OBI filled application of Phase 1 human clinical study for Novel Botulinum Toxin preparation, OBI-858, to TFDA
(1) Name of the new drug: Novel Botulinum Toxin preparation, OBI-858
(2) Uses: The new clostridium botulinum toxin preparation is expected to be use in medication and cosmetology.
(3) Planned development: Phase I, II, III clinical trial and NDA
(4) Ongoing development:
A. Filed application/ Granted/ Denied: Filed application of Phase 1 human clinical studies to TFDA
B. Risk and countermeasures for denied applications: Not applicable
C. Outlook for granted applications: Not applicable
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 1 human clinical study
A. Next phase of development: expected to complete in 2021, the actual schedule will be adjusted according to the timeline.
B. Expected obligation: None
(6) Current market: According to Global Market Insights, the cosmetic and medicinal markets for Botulinum Toxin products are about US$4.7 billion in 2018. The Compound Annual Growth Rate (CAGR) is expected to be 9.1%, and the global market is expected to be US$8.5 billion by 2025. Up to date, about 8-9 competitors have entered the market. The novel botulinum toxin, OBI-858, is expected to be use in medication and cosmetology.
(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.