Biotest Pharmaceuticals Announces First Commercial Sales of BIVIGAM™
02/ 4/2013 8:00 am
Boca Raton, Fla. and Dreieich, Germany February 4, 2013 – Biotest Pharmaceuticals Corporation (BPC) a wholly owned U.S. subsidiary of Biotest AG, is pleased to announce the first commercial sales and successful shipments of BIVIGAM™ [Immune Globulin Intravenous (Human), 10% Liquid] into the pharmaceutical distribution channel for use by physicians, pharmacists and hospitals throughout the United States. The product is now available on a regular basis for patients with Primary Humoral Immunodeficiency (PI).
To best serve the U.S. market and patient population, Biotest has made significant investments in its infrastructure and its ability to efficiently manufacture and deliver the product. In addition to a greater than $50 million investment to enhance the capacity of its state-of-the-art Boca Raton, Florida protein purification facility, Biotest also has developed and deployed a comprehensive logistics operation to better serve its customers.
“The U.S. Food and Drug Administration’s (FDA) approval and first commercial sales of BIVIGAM are key corporate milestones for Biotest. The expansion and enhancement of our manufacturing capabilities have positioned us strongly to meet current and future patient and market demand,” said Jordan Siegel, Chief Executive Officer of BPC. “We are committed to supporting PI patients with BIVIGAM to ensure their uncompromised living.”
BIVIGAM is a sugar-free, glycine stabilized intravenous immune globulin that was approved by the FDA December 19, 2012 and is available in 50 mL (5 grams) and 100 mL (10 grams) tamper-evident vials. The product uses a label with an integrated hanger and the packaging material is latex free. For Full Prescribing Information and more information about the product, the indication and additional services, please visit www.BIVIGAM.com.
For ordering information, please contact our customer support at 1.800.458.4244 and select Option 1.
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 AG
Biotest is a provider of pharmaceutical and biotherapeutic drugs. With a value added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of application of clinical immunology, hematology and intensive medicine. 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 hematopoietic 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. 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, 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
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover,
About Biotest Pharmaceuticals Corporation
Biotest Pharmaceuticals Corporation was created as a wholly-owned US subsidiary of Biotest AG in December 2007. Innovative technologies and a sharp focus on safety are incorporated into every facet of the business. From plasma collection to product manufacturing and distribution – from nature for life – Biotest Pharmaceuticals Corporation is committed to maintaining high standards of excellence.
With further questions, please contact the Customer Support at 1-800-458-4244