June 26, 2023

Grifols begins European launch of XEMBIFY® in Spain to treat immunodeficiencies

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  • Primary immunodeficiencies (PID) affect one in every 2,000 births. For secondary immunodeficiencies (SID), it is estimated that antibody deficiency may be 30 times more common than primary deficiencies1
  • Spain is the first country of the European Union where the product is available. Grifols expects to expand the number of countries with access to XEMBIFY® over the next year
  • Grifols' strategy is focused on helping treat the expected significant growth in immunodeficiencies and the development of new indications

Barcelona, Spain, June 26, 2023 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global leader in plasma medicines, has started marketing XEMBIFY®, its 20% subcutaneous immunoglobulin, in Spain. This plasma medicine is indicated for treating primary immunodeficiencies (PID) and certain secondary immunodeficiencies (SID), which are expected to grow significantly in the coming years.

Spain is the first country in the European Union where the product is available, although it has already been approved by the health authorities of several European countries and the United Kingdom. Grifols plans to expand the number of countries with access to XEMBIFY® over the next year.

PID affects one in every 2,000 births1. For SID, it is estimated that antibody deficiency can be 30 times more common than primary deficiencies. These include those produced in patients with multiple myeloma, a type of cancer of which between 2,500 and 3,000 new cases2 are diagnosed in Spain each year, and those produced in patients with chronic lymphocytic leukemia (CLL), the most frequent type of leukemia in the western world,3 with an estimated average annual prevalence of some 16,000 cases in Spain from 2011 to 2025.4

In addition, Grifols plans to launch XEMBIFY® in Australia in the second half of the year and continues to drive growth in the United States. Available in the U.S. since 2019, XEMBIFY® is an effective, safe and well-tolerated treatment for patients and continues to gain traction. In the first quarter of 2023, XEMBIFY® revenues increased by +34% at constant exchange rates.

"Grifols is proud that XEMBIFY® is now available in the Spanish market, the first in a series of upcoming launches planned in different countries throughout the European Union. Thousands of patients and healthcare professionals in Spain can benefit from this new treatment, which will contribute to improving the quality of life of patients," said Joana Sabat, Grifols Senior Vice-President, Biopharma Launch Unit.

In addition, Grifols is working to obtain an indication for XEMBIFY® in the U.S. for the treatment of patients with hypogammaglobulinemia and recurrent or severe infections associated with B-cell CLL.

This is one of the indications with the highest growth potential in the field of SID, as CLL is expected to increase 9.5% in the U.S. between 2018-2025,5 with a potential market exceeding USD 1 billion.

A market with significant potential

PID and SID, as well as minority diseases such as chronic inflammatory demyelinating polyneuropathy, Guillain Barré syndrome, Kawasaki disease, multifocal motor neuropathy, chronic immune thrombocytopenia and myasthenia gravis, are treated with immunoglobulins. The use of immunoglobulins continues to grow in major markets. Between 2016-2020, it is estimated that the consumption of immunoglobulins had an average annual growth rate of over 8%.6

The global immunoglobulin market is expected to continue to grow in the coming years, driven primarily by PID and SID, which account for approximately 40% to 55% of the total immunoglobulin market.

This growth is due to the improvement in the diagnosis of PID, which has resulted in more patients being treated with immunoglobulins.7 SID have increased notably due to the aging of the population and the use of immunosuppressive therapies, such as immuno-oncological treatments, for which immunoglobulins are the only option to avoid the development of complications.8

About XEMBIFY®

XEMBIFY®, with proven safety, efficacy and tolerability, presents a balanced formulation to confidently treat a wide range of immunodeficiency patients.

XEMBIFY® features a unique caprylate chromatography manufacturing process that yields highly purified immunoglobulin G (IgG). XEMBIFY® provides a flexible immunoglobulin treatment option (daily, weekly or biweekly), offering patients reliable protection against infections.

 

1Patel SY, Carbone J, Jolles S. The Expanding Field of Secondary Antibody Deficiency: Causes, Diagnosis, and Management. Front Immunol. 2019;10:33

 

3Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(1):23-33. doi:10.1016/j.annonc.2020.09.019

 

4Montañés B, Casado G, Medina Á, Nieto P, Ramírez-Payer Á. Cost minimization analysis of chronic lymphocytic leukemia in Spain in the era of oral targeted therapies. Farm Hosp. 2022;46(2):72-79. Published 2022 Jan 11.

 

5Marketing Research Bureau. Report Analysis of the 2018 IVIG/SCIG Market in the United States and 2025 Forecast.

 

6Marketing Research Bureau. Global Usage and Forecast of the Immunoglobulin Market by Region 

 

7J. Kerr, I. Quinti, M. Eibl, H. Chapel, P. J. Späth, W. A. Carrock Sewell, A. Salama, I. N. van Schaik, T. W. Kuijpers and H.-H. Peter, “Is dosing of therapeutic immunoglobulins optimal? A review of a three-decade long debate in Europe,” Front Immunol, vol. 5, no. 629, 2014.

 

8Sánchez-Ramón S, Bermúdez A, González-Granado LI, Rodríguez-Gallego C, Sastre A, Soler-Palacín P; ID-Signal Onco-Hematology Group. Primary and Secondary Immunodeficiency Diseases in Oncohematology: Warning Signs, Diagnosis, and Management. Front Immunol. 2019 Mar 26;10:586.