SAN DIEGO, Aug. 30, 2016 /CNW/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) today announced that Valeant
Canada, a subsidiary of Valeant Pharmaceuticals International,
Inc., or its affiliates, will commercialize Contrave® (naltrexone
HCl / bupropion HCl extended release) in Canada. Under the terms of the agreement
between Valeant and Orexigen's wholly owned subsidiary Orexigen
Therapeutics Ireland Ltd., Valeant will be responsible for
obtaining Canadian regulatory approval and for all
commercialization activity and expenses. Orexigen will supply
Contrave tablets to Valeant Canada or its affiliates for an agreed
transfer price and certain potential regulatory and sales milestone
payments. Orexigen expects Valeant to file with Health Canada for
regulatory approval by January
2017.
"Valeant Canada has a growing portfolio of innovative medicines
addressing cardiometabolic disease, as well as strong regulatory
and commercial capabilities, and we believe they are an ideal
partner for Contrave in Canada,"
said Mike Narachi, CEO of Orexigen.
"Partnering with strong pharmaceutical companies outside
the United States supports our
global mission to improve the health and lives of patients
struggling to lose weight and allows Orexigen to realize the global
value of Contrave / Mysimba®."
"Our agreement with Orexigen will bring long-term value to one
of our key growth platforms," said Richard
Lajoie, Vice-President of the Pharma Business Unit at
Valeant Canada. "This addition to our portfolio helps us to offer
an even broader range of innovative treatments to physicians and
weight management specialists for patients suffering from
obesity."
Obesity and related comorbidities are a growing problem in
Canada, with almost two thirds of
Canadian adults now either overweight or obese, according to recent
data from Statistics Canada. Estimates of the economic burden of
obesity in Canada range from
$4.6 billion to $7.1 billion
annually.
Orexigen and Valeant previously announced a commercialization
agreement for Mysimba® (naltrexone HCl / bupropion HCl prolonged
release) in 19 countries in Central and Eastern Europe in March
2016. Orexigen and Valeant anticipate launching Mysimba in
11 countries in the fourth quarter of 2016, to be followed by two
additional countries in the first quarter of 2017.
About Valeant
Valeant Canada is a subsidiary of
Valeant Pharmaceuticals International Inc., a multinational
specialty pharmaceutical company that develops, manufactures, and
markets a broad range of pharmaceutical products, primarily in the
areas of dermatology, eye health, cardio-metabolic, and neurology.
More information about Valeant Canada can be found at
www.valeantcanada.com.
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
About CONTRAVE
CONTRAVE, approved by the United States
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).
The exact neurochemical effects of CONTRAVE leading to weight
loss are not fully understood. CONTRAVE has two components:
naltrexone, an opioid antagonist, and bupropion, a relatively weak
inhibitor of the neuronal reuptake of dopamine and norepinephrine.
Nonclinical studies suggest that naltrexone and bupropion have
effects on two separate areas of the brain involved in the
regulation of food intake: the hypothalamus (appetite regulatory
center) and the mesolimbic dopamine circuit (reward system).
Four 56-week multicenter, double-blind, placebo-controlled Phase
3 clinical trials were conducted to evaluate the effect of CONTRAVE
in conjunction with lifestyle modification in 4,536 subjects
randomized to CONTRAVE or placebo. In these studies, the most
common adverse reactions (>5 percent) seen in patients taking
CONTRAVE included nausea, constipation, headache, vomiting,
dizziness, insomnia, dry mouth, and diarrhea.
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 (eg, methadone) or partial agonists (eg,
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 (eg, 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 (ie, 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 (eg, 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 (eg, 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 (eg, 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 (eg, 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
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" 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 for Valeant
to file with Health Canada for regulatory approval of Contrave by
January 2017; the potential for
Valeant to be an ideal partner for Contrave in Canada; the potential that partnering with
strong pharmaceutical companies outside the United States will allow Orexigen to
realize the global value of Contrave/Mysimba; and the anticipated
launch of Mysimba in 11 Central and Eastern European countries in
the fourth quarter of 2016, with two additional countries to follow
in the first quarter of 2017. 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 will not be successful, particularly
in the U.S. following the transition from Takeda; the capabilities
of our existing distribution partners and the ability to obtain
partnerships and marketing authorizations globally; 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; our ability to retain ownership of Contrave and
Mysimba and create value in certain markets outside of the United
States; our ability to adequately inform consumers about
Contrave; our ability to successfully commercialize Contrave with a
specialty sales force in the United
States; our ability to obtain and maintain global
intellectual property protection for Contrave and Mysimba; 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; our
ability to successfully acquire, develop and market additional
product candidates or approved products; our ability to maintain
sufficient capital to fund our operations for the foreseeable
future; estimates of the capacity of manufacturing and other
facilities to support Contrave; the potential for a Delaware court to determine that one or more
of the patents are not valid or that Actavis' 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 August
5, 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:
McDavid Stilwell
Corporate Communications and Business Development
Orexigen Therapeutics, Inc.
+1-858-875-8629
mstilwell@orexigen.com
Julie Normart
BrewLife (Media Contact for Orexigen)
+1-415-946-1087
jnormart@brewlife.com
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SOURCE Orexigen Therapeutics, Inc.