SAN DIEGO, Aug. 4, 2016 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced business and financial results for the second quarter ended June 30, 2016.
"Earlier this week we completed our acquisition of U.S. rights to Contrave®, transforming Orexigen into a fully integrated commercial pharmaceutical company focused on our mission to improve the health and lives of patients struggling to lose weight," said Mike Narachi, CEO of Orexigen. "With the completion of this acquisition and the development of our independent commercialization capabilities over the past several months, Orexigen is ready to execute on our strategy to grow Contrave sales in the U.S. with our targeted specialty sales force and to market Mysimba® and Contrave outside the U.S. through multiple, regionally specific partnerships."
Recent business highlights:
- Completed the acquisition of full rights to Contrave (naltrexone HCl / bupropion HCl extended release) in the U.S. and relaunched Contrave with a dedicated sales and marketing team on August 1
- Received the Wholesale Distribution Authorisation from the Irish Health Product Regulatory Authority, enabling Orexigen Therapeutics Ireland Ltd. to ship product supply to distributor partners in Europe. Valeant is planning to launch Mysimba in 11 European Union countries by year end 2016 and in Greece and Cyprus in the first quarter of 2017
- Executed a commercialization and distributorship agreement with Laboratorios Farmaceuticos Rovi, S.A. for Mysimba in Spain
- Announced launch of Contrave in South Korea by partner Kwang Dong Pharmaceuticals
- Kwang Dong is now executing on a comprehensive commercial plan that leverages their medical and sales teams to target hospitals, clinics and physicians
- Reported favorable Markman ruling in Contrave patent litigation
- There are 10 Contrave patents listed in the Orange Book, the last of which expires in 2032
- Promoted Thomas Cannell, D.V.M., to Chief Operating Officer and President of Global Commercial Products, Jason Keyes to Chief Financial Officer, and Peter Flynn, Ph.D., to Head of Global Development, Regulatory and Safety
- The Company's senior executive leadership team is now in place to take full control and responsibility for Contrave, and to manage an effective and efficient U.S. sales and marketing organization in addition to a growing number of partnerships around the world for ex-U.S. commercialization of Contrave and Mysimba
Business and financial results for the three months ended June 30, 2016
According to IMS Health, 191,033 prescriptions of Contrave were filled in the second quarter of 2016.
For the three months ended June 30, 2016, Orexigen reported a net loss of $25.2 million, or $1.73 per share, as compared to a net loss of $22.5 million, or $1.80 per share, for the second quarter of 2015.
Orexigen reported second quarter 2016 revenue of $7.8 million, including $2.5 million in royalties earned on U.S. net sales of Contrave, $2.4 million in collaborative income, and $2.9M in net product sales to an ex-U.S. commercial partner. Total revenue for the second quarter of 2015 was $5.2 million, including $3.1 million in royalties on net sales of Contrave.
Orexigen reported cost of product sales of $1.8 million in the second quarter of 2016 associated with its product sales to an ex-U.S. commercial partner.
Total operating expenses for the second quarter of 2016 were $39.2 million compared to $25.9 million for the second quarter of 2015. The increase was driven primarily by an increase in SG&A associated with the hiring and build out of the global commercial organization.
As of June 30, 2016, Orexigen had $264.4 million in cash, restricted cash and investments, and short term investments.
Conference Call Today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time)
The Orexigen management team will host a teleconference and webcast to discuss the second quarter 2016 financial results. The live call may be accessed by phone by calling (888) 771-4371 (domestic) or (847) 585-4405 (international), participant code 42982061.
About Contrave and Mysimba
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). In Europe, the medicine was approved in March 2015 with the brand name Mysimba.
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.
The clinical trial program also includes a double-blind, placebo-controlled cardiovascular outcomes trial known as the Light Study. The primary objective of this study was to evaluate the occurrence of major adverse cardiovascular events (MACE) in overweight and obese adults with cardiovascular risk factors receiving Contrave. A second study, designed to address post-approval requirements in both Europe and the United States, is planned in order to further evaluate cardiovascular outcomes.
Further information can be found at http://www.orexigen.com/.
Important Safety Information for CONTRAVE and MYSIMBA
(naltrexone HCl and bupropion HCl) 8 mg/90 mg extended-release tablets
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
Suicidality and Antidepressant Drugs
Not approved for use in the treatment of major depressive disorder or other psychiatric disorders. 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, 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. 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 not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.
Contraindications
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 used concomitantly with MAOIs and use with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated; known allergy to any component, 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 because one component, bupropion, is a member of an antidepressant class.
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