Shares of BioVie Inc. (NASDAQ: BIVI) experienced a remarkable surge in trading last Friday, with stock prices climbing by an impressive 109.82% during regular session to close at $2.35.
This upward trajectory continued into the extended session, where BIVI stock gained an additional 9.77%, reaching $2.58. This significant increase in value is attributed to a pivotal regulatory milestone achieved by the company in Japan.
Regulatory Achievement
BioVie (BIVI) declared late last week that the Japan Patent Office had granted it a Notice of Allowance for patent application number 2021-569344, which is entitled “Formulations of Terlipressin.”
After administrative procedures are finished, it is expected that this Notice of Allowance will result in the issuing of a Japanese patent in the following two to three weeks. The authorized claims relate to a new liquid version of terlipressin acetate that is easily packed in a pre-filled syringe and has a two-year shelf life at room temperature.
Taking Care of Medical Needs
The goal of BioVie’s novel formulation is to develop a more patient-centered ambulatory treatment plan for Americans with hepatic failure and ascites. The prognosis for those who develop refractory ascites is difficult; their one-year survival rate is just about 50%. Currently, there is no approved therapy specifically targeting refractory ascites, leaving management reliant on temporary procedures that do not offer lasting solutions.
Enhanced Treatment Potential
Terlipressin is a well-established drug utilized in over 40 countries for treating complications related to liver cirrhosis. It has recently gained approval in the United States, albeit as a lyophilized powder requiring reconstitution and refrigeration.
BioVie’s liquid formulation presents a significant advancement, providing stability at room temperature for 24 months. This feature, combined with the pre-filled syringe format, enhances dosing convenience and safety, particularly in home-care settings.
Furthermore, the receipt of this patent will fortify BioVie’s intellectual property protections, thereby bolstering the value proposition of its BIV201 program. In addition to the recent approvals in the US and Japan, BioVie (BIVI) holds patent protections for its liquid formulation in India and Chile, with additional patents pending globally.
