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Biotest AG. (1/16/13). "Press Release: Biotest Announces Strategic Long-term Manufacturing, Supply and License Agreement". Dreieich & Baco Raton, FL.

Region Region United States (USA)
Organisations Organisation Biotest Pharmaceuticals Corporation
  Group Creat (Group)
  Organisation 2 ADMA Biologics Inc.
Product Product  contract manufacturing (biologicals)
Person Person Schulz, Gregor (Biotest 201212 CEO)

- Manufacturing & Supply agreement

- License agreement for ADMA's Respiratory Syncytial Virus IGIV product candidate for EU and selected countries

Biotest announces, that Biotest Pharmaceuticals Corp. (BPC), a wholly owned U.S. subsidiary of Biotest AG (Dreieich, Germany) has entered into a strategic long-term manufacturing, supply and license agreement with ADMA Biologics, Inc.(ADMA).

Under the terms of the agreement, ADMA has agreed to purchase exclusively from BPC its worldwide requirements and product supply of RSV (Respiratory Syncytial Virus) immune globulin (RI-002) manufactured from human plasma containing RSV antibodies. The initial term of the agreement is for ten years.

RI-002 is a specialty immune globulin for primary immune deficiency patients, which is derived from human plasma containing high levels of Respiratory Syncytial Virus (RSV) antibodies. For patients that are immunocompromised naturally or medically due to an underlying illness or a transplant, an RSV infection can present significant morbidity and mortality. ADMA is currently preparing a pivotal Phase III clinical trial in primary immune deficiency patients with this product in the United States.

Also in connection with the manufacturing and supply agreement, ADMA has out-licensed RI-002 to Biotest AG, to market and sell in Europe and selected countries in North Africa and the Middle East. In return for this license, Biotest AG will compensate ADMA upon the completion of certain milestones as well as pay a royalty based on a percentage of sales of RSV immune globulin in the territory. 'This specialty immune globulin product will perfectly complement our hyper-immune globulin portfolio', Prof. Gregor Schulz, CEO of Biotest comments this deal.

About ADMA's lead product candidate

ADMA's lead product candidate, RI-002 is a specialty plasma-derived, polyclonal, Intravenous Immune Globulin, or IGIV, prepared with high levels of antibodies against respiratory syncytial virus, or RSV. ADMA is pursuing an indication for the use of this specialty IGIV product for treatment of patients diagnosed with primary immunodeficiency disease, or PIDD. Polyclonal antibodies are the primary component of IGIV products. PIDD is a disorder that causes a person's immune system to not function properly. PIDD is caused by hereditary or genetic defects and can affect anyone regardless of age or gender.

About ADMA Biologics, Inc.

ADMA is a late-stage biotechnology company focused on developing specialty immune globulin therapeutics and commercialization of human plasma. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted at niche patient populations some with unmet medical needs. In addition, ADMA operates ADMA Bio Centers, a wholly-owned subsidiary which is an FDA-licensed source plasma collection facility located in Norcross, Georgia. Please visit for more information.


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.

About Biotest

Biotest is a provider of pharmaceutical and biotherapeutic 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 application of clinical immunology, haematology and intensive medicine. In its Plasma Protein portfolio Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest also researches into the development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1.600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich,
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
fax: +49 (0) 6103 801-347

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Stuttgart

Record changed: 2017-04-02


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