- Date of occurrence of the event: Sept 19, 2018
- Company name: OBI Pharma Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
- Reciprocal shareholding ratios: N/A
- Cause of occurrence: OBI Pharma received a notice from the FDA for orphan drug designation for OBI-3424 in treating Acute Lymphoblastic Leukemia (abbreviated as ALL). The FDA’s Office of Orphan Drug Products grants orphan drug status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S. Once granted, potential benefits include market exclusivity upon regulatory approval, exemption of FDA application fees, and tax credits for qualified clinical trials.
- Countermeasures: None
- Any other matters that need to be specified:
(1)Name of the new drug: Novel Chemotherapeutic Prodrug OBI-3424
(2)Uses: OBI-3424 selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme.
(3)Planned development: Phase I, II, III clinical trial and NDA
A.Filed application/ Granted/ Denied: Granted FDA Orphan Drug Designation for OBI-3424 for the treatment of Acute Lymphoblastic Leukemia (abbreviated as ALL).
B.Risk and countermeasures for denied applications: N/A
C.Outlook for granted applications: Ongoing Phase I/II study as originally planned
D.Total invested capital: To be kept confidential to avoid complications in future negotiation of licensing deals, and as for the best interest of shareholders.
(5)Next phase of development: Phase I
A.Expected timeline: Project timeline will be evaluated based on the overall strategic planning and product portfolio.
B.Expected obligation: None
(6)Current market: According to EvaluatePharma, the global market for anti-tumor drugs is about US$100.9 billion in 2017, the largest among the top 10 categories. OBI-3424 is still in the early stage of clinical development; the potential indications of OBI-3424 in liquid tumors include T-cell Acute Lymphoblastic Leukemia (abbreviated as T-ALL).
(7)New drug development is a long process associated with high costs. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.