OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)

Announcement on the board resolution at Annual General Meeting 2018
June 27, 2018
  1. Date of occurrence of the event: Jul 7, 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: On Jul 6, 2018 (US Time), OBI Pharma received a notice from the FDA for orphan drug designation for OBI-3424 in treating of Hepatocellular Carcinoma (abbreviated as HCC). The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S. Once granted as orphan drug, potential benefits including market exclusivity upon regulatory approval, exemption of FDA application fees, and tax credits for qualified clinical trials may apply.
  6. Countermeasures: N/A
  7. 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
    (4)Ongoing development:
    A.Filed application/ Granted/ Denied: Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)
    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: Plan to enter Phase II (cohort expansion) after completing Phase I (dose escalation)
    A.Expected timeline: Phase I (does escalation) Clinical Trial of OBI-3424 is scheduled to take 1 year. The timeline may be adjusted based on actual study progress
    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 solid tumors include AKR1C3 over-expressed hepatocellular carcinomas (HCC) and castrate-resistant prostate cancer (CRPC)
    (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