Grifols takes another step in the fight against Alzheimer's, partners with Ace to open first AMBAR® Center in Barcelona

The center will collect real-world data on AMBAR® clinical program

- AMBAR^® Center combines Grifols' more than 15 years of knowledge researching this devastating disease with the experience of the non-profit medical foundation Ace Alzheimer Center Barcelona in diagnosing and treating Alzheimer's patients, including application of AMBAR^® (Alzheimer Management by Albumin Replacement)

- The AMBAR^® clinical program, based on periodic plasma exchange with albumin, has shown a delay in the cognitive and functional progression of Alzheimer's disease in mild-to-moderate patients

- Ace Alzheimer Center will manage the center, to be located on its premises in Barcelona. Grifols will partner with other leading medical institutions to open expected future centers in the EU, U.S. and China, obtaining AMBAR^® data from clinical practice and advancing further in the therapeutic management of the disease

BARCELONA, Spain, May 19, 2021 /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P, andNASDAQ: GRFS), a leading global producer of plasma-derived medicines with a history of more than 110 years contributing to improve the health and well-being of people, today announced it's collaborating with the medical foundation Ace Alzheimer Center Barcelona to open the first AMBAR^® Center, where AMBAR^® procedure for Alzheimer's disease will be applied to obtain data from clinical practice.

This next phase in the fight against Alzheimer's will serve to optimize the application of AMBAR^® in medical practice and make it a new option for suitable patients as soon as possible. It comes after more than 15 years of advancing Alzheimer's research through the AMBAR^® clinical program, which includes an international clinical study demonstrating that periodic plasma exchange with albumin safely slows the cognitive and functional progression of Alzheimer's in mild-to-moderate patients.

The overall patient experience at AMBAR^® Center will combine the know-how that Grifols has accumulated as developer of AMBAR^® with Ace Alzheimer Center's expertise in diagnosing and treating Alzheimer's patients, as well as in basic and applied research. Its knowledge also includes applying AMBAR^® through its participation in the development of the clinical program since it began in 2004.

AMBAR^® Center will be located at Ace's facilities in Barcelona and managed by its healthcare professionals including neurologists, neuropsychologists, apheresis specialists and nurses trained and experienced in AMBAR^®.

"AMBAR^® Center will obtain medical data to optimize the application of the innovative AMBAR^® procedure and reinforce its robustness," said Dr. Antonio Páez, Medical Director of the AMBAR^® Clinical Program at Grifols. "Grifols is very pleased that its longtime collaborator Ace Alzheimer Center Barcelona, with its vast experience caring for Alzheimer's patients as well as its working knowledge of AMBAR^®, will manage the first center."

According to Dr. Mercè Boada, neurologist and co-founder of Ace: "We have worked closely with Grifols since the beginning of the AMBAR^® clinical program and are excited that AMBAR^® is taking this important next step of obtaining data through regular clinical practice. This will build on the important work of Ace Alzheimer Center Barcelona, which throughout our more than 25 years has been first and foremost about global, personalized care and attention for our patients and their families as they cope with Alzheimer's."

Grifols plans to open additional AMBAR^® Centers in the EU, U.S. and China. It will partner with leading medical institutions distinguished for their work in Alzheimer's, a disease that currently affects more than 35 million people worldwide.

Stated Victor Grifols Roura, president of Grifols: "Since the beginning of the AMBAR^® program our overriding objective has been to find a treatment for Alzheimer's disease and to help patients, their families and society fight this awful condition. With the opening of our first AMBAR^® Center and the expectation to open more, we are closer to this goal and we will continue to work to accomplish it."

For more information please visit www.ambar.grifols.com or www.fundacioace.org.

About AMBAR^® study

AMBAR^® (Alzheimer Management by Albumin Replacement) study is an international, multicenter, randomized, double-blind, placebo-controlled, with parallel assignment clinical trial that enrolled patients with mild and moderate Alzheimer's from 41 treatment centers in Spain and the United States.

The study was designed to evaluate the efficacy and safety of therapeutic plasma exchange with albumin replacement.

AMBAR^® study targets a multimodal approach to the management of the disease based on the hypothesis that most of the amyloid-beta protein – one of the proteins accumulated in the brains of Alzheimer's patients – is bound to albumin and circulates in plasma. Extracting this plasma may flush amyloid-beta, thus limiting the disease's impact on the patient's cognitive functions. Additionally, albumin has antioxidant, immunomodulatory and anti-inflammatory properties. 

The AMBAR^® study included 496 patients aged 55 to 85 years, randomized in three treatment groups and one control (placebo) group. An independent contract research organization (CRO) oversaw the trial's clinical monitoring phase and managed the data collection and analysis stages. The trial employed a randomized and double-blind design, meaning that neither patients nor evaluators knew whether subjects were receiving the treatment or the placebo. Results were published in July 2020 in Alzheimer's & Dementia: The Journal of the Alzheimer's Association.¹

Grifols began its research on Alzheimer's disease in 2004, with several preclinical trials, two pilot studies and a Phase II clinical trial before launching the AMBAR^® trial.

Ace Alzheimer Center and the Alzheimer's Disease Research Center of the University of Pittsburgh, Pa., USA, have been instrumental partners in the AMBAR^® research and in Grifols' Alzheimer's program since its initiation in 2004.

About Grifols

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services that are sold in more than 100 countries.

Pioneers in the plasma industry, Grifols operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat chronic, rare and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Grifols, with nearly 24,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.

In 2020, Grifols' economic impact in its core countries of operation was EUR 7.5 billion. The company also generated 140,000 jobs, including indirect and induced.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).

For more information, please visit www.grifols.com

About Ace Alzheimer Center Barcelona Foundation

Ace Alzheimer Center Barcelona, an innovative and renowned non-profit entity in Catalonia, was established in 1995 with the goal of meeting the growing demand for the treatment and awareness around people who suffer from cognitive decline and dementia, especially Alzheimer's, offering personalized and complete attention and accompaniment to patients and their families. Each year, its Diagnostic Unit treats more than 8,000 people, 4,000 of whom suffer dementia (3,000 of them, a type of Alzheimer's). Ace is considered an international reference in research, especially in clinical, genetic  and neuropsychological research. Regarding applied research, Ace participates in numerous clinical trials (phases I, II and III) targeting the continuum of the disease. Because of its experience and know-how, it has led two Innovative Medicines Initiative (IMI) projects granted by the European Union, one on Alzheimer's genetics (ADAPTED) and the other on active patient engagement models (MOPEAD). In addition, Ace collects biological samples to study how genetic characteristics could enable the personalization of dementia treatments according to each patient's physiopathological conditions.

AMBAR^® is a registered trademark of Grifols.

LEGAL DISCLAIMER

The facts and figures contained in this report that do not refer to historical data are "future projections and assumptions". Words and expressions such as "believe", "hope", "anticipate", "predict", "expect", "intend", "should", "will seek to achieve", "it is estimated", "future" and similar expressions, insofar as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.

¹ Boada, M., López, O. L., Olazarán, J., Núñez, L., Pfeffer, M., Paricio, M., Lorites, J., Piñol-Ripoll, G., Gámez, J. E., Anaya, F., Kiprov, D., Lima, J., Grifols, C., Torres, M., Costa, M., Bozzo, J., Szczepiorkowski, Z. M., Hendrix, S., & Páez, A. (2020). A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer's disease: Primary results of the AMBAR Study. Alzheimer's & Dementia, 16(10), 1412–1425 https://doi.org/10.1002/alz.12137

SOURCE Grifols, SA

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