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
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SOURCE Orexigen Therapeutics, Inc.