.
3/19/20, “Mylan Ramps Up U.S. Manufacturing of Hydroxychloroquine Sulfate Tablets to Meet Potential COVID-19 Patient Needs,” newsroom.mylan.com, Hertfordshire, England, and Pittsburgh, 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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