• Investigational New Drug (IND) clearance from US FDA represents a key milestone in SynCore’s new drug pipeline development program
• The global Phase III study has Orphan Drug Designation granted by US FDA and European Medicines Agency for the indication of metastatic Pancreatic Cancer
• Commercial opportunity launch for a preferential product against an unmet medical need as first and only therapy of its kind with a strong intellectual property position
Taipei, Taiwan, April 18, 2017 – SynCore Biotechnology Co., Ltd. (SynCore) announced today that it has received clearance of an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) for SB05 (EndoTAG®-1) in combination with Gemcitabine in a pivotal global phase III study for patients with metastatic pancreatic cancer following FOLFIRINOX Treatment. SynCore was also granted Orphan Drug Designation by US FDA and European Medicines Agency, the novel treatment is considered in an accelerated path to approval with regulatory and commercial advantages. SynCore took over full development of SB05 (EndoTAG®-1) from Medigene (MDG1:GR) and was able to add value on previous high quality evidence to accomplish another successful milestone in the US. The future progress of the orphan drug will be a major breakthrough for human society.
About SB05 (EndoTAG®-1)
(EndoTAG®-1) is a novel composition of neutral and positive lipids loaded with Paclitaxel. By interacting with newly formed, negatively charged endothelial cells, which are specifically required for the growth of tumor blood vessels, the drug targeting the blood supply to tumors is expected to prevent the formation of new tumor blood vessels and to inhibit tumor growth. SB05 (EndoTAG®-1) targets indications with unmet medical needs, having completed phase II clinical studies in the treatment against pancreatic cancer, triple-negative breast cancer (TNBC), neoadjuvant breast cancer and liver metastasis. Encouraging clinical data shows that the oncology asset has achieved significant improvements in progression-free survival and/or overall survival with evidence of anti-tumor activity and a favorable safety profile. Along with other previously opened INDs in Belgium (EMA), Taiwan (TFDA) and Australia (TGA), the oncology asset is considered to own significant potential in the fight against cancer.
About Pancreatic Cancer
Pancreatic cancer is a highly malignant disease with patients usually diagnosed at an advanced stage. With an extremely low 5 year-survival rate and extremely poor prognosis for patients, the pancreatic cancer market has current unmet clinical needs.¹ The global treatment market is expected to grow from its current level of USD 2 billion to USD 2.9 billion by 2021 (GBI Research) revealing that promising new drugs in treating pancreatic cancer with potential market exclusivity might significantly impact the market.²
About SynCore
SynCore Biotechnology Co., Ltd (SynCore) (4192:TT) is a biopharmaceutical company with a comprehensive pipeline portfolio of new drugs in the areas of oncology, ophthalmology, dermatology and infectious diseases. The EndoTAG® technology platform is wholly owned by SynCore. Please visit the Company’s website at http://www.syncorebio.com/
For further information please contact:
Media: Charles Liang, CFO finance@syncorebio.com
Business Development: BD@syncorebio.com
Reference ¹ American Cancer Society. “Pancreatic Cancer Survival Rates, by Stage”. ² GBI Research. “Pancreatic Cancer Therapeutics in Major Developed Markets to 2021 – Strong Late Stage Pipeline Holds Promise for Increasingly Diverse Market Landscape” DISCLAIMER This press release may contain certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of SynCore Biotechnology Co., Ltd.