SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (NASDAQ: OREX) today provided an update on
recent progress and key business priorities for 2017 that will be
covered during the Company's presentation at the 35th
Annual J.P. Morgan Healthcare Conference in San Francisco, which is taking place
January 9-12.
"Since completing the acquisition of Contrave® in the U.S. in
August, we have focused our domestic efforts on building a solid
commercial footprint and foundation. Specifically, we have targeted
high-prescribing healthcare practitioners across the U.S., and two
weeks ago, we launched a broad and compelling patient activation
campaign across the range of traditional and digital media," said
Michael Narachi, President and Chief
Executive Officer of Orexigen. "In addition to these key U.S.
initiatives, we have made significant progress in building a global
network of distribution and selling partners with strong local and
regional relationships. These partnerships, spanning 38 countries
in total, position us well for additional regulatory approvals and
broad-based global growth in 2017."
Tom Cannell, Chief Operating
Officer and President of Global Commercial Products at Orexigen,
added, "Based on our research we believe that while only 8 percent
of patients currently struggling to lose weight are aware of
Contrave, 60 percent of healthcare practitioners will prescribe
Contrave if patients specifically request the product. Our goal
with this campaign is to drive patient awareness which we believe
will educate and empower patients to talk to their physicians about
Contrave. For appropriate patients who have difficulty accessing a
physician to discuss weight loss, we are conducting a telemedicine
pilot which provides a platform for a convenient, online physician
consultation and home delivery."
Orexigen's key business priorities in 2017 include the
following:
- Drive growth of U.S. Contrave® (naltrexone HCl and bupropion
HCl extended-release tablets) prescriptions by utilizing innovative
patient-centric marketing tactics aimed at facilitating productive
patient-physician weight loss engagement
- Monitor and optimize the recently launched "Brains Behind
Weight Loss" patient activation campaign in the first half of 2017
to maximize impact. The "Brains Behind Weight Loss" campaign
directly targets patients via traditional advertising and digital
media and highlights the role the brain can play in weight loss,
which Contrave is uniquely designed to address.
- Analyze response to the "Get Contrave Now" pilot telemedicine
program, which was recently launched in California and Texas to supplement primary care channels. The
program is driven by market research indicating that many patients
would prefer the convenience and anonymity of an online physician
consultation and home delivery.
- Grow global availability of Contrave and Mysimba® by
efficiently managing Orexigen's established network of regional
partners outside the U.S.
- Build on established partnerships to support regional
regulatory approvals and successful launches in partnered
territories. Anticipated Q1 2017 milestones include:
- Filing of New Drug Submission for Contrave with Health Canada
by our partner, Valeant Canada.
- Launch of Mysimba in Spain by
our partner, Laboratorios Farmacéuticos Rovi, S.A.
- Launch of Mysimba in additional Central and Eastern European
countries by our partner, Valeant Pharmaceuticals International,
Inc.
- Establish new strategic partnerships in remaining target
markets with strong sales opportunities.
- Advance two early-stage development programs in pain
management and medication-assisted therapy for drug addiction
toward IND filings
- Continue preclinical evaluation of OREX-1019, a novel orvinol
compound with potential as a treatment for opioid and cocaine
addiction, ahead of a potential IND filing in 2018. Preclinical
data has demonstrated an improved profile compared with
buprenorphine.
- Continue preclinical evaluation of OREX-1038, a partial agonist
at the Mu opioid receptor and nociceptive receptor, ahead of a
potential IND filing in 2018. Preclinical data demonstrated similar
analgesic effects as morphine with longer duration of effect at
significantly reduced concentrations. OREX-1038 also demonstrated a
significantly lower addiction signal than standard-of-care
opioids.
- Efficiently deploy capital to build value
- Reach agreement with regulators on the most cost-efficient
means of delivering high-quality data to satisfy the cardiovascular
outcomes post-marketing requirement.
- Optimize global supply chain to lower production costs.
- Diligently manage expenses and actively adjust capital
allocations to achieve the highest return on investment.
Orexigen will provide additional details on 2017 plans during
its presentation at the 35th Annual J.P. Morgan
Healthcare Conference 2017 on Thursday,
January 12, at 10:00 a.m. Pacific
Time. The presentation will be webcast live and can be
accessed via the "Investors" section of the Company's website at
www.orexigen.com.
About Contrave
CONTRAVE, approved by the U.S. Food and Drug Administration in
September 2014, is indicated for use
as an adjunct to a reduced-calorie diet and increased physical
activity for chronic weight management in adults with an initial
body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2
or greater (overweight) in the presence of at least one
weight-related comorbid condition (e.g., hypertension, type 2
diabetes mellitus or dyslipidemia).
Important Safety Information
WARNING: SUICIDAL
THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
Suicidality and Antidepressant Drugs
CONTRAVE is not approved for use in the treatment of major
depressive disorder or other psychiatric disorders. CONTRAVE
contains bupropion, the same active ingredient as some other
antidepressant medications (including, but not limited to,
WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN).
Antidepressants increased the risk of suicidal thoughts and
behavior in children, adolescents, and young adults in short-term
trials. These trials did not show an increase in the risk of
suicidal thoughts and behavior with antidepressant use in subjects
over age 24; there was a reduction in risk with antidepressant use
in subjects aged 65 and older. In patients of all ages who are
started on CONTRAVE, monitor closely for worsening, and for the
emergence of suicidal thoughts and behaviors. Advise families and
caregivers of the need for close observation and communication with
the prescriber. CONTRAVE is not approved for use in pediatric
patients.
Neuropsychiatric Reactions in Patients Taking Bupropion for
Smoking Cessation
Serious neuropsychiatric reactions have occurred in patients taking
bupropion for smoking cessation. The majority of these reactions
occurred during bupropion treatment, but some occurred in the
context of discontinuing treatment. In many cases, a causal
relationship to bupropion treatment is not certain, because
depressed mood may be a symptom of nicotine withdrawal. However,
some of the cases occurred in patients taking bupropion who
continued to smoke. Although CONTRAVE is not approved for smoking
cessation, observe all patients for neuropsychiatric reactions.
Instruct the patient to contact a healthcare provider if such
reactions occur.
Contraindications
CONTRAVE is contraindicated in: uncontrolled hypertension; seizure
disorder or a history of seizures; use of other
bupropion-containing products; bulimia or anorexia nervosa, which
increase the risk for seizure; chronic opioid or opiate agonist
(e.g., methadone) or partial agonists (e.g., buprenorphine) use, or
acute opiate withdrawal; patients undergoing an abrupt
discontinuation of alcohol, benzodiazepines, barbiturates, and
antiepileptic drugs; use during/within 14 days following treatment
with monoamine oxidase inhibitors (MAOIs)—there is an increased
risk of hypertensive reactions when CONTRAVE is used concomitantly
with MAOIs and use with reversible MAOIs such as linezolid or
intravenous methylene blue is also contraindicated; known allergy
to any component of CONTRAVE anaphylactoid/anaphylactic reactions
and Stevens-Johnson syndrome have been reported; pregnancy.
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation
All patients being treated with antidepressants for any indication
should be monitored appropriately and observed closely for clinical
worsening, suicidality, and unusual changes in behavior, especially
during the initial few months of a course of drug therapy, or at
times of dose changes, either increases or decreases. This warning
applies to CONTRAVE because one of its components, bupropion, is a
member of an antidepressant class.
Consideration should be given to changing the therapeutic
regimen, including possibly discontinuing the medication, in
patients whose depression is persistently worse, or who are
experiencing emergent suicidality or symptoms that might be
precursors to worsening depression or suicidality, especially if
these symptoms are severe, abrupt in onset, or were not part of the
patient's presenting symptoms.
Families and caregivers of patients being treated with
antidepressants for major depressive disorder or other indications,
both psychiatric and nonpsychiatric, should be alerted about the
need to monitor patients for the emergence of anxiety, agitation,
irritability, unusual changes in behavior, and other symptoms, as
well as the emergence of suicidality, and to report such symptoms
immediately to healthcare providers. Such monitoring should include
daily observation by families and caregivers. Prescriptions for
CONTRAVE should be written for the smallest quantity of tablets
consistent with good patient management, in order to reduce the
risk of overdose.
Neuropsychiatric Symptoms and Suicide Risk in Smoking
Cessation Treatment
CONTRAVE is not approved for
smoking cessation treatment, but serious neuropsychiatric symptoms
have been reported in patients taking bupropion for smoking
cessation. These have included changes in mood (including
depression and mania), psychosis, hallucinations, paranoia,
delusions, homicidal ideation, hostility, agitation, aggression,
anxiety, and panic, as well as suicidal ideation, suicide attempt,
and completed suicide. Observe patients for the occurrence of
neuropsychiatric reactions. Instruct patients to contact a
healthcare professional if such reactions occur.
Seizures
CONTRAVE can cause seizures. The risk
of seizure is dose-related. Discontinue treatment and do not
restart CONTRAVE in patients who experience a seizure. Caution
should be used when prescribing CONTRAVE to patients with
predisposing factors that may increase the risk of seizure,
including: history of head trauma or prior seizure, severe stroke,
arteriovenous malformation, central nervous system tumor or
infection, or metabolic disorders (e.g., hypoglycemia,
hyponatremia, severe hepatic impairment, and hypoxia); excessive
use of alcohol or sedatives, addiction to cocaine or stimulants, or
withdrawal from sedatives; patients with diabetes treated with
insulin and/or oral diabetic medications (sulfonylureas and
meglitinides) that may cause hypoglycemia; concomitant
administration of medications that may lower the seizure threshold,
including other bupropion products, antipsychotics, tricyclic
antidepressants, theophylline, systemic steroids.
Clinical experience with bupropion suggests that the risk of
seizure may be minimized by adhering to the recommended dosing
recommendations, in particular: the total daily dose of CONTRAVE
does not exceed 360 mg of the bupropion component (i.e., four
tablets per day); the daily dose is administered in divided doses
(twice daily); the dose is escalated gradually; no more than two
tablets are taken at one time; coadministration of CONTRAVE with
high-fat meals is avoided; if a dose is missed, a patient should
wait until the next scheduled dose to resume the regular dosing
schedule.
Patients Receiving Opioid Analgesics
Vulnerability to Opioid Overdose: CONTRAVE should not be
administered to patients receiving chronic opioids, due to the
naltrexone component, which is an opioid receptor antagonist. If
chronic opiate therapy is required, CONTRAVE treatment should be
stopped. In patients requiring intermittent opiate treatment,
CONTRAVE therapy should be temporarily discontinued and lower doses
of opioids may be needed. Patients should be alerted that they may
be more sensitive to opioids, even at lower doses, after CONTRAVE
treatment is discontinued. An attempt by a patient to overcome any
naltrexone opioid blockade by administering large amounts of
exogenous opioids is especially dangerous and may lead to a fatal
overdose or life-threatening opioid intoxication (e.g., respiratory
arrest, circulatory collapse). Patients should be told of the
serious consequences of trying to overcome the opioid blockade.
Precipitated Opioid Withdrawal: An opioid-free interval
of a minimum of 7 to 10 days is recommended for patients previously
dependent on short-acting opioids, and those patients transitioning
from buprenorphine or methadone may need as long as two weeks.
Patients should be made aware of the risks associated with
precipitated withdrawal and encouraged to give an accurate account
of last opioid use.
Increase in Blood Pressure (BP) and Heart Rate
(HR)
CONTRAVE can cause an increase in systolic BP,
diastolic BP, and/or resting HR. These events were observed in both
patients with and without evidence of preexisting hypertension. In
clinical practice with other bupropion-containing products,
hypertension, in some cases severe and requiring acute treatment,
has been reported. Blood pressure and pulse should be measured
prior to starting therapy with CONTRAVE and should be monitored at
regular intervals consistent with usual clinical practice,
particularly among patients with cardiac or cerebrovascular disease
and/or with controlled hypertension prior to treatment.
Allergic Reactions
Anaphylactoid/anaphylactic
reactions and symptoms suggestive of delayed hypersensitivity have
been reported with bupropion, as well as rare spontaneous reports
of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic
shock. Instruct patients to discontinue CONTRAVE and consult a
healthcare provider if they develop an allergic or
anaphylactoid/anaphylactic reaction (e.g., skin rash, pruritus,
hives, chest pain, edema, or shortness of breath) during this
treatment.
Hepatotoxicity
Cases of hepatitis, clinically
significant liver dysfunction, and transient asymptomatic hepatic
transaminase elevations have been observed with naltrexone
exposure. Patients should be warned of the risk of hepatic injury
and advised to seek medical attention if they experience symptoms
of acute hepatitis. CONTRAVE should be discontinued in the event of
symptoms/signs of acute hepatitis.
Activation of Mania
Bupropion, a component of
CONTRAVE, is a drug used for the treatment of depression.
Antidepressant treatment can precipitate a manic, mixed, or
hypomanic episode. The risk appears to be increased in patients
with bipolar disorder or who have risk factors for bipolar
disorder. Prior to initiating CONTRAVE, screen patients for history
of bipolar disorder and the presence of risk factors for bipolar
disorder (e.g., family history of bipolar disorder, suicide, or
depression). CONTRAVE is not approved for use in treating bipolar
depression.
Angle-Closure Glaucoma
The pupillary dilation
that occurs following use of many antidepressant drugs, including
bupropion, may trigger an angle-closure attack in a patient with
anatomically narrow angles who does not have a patent
iridectomy.
Hypoglycemia with Use of Antidiabetic
Medications
Weight loss may increase the risk of hypoglycemia in patients with
type 2 diabetes mellitus treated with insulin and/or insulin
secretagogues (e.g., sulfonylureas). Measurement of blood glucose
levels prior to starting CONTRAVE and during CONTRAVE treatment is
recommended in patients with type 2 diabetes. Decreases in
medication doses for antidiabetic medications which are
non-glucose-dependent should be considered to mitigate the risk of
hypoglycemia.
Adverse Reactions
Most common adverse reactions
(≥5%) include: nausea (32.5%), constipation (19.2%), headache
(17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry
mouth (8.1%), and diarrhea (7.1%).
Drug Interactions
Increased risk of
hypertensive reactions can occur when CONTRAVE is used
concomitantly with MAOIs. Use caution and consider dose reduction
of drugs metabolized by CYP2D6 when using with CONTRAVE. Avoid
concomitant use with CYP2B6 inducers. Reduce CONTRAVE dose when
taken with CYP2B6 inhibitors. Dose CONTRAVE with caution when used
with drugs that lower seizure threshold. Use caution and monitor
for CNS toxicity when using CONTRAVE concomitantly with
dopaminergic drugs (levodopa and amantadine). CONTRAVE can cause
false positive urine test results for amphetamines.
Indication
CONTRAVE is indicated as an adjunct
to a reduced-calorie diet and increased physical activity for
chronic weight management in adults with an initial body mass index
(BMI) of:
* 30 kg/m2 or greater (obese) or
* 27 kg/m2 or greater (overweight) in the presence of at least one
weight-related comorbid condition (e.g., hypertension, type 2
diabetes mellitus, or dyslipidemia)
Limitations of Use
The effect of CONTRAVE on
cardiovascular morbidity and mortality has not been established.
The safety and effectiveness of CONTRAVE in combination with other
products intended for weight loss, including prescription drugs and
over-the-counter drugs, and herbal preparations, have not been
established.
Please see accompanying full Prescribing Information and
Medication Guide for CONTRAVE.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
CONTRAVE® is a trademark of Orexigen Therapeutics, Inc.
registered with the U.S. Patent and Trademark Office. All
other trademarks are the property of their respective owners.
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 the European Union, 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" 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 potential strength of our local and ex-U.S.
relationships; the potential for and timing of additional
regulatory approvals and broad-based global growth in 2017; the
potential for the Company's patient centric marketing tactics to
drive the growth of U.S. Contrave prescriptions in 2017; the
potential success of the Company's pilot telemedicine program; the
potential success of marketing and commercialization of
Contrave/Mysimba in the United
States and elsewhere; the potential to grow global
availability of Contrave/Mysimba by effectively managing the
Company's ex-U.S. partners; the potential for and timing of the New
Drug Submission filing for Contrave in Canada; the potential for and timing of
commercial launch of Mysimba in Spain; the potential for and timing of
additional launches of Mysimba in Central and Eastern European
countries; the potential to establish new strategic partnerships
that will allow the Company to increase the global availability of
and realize the global value of Contrave/Mysimba; the therapeutic
potential for the OREX-1019 compounds in the treatment of opioid
and cocaine 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 to maximize operational
efficiencies by carefully managing operating expenses, specifically
the potential to reach agreement with regulators on the most
cost-efficient means of delivering high-quality data to satisfy the
cardiovascular outcomes post-marketing requirement; and the
potential to and the Company's ability to optimize its global
supply chain to deliver lower production costs. 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
potential that the marketing and commercialization of Contrave and
Mysimba will not be successful; the ability to obtain and
effectively manage partnerships and marketing authorizations
globally; the capabilities of our existing distribution partners;
competition in the global obesity market, particularly from
existing therapies; additional analysis of the interim results or
the final data from the terminated Light Study, including
safety-related data, and the additional CVOT may produce negative
or inconclusive results, or may be inconsistent with the conclusion
that the interim analysis was successful; the Company's ability to
retain ownership of Contrave and Mysimba and create value in
certain markets outside of the United
States; the Company's ability to obtain and maintain global
intellectual property protection for Contrave and Mysimba; the
potential that the interim analysis of the Light Study may not be
predictive of future results in the Light Study or other clinical
trials; legal or regulatory proceedings against Orexigen, as well
as potential reputational harm, as a result of misleading public
claims about Orexigen; the therapeutic and commercial value of
Contrave and Mysimba; the therapeutic and commercial value of
OREX-1019 and/or OREX 1038; the Company's ability to successfully
acquire, develop and market additional product candidates or
approved products; the Company's ability to maintain sufficient
capital to fund its operations for the foreseeable future;
estimates of the capacity of manufacturing and other facilities to
support Contrave; the Company's ability to vigorously enforce the
Contrave intellectual property rights; the potential for
Delaware court to determine that
one or more of the patents are not valid or that Actiavis' proposed
generic product is not infringing each of the patents at issue; 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, except as required by law. Further information
regarding these and other risks is included under the heading "Risk
Factors" in Orexigen's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on 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.
Contacts:
Jason Keyes
Chief Financial Officer
Orexigen Therapeutics,
Inc.
+1-858-875-8600
jkeyes@orexigen.com
Julie Normart
BrewLife (media contact for Orexigen)
+1-415-946-1087
jnormart@brewlife.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/orexigen-therapeutics-highlights-key-business-priorities-for-2017-300386143.html
SOURCE Orexigen Therapeutics, Inc.