SyB L-0501: FD lyophilized formulation /SyB L-1701: RTD liquid formulation /SyB L-1702: RI administration
Bendamustine hydrochloride (generic name), the active pharmaceutical ingredient of SyB L-0501 (brand name: TREAKISYM®), is an anti-cancer agent that has been in use for a number of years in Germany for the treatment of non-Hodgkin's lymphoma (NHL), multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). In the U.S., Cephalon, Inc. (Pennsylvania) obtained FDA approval in 2008 for bendamustine hydrochloride as a new chemotherapeutic agent for CLL and low-grade NHL. The new drug was recognized as having the greatest impact on the treatment of CLL in the 2008 report by the American Society of Clinical Oncology ("ASCO") summarizing the year's most important research achievements, and was listed as first-line therapy for indolent NHL and mantle cell lymphoma (MCL) in the NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology, the recognized standard for clinical policy in oncology.
SymBio obtained from Astellas Deutschland GmbH, a German subsidiary of Astellas Pharma Inc., exclusive rights for the development and sales of bendamustine in Japan (March 2005), and subsequently in China/Hong Kong, Korea, Taiwan and Singapore (April 2007). In August 2008, SymBio signed a license agreement with Eisai Co., Ltd. for co-development and commercialization in Japan with exclusive rights retained by SymBio (a second license agreement was signed with Eisai for the right to bendamustine in Korea and Singapore). In October 2010, the Ministry of Health, Labour and Welfare approved SymBio's New Drug Application (NDA) for TREAKISYM® (bendamustine) for the treatment of refractory/relapsed low-grade NHL and MCL in Japan and SymBio started domestic sales in December 2010. Also, in August 2016, SymBio obtained approval for CLL as an additional indication and started its sales domestically. TREAKISYM® has become an essential drug (standard drug) in the treatment of refractory/relapsed low-grade NHL and MCL, since its October 2010 approval, and following its December 2016 approval for the additional indication of first-line treatment of low-grade NHL and MCL, is expected to become widely used for this treatment. In March 2021, the lyophilized powder formulation (FD formulation) and in April 2021, the Ready To Dilute (RTD) liquid formulation received approval for an additional indication for the treatment of relapsed/refractory diffuse large B-cell lymphoma.
Since its incorporation, SymBio has focused on implementing a product lifecycle management strategy to maximize the business value of TREAKISYM® and as a part of this strategy, the Company has pursued the expansion of approved indications.
In September 2017, SymBio entered into an exclusive license agreement with Eagle Pharmaceuticals, Inc. for the development and commercialization in Japan of Eagle's bendamustine hydrochloride ready-to-dilute (RTD) and rapid infusion (RI) liquid formulation products (marketed in the U.S. by Teva Pharmaceutical Industries Ltd. under the tradename of BENDEKA®). Obtaining the exclusive rights for Eagle's patent-protected bendamustine liquid formulations (RTD and RI) enables SymBio to extend the product life of TREAKISYM® until 2031. Switching from the existing TREAKISYM® lyophilized powder formulation to ready-to-dilute (RTD) liquid formulation significantly reduces the preparation time and labor costs for healthcare providers, and developing and commercializing the rapid infusion (RI) formulation reduces infusion duration to 10 minutes (from the current 60 minutes), providing significant benefit and value to both patients and healthcare providers. SymBio launched the RTD formulation on January, 2021 and received approval of a partial change to its Marketing Authorization for RTD formulation to add rapid infusion (“RI”) administration on February, 2022.
What is non-Hodgkin's lymphoma?
Malignant lymphoma is a malignant tumor in which lymphocytes in white blood cells have become cancerous, and is a disease in which swollen lymph nodes and masses form. It is divided into Hodgkin's lymphoma and non-Hodgkin's lymphoma, and the majority of Japanese malignant lymphomas are non-Hodgkin's lymphoma.
Antibody therapy is administered with rituximab as the first-line drug for this disease, but currently there is no established treatment for cases of ineffectiveness or recurrence.