OBI Pharma Granted FDA Orphan Drug Designation for OBI-888 for the Treatment of Pancreatic Cancer

Department of Health (DOH) clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study in Hong Kong
November 15, 2018
Clarification on the news article by Up Media and other media groups
November 23, 2018
  1. Date of occurrence of the event: Nov 21, 2018
  2. Company name: OBI Pharma Inc.
  3. Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
  4. Reciprocal shareholding ratios: N/A
  5. Cause of occurrence: OBI Pharma received a notice from the FDA for orphan drug designation for OBI-888 in treating Pancreatic Cancer. 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.
  6. Countermeasures: None
  7. Any other matters that need to be specified:
    (1)Name of the new drug: immunotherapeutic monoclonal antibody OBI-888
    (2)Uses: an immunotherapeutic monoclonal antibody targeting Globo H for the treatment of cancer
    https://www.clinicaltrials.gov/ct2/show/NCT03573544
    (3)Planned development: Phase I, II, III clinical trial and NDA
    (4)Ongoing development:
    A.Filed application/ Granted/ Denied: OBI Pharma granted FDA orphan drug designation for OBI-888 for the treatment of Pancreatic Cancer
    B.Risk and countermeasures for denied applications: N/A
    C.Outlook for granted applications: N/A
    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: request for the next phase of clinical studies is planned to be submitted upon completion of Phase 1 clinical studies (Dose Escalation Phase and Cohort Expansion Phase
    A.Expected timeline: OBI-888 Phase 1 Dose Escalation Phase is ongoing and is expected to complete in 2019. Actual project timeline will be adjusted based on the actual study plans.
    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-888 is still in clinical development; its indications will be evaluated based on unmet medical needs, product opportunities, and company portfolio.
    (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.