HERTFORDSHIRE, England and
PITTSBURGH, May 12, 2020 /PRNewswire/ -- Mylan
N.V. (NASDAQ: MYL) today announced, as part of its ongoing
efforts to support patients and public health needs during the
COVID-19 pandemic, a global collaboration with Gilead Sciences to
expand access to the investigational antiviral remdesivir for the
potential treatment of COVID-19.
Under the terms of the license agreement signed with Gilead,
Mylan has rights to manufacture and distribute remdesivir in 127
low- and middle-income countries, including India. The agreement is non-exclusive,
allowing for multiple licensees to ensure extensive access to this
treatment, once approved as safe and effective for COVID-19
patients.
Mylan CEO Heather Bresch said:
"Mylan and Gilead have partnered for 15 years to fight infectious
diseases like HIV and hepatitis C, reaching nearly 10 million
patients in more than 100 countries with affordable medicine. We
applaud Gilead's progress on remdesivir and are committed to
continue deploying our resources and expertise in the fight against
COVID-19 by applying our R&D and manufacturing capabilities to
help expand access to this potential treatment option as it is
further evaluated by regulatory authorities."
To ensure preparedness in this critical time of need, Mylan is
confident it will be able to develop a bioequivalent version of
remdesivir, including production of its own active pharmaceutical
ingredient (API) and the finished dosage form (FDF) in sterile
powder lyophilized vials for administration of the medicine by
intravenous (IV) infusion. We will be in a position to provide
product in the coming months, subject to reviews by national
regulatory bodies and the Prequalification Program of the World
Health Organization (WHO).
Mylan President Rajiv Malik said:
"The unprecedented development timeline at Mylan is a direct
reflection of the investments we've made to build a first-class,
global research and manufacturing platform, including strong
technical expertise in injectable dosage forms. As a world leader
in the supply of antiretroviral drugs upon which approximately 40%
of those being treated for HIV/AIDs depend, we also understand
supply chain complexities that must be overcome in order to ensure
that the products we manufacture are able to reach the patients who
need them. Today's announcement is another example of how Mylan's
unique global infrastructure and expertise empower other companies
to expand their own reach by providing more patients with access to
critical medicines worldwide."
Remdesivir is the tenth medicine licensed to Mylan by Gilead,
who signed their first agreement in 2006 for the HIV medicine,
tenofovir disoproxil fumarate. Mylan has since been at the
forefront of increasing access to HIV and viral hepatitis
treatments developed by Gilead, including bioequivalent forms of
Atripla®, Sovaldi® and Descovy®, for which Mylan was the first
licensee to achieve approval by the WHO's Prequalification Program
or by the U.S. Food and Drug Administration (FDA) under the
President's Emergency Plan for AIDS Relief (PEPFAR). Mylan supplies
HIV treatments containing tenofovir to more than 8 million people
each year and has reached 1 million patients with hepatitis C
treatments containing sofosbuvir, also licensed from Gilead.
The growing global threat of COVID-19 requires a commitment to
action 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, manufacturing and supply
chain expertise can be of service.
About Remdesivir
Remdesivir is an investigational new
drug developed by Gilead Sciences. The treatment was recently
granted emergency use authorization (EUA) to treat hospitalized
COVID-19 patients in the U.S. In addition, it is recommended for
compassionate use in Europe and
recently received regulatory approval in Japan. Two global clinical trials conducted to
date have demonstrated positive results, reducing the recovery time
for patients with COVID-19, although the full efficacy and safety
of the treatment are still under investigation.
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
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 approximately 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.
Forward-Looking Statement
This press release includes statements that constitute
"forward-looking statements," including with regard to Mylan and
Gilead Sciences signing a global collaboration agreement for the
commercialization of remdesivir in 127 low- and middle-income
countries; the agreement being non-exclusive, allowing for multiple
licensees to ensure extensive access to this treatment, once
approved as safe and effective for COVID-19 patients; Mylan being
committed to continue deploying our resources and expertise in the
fight against COVID-19 by applying our R&D and manufacturing
capabilities to help expand access to this potential treatment
option as it is further evaluated by regulatory authorities; Mylan
being confident it will be able to develop a bioequivalent version
of remdesivir, including production of its own API and the finished
dosage form (FDF) in sterile powder lyophilized vials for
administration of the medicine by intravenous (IV) infusion; we
will be in a position to provide product in the coming months,
subject to reviews by national regulatory bodies and the
Prequalification Program of the World Health Organization (WHO);
today's announcement being another example of how Mylan's unique
global infrastructure and expertise empower other companies to
expand their own reach by providing more patients with access to
critical medicines worldwide; the timing and outcome of regulatory
approvals and the effectiveness and approval of potential
treatments. 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 potential widespread and highly
uncertain impact of public health outbreaks, epidemics 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.
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SOURCE Mylan N.V.
