- Race Oncology is currently pursuing a 505(b)(2) regulatory pathway for Bisantrene in the U.S.
- AML is the most common type of acute leukemia in adults
MELBOURNE, Australia and PARIS, April 3, 2017 /PRNewswire/ -- Race Oncology, Ltd. (RAC.AX) and BL&H Co, Ltd. announced an agreement granting BL&H an exclusive license for the sale of Bisantrene in South Korea for the treatment of acute myelogenous leukaemia) under a named patient program (NPP).
The NPP mechanism in South Korea allows for pre-approval access and sales of medicines in response to requests by physicians on behalf of specific, or "named," patients. "We are very excited to bring Bisantrene to the South Korean market. Bisantrene represents a unique commercial opportunity for our company because of its clinical benefits for AML patients," noted D. C. Roh, president, BL&H.
Peter Molloy, chief executive officer, Race Oncology added, "We see this an important agreement for Race that signals the commercial potential for Bisantrene NPP partnerships in Asia and anticipated NPP launches in Europe commencing later this year."
Bisantrene hydrochloride is a synthetic anti-neoplastic DNA intercalator with chemotherapeutic and immunologic effects. A product of rational drug design, bisantrene was engineered to reduce the cardiotoxicity and multidrug resistance commonly associated with anthracyclines and offer an improved therapeutic index. Over 40 clinical trials have been conducted with this agent against various cancers, including extensive study at the National Cancer Institute. Bisantrene has demonstrated efficacy in relapsed or refractory AML. Race Oncology is seeking regulatory approval for bisantrene in the U.S. through a 505(b)(2) regulatory pathway and plans to pursue the equivalent regulatory approach with the EMA.
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) allow for the FDA to rely on data not developed by the NDA applicant. 505(b)(2) candidates are derived from reference products for which extensive safety and efficacy information is available, they generally carry less risk, cost less and may achieve FDA approval in a much shorter time.
About Race Oncology, Ltd.
Race Oncology is a specialty pharmaceutical company, whose business model is to pursue late stage clinical assets, principally in oncology. For more information visit raceoncology.com
BL&H meets the demands of healthcare professionals by providing access to advanced and innovative products that offer patients a better quality of life. Their combined business, medical, regulatory and scientific expertise facilitates their approach to maximising distribution of high-quality, cutting-edge products. BL&H has represented CSL in the past and currently represents the Australian companies, Pharmaxis and Medical Developments International, in South Korea. For more information visit http://www.blnh.co.kr.
For more information, contact:
C. Gordon Beck
Senior Vice President