Mylan Announces Settlement Agreement for First-to-File Generic Version of TARGRETIN®

  Mylan Announces Settlement Agreement for First-to-File Generic Version of
                                  TARGRETIN®

Agreement includes a no-later-than July 9, 2015 launch

PR Newswire

PITTSBURGH, Dec. 17, 2013

PITTSBURGH, Dec. 17, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner
Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into
a settlement and license agreement with Eisai Inc. and Valeant Pharmaceuticals
Luxembourg S.a.r.l that will resolve patent litigation related to Bexarotene
Capsules, 75 mg. Bexarotene is the generic version of TARGRETIN®, which 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.

Pursuant to the agreement, the pending litigation will be dismissed, and Mylan
and Banner will receive a license to begin selling a generic version of the
product on July 9, 2015, or earlier under certain circumstances. All other
terms and conditions of the settlement and license agreement are confidential,
and the agreement itself is subject to review by the U.S. Department of
Justice and the Federal Trade Commission.

Mylan believes that its partner, Banner, is the first company to have filed a
substantially complete abbreviated new drug application (ANDA) containing a
Paragraph IV certification with the U.S. Food and Drug Administration (FDA)
for Bexarotene Capsules, 75 mg. TARGRETIN®, 75 mg, had U.S. sales of
approximately $53.6 million for the 12 months ending Sept. 30, 2013, according
to IMS Health.

Currently, Mylan has 178 ANDAs pending FDA approval representing $90.8 billion
in annual sales, according to IMS Health. Thirty-nine of these pending ANDAs
are potential first-to-file opportunities, representing $23.8 billion in
annual brand sales, for the 12 months ending June 30, 2013, according to IMS
Health. When including ANDAs associated with Mylan's recent acquisition of
Agila, the company now has a total of 300 ANDAs pending FDA approval.

This press release includes statements that constitute "forward-looking
statements," including with regard to the settlement of the litigation and
sales of the product. 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: any legal or regulatory
challenges to the settlement; strategies by competitors or other third parties
to delay or prevent product introductions; risks inherent in legal and
regulatory processes; 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.

Mylan is a global pharmaceutical company committed to setting new standards in
health care. 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 1,200 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral therapies,
upon which approximately 40% of HIV/AIDS patients in developing countries
depend. We also operate one of the largest active pharmaceutical ingredient
manufacturers and currently market products in approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated to
improving the customer experience and increasing pharmaceutical access to
consumers around the world. But don't take our word for it. See for yourself.
See inside. mylan.com

SOURCE Mylan Inc.

Website: http://www.mylan.com
Contact: Nina Devlin (Media), 724.514.1968, Kris King (Investors),
724.514.1813
 
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