Orexigen Announces Activities at European Congress on Obesity 2017

SAN DIEGO, May 16, 2017 /PRNewswire/ -- Orexigen Therapeutics, Inc. (NASDAQ: OREX) announced today that the company will present two oral presentations on naltrexone HCl / bupropion HCl, marketed as Contrave® in the United States and Mysimba® in the European Union, at the 24^th European Congress on Obesity (ECO) in Porto, Portugal on May 17 – 20, 2017.

The oral presentations are scheduled during the Pharmacotherapy session on Friday, May 19, 2017:

• Effect on body weight of naltrexone/bupropion in overweight and obese participants with cardiovascular risk factors in a large randomized double-blind study
• Authors:  A. Halseth; K. Shan; K. Gilder; L. Acevedo; J. Buse
• Naltrexone/bupropion is well tolerated and had no effect on serious adverse events in participants receiving antidepressant medication, including SSRIs, in a large randomized double-blind study
• Authors:  A. Halseth; K. Gilder; K. Shan; L. Acevedo; S. Smith

Orexigen will also sponsor a satellite symposium, "Integrating Pharmacotherapy into Obesity Management" on Thursday, May 18, 2017 to discuss the evolving clinical understanding of obesity and the brain as well as the role of pharmacotherapy in the management of the disease.  The following presenters will also share clinical trial evidence and practical experience with naltrexone HCl / bupropion HCl:

• Prof. Mike Lean, MA, MB, BChir, FRCP, FRCPS, University of Glasgow School of Medicine, Dentistry and Nursing
• Prof. Felipe F. Casanueva, MD, PhD, Head, Dept. of Endocrinology and Nutrition, Complejo Hospitalario Universitario de Santiago
• Deborah Bade Horn, DO, MPH, MFOMA, President, Obesity Medicine Association

"We look forward to a meaningful discussion at ECO and to presenting additional clinical data to support Mysimba as a prescription treatment option for adults who are struggling with obesity or overweight with related health conditions," said Peter Flynn, Ph.D., Senior Vice President, Global Head of Development, Regulatory Affairs and Safety at Orexigen.  "With global obesity rates continuing to rise, it is imperative that we maintain an active dialogue with physicians around effective treatment approaches for patients struggling to lose weight."

Orexigen is committed to leveraging its extensive alliance management capabilities to make Contrave/Mysimba available to patients who struggle to lose weight around the world.  The company has entered into strategic partnerships covering 44 countries outside the U.S.

About Contrave and Mysimba

Contrave, marketed as Mysimba in the European Union, is a prescription-only, FDA- and EMA-approved weight-loss medication believed to work on two areas of the brain—the hunger center and the reward system—to reduce hunger and help control cravings.  The exact neurochemical effects of Contrave/Mysimba leading to weight loss are not fully understood.  Contrave/Mysimba is uniquely formulated with a proprietary combination of naltrexone and bupropion.  Independently, naltrexone and bupropion have been used clinically for over 30 years.  The individual components are not approved for weight loss and Contrave/Mysimba is not approved to treat depression or other mental illnesses, alcohol or opioid dependency, or to help people quit smoking.

Naltrexone HCI/Bupropion HCI 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).  Contrave was approved by the FDA in September 2014, and Mysimba was approved by the EMA in March 2015.

Orexigen is committed to helping eligible patients learn about Contrave and recommend patients in the U.S. visit www.contrave.com for additional information.  For full U.S. prescribing information please visit www.contrave.com.

Important Safety Information for CONTRAVE and MYSIMBA

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 adverse 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.

Before taking CONTRAVE, 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 including if you have: 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).

Please see Full Prescribing Information, including 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.

Indication and Usage of MYSIMBA in the European Union

MYSIMBA is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of

• ≥ 30 kg/m² (obese), or
• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of one or more weight-related co‑morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)

Treatment with MYSIMBA should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

Please see Summary of Product Characteristics and more information about MYSIMBA for EU patients available at:  http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003687/human_med_001845.jsp&mid=WC0b01ac058001d124

Mysimba™ and Contrave ® are trademarks of Orexigen Therapeutics, Inc. 

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of weight loss and obesity.  Our mission is to help improve the health and lives of patients struggling to lose weight. Orexigen's first product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the U.S. in September 2014.  In the European Union, the medicine has been approved under the brand name Mysimba® (naltrexone HCl/ bupropion HCl prolonged release).  Millions around the globe continue to face challenges of weight loss.  Orexigen is undertaking a range of development and commercialization activities, both on its own and with strategic partners, to bring solutions to patients around the world.  As a patient-centric company, Orexigen continues to focus not only on innovating medicine for the treatment of obesity, pain management and medication-assisted therapy for drug addiction, but to also offer unique resources and healthcare delivery options to improve the patient experience.  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 the Company's current beliefs and expectations.  These forward-looking statements include statements regarding: the potential for Mysimba to improve the quality of life for patients who are overweight or struggle with obesity; the potential to grow the availability of Mysimba with commercial launches in 2017; the potential for the growth of the obesity problem; and the expectation to progress with our ex-U.S. commercial alliances in 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/Mysimba will not be successful, particularly, with respect to Contrave, in the U.S. following the launch of the patient-focused marketing campaign; the Company's ability to obtain and maintain partnerships and marketing authorization globally; 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 successfully complete the post-marketing requirement studies for Contrave; the capabilities and performance of various third parties on which we rely for a number of activities related to the manufacture, development and commercialization of Contrave/Mysimba; the therapeutic and commercial value of Contrave/Mysimba; competition in the global obesity market, particularly from existing and generic therapies; the Company's failure to successfully acquire, develop and market additional product candidates or approved products; the estimates of the capacity of manufacturing and the company's ability to secure additional manufacturing capabilities; 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; our ability to maintain sufficient capital to fund our operations for the foreseeable future; 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. Further information regarding these and other risks will be included under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q which Orexigen filed with the Securities and Exchange Commission on May 11, 2017 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.

Orexigen Investor Contact:
Jason Keyes, Chief Financial Officer
+1-858- 875-8600
ir@orexigen.com

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

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SOURCE Orexigen Therapeutics, Inc.