HERTFORDSHIRE, England and
PITTSBURGH, Feb. 12, 2019 /PRNewswire/ -- Mylan
N.V. (NASDAQ: MYL) today announced the launch of the first
FDA-approved therapeutically equivalent, substitutable generic
of ADVAIR DISKUS®, Wixela™
Inhub™ (fluticasone propionate and salmeterol
inhalation powder, USP), approved by the U.S. Food and Drug
Administration (FDA) through the Abbreviated New Drug Application
(ANDA) pathway. Wixela Inhub is indicated for certain patients
with asthma or chronic obstructive pulmonary disease (COPD).
All three strengths of Wixela Inhub will be offered at a
wholesale acquisition cost* 70% less than ADVAIR DISKUS and 67%
less than GSK's authorized generic version which launched on
Feb. 8. The wholesale acquisition
costs of Wixela Inhub 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50
mcg strengths are $93.71,
$116.44 and $153.14, respectively.
Mylan's Chief Commercial Officer Tony
Mauro commented, "We've had numerous discussions with
customers about the need for a unique launch strategy for the first
substitutable generic of ADVAIR DISKUS that increases
affordability to all in our healthcare system. We trust that by
launching Wixela Inhub at a significantly discounted list price, we
will demonstrate the savings that generics can deliver for patients
through reduced out-of-pocket costs, as well as the U.S. healthcare
system overall."
In addition, Mylan will offer patient services to provide
training and education about the treatment and device.
Wixela Inhub is indicated for the twice daily treatment of
asthma in patients age 4 and older not adequately controlled on
long-term asthma medications or whose disease warrants initiation
of treatment with both inhaled corticosteroids and
long-acting beta agonists; maintenance treatment of COPD; and
the reduction of COPD exacerbations in patients with a history of
exacerbations. It is not indicated for the relief of acute
bronchospasm.
*The WAC does not necessarily reflect the price paid
by consumers, pharmacies, or third-party payers.
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 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.
Forward-Looking Statements
This press release includes statements that constitute
"forward-looking statements," including with regard to statements
that: Mylan is launching
Wixela™ Inhub™, the first generic of
ADVAIR DISKUS®, at a list price 70% less than the brand; unique
pricing of Wixela Inhub will immediately benefit patients and
reduce overall cost to the U.S. healthcare system; all three
strengths of Wixela Inhub will be offered at a wholesale
acquisition cost of 70% less than ADVAIR DISKUS and 67% less than
GSK's authorized generic version launched on Feb. 8; the wholesale acquisition costs of Wixela
Inhub 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg
strengths are $93.71,
$116.44 and $153.14, respectively; we trust that by launching
Wixela Inhub at a significantly discounted list price, we will
demonstrate the savings that generics can deliver for patients
through reduced out-of-pocket costs, as well as the U.S. healthcare
system overall; and Mylan will offer patient services to provide
training and education about the treatment and device. These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. 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 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.