– Grifols gains exclusive rights to fostamatinib in all potential indications in Europe and Turkey

– Rigel to receive an upfront payment of $30 million, with the potential for $297.5 million in total regulatory and commercial milestones

– Potential milestones to Rigel include a $20 million payment upon EMA approval of fostamatinib in chronic immune thrombocytopenia (ITP), which is currently under review

– Rigel to receive stepped royalty payments reaching 30% of net sales of fostamatinib

SOUTH SAN FRANCISCO, CA, USA I January 23, 2019 I Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has entered into an exclusive license and supply agreement with Spain-based Grifols, S.A (MCE: GRF, MCE: GRF.P,NASDAQ: GRFS) to commercialize fostamatinib disodium hexahydrate in all potential indications in Europe and Turkey. Grifols is a global healthcare company and a leading producer of plasma-derived medicines for the treatment of rare and chronic diseases, including intravenous immunoglobulin (IVIG) which is used in the treatment of ITP and AIHA. Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) and is the first and only SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

“Grifols has a broad presence in Europe and an established position in the hematology commercial landscape, which supports our goal of bringing fostamatinib to patients in these countries,” said Raul Rodriguez, President and CEO of Rigel. “Our marketing authorization application for fostamatinib in chronic ITP is currently under review by the European Medicines Agency, and we anticipate a decision by the end of 2019. This provides a potential opportunity for fostamatinib to begin generating revenue in the European market in 2020.”

Under terms of the agreement, Rigel will receive a $30 million upfront cash payment, with the potential for $297.5 million in payments related to regulatory and commercial milestones, which includes a $20 million payment for EMA approval of fostamatinib for the treatment of chronic ITP. Rigel will receive significant stepped double-digit royalty payments based on tiered net sales which may reach 30% of net sales. In return, Grifols receives exclusive rights to fostamatinib in human diseases, including chronic ITP, autoimmune hemolytic anemia (AIHA), and IgA nephropathy (IgAN), in Europe and Turkey. In the event that, in 2021, after the second anniversary of the agreement, fostamatinib has not been approved by the EMA for the treatment of ITP in Europe, Grifols will have the option during a six-month time-frame to terminate the entire agreement which would terminate all their rights to ITP, AIHA, and all other indications.  In this limited circumstance, Rigel will pay Grifols $25 million and regain all rights to fostamatinib in Europe and other territories.  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).

“Given our global leadership position as a manufacturer of plasma medicines and our in-depth knowledge and expertise in blood disorders, adding fostamatinib to our portfolio is a natural fit for Grifols,” said Joel Abelson, President, Bioscience Commercial Division of Grifols. “Its potential in multiple indications, including ITP, may provide significant benefit for patients and is a valuable addition to our portfolio.”

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 EMA’s Committee on Human Medicinal Products by the fourth quarter of 2019 and potential European approval by the end of 2019. 

About 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.

TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated in the US for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

About Rigel (www.rigel.com
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 clinical development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.

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, chronic and, 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

SOURCE: Rigel Pharmaceuticals