SAN DIEGO, Aug. 1, 2016 /PRNewswire/ -- Orexigen
Therapeutics (NASDAQ: OREX) announced today that it has
successfully completed its previously announced acquisition of
the United States rights to
Contrave® (naltrexone HCl/bupropion HCl extended release) and
relaunched Contrave with the Company's own sales organization. The
acquisition was originally announced March
2016 and was completed two months ahead of schedule.
"We are pleased to announce the accelerated completion of the
acquisition of all U.S. rights to Contrave. This transformational
event creates a 'New Orexigen', magnifying our anticipated
long-term corporate profitability and enabling new strategic
options for the company," said Michael
Narachi, Orexigen's CEO. "We are in full execution mode with
our team of dedicated and seasoned individuals focused on growing
the U.S. Contrave business in order to help improve the health and
lives of obese patients struggling to lose weight."
Orexigen is now entitled to 100 percent of net sales and
controls all U.S. commercial and development activities. Outside
the U.S., Orexigen's strategy is to commercialize Contrave and
Mysimba®, as the drug is known in Europe, through partnerships.
This year U.S. pharmacies will fill approximately 11 million
prescriptions for anti-obesity medications, including branded drugs
as well as generic amphetamines, which have approximately
75 percent share of the overall market. Contrave was launched
in October 2014 and by June 2015 had become the leading branded
anti-obesity drug.
"Over the next three years, we have the potential to achieve our
sales and profitability targets through execution on three key
strategies: launching an effective and efficient U.S. commercial
organization focused on the highly concentrated 20,000 health care
practitioners who write the majority of prescriptions for Contrave
and other branded and generic anti-obesity medicines;
achieving strong growth of Contrave by differentiating versus
generic amphetamines; and improving the gross to net ratio through
appropriate discount and pricing strategies," said Dr. Thomas Cannell, Chief Operating Officer and
President of Global Commercial Products.
Information about the acquisition will be discussed on the
Company's second quarter 2016 conference call on Thursday, August 4th at 5:00pm EDT. The live call may be accessed by
phone by calling (888) 771-4371 (domestic) or (847) 585-4405
(international), participant code 42982061.
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
long-term corporate profitability and new strategic options for
Orexigen; the potential growth of the U.S. Contrave business; the
potential for Contrave to improve the health and lives of patients
struggling to lose weight; our potential to commercialize
Contrave/Mysimba outside the U.S. through partnerships; and the
potential to achieve our sales and profitability targets through
launching an effective and efficient U.S. commercial organization,
achieving strong growth of Contrave by differentiating it from
generic amphetamines, and improving the gross to net ratio through
appropriate discount and pricing strategies. 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 Annual Report on Form 10-Q filed with the
Securities and Exchange Commission on May 6,
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.