Biotest AG: Biotest’s Hyperimmunoglobulin Cytotect® CP receives five additional Marketing Authorisations in Europe

PRESS RELEASE

Biotest’s Hyperimmunoglobulin Cytotect^® CP receives five additional Marketing Authorisations in Europe

• Approval of Biotest’s CMV-hyperimmunoglobulin in now 28 markets will secure future revenue growth
• Biotest’s CMV-hyperimmunoglobulin is indicated for prophylaxis of clinical manifestations of cytomegalovirus (CMV) infections – a major complication after transplantation
• Adult and Paediatric transplant patients benefit from an additional therapy option to combat CMV infection
• Biotest is one of only two providers of CMV-hyperimmunoglobulins worldwide, Cytotect^® CP Biotest is the only product available in Europe

Dreieich, 4 May 2023. Biotest AG, a leading manufacturer of innovative human blood plasma-based drugs for haematology and immunology, is proud to announce that its product Cytotect^® CP Biotest has gained marketing authorizations in five additional markets, namely Slovakia, Czech Republic, Lithuania, Romania and Ireland. With these new authorizations, Biotest’s hyperimmunoglobulin has now marketing authorizations in 28 countries, most of them in Europe. This further enlarges the footprint of Biotest’s CMV-hyperimmunoglobulin in Europe, and reinforces Biotest’s commitment to providing life-saving treatments to patients in need.

"We are pleased to receive additional marketing authorizations for Biotest’s hyperimmunoglobulin in these five European markets," said Enrico D’Aiuto, Senior Vice President, Head of Global Sales and Marketing. "Our commitment to improving patients' lives remains strong, and we will continue to work diligently to bring our treatments to transplant patients around the world."

Biotest’s hyperimmunoglobulin is a human cytomegalovirus immunoglobulin, which is used for the prophylaxis of clinical manifestations of CMV infections in patients who receive immunosuppressive therapy, particularly after they have undergone solid organ or stem cell transplantation. CMV infections can cause serious complications in those vulnerable patients who have received transplants, and Cytotect^® CP Biotest is an important tool in reducing the risk of such infections. With these new marketing authorizations, even more vulnerable transplant patients can benefit from the protection provided by Biotest’s CMV-hyperimmunoglobulin.

The marketing authorizations for Biotest’s CMV-hyperimmunoglobulin were granted following a thorough review of clinical data including the well-characterised safety profile by the corresponding national authorities. Worldwide, Biotest is one of only two providers of this class of product, with Cytotect^® CP Biotest being the only CMV-hyperimmunoglobulin available in Europe. Biotest AG is committed to ensuring the safety and efficacy of all its products, and the approval of Biotest’s CMV-hyperimmunoglobulin in these markets is a testament to the company's rigorous approach to drug development.

About Cytotect^® CP Biotest

Cytotect^® CP Biotest is a cytomegalovirus (CMV)-specific hyperimmunoglobulin preparation with a high antibody titre against CMV. The product is approved for prophylaxis of clinical manifestations of CMV infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients. The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis. Cytotect^® CP (also marketed in various countries as Megalotect^®, Megalotect CP^®, Cytomegatect^®, Cytotect^®, Cymvigo^® and NeoCytotect^®).

About Biotest

Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,300 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. Since May 2022, Biotest is part of the Grifols Group, Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate
 

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.