CARSON, Nev. - BioVie Inc. (NASDAQ: BIVI), a clinical-stage biopharmaceutical company, announced today that it has received a Notice of Allowance for its patent application in Japan for a novel liquid formulation of terlipressin, a drug used to treat complications related to liver cirrhosis. The Japan Patent Office's approval is expected to lead to a patent issuance within the next two to three weeks after administrative processes are completed.
The patent covers a liquid formulation of terlipressin acetate that remains stable at room temperature for up to 24 months, which is a significant improvement over the currently available lyophilized powder form that requires reconstitution and refrigeration. This new formulation can be packaged in pre-filled syringes, potentially simplifying administration and storage, particularly for patients receiving home care.
Terlipressin is used in over 40 countries to manage complications of liver cirrhosis such as ascites, a condition where fluid accumulates in the abdomen due to liver and kidney dysfunction. The U.S. recently approved terlipressin as a lyophilized powder for in-hospital use, which necessitates reconstitution with sterile sodium chloride and refrigeration.
BioVie's President and CEO, Cuong Do, emphasized the benefits of the liquid formulation, suggesting it could offer a more patient-centric treatment option, especially for those with refractory ascites—a condition with a high mortality rate and no approved medical therapy.
In addition to the Japanese market, BioVie has secured patent protection for its terlipressin formulation in the United States, India, and Chile, with patents pending in other major markets including Australia, Canada, China, Europe, Hong Kong, South Korea, Mexico, and Brazil.
The company is also developing BIV201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis, which has received Orphan Drug designation and Fast Track status from the U.S. Food and Drug Administration (FDA). A Phase 3 trial design has been agreed upon with the FDA to evaluate BIV201 for the treatment of hepatorenal syndrome-acute kidney injury (HRS-AKI), potentially supporting a New Drug Application (NDA) filing.
BioVie focuses on developing therapies for neurological and neurodegenerative disorders as well as advanced liver disease. The company's approach to addressing these conditions includes a drug candidate for neurodegenerative diseases that inhibits neuroinflammation and insulin resistance and a treatment for advanced liver disease that seeks to reduce complications and improve patient outcomes.
This news is based on a press release statement from BioVie Inc.
In other recent news, BioVie Inc. has been granted a Notice of Allowance by the USPTO for its novel liquid formulation of terlipressin. This formulation aims to improve the management of ascites in patients with cirrhosis and hepatic failure. The company also announced its plans for a public offering of common stock and purchase warrants, managed by ThinkEquity, with the net proceeds intended for working capital and general corporate purposes.
BioVie has also made progress in its clinical trials, securing FDA authorization for its Investigational New Drug application for bezisterim, a potential treatment for long COVID symptoms. The company has also secured a Department of Defense grant that could amount to $12.6 million upon achieving certain milestones.
In a significant change in the firm's leadership structure, BioVie reported the resignation of director Steve Gorlin. The company has also regained compliance with Nasdaq's minimum bid price requirement, following a 1-for-10 reverse stock split of its Class A common stock.
BioVie has presented new clinical data on bezisterim at the 11th Aging Research and Drug Discovery (NASDAQ:WBD) Meeting, suggesting that bezisterim may influence the biological aging process and chronic inflammation related to aging-related diseases. The drug is being investigated for its potential in treating Alzheimer's and Parkinson's diseases, with promising results from Phase 2 and Phase 3 studies. These are all recent developments in BioVie's ongoing commitment to pharmaceutical innovation and corporate evolution.
InvestingPro Insights
As BioVie Inc. (NASDAQ: BIVI) advances its novel terlipressin formulation, investors should consider the company's current financial position and market performance. According to InvestingPro data, BioVie has a market capitalization of $9.04 million, reflecting its status as a small-cap biopharmaceutical company focused on developing innovative therapies.
The company's financial health presents a mixed picture. An InvestingPro Tip highlights that BioVie holds more cash than debt on its balance sheet, which could provide some financial flexibility as it pursues its clinical development programs. Additionally, liquid assets exceed short-term obligations, potentially offering a buffer against immediate financial pressures.
However, investors should note that BioVie is not currently profitable, with an adjusted operating income of -$32.18 million for the last twelve months as of Q4 2023. This is not uncommon for clinical-stage biotech companies investing heavily in research and development. The company's price-to-book ratio of 0.58 suggests that the stock may be undervalued relative to its book value, which could be of interest to value-oriented investors.
The stock's recent performance has been challenging, with InvestingPro data showing a one-year price total return of -96.77% as of the latest available data. This significant decline aligns with an InvestingPro Tip indicating that the stock has taken a big hit over the last week and has performed poorly over the last month. The RSI suggests the stock is in oversold territory, which may interest contrarian investors looking for potential turnaround opportunities.
For those considering BioVie's long-term potential, it's worth noting that analysts have set a fair value target of $30 per share, significantly above the current trading price. However, this should be weighed against the company's current challenges and the inherent risks in the biopharmaceutical sector.
InvestingPro offers 13 additional tips for BIVI, providing a more comprehensive analysis for investors interested in delving deeper into the company's prospects and challenges.
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