BioVie Inc. announced that following the company’s successful Phase 2a study, it has received guidance from the US Food and Drug Administration (“FDA”) regarding the next clinical trial design for BIV201 (continuous infusion terlipressin) in patients with refractory ascites due to liver cirrhosis. The Company plans to commence a randomized 24-patient Phase 2 study this year, to be followed by a larger pivotal Phase 3 clinical trial targeted to begin the first half 2021. The FDA has communicated that pending positive Phase 2 study results, a sufficiently large and well-controlled Phase 3 trial, with supportive data from the Phase 2 (statistical significance not required), could potentially yield the clinical data needed to apply for BIV201 marketing approval. The Company estimates that the pivotal Phase 3 study will involve approximately 120 ascites patients. Importantly, BioVie may use the new patent-pending BIV201 prefilled syringe in the upcoming Phase 2 trial subject to conducting certain additional standard analytical testing that is expected to take approximately two weeks. Room temperature stability of the prefilled syringe has been confirmed at 6 months, with the potential for 12 months or up to two years of stability (yet to be confirmed). 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. Terlipressin, which is not available in the US or Japan, is often sold as a lyophilized powder for reconstitution in hospital pharmacies in Europe and Asia. The traditional powder format is satisfactory for hospital use, but creates a logistical challenge when administering terlipressin via ambulatory infusion pump in patients located outside the hospital setting. To solve this challenge, the Company developed a patent-pending liquid formulation for delivery via prefilled syringe. This novel drug delivery system is expected to simplify at-home patient treatment and improve patient compliance by enabling easy injection of the liquid concentrate into the IV bag connected to the infusion pump. It avoids the manual mixing of minute (2 – 4 mg) quantities of terlipressin powder in saline solution, thereby reducing the possibility of dosing errors during reconstitution, and is expected to improve drug solution sterility. BIV201 (continuous infusion terlipressin) has received an Orphan Drug designation from the FDA for the treatment of ascites. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the United States for the designated use(s). In addition, the Company has begun applying for global patent protection of its proprietary liquid formulation of terlipressin. This could eventually provide up to 20 years of patent coverage in each country for which the Company seeks patent protection, including the US, according to the patent laws of that country.