Ritedose is Proud to Partner with Verona Pharma to Deliver First-In-Class COPD Drug, Ohtuvayre (ensifentrine)*
Ritedose, the largest CDMO in the US specializing in sterile Blow Fill Seal production, has partnered with Verona Pharma (Nasdaq: VRNA) to develop and manufacture Ohtuvayre (ensifentrine), a novel COPD treatment. The FDA approved Ohtuvayre on June 26 for maintenance treatment of COPD in adults, marking the first inhaled product with a new mechanism of action in over 20 years. Ohtuvayre, delivered via standard jet nebulizer, is a first-in-class PDE3 and PDE4 inhibitor that aims to redefine COPD treatment. With COPD affecting over 480 million people globally and 14 million in the US, this partnership between Ritedose and Verona Pharma brings a significant advancement to the respiratory market.
Ritedose, il più grande CDMO negli Stati Uniti specializzato nella produzione sterile Blow Fill Seal, ha stretto una partnership con Verona Pharma (Nasdaq: VRNA) per sviluppare e produrre Ohtuvayre (ensifentrina), un nuovo trattamento per la BPCO. La FDA ha approvato Ohtuvayre il 26 giugno per il trattamento di mantenimento della BPCO negli adulti, segnando il primo prodotto inalato con un nuovo meccanismo d'azione in oltre 20 anni. Ohtuvayre, somministrato tramite nebulizzatore a getto standard, è un inibitore di prima classe della PDE3 e PDE4 che mira a ridefinire il trattamento della BPCO. Con la BPCO che colpisce oltre 480 milioni di persone nel mondo e 14 milioni negli Stati Uniti, questa partnership tra Ritedose e Verona Pharma rappresenta un significativo progresso nel mercato respiratorio.
Ritedose, el mayor CDMO en EE.UU. especializado en la producción estéril por Blow Fill Seal, se ha asociado con Verona Pharma (Nasdaq: VRNA) para desarrollar y fabricar Ohtuvayre (ensifentrina), un tratamiento novedoso para la EPOC. La FDA aprobó Ohtuvayre el 26 de junio para el tratamiento de mantenimiento de la EPOC en adultos, marcando el primer producto inhalado con un nuevo mecanismo de acción en más de 20 años. Ohtuvayre, administrado a través de un nebulizador a chorro estándar, es un inhibidor de primera clase de PDE3 y PDE4 que busca redefinir el tratamiento de la EPOC. Con la EPOC afectando a más de 480 millones de personas en todo el mundo y 14 millones en EE.UU., esta asociación entre Ritedose y Verona Pharma representa un avance significativo en el mercado respiratorio.
Ritedose는 무균 Blow Fill Seal 생산에 특화된 미국 최대 CDMO로, Verona Pharma (Nasdaq: VRNA)와 협력하여 Ohtuvayre (ensifentrine)를 개발하고 제조하고 있습니다. FDA는 6월 26일 성인을 위한 COPD 유지 치료제로 Ohtuvayre를 승인했으며, 이는 20년 이상 동안 새로운 작용 메커니즘을 가진 최초의 흡입 제품입니다. Ohtuvayre는 표준 제트 네뷸라이저를 통해 전달되며, 1급 PDE3 및 PDE4 억제제로 COPD 치료를 재정의하려고 합니다. COPD는 전 세계적으로 4억 8천만 명, 미국 내에서 1천4백만 명 이상에게 영향을 미치고 있어, Ritedose와 Verona Pharma 간의 파트너십은 호흡기 시장에 중요한 발전을 가져옵니다.
Ritedose, le plus grand CDMO aux États-Unis spécialisé dans la production stérile par Blow Fill Seal, a établi un partenariat avec Verona Pharma (Nasdaq: VRNA) pour développer et fabriquer Ohtuvayre (ensifentrine), un nouveau traitement de la BPCO. La FDA a approuvé Ohtuvayre le 26 juin pour le traitement de maintien de la BPCO chez les adultes, marquant le premier produit inhalé avec un nouveau mécanisme d'action en plus de 20 ans. Ohtuvayre, administré via un nébuliseur à jet standard, est un inhibiteur de classe 1 de la PDE3 et de la PDE4 qui vise à redéfinir le traitement de la BPCO. La BPCO affectant plus de 480 millions de personnes dans le monde et 14 millions aux États-Unis, ce partenariat entre Ritedose et Verona Pharma représente une avancée significative sur le marché respiratoire.
Ritedose, der größte CDMO in den USA, der sich auf die sterile Blow Fill Seal-Produktion spezialisiert hat, hat sich mit Verona Pharma (Nasdaq: VRNA) zusammengeschlossen, um Ohtuvayre (ensifentrine), ein neuartiges COPD-Medikament, zu entwickeln und herzustellen. Die FDA genehmigte Ohtuvayre am 26. Juni zur Erhaltungstherapie von COPD bei Erwachsenen und markierte das erste inhalative Produkt mit einem neuen Wirkmechanismus seit über 20 Jahren. Ohtuvayre, das über einen Standard-Jetvernebler verabreicht wird, ist ein erstes PDE3- und PDE4-Inhibitor, das darauf abzielt, die COPD-Behandlung neu zu definieren. Da COPD weltweit über 480 Millionen Menschen und in den USA 14 Millionen betrifft, bringt diese Partnerschaft zwischen Ritedose und Verona Pharma einen bedeutenden Fortschritt auf dem Atemwegmarkt.
- FDA approval of Ohtuvayre for COPD maintenance treatment
- First inhaled product with a novel mechanism of action in over 20 years
- Partnership with Ritedose, the largest CDMO in the US for sterile BFS production
- Potential to redefine COPD treatment paradigm
- Addresses a large market with over 480 million COPD patients globally
- None.
Insights
The FDA approval of Ohtuvayre represents a significant milestone in COPD treatment. As the first new mechanism of action in over two decades, it has the potential to disrupt the current treatment landscape. The partnership between Ritedose and Verona Pharma is strategically important, combining Verona's innovation with Ritedose's manufacturing expertise.
This collaboration could lead to increased market share for both companies in the lucrative COPD market, estimated at
Ohtuvayre's approval is a game-changer for COPD management. Its dual PDE3 and PDE4 inhibition mechanism offers a novel approach to addressing both bronchodilation and anti-inflammatory effects simultaneously. This could potentially provide superior symptom control compared to current therapies.
However, it's important to note that while this advancement is promising, long-term real-world efficacy and safety data will be essential. The nebulizer delivery method may also impact patient adherence, as some prefer more portable inhaler devices. Nevertheless, for patients with persistent symptoms despite current therapies, Ohtuvayre represents a valuable new option in our treatment arsenal.
The COPD market is ripe for innovation, with a global patient population exceeding 480 million. Ohtuvayre's entry into this space could significantly alter market dynamics. If it demonstrates superior efficacy, it could rapidly gain market share from established players like GSK and AstraZeneca.
Ritedose's position as the largest CDMO for sterile BFS production in the U.S. gives it a competitive edge in securing future partnerships. This collaboration could boost Ritedose's revenue and market position substantially. For Verona Pharma, successful commercialization of Ohtuvayre could transform it from a clinical-stage to a commercial-stage company, potentially leading to increased investor interest and market valuation.
-Ritedose is the development partner and manufacturer of Ohtuvayre (ensifentrine)*, the first inhaled product with a novel mechanism of action in more than 20 years for the maintenance treatment of COPD.
The
"Ritedose is the leading manufacturer of inhaled products for asthma and COPD. We are proud to partner with Verona Pharma for the development and manufacturing of Ohtuvayre. We have served the respiratory market for over 25 years and are excited to help bring this novel therapy to commercialization. We have the resources to deliver significant doses of Ohtuvayre on time, every time," said Jody Chastain, president and CEO of The Ritedose Corporation.
"Ohtuvayre is a significant advancement in the treatment of COPD. We believe Ohtuvayre's novel profile can change the treatment paradigm for COPD, and we wanted to partner with Ritedose to ensure the highest manufacturing quality. The COPD community deserves nothing less," said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma.
COPD affects more than 480 million people across the globe and more than 14 million people in
Ritedose is proud to work alongside Verona Pharma on the development and manufacturing of national launch quantities of Ohtuvayre so this novel product can be available to all the COPD patients who need it.
About The Ritedose Corporation
Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow Fill Seal (BFS) technology that ensures sterile, consistent, and safe unit dose delivery. The company's process guides the development of molecules from clinical trials to commercialization of branded and generic inhalation and ophthalmic medications. With a focus on quality, innovation, and customer satisfaction, Ritedose partners with leading pharmaceutical companies to deliver safe, effective, and reliable medications that improve patient outcomes. For more information about Ritedose and its services: visit Ritedose.com
About Verona Pharma
Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs, including COPD, non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com .
About COPD
Chronic Obstructive Pulmonary Disease (COPD) is a chronic inflammatory lung disease that obstructs airflow of the lungs. Symptoms include difficulty breathing, cough, excessive production of mucus and wheezing. COPD can be caused by long-term exposure to irritants such as air pollution and cigarette smoke. People with COPD are at increased risk of developing other health problems, such as heart disease and lung cancer. COPD is not curable but the disease can be treated with medicines, oxygen and pulmonary rehabilitation.
*Please see full FDA approved prescribing information at www.veronapharma.com.
Alex Keown
630-346-5141
akeown@inspire-agency.com
On Behalf of Ritedose
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SOURCE Ritedose
FAQ
What is Ohtuvayre and when was it approved by the FDA for COPD treatment?
How is Ohtuvayre different from other COPD treatments?
Who is manufacturing Ohtuvayre for Verona Pharma (VRNA)?
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