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<TITLE>Form 8-K</TITLE>
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 <P STYLE="line-height:0px;margin-top:0px;margin-bottom:0px;border-bottom:0.5pt solid #000000">&nbsp;</P>
<P STYLE="line-height:3px;margin-top:0px;margin-bottom:2px;border-bottom:0.5pt solid #000000">&nbsp;</P> <P STYLE="margin-top:4px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="5"><B>UNITED STATES </B></FONT></P>
<P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="5"><B>SECURITIES AND EXCHANGE COMMISSION </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT
STYLE="font-family:Times New Roman" SIZE="3"><B>WASHINGTON, DC 20549 </B></FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P><center>
<P STYLE="line-height:6px;margin-top:0px;margin-bottom:2px;border-bottom:1pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="5"><B>FORM 8-K
</B></FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P><center> <P STYLE="line-height:6px;margin-top:0px;margin-bottom:2px;border-bottom:1pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="3"><B>CURRENT REPORT </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT
STYLE="font-family:Times New Roman" SIZE="3"><B>Pursuant to Section&nbsp;13 or 15(d) of the </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="3"><B>Securities Exchange Act of
1934 </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="3"><B>Date of Report (Date of earliest event reported): August&nbsp;27, 2013 </B></FONT></P>
<P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P><center> <P STYLE="line-height:6px;margin-top:0px;margin-bottom:2px;border-bottom:1pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="6"><B>OREXIGEN THERAPEUTICS, INC. </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT
STYLE="font-family:Times New Roman" SIZE="2"><B>(Exact Name of Registrant as Specified in its Charter) </B></FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P><center>
<P STYLE="line-height:6px;margin-top:0px;margin-bottom:2px;border-bottom:1pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="2"><B>Delaware</B></FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="2"><B>001-33415</B></FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="2"><B>65-1178822</B></FONT></TD></TR>
<TR>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="1"><B>(State or Other Jurisdiction</B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:1px" ALIGN="center"><FONT
STYLE="font-family:Times New Roman" SIZE="1"><B>of Incorporation)</B></FONT></P></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="1"><B>(Commission</B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:1px" ALIGN="center"><FONT
STYLE="font-family:Times New Roman" SIZE="1"><B>File Number)</B></FONT></P></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="1"><B>(IRS Employer</B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:1px" ALIGN="center"><FONT
STYLE="font-family:Times New Roman" SIZE="1"><B>Identification No.)</B></FONT></P></TD></TR>
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<TD VALIGN="top" COLSPAN="3" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="2"><B>3344 N. Torrey Pines Ct., Suite 200, La Jolla, CA</B></FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="2"><B>92037</B></FONT></TD></TR>
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<TD VALIGN="top" COLSPAN="3" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="1"><B>(Address of Principal Executive Offices)</B></FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="1"><B>(Zip Code)</B></FONT></TD></TR>
</TABLE> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="2"><B>Registrant&#146;s telephone number, including area code: (858)&nbsp;875-8600 </B></FONT></P>
<P STYLE="margin-top:24px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="1"><B>(Former Name or Former Address, if Changed Since Last Report.) </B></FONT></P>
<P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P><center> <P STYLE="line-height:6px;margin-top:0px;margin-bottom:2px;border-bottom:1pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT
STYLE="font-family:Times New Roman" SIZE="2">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 (<I>see</I> General Instruction
A.2. below): </FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman" SIZE="2"><FONT STYLE="FONT-FAMILY:WINGDINGS">&#168;</FONT></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT STYLE="font-family:Times New Roman" SIZE="2">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </FONT></TD></TR></TABLE>
<P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman" SIZE="2"><FONT STYLE="FONT-FAMILY:WINGDINGS">&#168;</FONT></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT STYLE="font-family:Times New Roman" SIZE="2">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </FONT></TD></TR></TABLE>
<P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman" SIZE="2"><FONT STYLE="FONT-FAMILY:WINGDINGS">&#168;</FONT></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT STYLE="font-family:Times New Roman" SIZE="2">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </FONT></TD></TR></TABLE>
<P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman" SIZE="2"><FONT STYLE="FONT-FAMILY:WINGDINGS">&#168;</FONT></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT STYLE="font-family:Times New Roman" SIZE="2">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </FONT></TD></TR></TABLE>
<P STYLE="font-size:10px;margin-top:0px;margin-bottom:0px">&nbsp;</P> <P STYLE="line-height:0px;margin-top:0px;margin-bottom:0px;border-bottom:0.5pt solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0px;margin-bottom:0px"><FONT STYLE="font-family:Times New Roman" SIZE="2"><B>Item&nbsp;8.01 Other Events. </B></FONT></P>
<P STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%;padding-bottom:0px; "><FONT STYLE="font-family:Times New Roman" SIZE="2">On August&nbsp;27, 2013, Orexigen Therapeutics, Inc. (the &#147;<B><I>Company</I></B>&#148; or
&#147;<B><I>Orexigen</I></B>&#148;) announced that the independent Data Monitoring Committee (&#147;<B><I>DMC</I></B>&#148;) for its Light Study, a long-term research study of Contrave<FONT STYLE="font-family:Times New Roman" SIZE="1"><SUP
STYLE="vertical-align:baseline; position:relative; bottom:.8ex">&reg;</SUP></FONT> (naltrexone SR/bupropion SR), has recently confirmed that sufficient major adverse cardiovascular events (&#147;<B><I>MACE</I></B>&#148;) are expected to occur within
the next two months, enabling the interim analysis to be conducted by early December and the potential resubmission of the
Contrave<FONT STYLE="font-family:Times New Roman" SIZE="1"><SUP STYLE="vertical-align:baseline; position:relative; bottom:.8ex">&reg;</SUP></FONT> New Drug Application (&#147;<B><I>NDA</I></B>&#148;) by year end. </FONT></P>
<P STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%;padding-bottom:0px; "><FONT STYLE="font-family:Times New Roman" SIZE="2">Orexigen also reiterated its plan to submit a Marketing Authorization Application (&#147;<B><I>MAA</I></B>&#148;)
for Contrave<FONT STYLE="font-family:Times New Roman" SIZE="1"><SUP STYLE="vertical-align:baseline; position:relative; bottom:.8ex">&reg;</SUP></FONT> to the European Medicines Agency (&#147;<B><I>EMA</I></B>&#148;) in advance of the Light Study
interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use Day 120 List of Questions. </FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT
STYLE="font-family:Times New Roman" SIZE="2">* * * </FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%"><FONT STYLE="font-family:Times New Roman" SIZE="2">Orexigen cautions you that statements included in this report that are not
a description of historical facts are forward-looking statements. Words such as &#147;believes,&#148; &#147;anticipates,&#148; &#147;plans,&#148; &#147;expects,&#148; &#147;indicates,&#148; &#147;will,&#148; &#147;should,&#148; &#147;intends,&#148;
&#147;potential,&#148; &#147;suggests,&#148; &#147;assuming,&#148; &#147;designed&#148; and similar expressions are intended to identify forward-looking statements. These statements are based on the Company&#146;s current beliefs and expectations.
These forward-looking statements include statements regarding: the potential for, and timing of, the interim analysis and submission of a Contrave NDA; the potential for, and timing of, the accrual and adjudication of MACE; the expected retention
rate for patients in the Light Study; the probability of success of the Light Study; the possibility of resubmitting the Contrave NDA with the independent DMC report on the interim analysis and without the clinical study report for the interim
analysis; the potential to accelerate the timing of the review of the Contrave NDA; the safety and effectiveness of Contrave; the potential for and timing of a submission of an MAA in the European Union; and the potential for approval of the
Contrave MAA by the EMA. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this report
due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the complete study report for the interim
analysis; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to
comply with the agreed upon trial protocol; Orexigen&#146;s ability to conduct the Light Study and the progress and timing thereof, including risks associated with enrolling and retaining the appropriate patients in the Light Study; Orexigen&#146;s
ability to demonstrate in the Light Study that the risk of MACE in overweight and obese patients treated with Contrave does not adversely affect Contrave&#146;s benefit-risk profile; the potential that earlier clinical trials may not be predictive
of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE data; the potential for the Light Study to cost more than what is projected; the potential for early termination of
Orexigen&#146;s North American collaboration agreement with Takeda Pharmaceutical Company Limited; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of the Contrave NDA; the
therapeutic and commercial value of Contrave; Orexigen&#146;s ability to maintain sufficient capital to fund our operations through potential approval of Contrave in 2014; Orexigen&#146;s ability to enter into a collaborative partnership for
Contrave outside North America on acceptable terms, if at all; and other risks described in Orexigen&#146;s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading
&#147;Risk Factors&#148; in Orexigen&#146;s Annual Report on Form 10-K filed with the Securities and Exchange Commission March&nbsp;14, 2013 and its other reports, which are available from the SEC&#146;s website (www.sec.gov) and on Orexigen&#146;s
website (www.orexigen.com) under the heading &#147;Investor Relations.&#148; All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section&nbsp;21E of
the Private Securities Litigation Reform Act of 1995. </FONT></P>

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 <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT STYLE="font-family:Times New Roman" SIZE="2"><B>SIGNATURES </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%"><FONT
STYLE="font-family:Times New Roman" SIZE="2">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. </FONT></P>
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<TD VALIGN="bottom"><FONT STYLE="font-family:Times New Roman" SIZE="2">OREXIGEN THERAPEUTICS, INC.</FONT></TD></TR>
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<TD VALIGN="top"><FONT STYLE="font-family:Times New Roman" SIZE="2">Date: August&nbsp;27, 2013</FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="bottom"> <P STYLE="margin-top:0px;margin-bottom:1px;border-bottom:1px solid #000000"><FONT STYLE="font-family:Times New Roman" SIZE="2">By: /s/ Joseph P. Hagan</FONT></P></TD></TR>
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<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="bottom"><FONT STYLE="font-family:Times New Roman" SIZE="2">Name: Joseph P. Hagan</FONT></TD></TR>
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<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="bottom"><FONT STYLE="font-family:Times New Roman" SIZE="2">Title: Chief Business Officer</FONT></TD></TR>
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Form 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 27, 2013
OREXIGEN THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
001-33415
65-1178822
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
3344 N. Torrey Pines Ct., Suite 200, La Jolla, CA
92037
(Address of Principal Executive Offices)
(Zip Code)
Registrant's telephone number, including area code: (858) 875-8600
(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 (
see
General Instruction
A.2. below):
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On August 27, 2013, Orexigen Therapeutics, Inc. (the "
Company
" or
"
Orexigen
") announced that the independent Data Monitoring Committee ("
DMC
") for its Light Study, a long-term research study of Contrave
®
(naltrexone SR/bupropion SR), has recently confirmed that sufficient major adverse cardiovascular events ("
MACE
") are expected to occur within
the next two months, enabling the interim analysis to be conducted by early December and the potential resubmission of the
Contrave
®
New Drug Application ("
NDA
") by year end.
Orexigen also reiterated its plan to submit a Marketing Authorization Application ("
MAA
")
for Contrave
®
to the European Medicines Agency ("
EMA
") in advance of the Light Study
interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use Day 120 List of Questions.
* * *
Orexigen cautions you that statements included in this report that are not
a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "should," "intends,"
"potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations.
These forward-looking statements include statements regarding: the potential for, and timing of, the interim analysis and submission of a Contrave NDA; the potential for, and timing of, the accrual and adjudication of MACE; the expected retention
rate for patients in the Light Study; the probability of success of the Light Study; the possibility of resubmitting the Contrave NDA with the independent DMC report on the interim analysis and without the clinical study report for the interim
analysis; the potential to accelerate the timing of the review of the Contrave NDA; the safety and effectiveness of Contrave; the potential for and timing of a submission of an MAA in the European Union; and the potential for approval of the
Contrave MAA by the EMA. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this report
due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the complete study report for the interim
analysis; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to
comply with the agreed upon trial protocol; Orexigen's ability to conduct the Light Study and the progress and timing thereof, including risks associated with enrolling and retaining the appropriate patients in the Light Study; Orexigen's
ability to demonstrate in the Light Study that the risk of MACE in overweight and obese patients treated with Contrave does not adversely affect Contrave's benefit-risk profile; the potential that earlier clinical trials may not be predictive
of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE data; the potential for the Light Study to cost more than what is projected; the potential for early termination of
Orexigen's North American collaboration agreement with Takeda Pharmaceutical Company Limited; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of the Contrave NDA; the
therapeutic and commercial value of Contrave; Orexigen's ability to maintain sufficient capital to fund our operations through potential approval of Contrave in 2014; Orexigen's ability to enter into a collaborative partnership for
Contrave outside North America on acceptable terms, if at all; and other risks described in Orexigen's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading
"Risk Factors" in Orexigen's Annual Report on Form 10-K filed with the Securities and Exchange Commission March 14, 2013 and its other reports, which are available from the SEC's website (www.sec.gov) and on Orexigen's
website (www.orexigen.com) under the heading "Investor Relations." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of
the Private Securities Litigation Reform Act of 1995.
SIGNATURES
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.
OREXIGEN THERAPEUTICS, INC.
Date: August 27, 2013
By: /s/ Joseph P. Hagan
Name: Joseph P. Hagan
Title: Chief Business Officer