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Biotest AG: Biotest receives marketing authorisation for Albiomin 20% in China


Biotest AG / Key word(s): Regulatory Approval

05.11.2014 / 16:38



PRESS RELEASE

Biotest receives marketing authorisation for Albiomin 20% in China

- Marketing approval granted for Albumin in China

- The Chinese Pharmamarket is the second largest market for pharmaceuticals

Dreieich, Germany, November 5 2014. Biotest has received the marketing authorization for Albiomin 20% (20% solution of human albumin) on October 31th, 2014 from the Chinese FDA (China Food and Drug Administration).

Human albumin is used for stabilization of the blood circulation in severe diseases such as burns as well as chronic diseases of the liver and kidneys or complications associated with protein loss.

In the Chinese pharmaceutical market only human albumin made from US plasma is authorized for selling. For this our international production structure offers unparalleled advantages. Plasma collected from US blood donors is the source material for Albiomin 20% for the Chinese market.

The Chinese pharmaceutical market grows annually by approx. 26%. China is the second largest pharmaceutical market besides the USA. China has a rising demand for human albumin: 205 tons were already sold in 2012, more than 60 % of which was imported.

With the distribution partner of Biotest, Wanbang Biopharmaceuticals, Shanghai, China- a subsidiary of the Fosun Pharmaceuticals Group, one of China's largest pharmaceutical companies, Biotest expects to be on the Chinese market with Albiomin 20% from 2015 onwards. First sales are expected beginning of 2015 after the batch release by the authorities.

As demand for human albumin is rising Biotest is expanding the production capacity. Considerable investments were committed in the past few years to double existing albumin production. Production capacity for albumin in Dreieich increased to around 42 tons per year. Within the Biotest Next Level expansion program, capacity will be ramped up even further. By 2018/ 2019, production capacity should rise to around 75 tons.


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.

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 albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2.000 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

Human Albumin

Albumin is used in particular in intensive care medicine and acute care. Patients with extensive blood or fluid loss, due to burns among other things, have too little of the important proteins in their blood. This protein loss is compensated by administering Albumin. Albumin is also used for volume replacement in cases of blood poisoning. Unlike synthetically manufactured drugs, Albumin produced from human plasma offers particularly good tolerability. It is also the most important protein carrier in the blood for binding and removing (harmful) substances from the vascular system.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations@biotest.de
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





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295314  05.11.2014