• The FDA target date (PDUFA date) for completion of the review is May 10, 2023
• FDA is currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting
• If approved, brexpiprazole would be the first pharmacological treatment indicated for agitation in patients with Alzheimer's dementia in the U.S.

Valby, Denmark, January 7, 2023 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that the U.S. Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer's dementia (AAD) is sufficiently complete to permit a substantive review.

The FDA has assigned the application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. The FDA also indicated that they are currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting to discuss the application.

The sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213, treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05). Brexpiprazole also demonstrated a generally favorable safety and tolerability profile in the studies.

"This milestone is important in our efforts to bring patients with Alzheimer's dementia and their caregivers one step closer to having a potential treatment option that may address a major disabling neuropsychiatric symptom of the disease," said Johan Luthman, Executive Vice President, Lundbeck Research & Development.

About Agitation in Alzheimer's Dementia
Neuropsychiatric symptoms (NPS) of Alzheimer's dementia, such as agitation are associated with poor caregiver outcomes, including reduced quality of life and poorer health.

Agitation is a common neuropsychiatric symptom of Alzheimer's dementia. It is reported in approximately 45 percent of patients with Alzheimer's dementia and has a large impact on quality of life for the patients, family members, and caregivers. Agitation covers a large group of behaviors occurring in patients with Alzheimer's dementia, and it is an excessive/inappropriate manifestation of "normal" human emotions and behaviors. Such behaviors include pacing, gesturing, profanity, shouting, shoving, and hitting.

Symptoms of agitation are also a consistent predictor of nursing home admission in patients with dementia.

About Brexpiprazole
Brexpiprazole was originally approved in the U.S. on July 10, 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. Brexpiprazole was also approved in 2017 in Health Canada and by the EMA in Europe in 2018 for the treatment of schizophrenia. In addition, brexpiprazole has been approved in multiple other countries across the world. Brexpiprazole is distributed and marketed under the brand name REXULTI[®]. In Europe, brexpiprazole is distributed and marketed under the brand name Rxulti[®].

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown, however the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors and antagonism at serotonin 5-HT2A receptors.  In addition, brexpiprazole is an antagonist at noradrenaline alpha 1a, 1b, 1d and 2c receptors and all at pharmacologically relevant potencies.

Lundbeck contacts

Investors:                                    Media:
Palle Holm Olesen Juliane Lenzner
Vice President, Investor Relations Vice President, Head of
Communications & Public Affairs
PALO@lundbeck.com JULZ@lundbeck.com (thmr@lundbeck.com)
+45 30 83 24 26 +45 30 83 23 97

About H. Lundbeck A/S
Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck andvia LinkedIn. 

Safe Harbor/Forward-Looking Statements

This corporate release contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Forward looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance or achievements, and may contain words like "believe", "anticipate", "expect", "estimate", "intend", "plan", "project", "will be", "will continue", "will result", "could", "may", "might", or any variations of such words or other words with similar meanings. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements.

Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Factors that may affect future results include, among others, interest rate and currency exchange rate fluctuations, delay or failure of development projects, production or distribution problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.

The forward-looking statements in this document and oral presentations made on behalf of Lundbeck speak only as at the date of this presentation. Lundbeck does not undertake any obligation to update or revise forward-looking statements in this presentation or oral presentations made on behalf of Lundbeck, nor to confirm such statements to reflect subsequent events or circumstances after the date of the presentation or in relation to actual results, unless otherwise required by applicable law or applicable stock exchange regulations.