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Grifols S.A.. (1/23/19). "Press Release: Grifols Announces Collaboration and License Agreement with Rigel Pharmaceuticals to Commercialize Fostamatinib in Europe". Barcelona.

Region Region Europe
Organisations Organisation Grifols S.A.
  Group Grifols (Group)
  Organisation 2 Rigel Pharmaceuticals Inc. (Nasdaq: RIGL)
Products Product Tavalisse®
  Product 2 kinase inhibitor
Index term Index term Grifols–Rigel: fostamatinib, 201901– collab + license $30m upront + $297.5m milestones + royalties all indications in Europe + Turkey
     


> Grifols gains exclusive rights to fostamatinib (TAVALISSE®) in chronic immune thrombocytopenia (ITP) and other indications

> Rigel receives a $30M upfront payment from Grifols, with the potential to receive up to $297.5 million in payments related to regulatory and commercial milestones, which includes a $20M payment upon EMA approval

> Potential European approval of fostamatinib for the treatment of chronic ITP is expected by the end of 2019

> This agreement represents an opportunity to further complement Grifols Bioscience Division portfolio to treat more chronic and rare diseases, since fostamatinib has potential in multiple indications in addition to ITP

Barcelona (Spain), January 23, 2019.- 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 has entered into an exclusive license agreement with the US-based biotechnology company Rigel Pharmaceuticals (NASDAQ: RIGL) to commercialize fostamatinib disodium hexahydrate in all potential future indications in Europe and Turkey.

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

Rigel marketing authorization application for fostamatinib in chronic ITP is currently under review by the European Medicines Agency (EMA). On October 4, 2018, the EMA validated the marketing authorization application for fostamatinib in adult chronic ITP, which was submitted by Rigel. The company anticipates a decision from the Committee on Human Medicinal Products by the fourth quarter of 2019 and potential European approval by the end of 2019.

Under terms of the agreement, Rigel will receive from Grifols a $30 million upfront cash payment, with the potential to receive up to $297.5 million in payments related to regulatory and commercial milestones, which includes a $20 million payment upon EMA approval of fostamatinib for the treatment of chronic ITP.

Rigel will receive several stepped royalty payments based on tiered net sales. In return, Grifols receives exclusive rights to fostamatinib in chronic ITP, autoimmune hemolytic anemia (AIHA), and IgA nephropathy (IgAN) in Europe and Turkey. Rigel retains the remaining global rights to fostamatinib outside the Grifols territories and those rights previously granted to Kissei Pharmaceuticals (in Japan, China, Taiwan and the Republic of Korea).


About the 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 with more than 75 years of legacy dedicated to improving the health and well-being of people around the world. Grifols produces essential plasma-derived medicines for patients, and provides hospitals and healthcare professionals with the tools, information and services they need to help them deliver expert medical care.

Grifols’ three main divisions – Bioscience, Diagnostic and Hospital – develop, produce and market innovative products and services that are available in more than 100 countries. With a network of 250 plasma donation centers, Grifols is a leading producer of plasma-derived medicines used to treat rare, chronicand, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of diagnostic products designed to support safety from donation through transfusion. The Hospital Division provides intravenous (IV) therapies, clinical nutrition products and hospital pharmacy systems, including systems that automate drug compounding and control drug inventory.

Grifols is headquartered in Barcelona, Spain, and has 20,000 employees in 30 countries. In 2017, sales exceeded 4,300 million euros. Grifols demonstrates its strong commitment to advancing healthcare by allocating a significant portion of its annual income to research, development and innovation. 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 US NASDAQ via ADRs (NASDAQ:GRFS). For more information, 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), an 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 current clinical programs include an upcoming Phase 3 study of fostamatinib in autoimmune hemolytic anemia and an ongoing Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program. In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics. For more information, visit www.rigel.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

Information contained in this press release doesn´t represent any commercial or promotional offer to healthcare professionals or patients and is not aimed to US audience.

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: 2019-02-10

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