Biotest AG: Biotest's CMV-specific hyperimmunoglobulin Cytotect CP Biotest receives UK marketing authorisation

DGAP-News: Biotest AG / Key word(s): Regulatory Approval
15.01.2020 / 07:00
The issuer is solely responsible for the content of this announcement.

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PRESS RELEASE

Biotest's CMV-specific hyperimmunoglobulin Cytotect CP Biotest receives UK marketing authorisation

• Approval of Cytotect CP Biotest in the UK will support further growth
• Cytotect CP Biotest is indicated for prophylaxis of clinical manifestations of Cytomegalovirus (CMV) infections
• Patients benefit from an additional therapy option to combat CMV infection
• Cytotect CP Biotest is the only CMV hyperimmunoglobulin available in Europe

Dreieich, 15 January 2020. Biotest AG has announced today that United Kingdom (UK) marketing authorisation has been granted for its CMV-specific hyperimmunoglobulin preparation, Cytotect CP Biotest. The successful finalisation of the Repeat Use Procedure (RUP) as well as the UK approval of Cytotect CP Biotest were completed in less than 90 days.

"We are pleased that approval has been granted for Cytotect CP Biotest in the UK. Cytomegalovirus is one of the most common opportunistic pathogens after solid organ and stem cell transplantation. The availability of Cytotect CP Biotest will provide transplant physicians with additional strategies to prevent and manage CMV infection and thereby improve patient care and post-transplant recovery", says Patricia Morey, Managing Director, Biotest UK.

In the UK, annually more than 3,700 patients receive a kidney, lung, heart or liver transplant^[1], while almost 1,700 patients undergo allogeneic hematopoietic stem cell transplantation^[2]. Infection with CMV can occur in up to one third of these patients and, if left untreated, can cause serious complications leading to organ rejection, graft-versus-host disease (GvHD) as well as tissue-invasive disease (e.g. colitis, pneumonitis or retinitis).

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. Cytotect CP Biotest is indicated for prophylaxis of clinical manifestations of CMV infections in patients subjected to immunosuppressive therapy, particularly in transplant recipients, and is recommended as concomitant therapy alongside virostatic agents. Cytotect CP Biotest has a specific and targeted unique mode of action, which is different, yet complementary to antivirals.

Cytotect CP Biotest is an important contributor to Biotest's future business, is sold in more than 30 countries, and has seen a double-digit sales increase in 2019.

Now that Cytotect CP Biotest has been approved, patients throughout the UK can benefit from an additional therapy option to prevent the clinical manifestations of CMV infection.

About Cytotect CP Biotest^(R)
Cytotect CP Biotest^(R) is a cytomegalovirus-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 Biotest^(R) is also marketed as Megalotect^(R), Megalotect CP^(R), Cytomegatect^(R) and NeoCytotect^(R) in different countries.

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 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 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: investor_relations@biotest.de

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.

^[1] NHS Blood and Transplant, Organ Donation and Transplantation Directorate, https://www.organdonation.nhs.uk/
^[2] British Society of Blood and Marrow Transplantation and Cellular Therapy (BSBMT), http://bsbmt.org/activity/2018/

15.01.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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