BioVie Receives Notice of Allowance for Japan Patent Application Covering Novel Liquid Formulation of Terlipressin
BioVie Inc. (NASDAQ: BIVI) has received a Notice of Allowance from the Japan Patent Office for its novel liquid formulation of terlipressin acetate. This formulation, which is stable at room temperature for up to 24 months, can be packaged in a pre-filled syringe, offering significant advantages for treating patients with cirrhosis and ascites, particularly in home-care settings.
The company has now secured patents for this formulation in the United States, India, Japan, and Chile, with pending applications in eight additional markets. This development strengthens BioVie's intellectual property protection and enhances the value of its BIV201 program, which aims to provide a more patient-centric ambulatory treatment for ascites and hepatic failure.
Terlipressin is currently used in over 40 countries to treat complications of liver cirrhosis, but the recent US approval is for a lyophilized powder form requiring reconstitution and refrigeration. BioVie's liquid formulation offers improved convenience and safety, potentially benefiting patients with cirrhosis and ascites, who currently face treatment options and poor survival rates.
BioVie Inc. (NASDAQ: BIVI) ha ricevuto un Avviso di Concessione dall'Ufficio Brevetti del Giappone per la sua nuova formulazione liquida di acetato di terlipressina. Questa formulazione, che rimane stabile a temperatura ambiente per un massimo di 24 mesi, può essere confezionata in una siringa pre-riempita, offrendo vantaggi significativi per il trattamento dei pazienti affetti da cirrosi e ascite, in particolare in contesti di assistenza domiciliare.
La società ha ora ottenuto brevetti per questa formulazione negli Stati Uniti, India, Giappone e Cile, con domande pendenti in otto mercati aggiuntivi. Questo sviluppo rafforza la protezione della proprietà intellettuale di BioVie e ne aumenta il valore del programma BIV201, che mira a fornire un trattamento ambulatoriale più incentrato sul paziente per l'ascite e l'insufficienza epatica.
La terlipressina è attualmente utilizzata in oltre 40 paesi per trattare le complicazioni della cirrosi epatica, ma la recente approvazione negli Stati Uniti riguarda una forma in polvere liofilizzata che richiede ricostituzione e refrigerazione. La formulazione liquida di BioVie offre maggiore comodità e sicurezza, potenzialmente a beneficio dei pazienti con cirrosi e ascite, che attualmente affrontano opzioni di trattamento limitate e basse percentuali di sopravvivenza.
BioVie Inc. (NASDAQ: BIVI) ha recibido un Aviso de Concesión de la Oficina de Patentes de Japón para su novedosa formulación líquida de acetato de terlipresina. Esta formulación, que es estable a temperatura ambiente durante un máximo de 24 meses, puede ser empaquetada en una jeringa precargada, ofreciendo ventajas significativas para tratar a pacientes con cirrosis y ascitis, especialmente en entornos de atención domiciliaria.
La empresa ha asegurado ahora patentes para esta formulación en los Estados Unidos, India, Japón y Chile, con solicitudes pendientes en ocho mercados adicionales. Este desarrollo fortalece la protección de la propiedad intelectual de BioVie y aumenta el valor de su programa BIV201, que tiene como objetivo proporcionar un tratamiento ambulatorio más centrado en el paciente para la ascitis y la insuficiencia hepática.
La terlipresina se utiliza actualmente en más de 40 países para tratar las complicaciones de la cirrosis hepática, pero la reciente aprobación en EE. UU. es para una forma en polvo liofilizado que requiere reconstitución y refrigeración. La formulación líquida de BioVie ofrece mayor comodidad y seguridad, beneficiando potencialmente a pacientes con cirrosis y ascitis, quienes actualmente enfrentan opciones limitadas de tratamiento y bajas tasas de supervivencia.
BioVie Inc. (NASDAQ: BIVI)는 일본 특허청으로부터 테르리프레신 아세테이트의 새로운 액체 제형에 대한 허가 통지를 받았습니다. 이 제형은 실온에서 최대 24개월 동안 안정적이며, 미리 채워진 주사기로 포장될 수 있어, 특히 자가 치료 환경에서 간경변증 및 복수 환자 치료에 중요한 장점을 제공합니다.
회사는 이제 미국, 인도, 일본 및 칠레에서 이 제형에 대한 특허를 확보했으며, 추가로 8개의 시장에 대한 신청이 진행 중입니다. 이번 개발은 BioVie의 지적 재산 보호를 강화하고 복수 및 간 기능 부전 환자를 위한 보다 환자 중심의 외래 치료를 제공하는 BIV201 프로그램의 가치를 향상시킵니다.
테르리프레신은 현재 40개국 이상에서 간경변증 합병증 치료에 사용되고 있지만, 최근 미국 승인된 것은 재구성이 필요하고 냉장이 필요한 리오필라이즈된 분말 형태입니다. BioVie의 액체 제형은 편의성과 안전성을 개선하여, 현재 제한된 치료 옵션과 낮은 생존율에 직면한 간경변증 및 복수 환자들에게 잠재적인 혜택을 제공합니다.
BioVie Inc. (NASDAQ: BIVI) a reçu un Avis de Concession du Bureau des Brevets du Japon pour sa nouvelle formulation liquide d'acétate de térlipressine. Cette formulation, qui est stable à température ambiante pendant jusqu'à 24 mois, peut être conditionnée dans une seringue préremplie, offrant des avantages significatifs pour le traitement des patients atteints de cirrhose et d'ascite, en particulier dans un cadre de soins à domicile.
L'entreprise a désormais obtenu des brevets pour cette formulation aux États-Unis, en Inde, au Japon et au Chili, avec des demandes en attente dans huit autres marchés. Ce développement renforce la protection de la propriété intellectuelle de BioVie et augmente la valeur de son programme BIV201, qui vise à fournir un traitement ambulatoire plus centré sur le patient pour l'ascite et l'insuffisance hépatique.
La térlipressine est actuellement utilisée dans plus de 40 pays pour traiter les complications de la cirrhose hépatique, mais la récente approbation aux États-Unis concerne une forme en poudre lyophilisée nécessitant reconstitution et réfrigération. La formulation liquide de BioVie offre une commodité et une sécurité améliorées, pouvant ainsi bénéficier aux patients souffrant de cirrhose et d'ascite, qui font actuellement face à des options de traitement limitées et à de faibles taux de survie.
BioVie Inc. (NASDAQ: BIVI) hat eine Aufforderung zur Erteilung eines Patents vom japanischen Patentamt für ihre neuartige flüssige Formulierung von Terlipressinacetat erhalten. Diese Formulierung ist bei Raumtemperatur bis zu 24 Monate stabil und kann in einer vorgefüllten Spritze verpackt werden, was erhebliche Vorteile für die Behandlung von Patienten mit Zirrhose und Aszites, insbesondere in der häuslichen Pflege, bietet.
Das Unternehmen hat nun Patente für diese Formulierung in den Vereinigten Staaten, Indien, Japan und Chile gesichert, mit ausstehenden Anträgen in acht weiteren Märkten. Diese Entwicklung stärkt den Schutz des geistigen Eigentums von BioVie und erhöht den Wert seines BIV201-Programms, das darauf abzielt, eine patientenzentrierte ambulante Behandlung für Aszites und Leberversagen bereitzustellen.
Terlipressin wird derzeit in über 40 Ländern zur Behandlung von Komplikationen der Leberzirrhose eingesetzt, doch die kürzliche Genehmigung in den USA betrifft eine lyophilisierte Pulverform, die eine Rekonstitution und Kühlung erfordert. Die flüssige Formulierung von BioVie bietet verbesserte Bequemlichkeit und Sicherheit, was potenziell Patienten mit Zirrhose und Aszites zugutekommen kann, die derzeit mit begrenzten Behandlungsoptionen und schlechten Überlebensraten konfrontiert sind.
- Received Notice of Allowance for Japan patent application covering novel liquid formulation of terlipressin
- Liquid formulation stable at room temperature for up to 24 months
- Patents secured in United States, India, Japan, and Chile, with applications pending in eight additional markets
- Pre-filled syringe format can improve dosing convenience and safety
- Strengthens intellectual property protection and increases value proposition of BIV201 program
- None.
Insights
The Notice of Allowance for BioVie's terlipressin liquid formulation patent in Japan is a significant development. This extends their intellectual property protection to a major pharmaceutical market, complementing existing patents in the US, India and Chile. The formulation's 24-month room-temperature stability is a key advantage, potentially enabling home-based treatment for cirrhosis patients with ascites.
The pre-filled syringe format could improve dosing accuracy and reduce preparation errors. This formulation addresses limitations of the recently approved lyophilized powder version in the US, which requires reconstitution and refrigeration. The expanded patent portfolio strengthens BioVie's market position and could attract partnership or licensing opportunities.
However, it's important to note that patent approval doesn't guarantee regulatory approval or commercial success. BioVie still faces challenges in clinical development, regulatory approval and market adoption. The small market cap of
BioVie's liquid terlipressin formulation represents a potential advancement in treating refractory ascites, a severe complication of cirrhosis with a poor prognosis. The 50% one-year survival rate for patients with refractory ascites underscores the urgent need for effective treatments. Current management strategies like large-volume paracentesis and TIPS are temporary and carry significant risks.
A room-temperature stable, pre-filled syringe formulation could enable outpatient management, potentially reducing hospitalizations and improving quality of life. This approach aligns with the trend towards home-based care for chronic conditions. However, terlipressin's safety profile, including risks of respiratory failure and sepsis, will be important in determining its suitability for home administration.
While this formulation addresses important practical issues, its clinical efficacy and safety in treating refractory ascites will be the ultimate determinants of its value to patients and healthcare systems. BioVie will need to demonstrate these benefits in rigorous clinical trials.
Patents covering BioVie’s terlipressin liquid formulation now secured in the United States, India, Japan and Chile, and are pending in eight additional markets
Liquid 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, Nev., Oct. 15, 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 Japan Patent Office for patent application no. 2021-569344 entitled "Formulations of Terlipressin." This Notice of Allowance is expected to result in the issuance of a Japanese patent in 2 to 3 weeks 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. 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 recent notice of allowance received for US and Japan, 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, 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 are frequently readmitted to the hospital frequently 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 Japan; and patents are pending in Australia, Canada, China, Europe, Hong Kong, 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 a New Drug Application (“NDA”) filing with the FDA.
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, Alzheimer's disease and Parkinson’s disease) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor, Nuclear factor- kB, and the associated neuroinflammation and insulin resistance but not ERK and NFkB homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance 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
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