Current Report Filing (8-k)
August 25 2016 - 6:04AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 24, 2016
Arena Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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000-31161
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23-2908305
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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6154 Nancy Ridge Drive, San Diego, California 92121
(Address of principal executive offices) (Zip Code)
858.453.7200
(Registrants telephone number, including area code)
N/A
(Former name or
former address, if changed since last report)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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In this report, Arena Pharmaceuticals, Arena, Company, we,
us and our refer to Arena Pharmaceuticals, Inc., and/or one or more of our wholly owned subsidiaries, unless the context otherwise provides. Arena
Pharmaceuticals
®
and Arena
®
are registered service marks of Arena Pharmaceuticals, Inc.
Item 8.01 Other Events.
We and Eisai Inc. have
received a Paragraph IV certification notification with respect to patents for BELVIQ
®
(lorcaserin hydrochloride tablets, 10 mg) listed in the FDAs Approved Drug Products
with Therapeutic Equivalence Evaluations, or the Orange Book. The certification was from an Abbreviated New Drug Application (ANDA) for a proposed generic version of BELVIQ
®
.
The notification is currently under investigation. In accordance with the Hatch-Waxman Act, we and Eisai have 45 days from the receipt of the notification to
file a patent infringement suit against the ANDA filer which would result in the stay of FDA approval of the ANDA under statutory guidelines.
We and
Eisai intend to vigorously defend our intellectual property rights. We cannot predict the outcome of any litigation matter.
Forward-Looking Statements
Certain statements in this Form 8-K are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements
include our and Eisais plans to defend our intellectual property rights and any lawsuit. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from
our expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks related to litigation, intellectual property rights and collaborations. Additional factors that
could cause actual results to differ materially from those stated or implied by Arenas forward-looking statements are disclosed in our filings with the Securities and Exchange Commission. These forward-looking statements represent our judgment
as of the time of this Form 8-K. We disclaim any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Date: August 24, 2016
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Arena Pharmaceuticals, Inc.
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By:
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/s/ Amit Munshi
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Amit Munshi
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President and Chief Executive Officer
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