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Grifols S.A.. (11/17/17). "Press Release: FDA Approval of Genetic Test for Alpha-1 Deficiency and EMA Approval of Fibrin Sealant". Barcelona.

Region Region EUR(WEST)+AM(NORTH)
Organisations Organisation Grifols S.A.
  Group Grifols (Group)
  Organisation 2 Progenika Biopharma S.A.
  Group Grifols (Group)
Products Product A1AT Genotyping Test (Progenika Biopharma)
  Product 2 plasma protein
     


Grifols further consolidates its research efforts

> Grifols, through Progenika Biopharma, has developed a latest-generation test capable of identifying the most common mutations associated with alpha-1 antitrypsin deficiency.

> Alpha-1 antitrypsin deficiency is a genetic rare disease that can cause pulmonary emphysema. The disorder affects roughly 25 per 100,000 individuals1 and an estimated 90% of cases remain undiagnosed.

> On the other hand, the European Medicines Agency (EMA) has approved a new Grifols product, a biological sealant composed of human fibrinogen and thrombin for use in surgical interventions in adults.


Grifols (MCE:GRF, MCE:GRF.P NASDAQ:GRFS) has received approval by the U.S. Food and Drug Administration (FDA) for a new genetic test to detect alpha-1 antitrypsin deficiency. The authorization marks an important milestone in the industry as it is the first time the FDA has approved a biological molecular test that uses the DNA of the patient for the diagnostic.

The FDA has approved the test for both DNA extracted from blood, as well as a drop of blood collected on paper (dry blood spot). A1AT Genotyping Test, developed by Progenika Biopharma, a Grifols subsidiary headquartered in Bilbao (Spain) is capable of simultaneously analyzing 99% of the most prevalent known mutations causing alpha-1 antitrypsin deficiency.

The molecular test analyzes simultaneously 192 samples per kit, and in a single reaction, identifies 14 of the most prevalent known mutations in the SERPINA1 gene, responsible for this genetic disorder. Although highly complex, the test has been designed so any molecular biology laboratory can process it with minimal human intervention.

A1AT Genotyping Test also has the CE marking from December 2016.

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1 Source: Orphanet Report Series, Rare Diseases Collection, May 2014.
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Grifols, global leader in the production and sale of alpha-1 antitrypsin, focus its growth strategy for this plasma protein on improving the diagnosis of the alpha-1 antitrypsin deficiency.

Grifols’ portfolio of products already includes a diagnostic test that measures the level of this protein in the bloodstream. With this latest FDA approval, Grifols further consolidates its strategy and adds a new diagnostic test to continue actively advancing the diagnosis of alpha-1 antitrypsin deficiency in the United States, Europe, and more recently in Latin America.

The FDA approval also reinforces Grifols’ strategy of promoting synergies among its business lines through the development of complementary products and services for its divisions.

New Fibrin Biological Sealant

The European Commission, following a favorable recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), has approved a new Grifols product, a fibrin sealant composed of two plasma proteins (human fibrinogen and thrombin) for surgical use in adult patients.

Grifols obtained FDA approval for this product on November 1, 2017.

The recent approval of the product by the European and U.S. health authorities culminates an important R&D effort for Grifols, allowing it to expand its offer of plasma-derived products. The biological sealant will be manufactured at the Grifols industrial complex located in Parets del Vallès (Barcelona, Spain).

Alpha-1 antitrypsin deficiency, an inherited and under-diagnosed disorder

Alpha-1 deficiency is an inherited disorder that causes a deficiency or absence of the alpha-1 protein in the plasma. It has a higher prevalence than other rare lung diseases such as cystic fibrosis and pulmonary arterial hypertension. While AATD symptoms vary depending on the degree of severity and type of genetic mutation, the most common is a progressive loss of pulmonary function.

Alpha-1-antitrypsin deficiency affects an estimated 25 cases per 100,000 people1, more than 90% of cases remain undiagnosed. In the U.S., approximately 100,000 people suffer from AATD, with similar numbers estimated in Europe. In Spain, roughly 10,000 to 12,000 people have alpha-1 antitrypsin deficiency.

Common symptoms of alpha-1 deficiency include dyspnea, or shortness of breath following physical exertion; chronic coughing; excessive mucous production; and wheezing, with or without the presence of respiratory infections. The symptomology of AATD concurs with that of chronic obstructive pulmonary disease (COPD), asthma, and other pulmonary diseases, leading many patients to be treated for other disorders while the root cause remains unaddressed.

Early diagnosis of AATD is vital. Without adequate treatment, patients are at risk for pulmonary emphysema, which can prove fatal without a lung transplant. AATD is also the most common cause of liver disease in children.


About Grifols

Grifols is a global healthcare company founded in 1940. Grifols has over 75 years improving people’s health and wellbeing through the development of life-saving plasma medicines, diagnostics systems, and hospital pharmacy products. The company is present in more than 100 countries worldwide and is headquartered in Barcelona, Spain. Grifols is a leader in plasma collection with a network of close to 180 plasma donor centers, and a leading producer of plasma-derived biological medicines. The company also provides a comprehensive range of transfusion medicine, hemostasis, and immunoassay solutions for clinical laboratories, blood banks and transfusion centers, and is a recognized leader in transfusion medicine. In 2016, sales exceeded 4,000 million euros with a headcount close to 15,000 employees. Grifols demonstrates its commitment to advancing healthcare by allocating a significant portion of its annual income to R&D. The company class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE: GRF). Its non-voting class B shares are listed on the Mercado Continuo (MCE: GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more information visit www.grifols.com


Investors contact:
Investor Relations Department
inversores@grifols.com - investors@grifols.com
Phone number: +34 93 571 02 21

Media contact:
Raquel Lumbreras
raquel_lumbreras@duomocomunicacion.com
Borja Gómez
borja_gomez@duomocomunicacion.com
Duomo Comunicación - Grifols Press Office
Phone number: +34 91 311 92 89 - +34 91 311 92 90


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, in so far 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.

   
Record changed: 2017-11-26

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