Biotest submits BivigamTM dossier for regulatory approval to US Food and Drug Administration
- Important step to expand US market position
- Annual sales potential of around USD 100 Mio.
- Biotest expects approval for end of 2011
Dreieich, November 3, 2010. -- Biotest Pharmaceuticals Corp., Boca Raton, Florida - USA, has submitted today the dossier for regulatory approval of the polyspecific immunoglobulin BivigamTM to the US regulatory agency FDA (US Food and Drug Administration).
Bivigam TM is a polyspecific immunoglobulin for the treatment of antibody deficiencies. The product is a ready for use 10% solution, stabilised by glycin and therefore sugarfree. This is a considerable advantage for the clinical application. This preparation was developed exclusively for the US market. In Europe and other global markets, Intratect® will continue to be marketed.
The submission of the dossier for regulatory approval of BivigamTM to the FDA marks an important step for the expansion of the US presence of Biotest. The US market is the worldwide largest single market for polyspecific immunoglobulins, with high and stable prices. The expected demand in the US of 44 tons of immunoglobulins in 2010 represents approx. 44% of the worldwide consumption. Biotest expects the approval of BivigamTM for the end of 2011. As of today, the expected annual sales potential is approx. USD 100 Mio.
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.
Biotest is a provider of pharmaceutical and biotherapeutic drugs as well as reagents and systems for
microbiology. 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 immunology and haematology. In its
Plasma Protein segment, 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
the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies,
including in the indications of rheumatoid arthritis and cancer of plasma cells. The products of the
Microbiological Monitoring segment are primarily used in hygiene monitoring. Biotest has more than 1,900
employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
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/Regulated market Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart