Grifols signs global collaboration and licensing agreement with Endpoint Health to develop and commercialize Antithrombin III for Sepsis

  • Grifols will be the exclusive supplier of Antithrombin III (AT-III) for treatment of Sepsis, a life-threatening medical emergency
  • Endpoint Health expects to submit its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial of Grifols' Antithrombin III in Sepsis later this year
  • Upon FDA approval, the companies will invest to expand existing Antithrombin III production capabilities at Grifols sites
  • Grifols strengthens its plasma economics as part of its commitment to drive sustainable growth through innovation

BARCELONA, Spain, Feb. 24, 2022 /PRNewswire/ -- Grifols (MCE: GRF) (MCE: GRF.P) (NASDAQ: GRFS), one of the world's leading producers of plasma-derived medicines, today announced a collaboration with Endpoint Health, Inc., a precision-medicine therapeutics company dedicated to addressing urgent needs in immune-driven critical care, to develop and commercialize an Antithrombin III (AT-III) therapy to treat Sepsis.

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As part of the agreement, Grifols will contribute its industry-leading expertise in plasma-protein therapies and be the exclusive supplier of AT-III, a plasma protein that treats patients with blood clotting issues.

Later this year an Investigational New Drug (IND) application will be submitted to the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial with Grifols' Antithrombin III. This therapy is the only plasma-protein therapy authorized and approved by the FDA for use in the country to treat Antithrombin III deficiency, an inherited blood-clotting disorder. Grifols has committed to provide up to USD 25 million to support the clinical development program.

As part of the collaboration, and subject to the FDA's acceptance of its IND and Investigational Device Exemption (IDE) filings, Endpoint Health will deploy its AI technology and its proprietary diagnostic test in a phase II trial designed to identify septic patients mostly likely to respond to AT-III. Upon FDA approval, the companies will invest in a build-out of AT-III production at Grifols sites.

Endpoint Health will manage the clinical development, the subsequent regulatory approval process and commercialization. It will have exclusive development and commercial rights globally, except for China. In addition to any revenues under the AT-III supply agreement, Grifols will receive from Endpoint Health royalties on future net sales.

With this collaboration Grifols strengthens the company's plasma economics as part of its commitment to drive sustainable growth through innovation.

"Through this global collaboration we hope to see the therapeutic benefit of Antithrombin III combined with precision-medicine diagnostics to treat patients with Sepsis, which we hope will improve patient outcomes," said Víctor Grifols Deu, co-CEO of Grifols. "Grifols continues to apply its deep knowledge of plasma therapeutic proteins, both through internally inspired innovations and increasingly with external partners, to address serious public health issues."

"This collaboration agreement is a major step forward to developing new precision therapies to treat patients with critical and chronic immune-driven illnesses," said Jason Springs, co-founder and Chief Executive Officer of Endpoint Health. "We identified Antithrombin III as a potentially promising treatment for Sepsis using our proprietary AI platform and we believe we can transform the standard of care in immune-driven illnesses."

About Sepsis

Sepsis occurs when the body's immune response to an infection becomes dysregulated. This can cause a cascade of changes that damage multiple organ systems, leading them to fail, sometimes even resulting in death. The World Health Organization considers Sepsis a global health threat because it is frequently a final common pathway to death from many infectious diseases, including COVID-19. Annually, there are an estimated 48.9 million cases and 11 million Sepsis-related deaths worldwide, which account for almost 20% of all global deaths.[1]

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 Endpoint Health, Inc.

Endpoint Health is a precision-first therapeutics company dedicated to addressing urgent needs in immune-driven critical and chronic illnesses by building a pipeline of therapies designed to personalize treatment to each patient's biology. It combines therapeutics, therapy guiding tests, and AI to develop targeted therapies for patients with inflammatory illnesses, such as acute respiratory distress syndrome (ARDS), Sepsis, rheumatoid arthritis, and inflammatory bowel disease. Its vision is a world in which all patients get the best treatment possible for their unique biology and disease. For more information, visit www.endpointhealth.com.

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] World Health Organization, Accessed at https://www.who.int/news-room/fact-sheets/detail/sepsis

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Company Codes: NASDAQ-NMS:GRFS, Madrid:GRF, Madrid:GRF.P

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