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Octapharma USA Sponsors International Advisory Board for Evaluating Treatment of Patients with von Willebrand Disease
HOBOKEN, N.J. (June 28, 2011) – Octapharma USA recently hosted an International Physician Advisory Board in New York City, bringing together medical experts from around the world who have extensive experience internationally with taking care of patients with von Willebrand’s Disease (VWD). As the most common inherited bleeding disorder in humans, VWD affects one to two percent of the general population or approximately 3 million people in the United States. Octapharma manufactures wilate®, a therapy introduced to the U.S. market for VWD over the last year that has been available in many other countries for a decade. The U.S. Food and Drug Administration (FDA) has granted Octapharma orphan drug exclusivity for wilate® (von Willebrand Factor/Factor VIII Concentrate, Human), the first replacement therapy developed specifically for VWD. “Our goal was to promote a scientific dialogue among the medical community in the U.S. and abroad,” said Octapharma USA President Flemming Nielsen. “Overall the advisory meeting’s clinical platform encouraged significant discussion and debate around the treatment and management of VWD patients and evaluated data and experiences in Europe. There was general agreement among the attendees that improving the care for VWD patients is possible and that more data either from clinical trials or scientific experience would be beneficial.” The meeting was jointly chaired by Jerry S. Powell, M.D., Professor at the University at California-Davis and Director of the UC-Davis Hemophilia and Thrombosis Center; and John Pasi, M.D., Professor of Haemostasis and Thrombosis, Barts and The London School of Medicine and Dentistry, London. “As physicians, we need to continue to gain experience in treating all clinical concerns of all types of VWD patients in the U.S.,” said Dr. Powell. “For years, treatment options in the U.S. have been extremely limited so the opportunity to learn from our European colleagues, who have extensive experience in VWD and the use of wilate®, was quite valuable. Taking advantage of the lessons learned in Europe and determining how the clinical data can lead to improved treatment options will be beneficial to U.S. patients.” Dr. Pasi discussed the significant VWD experience at the Royal London Haemophilia Centre and the organization’s decision to utilize wilate® as its primary therapy. “wilate® is the first double-virus inactivated VWF/FVIII high-purity concentrate, utilizing the solvent/detergent process and a special terminal dry-heating system,” said Dr. Pasi. “We believed wilate® was truly a next generation therapy because it was double-virus inactivated. Our desire to utilize a factor concentrate specifically designed to treat VWD also weighed heavily in the decision as did clinical trial experience.” The Advisory Board Meeting is the latest step in Octapharma’s continuing support for educational programs designed to enhance treatment for VWD patients. In the last year, Octapharma has supported educational symposia at the Annual Meeting of the National Hemophilia Foundation and a Continuing Education initiative of the National Home Infusion Association focusing on VWD. “With several of the world’s most respected VWD scientific experts on hand, attendees were able to exchange ideas and experiences that were truly valuable,” said Nielsen. “Scientific and clinical advancements and unmet needs in the treatment of VWD patients are paramount challenges. All participants were truly concerned with better controlling patient bleeding episodes and improving the quality of life for VWD patients, underscoring the need for continued scientific research.”
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for over 27 years. Octapharma’s core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma’s IGIV product, octagam® (immune globulin intravenous [human] 5%), is used to treat disorders of the immune system, and Octapharma’s albumin (Human) is indicated for the restoration and maintenance of circulating blood volume. Octapharma’s wilate® received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com.
Forward-looking statements
This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company’s control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.
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CONTACT:
Fred Feiner, Yankee Public Relations
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800-977-1910, Ext. 4
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Photos are of models and for illustrative purposes only.
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FOR IMMEDIATE RELEASE
Octapharma USA Supports HTRS Blood Disorders Educational Initiatives at Annual Scientific Symposium
HOBOKEN, N.J. (April 2, 2013) – Octapharma USA will present an impressive eight clinical posters and will sponsor the Hemophilia & Thrombosis Research Society (HTRS) Annual Scientific Symposium, scheduled for April 11 – 13 at The Westin Charlotte in North Carolina.
Designed for researchers and healthcare providers who care for patients with bleeding and clotting disorders, the conference supports the HTRS mission to advance research, education and mentorship. Octapharma USA provided an unrestricted educational grant for the scientific symposium.
“Octapharma is committed to supporting the bleeding disorders community through research, product development and educational initiatives,” said Octapharma USA President Flemming Nielsen. “It is very important that we properly communicate the latest developments in bleeding disorders. Research advances are taking place rapidly in many areas and the healthcare community must stay abreast of changes impacting patient care.”
The titles of the Octapharma poster presentations are:
- Low inhibitor incidence in previously untreated patients with severe haemophilia A treated with octanate® – Update from the PUP-GCP clinical trial;
- Efficacy and safety of on-demand treatment with Human-cl rhFVIII in previously treated patients with severe haemophilia A;
- Clinical study in children with severe haemophilia A investigating efficacy, immunogenicity, pharmacokinetics, and safety of Human-cl rhFVIII;
- Human-cl rhFVIII effectively and safely prevents bleeding episodes in previously treated adult patients with severe haemophilia A;
- Final results of a prospective, non-interventional clinical study in 170 VWD patients with a new generation of VWF/FVIII concentrate in Germany;
- ITI with a VWF / FVIII concentrate in haemophilia A patients with inhibitors and a poor prognosis for ITI success: Progress report on octanate® in the ObsITI study;
- Glycoprotein Ib-mediated platelet adhesion and thrombus formation under flow: Role of VWF triplet bands; and
- Treatment of Congenital Fibrinogen Deficiency; Global Development Plan for a Double Virus Inactivated Fibrinogen Concentrate.
Octapharma USA encourages attendees to visit its conference booth throughout the three-day event. Product information will be available for wilate® (Von Willebrand Factor/Factor VIII Concentrate, Human), a therapy for treating all three types of Von Willebrand Disease (VWD). The company will also have a booth and staff presence at the following April conferences:
About wilate®
wilate® is a plasma-derived, stable, highly purified concentrate of freeze-dried human Von Willebrand Factor (VWF) and coagulation factor VIII (FVIII). Two well-established virus inactivation steps are incorporated into the manufacturing process of wilate®, specifically a solvent/detergent (S/D) and terminal dry heat treatment.
wilate® is a Von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe Von Willebrand Disease (VWD), as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. wilate® is not indicated for the prophylaxis of spontaneous bleeding episodes, or the prevention of excessive bleeding during and after surgery in VWD patients. wilate® is not indicated for Hemophilia A.
Important Safety Information
wilate® is contraindicated for patients who have known anaphylactic or severe systemic reaction to plasma-derived products, any ingredient in the formulation, or components of the container. Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement therapies. FVIII activity should be monitored to avoid sustained excessive FVIII levels. wilate® is made from human plasma. The risk of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jacob disease agent, cannot be completely eliminated. The most common adverse reactions to treatment with wilate® in patients with VWD have been uticaria and dizziness. The most serious adverse reactions to treatment with wilate® have been hypersensitivity reactions.
For more information and full prescribing on wilate®, please visit www.wilateusa.com.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is one of the world’s largest human protein products manufacturers and has been committed to patient care and medical innovation for 30 years. With a broad and expanding pipeline, Octapharma’s core business is the development, production, and sale of high quality human protein therapies from both human plasma and human cell-lines, including intravenous immune globulin and von Willebrand Factor/Coagulation Factor VIII Complex. Octapharma employs more than 5,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, New Jersey. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharma.com, www.octaplasus.com, or www.wilateusa.com.
MEDIA CONTACT:
Fred Feiner
Yankee Public Relations
(908) 425-4878
fred@yankeepr.com |
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Octapharma Sponsors Educational Programs, Presents Research at the 64th Annual NHF Meeting in Orlando
HOBOKEN, N.J. (November 7, 2012) – As part of its commitment to support the bleeding disorders community, Octapharma USA will sponsor several educational programs and present five clinical posters at the National Hemophilia Foundation’s (NHF) 64th Annual Meeting to be held November 8 – 10 in Orlando, Fla.
As a corporate sponsor, Octapharma USA will support the “Victory for Women (V4W) Reception” on November 8. V4W is a health initiative to address the critical issues faced by women with bleeding disorders. Program goals are to increase awareness of women’s bleeding disorders so that girls and women receive early, accurate diagnoses, leading to better health outcomes; and to provide women affected by bleeding disorders with the education, support, skills and resources they need to advocate for their healthcare, financial and social support needs.
Also on November 8, Octapharma USA will sponsor “Von Willebrand Disease 101,” a session led by Cynthia A. Gauger, M.D., a Pediatric Oncologist and Pediatric Hematologist at Wolfson Children’s Hospital in Jacksonville. Dr. Gauger will discuss coping with the diagnosis of VWD, management of the disorder and specific challenges it presents during childhood. Topics will also include medication and other therapies for treatment and prevention of bleeding episodes; progression of VWD from infancy through adulthood; the benefits of a team approach to treating physical and psychological aspects; and the services that are available at a hemophilia treatment center.
On November 9, Octapharma USA will sponsor the “One-to-One VWD Community Reception,” an opportunity to informally learn about managing VWD and share thoughts, concerns, questions and personal goals with peers. As the most common inherited bleeding disorder in humans, VWD affects one to two percent of the general population or approximately 3 million people in the United States.
The titles of the Octapharma poster presentations are:
- Efficacy and safety of a new generation high purity, double virus inactivated VWF/FVIII concentrate in children with VWD following product switch;
- ITI with a VWF/ FVIII concentrate in haemophilia A patients with inhibitors and a poor prognosis for ITI success: Progress report on octanate® in the ObsITI study;
- Low inhibitor incidence in previously untreated patients with haemophilia A treated with octanate® – Update from the PUP-GCP clinical trial;
- Efficacy and Safety Data of prophylactic treatment with Human-cl rhFVIII in previously treated patients with severe haemophilia A; and
- Pharmacokinetics, efficacy and safety of on-demand treatment with Human-cl rhFVIII in previously treated patients with severe haemophilia A.
Octapharma USA encourages attendees to visit its conference booth throughout the three-day event. Product information will be available for wilate® (Von Willebrand Factor/Factor VIII Concentrate, Human), a therapy for treating certain types of Von Willebrand Disease (VWD).
wilate® is a plasma-derived, stable, highly purified concentrate of freeze-dried human Von Willebrand Factor (VWF) and coagulation factor VIII (FVIII). Two well-established virus inactivation steps are incorporated into the manufacturing process of wilate®, specifically a solvent/detergent (S/D) and terminal dry heat treatment.
wilate® is a Von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe Von Willebrand Disease (VWD), as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.
wilate® is contraindicated for patients who have known anaphylactic or severe systemic reaction to plasma-derived products, any ingredient in the formulation, or components of the container. Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement therapies. FVIII activity should be monitored to avoid sustained excessive FVIII levels. wilate® is made from human plasma. The risk of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jacob disease agent, cannot be completely eliminated. The most common adverse reactions to treatment with wilate® in patients with VWD have been uticaria and dizziness. The most serious adverse reactions to treatment with wilate® have been hypersensitivity reactions.
For more information and full prescribing on wilate®, please visit www.wilateusa.com.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is one of the world’s largest human protein products manufacturers and has been committed to patient care and medical innovation for nearly 30 years. With a broad and expanding pipeline, Octapharma’s core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including intravenous immune globulin and von Willebrand Factor/Coagulation Factor VIII Complex. Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharma.com or www.wilateusa.com.
Media Contact:
Fred Feiner, Yankee Public Relations
fred@yankeepr.com
800-977-1910, Ext. 4
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FOR IMMEDIATE RELEASE
Octapharma USA Supports HTRS Blood Disorders Educational Initiatives at Annual Scientific Symposium
HOBOKEN,
Octapharma Sponsors Educational Programs, Presents Research at the 64th Annual NHF Meeting in Orlando
HOBOKEN,
Octapharma Launches Clinical Trial to Evaluate Efficacy & Safety of wilate® In Preventing
Octapharma USA Sponsors International Advisory Board for Evaluating Treatment of Patients with von Willebrand
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