Korean Distributorship Agreement with Kwang Dong Pharmaceutical Company
Kwang Dong Pharmaceutical Company, Ltd. Is Orexigen’s distributorship partner for South Korea for Contrave® (naltrexone HCl / bupropion HCl extended release) monotherapy for weight management in overweight or obese adult patients. Kwang Dong launched Contrave in South Korea in June 2016. Under the terms of the agreement, Kwang Dong is for all commercialization activity and expenses. Orexigen will supply Contrave tablets to Kwang Dong for a $7 million upfront payment, approximately 35 – 40% of net sales, potential sales-based milestone payments, and other fees.
Central and Eastern European Commercialization and Distributorship Agreement with Valeant
Valeant Pharmaceuticals International, Inc. is Orexigen’s commercial and distribution partner for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in Central and Eastern Europe. The distribution agreement between Valeant Holdings Ireland and Orexigen's wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., includes 13 countries where Mysimba has been approved for marketing in the European Union (EU): Greece, Slovenia, Slovakia, Czech Republic, Hungary, Croatia, Lithuania, Estonia, Poland, Latvia, Bulgaria, Cyprus and Romania. The agreement also extends to several non-EU countries where Valeant will apply for marketing authorization: Serbia, Bosnia and Herzegovina, Albania, Macedonia, Montenegro, Kosovo and Turkey. In the fourth quarter 2016, the partnership was expanded to include the Republic of South Africa. Valeant will be responsible for all commercialization activities and for obtaining regulatory approvals in the non-EU countries. Orexigen will retain regulatory affairs responsibilities in EU countries. Orexigen will supply Mysimba tablets to Valeant at an agreed transfer price.
Spanish Commercialization and Distributorship Agreement with Laboratorios Farmacéuticos Rovi, S.A.
Laboratorios Farmacéuticos Rovi, S.A. (ROVI) is Orexigen’s commercialization and distributorship partner for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in Spain. Under the terms of the ROVI agreement, ROVI will be responsible for all commercialization activity and expenses. Orexigen will supply Mysimba tablets to ROVI for an upfront fee, a transfer price, and various potential commercial milestone payments.
Canadian Commercialization and Distributorship Agreement with Valeant Canada for Contrave® (naltrexone HCl / bupropion HCl extended release)
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, 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.
Naltrexone HCl /bupropion HCl: Rest-of-World Commercialization Strategy
Orexigen is seeking to establish co-marketing or distributor partnerships for Mysimba in Europe and to fully partner Contrave / Mysimba in all ex-U.S. territories outside of Europe and Korea.
Important Safety Information for Contrave
CONTRAVE can cause serious side effects of suicidal thoughts or actions. One of the ingredients in CONTRAVE is bupropion HCl. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.
Do not take CONTRAVE if you:
Stop taking CONTRAVE and call a healthcare provider right away if you, or your family member, 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 very agitated or restless; panic attacks; trouble sleeping (insomnia); irritability; acting aggressive, being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.
While taking CONTRAVE, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings and maintain communication with your healthcare provider. CONTRAVE has not been studied in and is not approved for use in children under the age of 18.
Tell your healthcare provider about all of your medical conditions
- Have uncontrolled high blood pressure
- Have or have had seizures
- Use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN
- Have or have had an eating disorder called anorexia or bulimia
- 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, as this may increase your chance of having a seizure; or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them all of a sudden
- Have taken medicines called monoamine oxidase inhibitors (MAOIs), including linezolid, within the last 14 days
- Are allergic to naltrexone HCl or bupropion HCl or any of the ingredients in CONTRAVE
- Are pregnant or planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking CONTRAVE
, especially: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of your brain or spine; low blood sugar or low levels of sodium in your blood; liver or kidney problems; high blood pressure; heart problems or stroke; eating disorder. Also tell your doctor if you drink a lot of alcohol and plan to suddenly stop; abuse prescription medicines or street drugs; are over the age of 65; have any other medical conditions; or are breastfeeding or plan to breastfeed.
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 has said it is okay to take them
Swallow CONTRAVE tablets whole. Do not cut, chew, or crush CONTRAVE tablets
. Tell your healthcare provider if you cannot swallow CONTRAVE tablets whole. Do not
take CONTRAVE with high-fat meals. It may increase your risk of seizures. Take CONTRAVE exactly as prescribed.
Possible serious side effects of CONTRAVE:
- If you have a seizure, stop taking CONTRAVE, tell your healthcare provider right away, and do not take CONTRAVE again
- If you take opioid medicines, there may be a risk of opioid overdose. You should get emergency medical help right away if you have trouble breathing; become drowsy with slowed breathing; have slow, shallow breathing; or feel faint, dizzy, or confused
- Sudden opioid withdrawal can be severe and may require hospitalization
- Stop taking CONTRAVE and get medical help immediately if you have any of the following 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 may occur
- CONTRAVE can cause liver damage or hepatitis. Stop taking CONTRAVE if you have any of the following 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 can occur. CONTRAVE can cause some people who were manic or depressed in the past to become manic or depressed again
- CONTRAVE can cause visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your doctor to find out if you are at risk and to get treatment to prevent it
- 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). You should check your blood sugar before you start and while taking CONTRAVE
The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea.
Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of CONTRAVE.
Use of CONTRAVE
CONTRAVE is a prescription medicine that contains 2 medicines (naltrexone HCl and bupropion HCl) that may help some obese adults*, or overweight adults who also have weight-related medical problems†, lose weight and keep the weight off.
*Body mass index (BMI) of 30 kg/m2 or greater.
- 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
†BMI of 27 kg/m2 or greater with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes.
Talk to your healthcare provider. Please see accompanying Full Prescribing Information, including Medication Guide, for CONTRAVE.
You are encouraged to report negative side effects of prescription drugs to the FDA.
or call 1-800-FDA-1088.