HERTFORDSHIRE, England and
PITTSBURGH, July 9, 2015 /PRNewswire/ -- Mylan N.V.
(Nasdaq: MYL) today announced the U.S. launch of Bexarotene 75mg
Capsules, which is the generic version of Valeant's
Targretin® Capsules. This product is indicated for the
treatment of cutaneous manifestations of cutaneous t-cell lymphoma
in patients who are refractory to at least one prior systemic
therapy.(1)
Mylan CEO Heather Bresch
commented: "Mylan's launch of the first and only generic Targretin
is another example of our commitment to expand access to high
quality, more affordable medicines. The launch also strengthens
Mylan's growing oncology franchise of more than 30 approved
oncology treatments, and associated supportive care and diagnostic
products in the U.S. We look forward to continue meeting patient,
payor and provider needs in this space."
Bexarotene 75mg Capsules had U.S. sales of approximately
$155.5 million for the 12 months
ending March 31, 2015, according to
IMS Health.
Currently, Mylan has 270 ANDAs pending FDA approval representing
$107.2 billion in annual brand sales,
according to IMS Health. Forty-seven of these pending ANDAs are
potential first-to-file opportunities, representing $33.3 billion in annual brand sales, for the 12
months ending December 31, 2014,
according to IMS Health.
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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which nearly 50% of HIV/AIDS patients in developing
countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people is dedicated to creating better health
for a better world, one person at a time. Learn more at
mylan.com.
This press release includes statements that constitute
"forward-looking statements," including with regard to sales of
products and the company's strategy, future growth and performance.
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: the impacts of competition; changes in economic and
financial conditions of the company's business; strategies by
competitors or other third parties to delay or prevent product
introductions; risks inherent in legal and regulatory processes;
changes in third party relationships; uncertainties and matters
beyond the control of management; and the other risks detailed in
the company's filings with the Securities and Exchange Commission.
The company undertakes no obligation to update these statements for
revisions or changes after the date of this release.
(1) Targretin Capsules are a member of the retinoid class
of drugs that is associated with birth defects in humans. Targretin
Capsules must not be administered to a pregnant woman.
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SOURCE Mylan N.V.