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. (FRAZER, Pa.) 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 is 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.
Moreover, we achieved favorable results from a phase 3 study in relapsed/refractory diffuse large B-cell lymphoma or r/r DLBCL, with the overall response rate, which was the primary endpoint of the trial, exceeding expectations and submitted a partial change application with respect to its marketing approval for TREAKISYM® in May 2020. DLBCL accounts for the largest number of patients with malignant lymphoma in Japan.
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 will significantly reduce the preparation time and labor costs for healthcare providers, and developing and commercializing the rapid infusion (RI) formulation will reduce infusion duration to 10 minutes (from the current 60 minutes), providing significant benefit and value to both patients and healthcare providers. SymBio plans to market the RTD formulation on January ,2021 and launch the RI formulation on the subsequent date.
NHL is a cancer of the lymphatic system in which B or T white blood cells (lymphocytes) develop malignant growths. At last count, there were about 35 different types of lymphoma formally recognized and classified into two main groups: Hodgkin's lymphoma (five sub-types), and non-Hodgkin's lymphoma (thirty sub-types); the majority of Japanese patients are suffering from non-Hodgkin's lymphomas.|
The standard treatment for NHL is chemotherapy, sometimes in combination with radiotherapy.
Although a variety of drug combinations have been used to treat NHL, CHOP (Cyclophosphamide + Hydroxydaunorubicin + Oncovin + Prednisolone) continues to be the "gold standard" for treatment. However, final results reported at the 51st American Society of Hematology (ASH) Meeting in 2009 from a randomized phase III trial (n=549) conducted by Dr. M. J. Rummel and researchers affiliated with Study Group Indolent Lymphomas (StiL) in Germany investigating efficacy and safety of bendamustine + rituximab (B-R) vs CHOP-R in first-line follicular (FL), indolent and mantle cell lymphomas (MCL) are very encouraging. In 513 evaluable patients, B-R improved progression-free survival (PFS) and complete remission (CR) rates with a better tolerability profile than CHOP-R, and has the potential to become a new first-line treatment option for patients with FL, MCL and indolent lymphomas.
The RTD formulation eliminates preparation time and labor costs, providing significant benefit to healthcare providers. The RI formulation benefits patients by reducing the infusion duration to 10 minutes (from the current 60 minutes).[Process flow from prescription to infusion to patient]