Biotest invests more than 10 per-cent of its yearly turnover in research and development. Our projects focus on areas with particularly high needs and/or with a high patient or user potential.  
 
In the centre of our R&D activities are three monoclonal antibodies (MAB). The biotechnologically produced substances BT-061, BT-062, and BT-063 are all in the phase of clinical development. As far as BT-061 and BT-062 are concerned, we have already obtained encouraging data on efficacy and tolerability.
 
All three candidates have a common feature: they are being developed for leading indications, where there are so far no specific therapies, or where the efficacy of existing therapeutic approaches is insufficient, or their adverse effects are very severe. These products have an enormous economic potential: in the sector of rheumatoid arthritis alone the market volume of biotechnologically engineered products is estimated to represent an amount of more than 10 billion US dollars.
 
According to our R&D concept, we intend to develop the MABs up to the clinical phase II by our own efforts. From the cost-intensive clinical phase III onwards, we would like to continue the development in co-operation with globally acting pharmaceutical or biotechnological partners. While Biotest would keep the co-marketing rights for Europe and some other markets, the partner would be granted exclusive sales licences in other regions. In order to obtain these licences, the potential partner will be asked to make up-front and milestone payments. Furthermore, Biotest would be paid royalties as a participation in possible future profits on sales achieved by the partner. Currently, we are looking for such a partner for BT-061.

In the presentation of the segment biotherapeutics, you will find comprehensive information on the mechanism of action and the potential of the monoclonal antibodies. 

In the plasma proteins segment we are pursuing an R&D strategy based on three key aims:

• the expansion of our product range with new preparations and marketing authorisations in additional indications;
• the opening up of new international markets
• the addition of extra capacity to meet requirements.
  Through these aims, we intend to develop our position as specialists in innovative immunology and haematology.

We accordingly added further products to our plasma protein product range in 2009.
The significant developments in this connection were the marketing authorisations for our preparations in additional countries in Europe, such as the authorisation for the albumin preparations Albiomin® 5% and Albiomin® 20% in a further six European markets, and the authorisation of Hepatect® CP in the MR procedure in a further seven European countries. The marketing launch of the new subcutaneously administered Hepatitis B immunoglobulin Zutectra® has also been put in hand, following its authorisation by the European Commission in December 2009.

With respect to the R&D of our diagnostics products, we keep in mind the expansion of our position as a leader in quality and innovation. In the sector of hygiene monitoring, the future belongs to self-contained systems that include media, devices, software, and means of interpretation. Biotest has divers promising approaches to this kind of systems, the progress of which we will pursue alone or in co-operation with specialised systems engineering companies.