Orexigen Announces Presentation of Data for OREX-1019, a Preclinical Candidate for the Treatment and Management of Drug Addiction

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 46^th 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

SOURCE Orexigen Therapeutics, Inc.

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