HERTFORDSHIRE,
England and PITTSBURGH, March 19,
2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL)
today announced its continued commitment to do its part in support
of public health needs amidst the evolving COVID-19 pandemic. The
company continues to focus its efforts on protecting our employees,
producing critically needed medications, and turning our scientific
and operational expertise towards identifying additional ways we
may be able to assist in the massive prevention, diagnosis and
treatment efforts needed to counter the spread of COVID-19.
For example, in the immediate term, Mylan has restarted
production of hydroxychloroquine sulfate tablets at its
West Virginia manufacturing
facility in the U.S. to meet the potential for increased demand
resulting from potential effectiveness of the product in treating
COVID-19. Mylan's hydroxychloroquine sulfate tablets are approved
by the U.S. Food and Drug Administration (FDA) for the treatment of
malaria, lupus erythematosus and rheumatoid arthritis. Although the
product is not currently approved for use in the treatment of
COVID-19, it is listed by the World Health Organization as a drug
under investigation for efficacy against the
coronavirus[1]. The company is also taking steps to
initiate production of this product outside the U.S. in the coming
weeks. We look forward to working with governments and health
authorities globally to ensure patient access to this medicine as
and where needed.
Mylan expects to be in a position to begin supplying product by
mid-April, and with the active pharmaceutical ingredient that we
currently have available, will be able to ramp up manufacturing to
provide 50 million tablets to potentially treat a total of more
than 1.5 million patients. The potential use of this medicine for
COVID-19 related treatment is pending additional FDA and other
regulatory body guidance.
The growing global threat of COVID-19 requires a commitment by
everyone involved in public health. Mylan takes its responsibility
seriously and is committed to continuing to work with governments,
partners and others to identify areas of need where our global
R&D, regulatory and manufacturing expertise and capacity can be
of service.
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in healthcare. Working together
around the world to provide 7 billion people access to high quality
medicine, we innovate to satisfy unmet needs; make reliability and
service excellence a habit; do what's right, not what's easy; and
impact the future through passionate global leadership. We offer a
growing portfolio of more than 7,500 marketed products around the
world, including antiretroviral therapies on which approximately
40% of people being treated for HIV/AIDS globally depend. We market
our products in more than 165 countries and territories. We are one
of the world's largest producers of active pharmaceutical
ingredients. Every member of our more than 35,000-strong workforce
is dedicated to creating better health for a better world, one
person at a time. Learn more at Mylan.com. We routinely post
information that may be important to investors on our website
at investor.mylan.com.
This press release includes statements that constitute
"forward-looking statements," including with regard to the
potential approval and/or use of hydroxychloroquine sulfate tablets
in the treatment of COVID-19; that Mylan expects to be in a
position to begin supplying product by the second week of April,
and with the active pharmaceutical ingredient that we currently
have available will be able to ramp up manufacturing to provide 50
million tablets to potentially treat a total of more than 1.5
million patients; that the potential use of this medicine for
COVID-19 related treatment is pending additional FDA and other
regulatory body guidance; and that Mylan is committed to continuing
to work with governments, partners and others to identify areas of
need where our global R&D, regulatory and manufacturing
expertise and capacity can be of service. Because forward-looking
statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such statements. Factors that could cause or contribute
to such differences include, but are not limited to the impact of
public health outbreaks and pandemics, such as the COVID-19
pandemic; any changes in, interruptions to, or difficulties with
Mylan's or its partners' ability to develop, manufacture, and
commercialize products; the effect of any changes in Mylan's or its
partners' customer and supplier relationships and customer
purchasing patterns; other changes in third-party relationships;
the impact of competition; changes in the economic and financial
conditions of the businesses of Mylan or its partners; the scope,
timing, and outcome of any ongoing legal proceedings and the impact
of any such proceedings on Mylan's or its partners' business; any
regulatory, legal, or other impediments to Mylan's or its partners'
ability to bring products to market; actions and decisions of
healthcare and pharmaceutical regulators, and changes in healthcare
and pharmaceutical laws and regulations, in the United States and abroad; Mylan's and its
partners' ability to protect intellectual property and preserve
intellectual property rights; risks associated with international
operations; other uncertainties and matters beyond the control of
management; and the other risks detailed in Mylan's filings with
the Securities and Exchange Commission. Mylan undertakes no
obligation to update these statements for revisions or changes
after the date of this release.
[1]
https://www.who.int/blueprint/priority-diseases/key-action/Table_of_therapeutics_Appendix_17022020.pdf?ua=1
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SOURCE Mylan N.V.