WASHINGTON, Dec. 7, 2016 /PRNewswire/ -- Vanda Grants Apotex
a license to sell generic Fanapt® beginning November 2027
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today
announced it has entered into a License Agreement (the License
Agreement) with Apotex Inc. and Apotex Corp. (collectively, Apotex)
to resolve Vanda's patent litigation against Apotex regarding
Apotex's Abbreviated New Drug Application seeking approval of its
generic version of Vanda's Fanapt® (iloperidone).
Under the License Agreement, Vanda granted Apotex a
non-exclusive license to manufacture and commercialize Apotex's
version of Fanapt® in the U.S. effective November 2, 2027, unless prior to that date Vanda
obtains pediatric exclusivity for Fanapt®, in which
case, the license will be effective May 2,
2028. Apotex may enter the market earlier under
certain limited circumstances.
The License Agreement is subject to review by the U.S. Federal
Trade Commission and the U.S. Department of Justice. The
License Agreement provides for a full settlement and release by
Vanda and Apotex of all claims that are the subject of the
litigation.
About Vanda Pharmaceuticals Inc.
Vanda is a
specialty pharmaceutical company focused on the development and
commercialization of novel therapies to address high unmet medical
needs and improve the lives of patients. For more on Vanda
Pharmaceuticals Inc., please visit www.vandapharma.com.
About Fanapt®
For full U.S. Prescribing
Information for Fanapt®, including indication, Boxed
Warnings and Important Safety Information, visit our Web site
at www.fanapt.com.
CAUTIONARY NOTE REGARDING Forward-Looking
Statements
This press release contains forward-looking
statements, including statements regarding the anticipated results
and actions to be taken under the License Agreement and plans to
submit the License Agreement for regulatory approval. These
forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions and
uncertainties. Important factors that could cause actual
results to differ materially from those reflected in Vanda's
forward-looking statements include, but are not limited to, risks
regarding whether regulatory authorities challenge the
enforceability of or seek to enjoin the entry into the License
Agreement, whether additional third parties may seek to market
generic versions of Fanapt® and the results of any
litigation that Vanda files to defend and/or assert its patents
against such third parties and other factors that are described in
the "Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of Vanda's
annual report on Form 10-K for the fiscal year ended
December 31, 2015 and quarterly report on Form 10-Q for
the quarter ended September 30, 2016, which are on file with
the SEC and available on the SEC's website at www.sec.gov. In
addition to the risks described above and in Vanda's annual report
on Form 10-K and quarterly reports on Form 10-Q, other
unknown or unpredictable factors also could affect Vanda's results.
There can be no assurance that the actual results or
developments anticipated by Vanda will be realized or, even if
substantially realized, that they will have the expected
consequences to, or effects on, Vanda. Therefore, no
assurance can be given that the outcomes stated in such
forward-looking statements and estimates will be achieved.
Investor Contact:
Jim
Kelly
Senior Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.