Otsuka Pharmaceutical and Lundbeck to Present Phase 3 Data for Brexpiprazole in Patients with Alzheimer’s Dementia at AAIC 2022

Rhea-AI Summary

Otsuka Pharmaceutical and H. Lundbeck A/S announced positive findings from a Phase 3 study of brexpiprazole targeting agitation in Alzheimer's dementia. The results, to be presented at the 2022 Alzheimer’s Association International Conference on August 4, highlight a potential treatment option for a significant unmet medical need, as no FDA-approved drugs currently exist for this condition. The study aims to improve the quality of life for patients and caregivers facing this prevalent issue.

Positive

• Phase 3 clinical study results of brexpiprazole show potential in treating agitation in Alzheimer's dementia.
• Presentation at the prestigious Alzheimer's Association International Conference signifies credibility and interest in the drug.

Negative

• Currently no FDA-approved treatments for agitation in Alzheimer's, indicating potential market risks and competition.
• Agitation's prevalence in Alzheimer's dementia may require extensive marketing efforts to educate and inform patients and caregivers.

Researchers to highlight positive results from a phase 3 clinical study for treatment of agitation in patients with Alzheimer’s dementia

PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)-- Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S (Lundbeck) today announce that new Phase 3 data for brexpiprazole will be presented at the 2022 Alzheimer’s Association International Conference (AAIC), which is being held virtually and in San Diego from July 31 through August 4. The oral presentation will be featured in the Neuropsychiatry and Behavioral Neurology: Agitation and Psychosis session on Thursday, August 4 from 9:45am to 11:00am PT.

“We are excited to be presenting data that further advances a possible option for a significant unmet need among this patient community,” said Robert McQuade, PhD, executive vice president, chief strategic officer and interim chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc.

Dr. Johan Luthman, executive vice president and head of Research & Development at Lundbeck commented, “Agitation is a very prevalent clinical manifestation in Alzheimer’s dementia and can have a significant impact on the quality of life among patients affected by the disease and their caregivers.”

Currently there are no FDA-approved pharmacological treatments for agitation in Alzheimer’s dementia.

The 2022 AAIC agenda can be viewed here.

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 and via LinkedIn.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka established a presence in the U.S. in 1973. Today, through holdings company, Otsuka America, Inc. (OAI), its affiliates Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI), employ 1,700 U.S. employees. Both develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.6 billion in 2021.

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at www.otsuka.co.jp/en/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220802005800/en/

MEDIA

Otsuka in US

Robert Murphy

Corporate Communications

Otsuka America Pharmaceutical, Inc.

robert.murphy@otsuka-us.com

Phone: +1 609 249 7262

Otsuka in Japan

Jeffrey Gilbert (Outside the US)

Leader, Pharmaceutical PR

Otsuka Pharmaceutical, Co., Ltd.

gilbert.jeffrey@otsuka.co.jp

Phone: +81 3 6361 7379

Lundbeck in US

Dyana Lescohier

Corporate Communications

DYLE@lundbeck.com

Phone: +1 847 894 3586

Lundbeck in Denmark

Thomas Mikkel Mortensen (Outside the US)

Media Relations Lead,

Corp. Communication

THMR@lundbeck.com

Phone: +45 30 83 30 24

Source: Otsuka Pharmaceutical Development & Commercialization, Inc.

FAQ

What are the results of the Phase 3 study for brexpiprazole presented by HLUYY?

The Phase 3 study demonstrated positive results, indicating brexpiprazole's potential to effectively treat agitation in Alzheimer's dementia.

When will the Phase 3 clinical study results for brexpiprazole be presented?

The results will be presented on August 4, 2022, at the Alzheimer’s Association International Conference.

What is the significance of the Phase 3 study results for patients with Alzheimer's dementia?

The study results offer hope for treating agitation, a critical unmet need among Alzheimer's patients and their caregivers.

What is the current status of FDA-approved treatments for agitation in Alzheimer's dementia?

Currently, there are no FDA-approved pharmacological treatments specifically for agitation in Alzheimer's dementia.