BioVie Advances Patent for Liquid Terlipressin Formulation
BioVie Secures Patent for Terlipressin Formulation
BioVie Inc. (NASDAQ: BIVI), a clinical-stage company focused on innovative treatments for neurological and liver diseases, has recently achieved a significant milestone by receiving a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its new liquid formulation of terlipressin. This innovative formulation provides remarkable room-temperature stability for up to 24 months, making it especially beneficial in managing ascites in patients suffering from cirrhosis and hepatic failure.
Importance of Terlipressin in Liver Disease Management
Terlipressin is already utilized in over 40 countries for treating liver cirrhosis complications, and its recent approval as a lyophilized powder for in-hospital use in the U.S. showcases its significance. BioVie’s liquid version, conveniently packaged in a pre-filled syringe, stands to enhance dosage safety and accessibility, presenting a game-changing opportunity for at-home treatment.
The Challenge of Managing Ascites
Ascites, characterized by fluid accumulation in the abdomen, is a severe and potentially life-threatening condition that often accompanies advanced liver cirrhosis. The current methods for handling refractory ascites offer little more than temporary relief without altering the underlying disease progression. With a survival rate hovering around 50% over one year, the need for effective treatments like BioVie’s new formulation is critical.
Strategic Focus on Patient-Centric Solutions
Cuong Do, President and CEO of BioVie, emphasized the strategic importance of the newly acquired patent in their mission to provide patient-centric solutions. The stability of the liquid formulation at room temperature simplifies the administration process, making it more user-friendly and safer for patients who manage their treatment at home.
Broadening Patent Protection for Terlipressin
The patent protection for this formulation goes beyond the U.S., with BioVie already securing intellectual property rights in countries such as India and Chile. Furthermore, they have pending patents in nine other regions, including Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico, and Brazil, ensuring robust protection as the company markets its innovative treatment.
Ongoing Clinical Developments and Future Outlook
BioVie's BIV201, which involves the continuous infusion of terlipressin, has been granted Orphan Drug designation and Fast Track status by the FDA for treating ascites due to liver cirrhosis. The company is actively discussing the initiation of Phase 3 clinical trials aimed at reducing further complications in patients with liver cirrhosis. These discussions highlight BioVie’s dedication to advancing its clinical programs and improving treatment options.
Recent Corporate Developments
In addition to its patent achievements, BioVie recently announced plans for a public offering of its common stock and purchase warrants, with the management of ThinkEquity overseeing this process. The success of this offering depends on favorable market conditions, with the proceeds earmarked for working capital and business expansion.
On another note, BioVie has received clearance from the FDA for its Investigational New Drug application for bezisterim, which aims to address symptoms of long COVID. This approval aligns with the commencement of a Phase 2 clinical trial, with substantial funding from a Department of Defense grant estimated at $12.6 million upon meeting certain milestones.
Leadership Changes and Compliance Updates
Recently, the company experienced a leadership shift with the resignation of director Steve Gorlin. In a significant move to enhance its financial standing, BioVie also regained compliance with Nasdaq's minimum bid price requirement after executing a 1-for-10 reverse stock split of its Class A common stock, a strategy approved by shareholders to consolidate shares.
Clinical Data on Bezisterim
BioVie has shared promising clinical data regarding bezisterim at a prominent meeting focused on aging research and drug discovery. Findings indicate that bezisterim might positively influence biological aging processes and chronic inflammation, which are critical factors in age-related diseases. The ongoing research promises to open avenues for treating conditions such as Alzheimer’s and Parkinson’s diseases.
Frequently Asked Questions
What is the significance of BioVie’s patent for terlipressin?
The patent is crucial as it offers intellectual property protection for BioVie’s innovative liquid formulation, enhancing its market position and potential for patient use.
How does the new formulation of terlipressin benefit patients?
By providing room-temperature stability and ease of administration, it allows for more effective management of conditions like ascites at home.
What recent developments has BioVie announced?
BioVie has plans for a public offering, received FDA approval for bezisterim, and experienced a leadership change with the resignation of a board director.
Where else is BioVie seeking patent protection for terlipressin?
The company seeks patent protection in multiple countries, including Australia, Canada, China, and several others, expanding its global footprint.
What challenges does BioVie face currently?
BioVie is operating in a challenging financial environment, with significant stock volatility and ongoing efforts to reach profitability amid its clinical pursuits.
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