Biotest is the first plasma protein manufacturer in Germany to produce an investigational hyperimmunoglobulin preparation against COVID-19 and can provide further production capacities if the treatment is proven safe and effective and authorized for use
- Biotest is participating in cross-industry development of an investigational therapy for the treatment of COVID-19
- Important milestone achieved in potential hyperimmune therapy against COVID-19
- COVID Convalescent Plasma (CCP) donations collected by the CoVIg-19 Plasma Alliance have been successfully processed to manufacture a potential hyperimmunoglobulin therapy against COVID-19 using production technology from Biotest
Dreieich, 18 February 2021. As part of the CoVIg-19 Plasma Alliance, Biotest is working intensively on a potential medicine against COVID-19 using CCP donated by recovered patients. The goal of the CoVIg-19 Plasma Alliance is to jointly develop a potential hyperimmunoglobulin against COVID-19 that each member can produce at their manufacturing facilities and subsequently make available following authorization. Plasma donations collected by members of the Alliance are pooled, concentrated and purified to make a medicine with high levels of antibodies to SARS-CoV-2, if proven safe and effective in a clinical trial, which has just completed enrolment. Biotest has many decades of experience as a specialist in manufacturing hyperimmunoglobulins from blood plasma. This technology has now also been used to manufacture a potential hyperimmunoglobulin preparation against COVID-19.
As part of the CoVIg-19 Plasma Alliance, Biotest has now achieved an important milestone. At the Dreieich site in Germany, the first batch of a hyperimmunoglobulin with a high content of neutralising antibodies against COVID-19 has been successfully produced at scale. The plasma donations as the raw material for production were collected in Europe and in the US by the CoVIg-19 Plasma Alliance partners. Biotest, and other members, can provide further production capacities if the product is authorized and there remains patient need at that time.
The first hyperimmunoglobulin preparations from the CoVIg-19 Plasma Alliance are already undergoing clinical trials coordinated by the US National Institutes of Health (NIH). Patient enrolment in the trial has now completed. On the basis of this cross-company clinical development, Biotest is aiming to obtain approval for its hyperimmunoglobulin, which is based on Biotest's established hyperimmunoglobulin technology.
About the CoVIg-19 Plasma Alliance
The CoVIg-19 Plasma Alliance is an unprecedented partnership of the world's leading plasma companies, spanning plasma collection, development, production and distribution. Rather than pursue our individual research, we are putting public and patient health first by working together. Our goals are to accelerate the development of a potential treatment, improve our chances of success and increase supply of the potential treatment.
Other Alliance members who have manufactured the H-Ig that we all refer to as CoVIg-19 include CSL Behring and Takeda.
The Alliance includes Biotest, CSL Behring, LFB, Octapharma, Sanquin, Takeda, BioPharma Plasma, GC Pharma and NBI. The Bill & Melinda Gates Foundation is providing advisory support. Microsoft is providing technology including the Alliance website and the Plasma Bot for donor recruitment.
About human blood plasma
Human blood plasma is a raw material used to produce plasma derived products, which are used to treat various illnesses of the immune system, the blood system, as well as in emergency medicine. Biotest is one of the world's six largest manufacturers of plasma protein medicines.
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 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
Dr Monika Buttkereit
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
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.
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