BioVie Receives Notice of Allowance for United States Patent Application Covering Novel Liquid Formulation of Terlipressin
BioVie Inc. (NASDAQ: BIVI) has received a Notice of Allowance from the USPTO for a patent application covering a novel liquid formulation of terlipressin acetate. This formulation demonstrates room-temperature stability for up to 24 months and can be packaged in a pre-filled syringe. The patent is expected to be listed in the Orange Book and supports BioVie's development of a more patient-centric ambulatory treatment for patients with ascites and hepatic failure.
The liquid formulation offers significant advantages over the recently approved lyophilized powder form of terlipressin in the US, which requires reconstitution and refrigerated storage. BioVie's formulation could improve dosing convenience and safety, particularly in home-care settings. The company has also secured patents for this formulation in India and Chile, with applications pending in nine additional markets.
BioVie Inc. (NASDAQ: BIVI) ha ricevuto un Avviso di Concessione dall'USPTO per una domanda di brevetto che copre una nuova formulazione liquida di acetato di terlipressina. Questa formulazione dimostra stabilità a temperatura ambiente fino a 24 mesi e può essere confezionata in una siringa pre-riempita. Si prevede che il brevetto venga elencato nel Libro Arancione e supporti lo sviluppo da parte di BioVie di un trattamento ambulatoriale più incentrato sul paziente per i pazienti con ascite e insufficienza epatica.
La formulazione liquida offre vantaggi significativi rispetto alla recente forma di polvere liofilizzata di terlipressina approvata negli Stati Uniti, che richiede ricostituzione e conservazione in frigorifero. La formulazione di BioVie potrebbe migliorare la comodità e la sicurezza del dosaggio, in particolare nei contesti di assistenza domiciliare. L'azienda ha inoltre ottenuto brevetti per questa formulazione in India e Cile, con domande pendenti in nove mercati aggiuntivi.
BioVie Inc. (NASDAQ: BIVI) ha recibido un Aviso de Concesión de la USPTO para una solicitud de patente que cubre una nueva formulación líquida de acetato de terlipresina. Esta formulación demuestra estabilidad a temperatura ambiente de hasta 24 meses y puede ser empaquetada en una jeringa precargada. Se espera que la patente se incluya en el Libro Naranja y apoye el desarrollo por parte de BioVie de un tratamiento ambulatorio más centrado en el paciente para aquellos con ascitis e insuficiencia hepática.
La formulación líquida ofrece ventajas significativas sobre la forma de polvo liofilizado de terlipresina recientemente aprobada en EE. UU., que requiere reconstitución y almacenamiento en refrigeración. La formulación de BioVie podría mejorar la conveniencia y seguridad de la dosificación, particularmente en entornos de atención domiciliaria. La compañía también ha asegurado patentes para esta formulación en India y Chile, con solicitudes pendientes en nueve mercados adicionales.
BioVie Inc. (NASDAQ: BIVI)는 테를리프레신 아세테이트의 새로운 액상 제형에 대한 특허 출원에 대해 USPTO로부터 허가 통지를 받았습니다. 이 제형은 실온에서 최대 24개월 동안 안정성을 유지합니다이며, 프리필 주사기로 포장될 수 있습니다. 이 특허는 오렌지 북에 등재될 것으로 예상되며, 복수 및 간부전 환자에게 보다 환자 중심의 외래 치료 개발을 지원합니다.
액상 제형은 재구성 및 냉장 보관이 필요한 최근 승인된 테를리프레신의 리오필화 분말 형태에 비해 상당한 장점을 제공합니다. BioVie의 제형은 특히 가정 치료 환경에서 투여의 편리함과 안전성을 개선할 수 있습니다. 이 회사는 또한 인도와 칠레에서 이 제형의 특허를 확보했으며, 아홉 개의 추가 시장에 대한 신청이 진행 중입니다.
BioVie Inc. (NASDAQ: BIVI) a reçu un Avis d'Acceptation de l'USPTO pour une demande de brevet couvrant une nouvelle formulation liquide d'acétate de terlipressine. Cette formulation démontre une stabilité à température ambiante allant jusqu'à 24 mois et peut être conditionnée dans une seringue pré-remplie. Le brevet devrait être inscrit dans le Livre Orange et soutient le développement par BioVie d'un traitement ambulatoire plus axé sur le patient pour les patients atteints d'ascite et d'insuffisance hépatique.
La formulation liquide offre des avantages significatifs par rapport à la forme en poudre lyophilisée de terlipressine récemment approuvée aux États-Unis, qui nécessite une reconstitution et un stockage au réfrigérateur. La formulation de BioVie pourrait améliorer la commodité et la sécurité du dosage, notamment dans les contextes de soins à domicile. L'entreprise a également obtenu des brevets pour cette formulation en Inde et au Chili, avec des demandes en attente dans neuf marchés supplémentaires.
BioVie Inc. (NASDAQ: BIVI) hat eine Mitteilung über die Genehmigung des USPTO für eine Patentanmeldung erhalten, die eine neuartige flüssige Formulierung von Terlipressinacetat abdeckt. Diese Formulierung zeigt Raumtemperaturstabilität von bis zu 24 Monaten und kann in einer vorgefüllten Spritze verpackt werden. Es wird erwartet, dass das Patent im Orange Book gelistet wird und die Entwicklung eines patientenzentrierten ambulanten Treatments für Patienten mit Aszites und Leberversagen unterstützt.
Die flüssige Formulierung bietet erhebliche Vorteile gegenüber der kürzlich in den USA genehmigten lyophilisierten Pulversorte von Terlipressin, die eine Rekonstitution und Kühllagerung erfordert. Die Formulierung von BioVie könnte die Dosierungskomfort und Sicherheit, insbesondere in der häuslichen Pflege, verbessern. Das Unternehmen hat auch Patente für diese Formulierung in Indien und Chile gesichert, während die Anträge in neun weiteren Märkten noch ausstehen.
- Received Notice of Allowance for US patent application covering novel liquid terlipressin formulation
- Formulation demonstrates room-temperature stability for up to 24 months
- Can be packaged in a pre-filled syringe, improving dosing convenience and safety
- Patent expected to be listed in the Orange Book, strengthening intellectual property protection
- Patents already secured in India and Chile, with applications pending in nine additional markets
- None.
Insights
The Notice of Allowance for BioVie's liquid terlipressin formulation patent is a significant development. This novel formulation offers room-temperature stability for up to 24 months, a important advantage over the current lyophilized powder form that requires refrigeration. The pre-filled syringe format enhances convenience and safety for home-care administration.
The patent's potential listing in the Orange Book is particularly noteworthy, as it strengthens market exclusivity and could deter generic competition. With patents secured in the US, India and Chile and pending in nine other markets, BioVie is building a robust global intellectual property portfolio for this formulation.
However, it's important to note that while this patent strengthens BioVie's position, the company still faces the challenges of clinical development, regulatory approval and market adoption. The market potential for this formulation in treating cirrhosis patients with ascites is significant, given the current lack of approved medical therapies for refractory ascites and the poor prognosis for these patients.
This patent allowance marks a important milestone for BioVie's BIV201 program. The liquid terlipressin formulation addresses key limitations of the recently approved US version, potentially expanding its use to home-care settings. This could significantly broaden the addressable market and improve patient outcomes.
The one-year survival rate of approximately 50% for patients with refractory ascites underscores the urgent need for effective treatments. BioVie's formulation could fill this gap, offering a more convenient and potentially safer option compared to current procedural interventions like large-volume paracentesis and TIPS.
From an investment perspective, this patent strengthens BioVie's competitive position and could attract partnership or licensing opportunities. However, investors should be aware that the company still faces the hurdles of clinical trials, regulatory approval and market launch. The small market cap of
Patents covering BioVie’s terlipressin liquid formulation now secured in the United States, India and Chile, and are pending in nine additional markets
Formulation has demonstrated room-temperature stability for up to 24 months, representing an important advantage for treating patients with cirrhosis and ascites in the home-care setting
CARSON CITY, Nev., Oct. 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 17/611,478 entitled "Formulations of Terlipressin." This Notice of Allowance is expected to result in the issuance of a US patent once administrative processes are completed.
The allowed claims cover a novel liquid formulation of terlipressin acetate that has stability at room temperature for two years and can be packaged in a pre-filled syringe. BioVie expects the resulting patent will be approved for listing in the Orange Book. The patent supports BioVie’s liquid formulation of terlipressin for development of a more patient-centric ambulatory treatment regimen for patients with ascites and hepatic failure in the US.
Patients with cirrhosis and ascites have large volumes of fluid accumulate in the abdomen (often exceeding 5 liters) due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately
"Terlipressin is a drug used in over 40 countries to treat related complications of liver cirrhosis that was only recently approved in the US as a lyophilized powder for in-hospital use, which requires reconstitution with sterile sodium chloride and refrigerated storage conditions for proper administration,” said Cuong Do, BioVie’s President and CEO. “Our novel liquid formulation of terlipressin is stable at room temperature for up to 24 months, offering an important advantage for treating patients with cirrhosis and ascites, particularly in the home-care setting. The pre-filled syringe format can improve dosing convenience and safety. The receipt of this patent will significantly strengthen BIV201’s intellectual property protection and increase the value proposition behind our BIV201 program.”
In addition to the US, BioVie has received patent protection for its liquid formulation of terlipressin in India and Chile, and has patents pending in Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico and Brazil.
About Ascites and Cirrhosis
Ascites (the excessive build-up of fluid in the abdomen) is the most common complication of advanced (“decompensated”) liver cirrhosis and can be life-threatening. In advanced liver cirrhosis, the liver becomes “clogged” and blood accumulates in the region below (called the splanchnic bed). With blood pooling below the liver, the blood volume in the arteries decreases and the person with cirrhosis experiences low effective blood volume. In an effort to correct this situation, the brain sends signals via the renin-angiotensin-aldosterone system (RAAS) to the kidneys to retain extreme amounts of water and salt to attempt to reflexively increase the blood volume in the arteries. The excess liquid weeps from the lymphatic system and collects in the abdomen – which is when ascites appears.
Advanced liver cirrhosis is most-commonly caused by the progression of NASH (non-alcoholic steatohepatitis), alcoholism, and infection with Hepatitis B & C. Chronic liver disease (“CLD”), including cirrhosis, and is responsible for the death of 42,000 Americans each year. As a population, people diagnosed with both liver cirrhosis and ascites experience frequent hospital readmissions each year, incurring an estimated
About BIV201
BIV201 (terlipressin for continuous infusion) is a prefilled syringe or vial with BioVie’s patented liquid formulation of terlipressin acetate. A synthetic analogue of vasopressin, terlipressin has been studied extensively overseas and is approved in more than 40 countries for in-hospital treatment of two deadly conditions related to ascites (bleeding esophageal varices, “BEV” and hepatorenal syndrome, “HRS”). Terlipressin has the potential to reduce the presence of ascites in the abdomen through vasoconstricting the blood vessels where the blood is pooling, hence restoring blood flow through the kidneys and liver. This reduces portal vein pressure and increases blood volume in the arteries. Consequently, the body may respond by shutting down the RAAS system which has been generating the ascites.
Terlipressin, a medication employed in over 40 countries to manage complications associated with liver cirrhosis, has recently gained U.S. approval as a lyophilized powder that requires reconstitution with sodium chloride and refrigerated storage up to 48 hours for proper administration. BioVie’s unique liquid formulation of terlipressin has demonstrated stability, not only under refrigerated conditions, but also at room temperature for up to 24 months, which can be an important advantage for treating patients with cirrhosis and ascites, particularly in the home-care setting. The Company has received patent protection for its liquid formulation of terlipressin in India and Chile; a notice of allowance in the US; and patents are pending in Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico and Brazil.
In the US, BioVie has secured Orphan Drug designation and Fast Track status covering the use of BIV201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis. BIV201 also has an Orphan drug designation for treating HRS and BioVie has reached agreement with the FDA on the design, duration, dosing and endpoints of a Phase 3 trial to evaluated BIV201 for the treatment of HRS-AKI (acute kidney injury) that could potentially be sufficient to support an NDA filing.
About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Long COVID, AD and PD) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
References
1 Gines P, Quintero E, Arroyo V, et al. Compensated cirrhosis: natural history and prognostic factors. Hepatology 1987; 7: 122–128.
2 Mortimer R, Volk M., Mortimer S, et al. U.S. hospitalization burden of patients with cirrhosis and ascites receiving paracentesis. Presented as a poster presentation, Liver Meeting, Nov 2022, Washington DC
For Investor Relations Inquiries:
Bruce Mackle
Managing Director, LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
For Media Relations Inquiries:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com
FAQ
What is the significance of BioVie's new terlipressin formulation patent for BIVI stock?
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