic setting. Since 2007, Vanderbilt researchers have made significant progress in finding possible treatments for multiple brain disorders, such as, schizophrenia, major depressive disorder, autistic spectrum disorders, dystonia, Parkinson's disease, Alzheimer's disease and post-traumatic stress disorder. The university's research has been funded publicly by the National Institute of Mental Health, the National Institute on Drug Abuse and the National Institute of Neurological Disorders and Stroke and privately by a number of partners.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the discovery, development and commercialization of any compounds from the above described license agreement and research collaboration. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    View Full Article Hide Full Article
  31. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the following two investor conferences:

    • 2020 BofA Securities Health Care Conference on Tuesday, May 12, 2020, at 11:00 a.m. Eastern Time.
    • 2020 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19, 2020, at 1:55 p.m. Eastern Time.

    These conferences will both be held virtually. Live webcasts of ACADIA's presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the following two investor conferences:

    • 2020 BofA Securities Health Care Conference on Tuesday, May 12, 2020, at 11:00 a.m. Eastern Time.
    • 2020 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19, 2020, at 1:55 p.m. Eastern Time.

    These conferences will both be held virtually. Live webcasts of ACADIA's presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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  32. With No Approved Treatments in Rett Syndrome, FDA Decision Highlights Significant Unmet Need

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) and Neuren Pharmaceuticals Limited (ASX: NEU) announced today that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder. Upon FDA approval of a product with RPD designation, the sponsor may be eligible to receive a Priority Review Voucher, which can be used to obtain FDA review of a New Drug Application for another product in an expedited period of six months.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200303006075/en/

    With No Approved Treatments in Rett Syndrome, FDA Decision Highlights Significant Unmet Need

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) and Neuren Pharmaceuticals Limited (ASX: NEU) announced today that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder. Upon FDA approval of a product with RPD designation, the sponsor may be eligible to receive a Priority Review Voucher, which can be used to obtain FDA review of a New Drug Application for another product in an expedited period of six months.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200303006075/en/

    "We are pleased that the FDA has recognized the unmet need currently experienced by Rett patients and their families and our goal is to bring a treatment option forward as soon as possible," said Serge Stankovic, M.D., M.S.P.H., ACADIA's President. "This is an encouraging step forward as we continue to enroll patients in our Phase 3 LAVENDER study with results expected in 2021."

    RPD designation is granted by the FDA in the case of serious or life-threatening diseases affecting fewer than 200,000 people in the U.S. and primarily in individuals 18 years of age and younger. Trofinetide was previously granted Fast Track Status and Orphan Drug Designation for Rett syndrome in the U.S. and Orphan Drug Designation for Rett syndrome in Europe.

    About Rett Syndrome

    Rett syndrome is a debilitating neurological disorder that occurs primarily in females following apparently normal development for the first six months of life. Rett syndrome has been most often misdiagnosed as autism, cerebral palsy, or non-specific developmental delay. Rett syndrome is caused by mutations on the X chromosome on a gene called MECP2. There are more than 200 different mutations found on the MECP2 gene that interfere with its ability to generate a normal gene product.

    Rett syndrome occurs worldwide in approximately one of every 10,000 to 15,000 female births and in the United States impacts 6,000 to 9,000 patients. Rett syndrome causes problems in brain function that are responsible for cognitive, sensory, emotional, motor and autonomic function. Typically, with symptoms presenting between six to 18 months of age, patients experience a period of rapid decline with loss of purposeful hand use and spoken communication and inability to independently conduct activities of daily living. Symptoms also include seizures, disorganized breathing patterns, an abnormal side-to-side curvature of the spine (scoliosis), and sleep disturbances. Currently, there are no FDA-approved medicines for the treatment of Rett syndrome.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Rare Pediatric Disease Designation for the treatment of Rett Syndrome in the U.S. and Orphan Drug Designation in the U.S. and Europe for both Rett syndrome and Fragile X syndrome.

    The Phase 3 trofinetide clinical program includes LAVENDER, a 12-week, double-blind, placebo-controlled study, and LILAC, an open-label, long-term extension study. The Phase 3 clinical program is progressing as planned with 11 study sites recruiting and more sites expected in the future.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, the negative symptoms of schizophrenia, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at www.acadia-pharm.com.

    In 2018, ACADIA entered into an exclusive North American license agreement with Neuren for the development and commercialization of trofinetide for Rett syndrome and other indications. Under the terms of the license agreement between ACADIA and Neuren, Neuren is eligible to receive one third of the market value of any Rare Pediatric Disease Priority Review Voucher, if awarded by the U.S. FDA upon approval of a New Drug Application for trofinetide.

    About Neuren Pharmaceuticals

    Neuren Pharmaceuticals Limited (Neuren) is a biopharmaceutical company developing new therapies for brain injury, neurodevelopmental and neurodegenerative disorders. Neuren has completed Phase 2 development of trofinetide for Rett syndrome and has completed a Phase 2 clinical trial in Fragile X syndrome.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the Phase 3 clinical trial evaluating trofinetide; the likelihood of success of such clinical trial; the prospects for FDA approval of trofinetide for Rett syndrome and other indications; and the success of any efforts to commercialize trofinetide in North America. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development, approval and commercialization. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    This ASX-announcement contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Neuren to be materially different from the statements in this announcement.

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  33. - Full Year 2019 Net Sales Grew to $339.1 Million, a 52% Increase over Full Year 2018

    - 2020 Net Sales Guidance of $440 to $470 Million

    - On-Track to Submit Supplemental New Drug Application for Dementia-Related Psychosis in Summer 2020

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2019.

    "In 2019 ACADIA demonstrated strong execution from our commercial and R&D teams, driving the continued growth of NUPLAZID and advancing our late-stage pipeline," said Steve Davis, Chief Executive Officer. "2020 will be a transformational year for ACADIA highlighted by a potential approval in dementia-related psychosis, additional pivotal study results in major depressive…

    - Full Year 2019 Net Sales Grew to $339.1 Million, a 52% Increase over Full Year 2018

    - 2020 Net Sales Guidance of $440 to $470 Million

    - On-Track to Submit Supplemental New Drug Application for Dementia-Related Psychosis in Summer 2020

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2019.

    "In 2019 ACADIA demonstrated strong execution from our commercial and R&D teams, driving the continued growth of NUPLAZID and advancing our late-stage pipeline," said Steve Davis, Chief Executive Officer. "2020 will be a transformational year for ACADIA highlighted by a potential approval in dementia-related psychosis, additional pivotal study results in major depressive disorder, commencement of a second pivotal study for the negative symptoms of schizophrenia and the continued enrollment of the Phase 3 trofinetide study for Rett syndrome. This exciting momentum has created a multi-year cadence of pivotal study readouts and potential regulatory approvals that position the company for long-term growth."

    Company Highlights

    • Presented positive top-line results from the Phase 3 HARMONY study of pimavanserin for the treatment of dementia-related psychosis at the Clinical Trials on Alzheimer's Disease (CTAD) meeting on December 4, 2019.
      • The Company plans to submit a supplemental NDA for pimavanserin for the treatment of dementia-related psychosis in the summer of 2020. Pimavanserin previously received Breakthrough Therapy Designation for this indication.
    • Announced positive top-line results from the pivotal Phase 2 ADVANCE study of pimavanserin for the negative symptoms of schizophrenia in November 2019.
      • The Company plans to initiate a second pivotal study, ADVANCE-2, of pimavanserin for the negative symptoms of schizophrenia during the summer of 2020.
    • The Company expects to announce top-line results from its Phase 3 CLARITY-2 study of pimavanserin as an adjunctive treatment for major depressive disorder in the fourth quarter of 2020.
    • Appointed Ponni Subbiah, M.D., M.P.H., as Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer and Stephanie Fagan as Senior Vice President, Corporate Affairs and Chief Communications Officer.

    Financial Results

    Revenue

    Net sales of NUPLAZID® (pimavanserin) were $98.3 million for the fourth quarter of 2019, an increase of 65% as compared to $59.6 million reported for the fourth quarter of 2018. End of fourth quarter days-on-hand channel inventory increased relative to the third quarter 2019, which resulted in approximately $2.5 million increase in fourth quarter 2019 net sales. For the years ended December 31, 2019 and 2018, ACADIA reported net product sales of $339.1 million and $223.8 million, respectively, an increase of 52% year-over-year.

    Research and Development

    Research and development expenses for the fourth quarter of 2019 were $57.5 million, compared to $48.2 million for the same period of 2018. For the years ended December 31, 2019 and 2018, research and development expenses were $240.4 million and $187.2 million, respectively. The increase during the 2019 periods as compared to 2018 was primarily due to development costs associated with trofinetide and additional clinical study costs for pimavanserin.

    Selling, General and Administrative

    Selling, general and administrative expenses for the fourth quarter of 2019 were $91.9 million, compared to $74.3 million for the same period of 2018. For the years ended December 31, 2019 and 2018, selling, general and administrative expenses were $325.6 million and $265.8 million, respectively. This increase during the 2019 periods as compared to 2018 was primarily due to increased general and administrative expenses including charitable contributions and personnel costs.

    Net Loss

    For the fourth quarter of 2019, ACADIA reported a net loss of $53.0 million, or $0.34 per common share, compared to a net loss of $65.5 million, or $0.50 per common share, for the same period in 2018. The net losses for the fourth quarters of 2019 and 2018 included $19.8 million and $20.4 million, respectively, of non-cash stock-based compensation expense. For the years ended December 31, 2019, ACADIA reported a net loss of $235.3 million, or $1.60 per common share, compared to a net loss of $245.2 million, or $1.94 per common share, for the same period in 2018. The net losses for the years ended December 31, 2019 and 2018 included $82.2 million and $81.6 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At December 31, 2019, ACADIA's cash, cash equivalents, and investment securities totaled $697.4 million, compared to $473.5 million at December 31, 2018. The increase was primarily due to net proceeds of $271.5 million from ACADIA's September 2019 public offering of common stock as well as additional cash proceeds from employee option exercises of $91.6 million.

    2020 Financial Guidance

    ACADIA's 2020 net sales guidance reflects annual revenue growth of approximately 34% for NUPLAZID, at the mid-point of the range. 2020 GAAP R&D guidance reflects the progression of four phase 3 studies this year. 2020 GAAP SG&A guidance reflects a similar level of investment to 2019 in PDP with new investments in preparing for a launch in DRP including disease-state educational initiatives and plans for the expansion of our commercial and medical affairs functions.

    • NUPLAZID net sales are expected to be between $440 and $470 million.
    • GAAP R&D is expected to be between $270 and $285 million.
    • GAAP SG&A is expected to be between $440 and $460 million.
    • Non-cash stock-based compensation expense is expected to be between $90 and $100 million.
    • 2020 year-end cash, cash equivalents, and investment securities are expected to be between $470 and $500 million.

    Conference Call and Webcast Information

    ACADIA management will review its fourth quarter and full year 2019 financial results and operations via conference call and webcast today at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the U.S. or Canada and 443-877-4067 for international callers (reference passcode 6692587). A telephone replay of the conference call may be accessed through March 11, 2020 by dialing 855-859-2056 for callers in the U.S. or Canada and 404-537-3406 for international callers (reference passcode 6692587). The conference call also will be webcast live on ACADIA's website, www.acadia-pharm.com, under the investors section and will be archived there through March 26, 2020.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for dementia-related psychosis, schizophrenia, major depressive disorder, or depressive symptoms in patients with Parkinson's disease. ACADIA discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, the negative symptoms of schizophrenia, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2020 NUPLAZID net sales and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2020, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2018 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

     

    Three Months Ended December 31,

     

    Years Ended December 31,

     

     

    2019

     

    2018

     

    2019

     

    2018

    Revenues

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    98,326

     

     

    $

    59,571

     

     

    $

    339,076

     

     

    $

    223,807

     

    Total revenues

     

     

    98,326

     

     

     

    59,571

     

     

     

    339,076

     

     

     

    223,807

     

    Operating expenses

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

     

    5,334

     

     

     

    4,392

     

     

     

    19,598

     

     

     

    18,330

     

    Research and development (1)

     

     

    57,520

     

     

     

    48,183

     

     

     

    240,385

     

     

     

    187,163

     

    Selling, general and administrative (1)

     

     

    91,871

     

     

     

    74,271

     

     

     

    325,638

     

     

     

    265,758

     

    Total operating expenses

     

     

    154,725

     

     

     

    126,846

     

     

     

    585,621

     

     

     

    471,251

     

    Loss from operations

     

     

    (56,399

    )

     

     

    (67,275

    )

     

     

    (246,545

    )

     

     

    (247,444

    )

    Interest income, net

     

     

    3,272

     

     

     

    1,670

     

     

     

    11,165

     

     

     

    5,348

     

    Other expense

     

     

    491

     

     

     

    127

     

     

     

    997

     

     

     

    (1,840

    )

    Loss before income taxes

     

     

    (52,636

    )

     

     

    (65,478

    )

     

     

    (234,383

    )

     

     

    (243,936

    )

    Income tax expense

     

     

    400

     

     

     

    14

     

     

     

    876

     

     

     

    1,256

     

    Net loss