OCTAPHARMA USA, INC.
PARAMUS, NJ

As the end-user of our products and services, we are dedicated to improving the quality of life of our patients suffering from a variety of blood clotting disorders, immune deficiencies, and other illnesses. By working closely with patients and patient associations in the United States and around the world, we are able to develop a better, more empathetic understanding of our patients’ needs and challenges. We then leverage this knowledge to further innovate and improve our products themselves and the overall patient experience. The safety record of Octapharma products provides a sense of confidence to both patients and healthcare professionals alike. Octapharma has pioneered the adoption of the solvent-detergent (S/D) treatment process for viral inactivation, which according to the World Federation of Hemophilia is the current gold standard for safety from highly infectious enveloped viruses, and “should be seriously considered as the option of choice when assessing products.” The S/D process in conjunction with other critical steps in the broader viral inactivation process, have collectively delivered our enviable record of no known viral transmissions over the last three decades. At Octapharma, patient safety is critically important and is never left to chance. Our enviable history and proven track record are a function of a highly rigorous process that begins with our plasma source. All blood donors, collection centers, and donated blood or plasma are held to the highest standards. Once received in our facility, a highly precise and multi-stage virus inactivation process takes over before releasing finished products for use in patients. Octapharma USA Expanded Access General Policy Octapharma is dedicated to improving the lives of patients.  Patients with serious illnesses who have exhausted all available treatment options often are interested in knowing if their condition could be treated with investigational drugs/biologics that have not yet been approved by the United States Food and Drug Administration (FDA).  In such cases the patient might ask if and how they can receive early access to Octapharma investigational products that might be helpful for their condition. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug.  This webpage sets forth Octapharma USA’s expanded access policy on investigational products intended to treat serious diseases.  In certain instances, an Expanded Access Program for a particular investigational product may be available to patients in these circumstances. Octapharma is required to collect data on the safety and effectiveness of any new biologic product in clinical trials and submit trial results to the FDA before the product can be legally marketed. To participate in a trial, a patient must conform to certain entry or exclusion criteria.  When clinical trial records containing information about expanded access to Octapharma’s investigational products become publicly available pursuant to section 402(j)(2)(A)(ii)(II)(gg) of the Public Health Service Act, Octapharma will add a hyperlink or other appropriate reference to those records on this website page.  In cases where a clinical trial is not an option and the patient has exhausted all available treatment options, the FDA may give permission for Octapharma to provide a treating physician with an unapproved drug to administer to the patient, outside of any ongoing clinical trial. Such individual use of an unlicensed investigational drug is called “expanded access.” If you would like to inquire about expanded access for any of Octapharma’s products that have investigational status, please have your treating physician contact the Octapharma USA Mission & Vision Since the 1980s, we have introduced     life-saving or life-enhancing treatments that have helped people lead normal lives. We are dedicated to improving the quality of life for patients with a variety blood clotting disorders, immune deficiencies, and other illnesses. Our company's mission is to enhance the safe and optimal use of human proteins.  Octapharma respects donated human plasma as a scarce and valuable resource. We meet our mission through the use of cutting-edge, validated viral inactivation and state-of-the-art purification technologies, in order to achieve the highest production yields and manufacture medical products with the highest possible safety margins. Octapharma has implemented a strategy of continuous investment in, and enhancement of both existing products as well as new products to develop a world-class portfolio of human proteins for the future. In addition to our plasma-based activities, Octapharma has dedicated increasing resources over the past decade to human recombinant protein Research & Development (R&D). This involves the use of cultured human cells to produce therapeutic protein products in specific therapy areas such as hemophilia. "The foundation of our identity is our patient-oriented corporate culture. We aim to increase our product portfolio to access the global market; to enter the recombinant business successfully; to increase plasma availability and throughput; to nurture a healthy organization with proud and talented employees and to continue to have open and transparent communication. These strategic pillars, we believe, will lead to further successes and profitable organic growth. These core elements define our future resource investments and continue to focus our internal and external activities." The story of Octapharma began in the 1980s, when we pioneered the introduction of virally inactivated Factor VIII for the treatment of hemophilia patients. Since then, we have introduced several life-saving or life-enhancing treatments that have helped people lead normal lives. We have provided innovative solutions that include helping several countries meet their self-sufficiency goals for plasma products by fractionating their collected plasma.