DUBLIN, March 31, 2020 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today provided an update
regarding the impact of COVID-19 on its business and the actions it
is taking to mitigate the spread of this virus.
"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 Bruce Cozadd,
chairman and chief executive officer of Jazz Pharmaceuticals.
"The company is in a strong financial position, having entered
the year with over $1 billion in cash
and investments and access to significant additional
liquidity. Our financial strength prepares us to navigate
through this pandemic while continuing to execute on our key
strategic objectives to support our long-term growth."
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
16 the 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, Ireland which produces Xyrem® (sodium oxybate)
oral solution and JZP-258, continues to be operational.
Jazz's Villa Guardia, Italy
manufacturing facility, which produces defibrotide, temporarily
ceased operations as of March 20
given 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, 2020 and 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
Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharmaceutical
company dedicated to developing life-changing medicines for people
with serious diseases — often with limited or no options. We have a
diverse portfolio of marketed medicines and novel product
candidates, from early- to late-stage development, in key
therapeutic areas. Our focus is in neuroscience, including sleep
medicine and movement disorders, and in oncology, including
hematologic and solid tumors. We actively explore new options for
patients including novel compounds, small molecule advancements,
biologics and innovative delivery technologies. Jazz is
headquartered in Dublin, Ireland
and has employees around the globe, serving patients in more than
90 countries. For more information, please visit
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
"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; Jazz Pharmaceuticals' belief that its
financial strength prepares it to navigate through the pandemic
while executing on key strategic objectives to support long-term
growth; and other statements that are not historical facts. These
forward-looking statements are based on Jazz
Pharmaceuticals' current plans, objectives, estimates,
expectations and intentions and inherently involve significant
risks and uncertainties. Actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with the scale and duration of the
COVID-19 pandemic and resulting global economic and financial
disruptions; potential impacts on Jazz Pharmaceuticals' supply
chain (including availability of packaging and logistics facilities
and transportation), commercial, regulatory and clinical
development plans, and all other business operations; and other
risks and uncertainties including those described from time to time
under the caption "Risk Factors" and elsewhere in Jazz
Pharmaceuticals plc's Securities and Exchange
Commission filings and reports (Commission File No.
001-33500), including Jazz Pharmaceuticals' Annual Report
on Form 10-K for the year ended December 31, 2019 and
future filings and reports by Jazz Pharmaceuticals. Other
risks and uncertainties of which Jazz Pharmaceuticals is not
currently aware may also affect Jazz
Pharmaceuticals' forward-looking statements and may cause
actual results and the timing of events to differ materially from
those anticipated. The forward-looking statements herein are made
only as of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made
available by Jazz Pharmaceuticals on its website or
otherwise. Jazz Pharmaceuticals undertakes no obligation to
update or supplement any forward-looking statements to reflect
actual results, new information, future events, changes in its
expectations or other circumstances that exist after the date as of
which the forward-looking statements were made.
Investor Contact:
Kathee
Littrell, Vice President, Investor Relations
Ireland +353 1 634
7887 U.S. +1 650
496 2717
Media Contact:
Jacqueline
Kirby, Vice President, Corporate Affairs & Government
Relations
Ireland +353 1 697
2141 U.S. +1 215
867 4910
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SOURCE Jazz Pharmaceuticals plc