SAN DIEGO, Nov. 16, 2016 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) today announced the presentation of preclinical data for OREX-1019 (BU10119) at Neuroscience
2016, the 46th annual meeting of the Society of Neuroscience, being held this week in San
Diego. OREX-1019 is being evaluated by Orexigen as a treatment for opioid and cocaine addiction and was exclusively
licensed by the company in 2015. OREX-1019 is a member of an orvinol compound series developed by Dr. Stephen Husbands, Ph.D. at the University of Bath in the United Kingdom.
The data presented this week, "A buprenorphine analog attenuates drug-primed and stress-induced cocaine reinstatement,"
was assembled by a team of researchers led by Dr. John Traynor, Ph.D. of the University of Michigan. The biochemical profile of several members of the licensed orvinol compound series,
including OREX-1019, demonstrates reduced Mu opioid receptor activity compared to buprenorphine. The presented data provide in
vivo evidence for the compound's therapeutic potential in drug addiction management and suggest a wider use in cocaine
addiction.
"OREX-1019 and compounds in this series may have significant potential in medication assisted treatment and management of drug
addiction, possibly with the added benefit of reduced drug dependency and other side effects compared with current standard of
care products," said Dr. Peter Flynn, Ph.D., Senior Vice President, Head of Development,
Regulatory Affairs and Safety at Orexigen. "With more than 15 years of experience developing products involving opioid receptor
biology, Orexigen is well-positioned to advance this compound. We look forward to continuing development of OREX-1019 towards
IND."
About Opioid and Cocaine Addiction
The United States Department of Health and Human Services estimates that in 2014 nearly two million Americans had a
substance abuse disorder involving prescription pain relievers, and nearly 600,000 were addicted to heroin. More than 28,000
people in the United States die each year from opioid related overdoses. HHS estimates that
opioid addiction is responsible for $55 billion in health and social costs and $20 billion in emergency department and inpatient care for opioid poisoning incidents. Cocaine addiction
afflicted nearly 1 million Americans in 2014, according to the Substance Abuse and Mental Health Services Administration. There
are no treatments approved by the United States Food and Drug Administration for cocaine addiction.
About Orexigen's Preclinical Early Development Programs
Orexigen was founded in 2002 to develop new treatments for obesity based, in part, on novel insights into the effects
of Mu opioid receptor modulation on the activity of the proopiomelanocortin, or POMC, neurons in the hypothalamus. In 2015,
Orexigen exclusively licensed from Bath University in the United Kingdom two opioid-analogue
compound families with intriguing early research data. Orexigen has since conducted independent research to validate and further
evaluate the therapeutic potential of these compounds. The Company is advancing each program toward an Investigational New Drug
Application.
One compound family includes OREX-1019 which demonstrates a molecular profile and initial data supporting therapeutic use in
the treatment and management of opioid and cocaine addiction. Compounds in the second series including OREX-1038 are promising
analgesics with the potential for significantly reduced abuse liability and physical dependence compared to current opioid
analgesics.
Orexigen expects to share additional information from these programs in coming months as research is published and
presented.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen's first
product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the United
States in September 2014 and became the most prescribed branded obesity medication in
the United States in June 2015. In Europe, the drug has been approved under the brand name Mysimba® (naltrexone HCl/ bupropion HCl prolonged
release). Orexigen is undertaking a range of development and commercialization activities, both on its own and with strategic
partners, to bring Contrave / Mysimba to patients around the world. Further information about Orexigen can be found at
www.orexigen.com
Forward-Looking Statements
Orexigen cautions you that statements included in this press release 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," "would," "may" 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 therapeutic potential for the OREX-1019 compounds in the treatment of opioid and
cocaine addiction; the potential for the OREX-1019 compounds to be a future therapeutic replacement for or addition to standard
of care buprenorphine products in step-down medication assisted treatment for addiction but with the benefit of reduced potential
drug dependency and other side effects; the potential for the OREX-1038 compounds to significantly reduce abuse liability and
physical dependence compared to current opioid analgesics; the potential for either of the compound families to advance towards
an Investigational New Drug Application; and the potential for and timing of the disclosure of additional information from the
programs. 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 release due to the risk and
uncertainties inherent in the Orexigen business, including, without limitation: the therapeutic value of the two compound
families; the potential that the preclinical data for the compound families may not be predictive of future results in the
related development programs; our ability to maintain sufficient capital to fund our operations for the foreseeable future; 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 news release 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 Quarterly Report on Form 10-Q we filed with the
Securities and Exchange Commission on or about November 7, 2016 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 "Investors." 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.
Orexigen Contact:
McDavid Stilwell VP, Corporate Communications and Business Development
(858) 875-8629
Media Contact:
Julie Normart, BrewLife
(415) 946-1087
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/orexigen-announces-presentation-of-data-for-orex-1019-a-preclinical-candidate-for-the-treatment-and-management-of-drug-addiction-300364507.html
SOURCE Orexigen Therapeutics, Inc.