Biotest announces clinical trial data for its new investigational Intravenous Immunoglobulin (IVIG) product for the US market
Dreieich, 11 April 2012. Biotest AG announces the publication of its US subsidiary Biotest Pharmaceuticals Corporation (BPC), Boca Raton, Florida, USA of Wasserman et al.,:
"Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency." in the Journal of Clinical Immunology (Http://dx.doi.org/10.1007/s10875-012-9656-5). The published clinical data reports the efficacy of a Biotest new investigational IVIG product, a 10% liquid product, which does not contain any sugar.
The primary investigator, Dr. Richard Wasserman, summarized the results of the clinical trial: “Biotest’s investigational IVIG product offers a modern 10% liquid and sugar-free immunoglobulin that was well tolerated in the study patients. The product met the primary and secondary endpoints of the study. The PIDD (Primary immune deficiency disorder) community will welcome a new alternative product.”
Dr. Georg Floss, CEO of Biotest Pharmaceuticals Corporation, stated: “Biotest Pharmaceuticals has diligently worked to develop this new IVIG 10% liquid specifically for the US market. Biotest is confident that this product will provide patients a unique alternative from a new source with a long legacy of dependability and quality around the world. We look forward to providing this new product to the US Healthcare system from our facility in Boca Raton, Florida, USA.”
The study followed 63 patients with defined primary antibody deficiency for 12 months. All patients maintained an average serum IgG (immunoglobulin) level above 500 mg/dL.
The primary efficacy endpoint, the rate of acute serious bacterial infections (SBI)
(0.035 SBI/patient-year), was well below the FDA target of ≤1.0 SBI/patient-year.
Among other efficacy parameters, the rate of days away from work or school due to infection was 2.28 days/patient-year. Additionally, 63.8% of patients in the trial did not miss a day of work or school.
Earlier this year Biotest’s investigational IVIG virus validation data was published in Results in Immunology: Dichtelmüller et al.:"Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process." (Immunology (Vol 2, 2012, pp 19-24)). The virus validation experiments concluded that the three virus inactivating and/or removal steps employed in Biotest’s manufacturing process are robust and effective.
Biotest is currently seeking marketing approval from the FDA for this investigational IVIG product based upon these and other clinical data. Biotest expects a decision regarding such approval sometime in the first half of 2012.
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. 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 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. Biotest has more than 1.600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
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 these same high standards of excellence. For inquiries about the US market, please contact Douglas Loock at +1 561 989 5732.
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
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