Orexigen Therapeutics Highlights Key Business Priorities for 2017

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 35^th 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 35^th 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 

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SOURCE Orexigen Therapeutics, Inc.