Jazz Pharmaceuticals Provides COVID-19 Business Update
"Jazz provides essential medicines to patients around the world and we are committed to delivering on this important mission. We have implemented a robust continuity plan to address the impact of COVID-19 on our business. We are highly focused on ensuring patients have access to our medicines and protecting the health and safety of our employees and the communities in which we operate," said
Jazz sees a limited financial impact today, given its portfolio of differentiated products addressing chronic and life-threatening diseases. However, given the global economic slowdown, reduced field-based interactions with healthcare professionals and the uncertainty surrounding the scale and duration of the pandemic, the company, at this time, cannot rule out future impact on its business and associated guidance. Jazz expects to provide an update on all key business areas during its first quarter 2020 financial results in early May.
The company will continue to closely monitor COVID-19 in order to make timely, informed decisions, in an effort to minimize the impact to key business areas.
Employees and Communities
- Jazz supports broad public health strategies designed to prevent the spread of COVID-19 and is focused on the health and welfare of its employees.
- In accordance with guidance issued by the Centers for Disease Control and Prevention, the World Health Organization and local authorities, beginning on
March 16the company's global workforce began working remotely, including the suspension of work-related travel and in-person customer interactions.
- Field sales force, market access and reimbursement, and medical support employees are utilizing telephone and web-based means to continue to engage healthcare professionals to support their patients and practices. The medical science liaison team continues their support of all brands and studies.
- Jazz is committed to support the company's local communities and patient focused organizations, and continues to explore additional ways to support local response efforts to COVID-19.
Supply of Jazz Medicines
- The company remains confident in its ability to supply its medicines to patients around the world and currently has ample supply to meet commercial needs well into the future, with the exception of Erwinaze® (asparaginase Erwinia chrysanthemi). The manufacturer of Erwinaze continues to have supply disruptions unrelated to COVID-19.
- Currently, the company expects adequate supply of lurbinectedin and JZP-258 to support the
U.S.launches following potential U.S. Food and Drug Administration(FDA) approvals.
- Jazz's manufacturing facility in Athlone,
Irelandwhich produces Xyrem® (sodium oxybate) oral solution and JZP-258, continues to be operational. Jazz's Villa Guardia, Italymanufacturing facility, which produces defibrotide, temporarily ceased operations as of March 20given the sufficient inventory and, importantly, the need to ensure the safety of the company's employees and communities in northern Italy.
- Jazz is working closely with the company's third-party manufacturers, distributors and other trusted partners to manage the supply chain activities and mitigate any potential disruptions to the company's product supply as a result of COVID-19. To date, all third-party manufacturers are continuing operations.
Clinical Studies and Regulatory Update
- Jazz is committed to the safety and well-being of patients enrolled in clinical studies with the goal of minimizing patient treatment disruptions due to COVID-19.
- For ongoing clinical studies, the company has taken proactive measures to implement remote and virtual approaches, including remote patient monitoring, where possible. With the current stress on the healthcare system, the company anticipates an impact to patient enrollment in certain studies and delays in the initiation of new clinical studies.
- Jazz remains engaged with regulatory authorities and is working closely with FDA on its two product candidates under review. JZP-258 and lurbinectedin are under priority review at FDA with Prescription Drug User Fee Act (PDUFA) action dates of
July 21, 2020and August 16, 2020, respectively. At this time, FDA has not notified Jazz of any planned delays in the New Drug Application reviews of these candidates.
About Jazz Pharmaceuticals plc
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' expectations regarding business and financial impacts of COVID-19, including with respect to product supply chain, regulatory activities, clinical studies (including patient enrollment) and all other business operations;
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