Strategic financing from Oaktree Capital Management and OMERS Life Sciences is expected to support the US launch of ensifentrine, Verona’s promising chronic obstructive pulmonary disease treatment.
Verona Pharma announced that it has secured strategic financing of up to $650 million from Oaktree Capital Management and OMERS Life Sciences, aiming to prepare for the potential US launch of ensifentrine, an investigational therapy for chronic obstructive pulmonary disease (COPD). According to the company, the funding includes up to $400 million in term loans and $250 million in a revenue interest purchase agreement based on future ensifentrine-related revenues. Under terms of the debt facility, Verona is expected to draw $55 million at closing, with the potential for an additional $70 million upon the FDA approval of ensifentrine, and $275 million between the achievement of certain net sales milestones and the support of strategic initiatives.1
“As we finalize preparations for the potential US approval and commercial launch of ensifentrine, we are pleased to be working with Oaktree and OMERS who are aligned with our view of ensifentrine’s importance to the COPD community and its commercial opportunity. This strategic agreement, with access to up to $650 million, allows us to further strengthen our cash position and improve our financial flexibility,” said David Zaccardelli, PharmD, president, CEO, Verona Pharma, in a press release. “These funds, together with our existing cash of $255 million, are expected to support the company through commercialization and growth beyond 2026.”
In September 2023, Verona announced that the FDA accepted its New Drug Application (NDA) for ensifentrine as a COPD treatment. At the time of the application, the agency assigned the NDA with a Prescription Drug User Fee Act date of June 26, 2024. As part of the application, Verona included data that demonstrated efficacy and safety from the Phase III ENHANCE trials, which reportedly showed improvements in lung functions and a reduced rate and risk of COPD exacerbations. Ensifentrine has also been evaluated in dry powder inhaler and pressurized metered-dose inhaler formulations.2
“We believe ensifentrine’s impressive clinical data generated to date and unique mechanism of action position it well to become a paradigm-shifting advancement in the maintenance treatment of COPD, a condition with continued unmet need,” said Aman Kumar, co-portfolio manager, Oaktree’s Life Sciences lending platform, in the press release. “This strategic investment in Verona Pharma underscores Oaktree’s commitment to provide flexible capital solutions to innovative life sciences companies that are working on bringing important therapies to patients and providers worldwide.”
According to the World Health Organization (WHO), COPD is the third leading cause of death globally, with over 3 million deaths reported in 2019. It can develop as a result of multiple factors such as tobacco exposure, indoor air pollution, and exposure to occupational hazards such as chemicals, dust, or fumes. As the disease progresses, it makes everyday activities much more challenging as a result of breathlessness.3
“Common symptoms of COPD develop from mid-life onwards,” reports WHO. “As COPD progresses, people find it more difficult to carry out their normal daily activities, often due to breathlessness. There may be a considerable financial burden due to limitation of workplace and home productivity, and costs of medical treatment.”
References
1. Verona Pharma Announces $650 Million Strategic Financing with Oaktree and OMERS. GlobeNewswire. May 9, 2024. Accessed May 9, 2024. https://www.globenewswire.com/news-release/2024/05/09/2878583/0/en/Verona-Pharma-Announces-650-Million-Strategic-Financing-with-Oaktree-and-OMERS.html
2. Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD. Verona Pharma. September 11, 2023. Accessed May 9, 2024. https://www.veronapharma.com/media/verona-pharma-announces-us-fda-has-accepted-new-drug-application
3. Chronic obstructive pulmonary disease (COPD). WHO. March 16, 2023. Accessed May 9, 2024. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)#:~:text=Chronic%20obstructive%20pulmonary%20disease%20(COPD)%20is%20the%20third%20leading%20cause,%2Dincome%20countries%20(LMIC).&text=Tobacco%20smoking%20accounts%20for%20over,cases%20in%20high%2Dincome%20countries.
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