HERTFORDSHIRE, England and
PITTSBURGH, Aug. 18, 2015 /PRNewswire/ -- Mylan N.V.
(Nasdaq: MYL) today confirmed that the company has been sued by BTG
International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc.,
and Janssen Research & Development, LLC in connection with the
filing of an Abbreviated New Drug Application (ANDA) with the U.S.
Food and Drug Administration (FDA) for Abiraterone Acetate Tablets,
250 mg. This product is the generic version of Zytiga®,
which is indicated in combination with prednisone for the treatment
of patients with metastatic castration-resistant prostate
cancer.
Mylan believes it is one of the first companies to have filed a
substantially complete ANDA containing a Paragraph IV certification
for this product and expects to be eligible for 180 days of
marketing exclusivity upon final FDA approval. The plaintiffs have
filed a lawsuit against Mylan in the United States District Court
for the District of New
Jersey.
For the 12 months ending June 30,
2015, Zytiga had U.S. sales of approximately $1.08 billion, according to IMS Health.
Currently, Mylan has 178 ANDAs pending FDA approval representing
$83.8 billion in annual sales,
according to IMS Health. Forty-two of these pending ANDAs are
potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12
months ending Dec. 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 the expected
first-to-file status and pending litigation. 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 use of
legal, regulatory and legislative strategies by competitors or
other third parties to delay or prevent product introductions;
risks inherent in legal and regulatory processes, 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.
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SOURCE Mylan N.V.