Grifols starts commercializing TAVLESSE® in Europe, diversifying its medicines portfolio

Grifols starts commercializing TAVLESSE® in Europe, diversifying its medicines portfolio

PR Newswire

BARCELONA, Spain, July 9, 2020

- European customers begin receiving TAVLESSE® (fostamatinib) for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments

- Grifols' first oral therapy from Bioscience Division to expand and diversify portfolio to benefit patients and offer more therapeutic options for healthcare professionals

BARCELONA, Spain, July 9, 2020 /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), one of world's top three producers of plasma-derived medicines and a forerunner in the research and development of therapeutic alternatives that drive scientific and social advancements, today announced it has begun European delivery of TAVLESSE® (fostamatinib) to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments.

This is the first non-plasma product that the company's flagship Bioscience Division has launched in Europe. Over time Grifols expects to further strengthen and complement its industry-leading portfolio through additional innovative in-licensing agreements to treat existing and emerging diseases, benefiting patients and offering additional therapeutic alternatives to healthcare providers.

TAVLESSE® is already available in Germany and the UK, with a phased rollout across the rest of Europe planned over the next 18 months before expanding into Turkey.

Grifols has exclusive rights to fostamatinib in chronic ITP, as well as any potential future indications like autoimmune hemolytic anemia (AIHA), and IgA nephropathy (IgAN), in Europe and Turkey thanks to a Collaboration and License Agreement reached with U.S.-based Rigel Pharmaceuticals in January 2019.

Fostamatinib is also commercially available in the U.S. under the brand name TAVALISSE®, the first and only SYK (spleen tyrosine kinase) inhibitor indicated in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. 

Early this year the European Commission approved TAVLESSE® to treat ITP in adult patients refractory to other treatments.

About chronic immune thrombocytopenia (ITP)

In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing.  Common symptoms of ITP are excessive bruising and bleeding.  People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death.  Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

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

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 Rigel

Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R552, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

For more information, visit www.rigel.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, 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.

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