ZLB Behring Announces Availability of Humate-P® with Smaller Diluent
Innovation Means Added Convenience for Patients and Caregivers
King of Prussia, PA — 15 February 2006
ZLB Behring today announced that
Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized) is now available featuring a smaller diluent - 50 percent less in all assay sizes.
The new formulation, which bears the current safety and efficacy profile of Humate-P, offers added convenience to patients, healthcare professionals, and caregivers who administer Humate-P. Humate-P is the only factor concentrate approved by the U.S. Food & Drug Administration for use in treating adult and pediatric patients who experience spontaneous and trauma-induced bleeding episodes in severe von Willebrand Disease (VWD), and in mild or moderate VWD where the use of desmopressin is known or suspected to be inadequate.
"ZLB Behring continually strives to bring innovation to the healthcare marketplace so we can offer products that enhance patients' overall quality of life," said Paul Perreault, ZLB Behring Executive Vice President, Worldwide Commercial Operations. "Humate-P with the smaller diluent is an excellent example of that effort. We are pleased to be bringing it to those patients who can benefit from the convenience it offers."
The smaller diluent size means that patients who use the new formulation can enjoy the convenience of spending less time receiving their infusions. In addition, vial and package sizes of the product are now smaller, translating to less required storage space.
Humate-P is a factor replacement therapy with more than 19 years of demonstrated safety and efficacy around the world. In more than one-half billion units infused, there is no documented evidence of viral transmission with Humate-P. It is an injectable drug that works by replacing the von Willebrand factor/factor VIII that is missing in patients with VWD. Humate-P contains the quality (high molecular weight) of multimers necessary for formation of stable hemostatic plugs. The content of high molecular weight multimers in Humate-P corresponds closely to that of normal human plasma. In addition, Humate-P contains the quantity of von Willebrand factor and factor VIII that is important for treating VWD.
About von Willebrand Disease
Von Willebrand disease, the most common hereditary bleeding disorder in the United States, is caused by a deficiency or abnormality of the von Willebrand factor, a protein in the blood that is necessary for normal blood clotting. Men and women are equally likely to be affected by VWD. VWD is classified by types, ranging from Type I (the most common and mild) to Type III (the most severe).
Women with VWD are more likely to experience heavy, prolonged menstruation. Other common symptoms of VWD include frequent nosebleeds and easy bruising. Bleeding can be mild or serious and can occur as a result of injury, or without any obvious cause. More serious symptoms include bleeding into joints and internal organs. The VWD patient may require special care during dental procedures, surgery and childbirth.
There is no "cure" for VWD, but it can be treated. Specific treatments may include desmopressin acetate to release stored von Willebrand factor; von Willebrand factor replacement therapies, such as Humate-P, Antihemophilic Factor/von Willebrand Factor Complex (Human) Dried, Pasteurized; and oral contraceptives to reduce menstrual bleeding and raise von Willebrand factor in the bloodstream.
Important Safety Information
Possible adverse events with the use of Humate-P include allergic reaction, urticaria (hives), chest tightness, rash, pruritus (itching) and edema (swelling). Anaphylactic reaction can occur in rare instances. Humate-P is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement therapy, especially in patients with known risk factors for thrombosis. In these patients, caution should be exercised and antithrombotic measures should be considered. Please visit www.ZLBBehring.com to read the prescribing information for Humate-P.
About ZLB Behring
ZLB Behring is a global leader in the plasma protein biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patients a wide range of related services. The company’s broad portfolio of life-saving therapeutics is used in the treatment of individuals with hemophilia and other bleeding disorders, immune deficiency disorders, and inherited emphysema; for the prevention of hemolytic diseases for the newborn; in cardiac surgery patients; and in shock and burn victims. Additionally, ZLB Behring operates one of the world’s largest, fully owned plasma collection networks. ZLB Behring is a subsidiary of CSL Limited, a biopharmaceutical company, which operates worldwide from its headquarters in Melbourne, Australia. For more information, please visit www.ZLBBehring.com.
||Sheila A. Burke
||Director, Communications & Public Relations
||Worldwide Commercial Operations