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Orexigen Therapeutics Launches "Brains Behind Weight Loss," a Dynamic Patient Focused Campaign to Educate Consumers on the Role of the Brain in Weight Loss
Date:1/3/2017

SAN DIEGO, Jan. 3, 2017 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) unveiled "Brains Behind Weight Loss," a new, national direct-to-consumer advertising campaign demonstrating to patients how the brain plays an important role in weight loss. The campaign will underscore how CONTRAVE (naltrexone HCl/bupropion HCl), an FDA-approved prescription weight-loss medicine, is believed to work on two important areas of the brain – the hypothalamus (hunger center) to reduce hunger and the mesolimbic reward system to help control cravings. (The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood). CONTRAVE is the number one prescribed weight loss brand in the United States.

"The increasing rates of obesity in this country show no signs of slowing down so it is imperative that patients know there are multiple options for treatment and they should work closely with health care practitioners to find the weight loss regimen that works best for them," said Michael Narachi, Orexigen's CEO. "As a patient-centered organization, we feel compelled to help educate patients that weight loss is complex, and for many people, diet and exercise alone may not be adequate. CONTRAVE is intended to be used with diet and exercise, and adding CONTRAVE to a weight-loss regimen may help adults, who are overweight or struggle with obesity, lose weight and, most importantly, keep it off."

The CONTRAVE campaign is Orexigen's first collaboration with Young & Rubicam New York since being tapped as agency of record. Kicking off at the start of the season amidst New Year's resolutions, the campaign emphasizes the strong connection between the brain and weight loss. The visually intriguing images feature real women who arrange themselves to simulate depictions of the human brain.

"People affected by the disease of obesity often struggle with the understanding of how their brains and bodies impact their weight. Science has taught us throughout time that there is much more to losing weight and keeping it off than simply dieting. 'Brains Behind Weight Loss' helps people better understand their obesity and the options to manage it," said Joe Nadglowski, Obesity Action Coalition (OAC) President and CEO.

"The purpose of the 'Brains Behind Weight Loss' campaign is to establish that the brain may play a powerful role for patients who are struggling to lose weight," said Salma Jutt, Vice President of US Marketing at Orexigen. "Our goal is to motivate patients to ask a health care practitioner about CONTRAVE, which is believed to work on two areas of the brain to reduce hunger and help control cravings. We want to help patients understand why they struggle to lose weight, help alleviate their frustration and encourage them to learn more about how CONTRAVE may help."

The concept was driven by extensive qualitative and quantitative research aimed at patients who were motivated and committed to lose weight. Orexigen learned that patients believe an inability to control cravings is a key reason why their intention to lose weight fails. "Brains Behind Weight Loss" explains how different areas of the brain can cause hunger and cravings, underscoring that diet and exercise alone may not be enough to treat the complexity of weight loss. The initial target is primarily women, as more than 80% of patients being treated are women. The integrated campaign will span network and cable television, magazines, digital displays, online video, social media and a new website.

See the TV commercial at www.CONTRAVE.com.

About CONTRAVE
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.

Important Safety Information
One of the ingredients in CONTRAVE, bupropion, may increase the risk of suicidal thinking in children, adolescents, and young adults. CONTRAVE patients should be monitored for suicidal thoughts and behaviors.  In patients taking bupropion for smoking cessation, serious neuropsychiatric events have been reported.  CONTRAVE is not approved for use in children under the age of 18.

Stop taking CONTRAVE and call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.

Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, APLENZIN or ZYBAN; have or have had an eating disorder; are dependent on opioid pain medicines or use medicines to help stop taking opioids such as methadone or buprenorphine, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking; are allergic to any of the ingredients in CONTRAVE; or are pregnant or planning to become pregnant.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider says it is okay.

Tell your healthcare provider about all of your medical conditions, especially: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant; or breastfeeding.

CONTRAVE may cause serious side effects, including:

Seizures. There is a risk of having a seizure when you take CONTRAVE.  If you have a seizure, stop taking CONTRAVE, tell your healthcare provider right away.

Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone.

Sudden opioid withdrawal. Do not use any type of opioid for at least 7 to 10 days before starting CONTRAVE.

Severe allergic reactions. Stop taking CONTRAVE and get medical help immediately if you have any signs and symptoms of severe allergic reactions: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing.

Increases in blood pressure or heart rate.

Liver damage or hepatitis. Stop taking CONTRAVE if you have any symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness.

Manic episodes.

Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye.

Increased risk of low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas).

The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea.

These are not all the possible side effects of CONTRAVE. Tell your healthcare provider about any side effect that bothers you or does not go away.

Use of CONTRAVE
CONTRAVE is a prescription weight-loss medicine that may help some adults with a body mass index (BMI) of 30 kg/m2 or greater (obese), or adults with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off.

CONTRAVE should be used with a reduced-calorie diet and increased physical activity.

It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke.

It is not known if CONTRAVE is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products.

CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation). One of the ingredients in CONTRAVE, bupropion, is the same ingredient in some other medicines used to treat depression and to help people quit smoking.

Ask your doctor or healthcare professional if CONTRAVE is right for you. Please see Full Prescribing Information, including Medication Guide, for CONTRAVE.

Access the full prescribing information and learn more about CONTRAVE at www.CONTRAVE.com. 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 Obesity
Obesity is a serious and rising health epidemic and has recently been declared a disease by the American Medical Association. It is a condition associated with having an excess of body fat, defined by genetic and environmental factors that are difficult to control when dieting. Obesity is classified as having a Body Mass Index (BMI) of 30 or greater. It is estimated that nearly 93 million Americans are affected by obesity, and that number is predicted to increase to 120 million Americans within the next five years. Obesity increases the risk of heart disease, type 2 diabetes, some types of cancer, sleep apnea, and a variety of other conditions.

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 therapeutic value of CONTRAVE. 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.; 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 November 4, 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:

Erika Hackmann
Y&R PR (Media Contact for Orexigen)
+1-917-538-3375
erika.hackmann@yr.com

Julie Normart
BrewLife (Media Contact for Orexigen)
+1-415-946-1087
jnormart@brewlife.com

 

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