Orexigen Announces Presentation of Data for OREX-1019 and OREX-1038, Preclinical Candidates for the Treatment of Chronic Pain with Reduced Addiction Liability and the Treatment and Management of...

SAN DIEGO, July 10, 2017 /PRNewswire/ -- Orexigen Therapeutics, Inc. (NASDAQ: OREX) announced today that the Company will present oral and poster presentations on OREX-1019 and OREX-1038 at the International Narcotics Research Conference (INRC) in Chicago, on July 9 – 14, 2017.

The two presentations highlight the preclinical efficacy and safety assessments of lead candidate molecules, OREX-1019 and OREX-1038, selected from two series of compounds developed by Prof. Stephen Husbands, Ph.D. at the University of Bath in the United Kingdom and exclusively licensed to Orexigen in 2015. Orexigen researchers, in collaboration with contract research organizations and renowned opioid researchers, have demonstrated the therapeutic potential of OREX-1019 and OREX-1038 in preclinical efficacy models of pain and addiction as well as established key drug development characteristics.

• OREX-1019; a small molecule with potential for addiction maintenance treatment and relapse prevention B. Belli, C. France, D. Maguire, L. Gerak, M. Bennett, G. Cami-Kobeci, S. Husbands, P. Flynn
• OREX-1038; a potent analgesic molecule with potential for reduced abuse liability B. Belli, C. France, D. Maguire, L. Gerak, M. Bennett, G. Cami-Kobeci, S. Husbands, P. Flynn

Key data for OREX-1019 includes opioid receptor activation data that suggests a profile between standard of care buprenorphine and naltrexone-based treatments. Pre-treatment with OREX-1019 significantly suppressed opioid self-administration in models of addiction while itself being significantly less priming in addiction models than buprenorphine.

Key data for OREX-1038 includes an agonist/antagonist opioid receptor activation profile and potent analgesic activity in several models of pain when compared to traditional opioid standards and significantly reduced self-administration in studies of addiction. Further, doses of OREX-1038 significantly higher than required for the analgesic activity did not induce constipation or other side effects associated with standard of care opioids.

"The statistics for prescription opioid and heroin abuse and addiction in the U.S. underscore a real public health epidemic that requires new and less addictive pain medications as well as new tools for treating addiction," said Peter Flynn, Ph.D., Senior Vice President, Head of Development, Regulatory Affairs and Safety at Orexigen. "We believe that the molecules designed by Prof. Husbands and developed by Orexigen may represent significant alternatives to standard of care opioid analgesics and increase the medication options available to addiction treatment specialists. We are encouraged by the data that has been generated and we look forward to moving the programs toward clinical development."

About Opioid Addiction
The United States Department of Health and Human Services (HHS) estimates that in 2014 nearly two million Americans had a substance abuse disorder involving prescription pain relievers, and nearly 600,000 were heroin users. 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.

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 two opioid-analogue compound families with intriguing early research data from Bath University in the United Kingdom. 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 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.

About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of weight loss and obesity. Our mission is to help improve the health and lives of patients struggling to lose weight. Orexigen's first product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the U.S. in September 2014. In the European Union, the medicine has been approved under the brand name Mysimba™ (naltrexone HCl/ bupropion HCl prolonged release). Millions around the globe continue to face challenges of weight loss. Orexigen is undertaking a range of development and commercialization activities, both on its own and with strategic partners, to bring solutions to patients around the world. As a patient-centric company, we continue to focus not only on innovating medicine for the treatment of obesity, pain management and medication-assisted therapy for drug addiction, but to also offer unique resources and healthcare delivery options to improve the patient experience. Further information about Orexigen can be found at www.orexigen.com.

Mysimba™ and Contrave ® are trademarks of Orexigen Therapeutics, Inc. 

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" and similar expressions are intended to identify forward-looking statements. These statements are based on our current beliefs and expectations. These forward-looking statements include statements regarding: the therapeutic potential for the OREX-1019 compounds in the treatment of opioid addiction; 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; legal or regulatory proceedings against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; 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 will be included under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2017 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 Contacts:

Jason Keyes
Chief Financial Officer
Orexigen Therapeutics, Inc.
+1-858-875-8600
jkeyes@orexigen.com

Erika Hackmann
Y&R PR (Media Contact for Orexigen)
+1-917-538-3375
erika.hackmann@yr.com

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SOURCE Orexigen Therapeutics, Inc.