Ritedose is Proud to Partner with Verona Pharma to Deliver First-In-Class COPD Drug, Ohtuvayre (ensifentrine)*

Rhea-AI Summary

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.

Positive

• 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

Negative

• None.

-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.

COLUMBIA, S.C., Sept. 17, 2024 /PRNewswire/ -- The Ritedose Corporation, Inc. (Ritedose), the largest CDMO in the United States specializing in sterile Blow Fill Seal (BFS) production of unit dose solutions for the ophthalmic and respiratory markets, is proud to partner with Verona Pharma plc (Nasdaq: VRNA) as the development and manufacturing partner of Ohtuvayre, a new novel product for Chronic Obstructive Pulmonary Disease (COPD).

The U.S. Food and Drug Administration (FDA) approved Ohtuvayre on June 26 for the maintenance treatment of COPD in adult patients. It is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years. Ohtuvayre is delivered through a standard jet nebulizer and is expected to redefine the treatment paradigm for COPD. Despite maintenance therapy in multiple combinations, most COPD patients grapple with daily symptoms including breathlessness and persistent coughing. Ohtuvayre, an innovative first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique, important advancement in the treatment of COPD.

"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 the United States. Approximately half of COPD patients experience almost daily symptoms, including increased shortness of breath, frequent coughing, wheezing and unusual tiredness. There is no cure for COPD. Treatments, including Ohtuvayre, are known as "maintenance" treatments. Despite available treatment options, COPD is the third leading cause of death globally.

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?

Ohtuvayre (ensifentrine) is a novel COPD maintenance treatment developed by Verona Pharma (VRNA). It was approved by the FDA on June 26, 2024, for adult patients with COPD.

How is Ohtuvayre different from other COPD treatments?

Ohtuvayre is the first inhaled product with a new mechanism of action for COPD maintenance treatment in over 20 years. It is a first-in-class PDE3 and PDE4 inhibitor, delivered through a standard jet nebulizer.

Who is manufacturing Ohtuvayre for Verona Pharma (VRNA)?

The Ritedose , the largest CDMO in the United States specializing in sterile Blow Fill Seal production, is the development and manufacturing partner for Ohtuvayre.

How many people are affected by COPD globally and in the United States?

COPD affects more than 480 million people globally and over 14 million people in the United States.