HERTFORDSHIRE, England and
PITTSBURGH, April 11, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced
that it has acquired global development and marketing rights from
Prayog Labs LLC to bring to market a fast-acting Meloxicam as a
proposed non-narcotic analgesic. This novel delivery has the
potential to provide a non-addictive treatment option for acute
pain that patients may experience, for example, during dentistry
procedures, post-surgery and with orthopedic defects. Meloxicam
also is proposed to treat chronic pain.
In October 2017, the U.S.
Department of Health and Human Services declared a nationwide
public health emergency regarding the opioid crisis, serving as a
rallying cry for affected families, communities, advocacy groups,
healthcare professionals, policymakers and the entire healthcare
industry to come together to address a serious epidemic
debilitating the country. Mylan plays a very small role in the
manufacture and sale of opioid products, but the company is
committed to being a part of the long-term solution. Promoting the
development of non-opioid pain treatments is one of the many
tactics the U.S. Food and Drug Administration is focused on as part
of its efforts to address this growing public health problem.
Mylan CEO Heather Bresch
commented, "We recognize the severity of the opioid crisis as a
nationwide public health issue and are committed to doing our part
to help in the fight against opioid addiction, abuse and misuse.
Offering an alternate, non-opioid pain treatment option represents
at least a step toward addressing this national health crisis. Over
the course of our almost 60-year history, we have leveraged our
expansive scientific capabilities on multiple occasions to help
address some of the world's toughest public health issues. We look
forward to bringing a novel delivery form of Meloxicam to market
for healthcare providers, patients and the public at-large who are
affected by this epidemic."
Prayog Labs has completed the initial active pharmaceutical
ingredient and formulation development, as well as a
pharmacodynamic and preclinical evaluation. Mylan will be
submitting an investigational new drug application to the U.S. Food
and Drug Administration and plans to use the 505(b)(2) regulatory
pathway for product approval.
Mylan President Rajiv Malik
added, "At Mylan, part of being built to last is finding the right
technologies that can advance our mission to deliver better health
for a better world. This novel delivery form of Meloxicam is
particularly significant because it could play an important role in
addressing a public health crisis. Adding a fast-acting Meloxicam
to our pipeline is meaningful not because it will be a key growth
driver, but because it's the right thing to do."
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 more than 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
leveraging its world-class scientific platform to develop a novel
delivery for Meloxicam, a non-opioid pain medication; that once
approved, the product could potentially offer a fast-acting,
non-addictive treatment for acute pain; that we look forward to
bringing a novel delivery form of Meloxicam to market for
healthcare providers, patients and the public at-large who are
affected by this epidemic; that Mylan will be submitting an
investigational new drug application to the U.S. Food and Drug
Administration and plans to use the 505(b)(2) regulatory pathway
for product approval; that the novel, delivery of Meloxicam is
particularly significant, because it could play an important role
in addressing a public health crisis. These statements are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Because such statements inherently
involve risks and uncertainties, actual future results may differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to: success of clinical
trials and our or our partners' ability to execute on new product
opportunities; any regulatory, legal or other impediments to our or
our partners' ability to bring products to market; other risks
inherent in product development; the scope, timing, and outcome of
any ongoing legal proceedings, including government investigations,
and the impact of any such proceedings on our or our partners'
businesses; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States
and abroad; the impact of competition; strategies by competitors or
other third parties to delay or prevent product introductions; the
effect of any changes in our or our partners' customer and supplier
relationships and customer purchasing patterns; any other changes
in third-party relationships; changes in the economic and financial
conditions of the businesses of Mylan or its partners;
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.