BOCA RATON, Fla., Jan. 19, 2016 /PRNewswire/ -- Biotest Pharmaceuticals Corporation (BPC), is pleased to announce the appointment of Kedrion Biopharma Inc. (Kedrion) as exclusive U.S. distributor of its IGIV product, BIVIGAM®. BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid], the most recent entrant into the U.S. immunoglobulin market, is approved for the treatment of patients with Primary Humoral Immunodeficiency (PI). The seven year cooperation agreement (including a two years wind-down period) will strengthen the position of BIVIGAM in the U.S. market.
"We are excited about this new partnership as it will help to further build upon the current market position of BIVIGAM," said Ileana Carlisle, BPC's recently appointed CEO. "Kedrion has an enviable reputation as a leader in plasma-derived therapeutics and a strong sales presence in the U.S. The expected increase in demand for BIVIGAM in the coming years will improve the utilization of BPC's production facility, further enhancing our future profitability."
As BPC enters this new chapter, Dr. Bernhard Ehmer, CEO of Biotest AG, BPC's parent company stated, "Further developing our footprint in the US market is strategic to our overall global business. We are extremely pleased to join forces with Kedrion. Their well-established distribution network will expand and enable more patient access to our BIVIGAM brand."
The exclusive right of distribution of BIVIGAM will transfer to Kedrion immediately, with current customers and partners seeing minimal change. The BIVIGAM license will be retained by BPC.
BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] has been approved for the treatment of patients with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. 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.
Important Safety Information for BIVIGAM® [Immune Globulin Intravenous (Human), 10% Liquid]
Warning: Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, the use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose. For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose recommended and infusion rate practicable. Ensure adequate hydration in patients before administrations. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for viscosity.
See full Prescribing Information for complete boxed warning.
BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy.
Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments; AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
As hemolysis can develop subsequent to treatment with IGIV products, monitor patients for hemolysis and hemolytic anemia.
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). If TRALI is suspected, test the product and patient for antineutrophil antibodies.
Because BIVIGAM is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to BIVIGAM (reported in ≥ 5% of clinical study subject) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increase, diarrhea, dizziness, and lethargy.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about BIVIGAM® please see full Prescribing Information.
About Biotest Pharmaceuticals Corporation
Biotest Pharmaceuticals is a wholly-owned subsidiary of Biotest AG, a German global provider of plasma products. The Company researches, develops and manufactures biotherapeutic plasma protein products, with a specialization in immunology and hematology and is a leader in the collection of source plasma. Biotest Pharmaceuticals owns and manages plasmapheresis centers across the United States and operates a state-of-the-art manufacturing facility in Boca Raton, Florida. We are committed to serving the thousands of patients worldwide who rely on plasma-based therapies, all the while striving to demonstrate our Mission, Vision and Principles in everything that we do.
Biotest Pharmaceuticals' team of over 900 employees is part of Biotest AG's global workforce of nearly 2100 associates worldwide. To learn more about Biotest Pharmaceuticals, our Plasma Centers and the difference we make in the lives of patients and the healthcare community, please visit us at www.biotestpharma.com and www.biotestplasma.com.
SOURCE Biotest Pharmaceuticals Corporation