Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 13

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 13
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. In June 2023 and December 2024, BioVie received guidance from the FDA
regarding the design and endpoints for definitive Phase 3 clinical testing of BIV201.

Our proprietary novel liquid formulation of terlipressin
is designed to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute
the current powder version of terlipressin. To date, analytical testing results have confirmed room temperature stability of the prefilled
syringe in storage for 2 years, with the potential for up two years stability. Room temperature storage presents a key product differentiation
versus terlipressin products in countries where the drug is approved. To the best of the Company’s knowledge, all other terlipressin
products sold globally must be stored under refrigeration and there is no prefilled syringe format of terlipressin available for treating
patients in these countries. BioVie has also filed a Patent Cooperation Treaty (“PCT”) application covering our novel liquid
formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170) and to date patents have
been granted in the U.S. (Patent no. 12,156,898), India (Patent No. 540813), Chile (Patent No. 68.965), China (Patent No. ZL 202080050758.X),
and Japan (7579811).

We believe BIV201 (continuous infusion terlipressin)
has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due
to hepatitis, nonalcoholic steatohepatitis, and alcoholism. The FDA has granted Fast-Track status and Orphan Drug designation for ascites
(due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet
medical need. Patients with cirrhosis and ascites account for an estimated 116,000 U.S. hospital discharges annually, with frequent early
readmissions. According to the HCUP Nationwide Readmissions Database 2016, those requiring paracentesis (removal of ascites fluid) experience
an average hospital stay lasting eight days incurring over $86,000 in medical costs. This translates into a total potentially addressable
ascites market size for BIV201 therapy exceeding $650 million based on Company estimates.