SAN DIEGO, Feb. 25, 2015 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced business and financial results for the fourth quarter and year ended December 31, 2014.
“2014 was a transformational year for Orexigen, with the US approval and commercial launch of Contrave® and the positive opinion of the CHMP recommending marketing authorization for Mysimba,” said Michael Narachi, CEO of Orexigen. “While the U.S. launch is still in its early stages, we are encouraged by the progress so far and by the positive reports we are hearing from Takeda’s field based teams about how the product is being received by health care professionals and their patients.”
Narachi continued: “In 2015 we are focused on the continued success of Contrave in the United States, securing approval for Mysimba in Europe, and taking concrete steps toward commercialization of Contrave/Mysimba in ex-US territories.”
Contrave (naltrexone HCl / bupropion HCl extended release):
Orexigen’s partner for North America, Takeda Pharmaceuticals, launched Contrave in the United States on October 20, 2014. U.S. net sales for the fourth quarter, recorded by Takeda, were $6.5 million, for which Orexigen earned $1.3 million in royalties. Gross sales for the quarter were $12.3 million.
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 (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).
Mysimba (naltrexone HCl / bupropion HCl prolonged release):
In Europe, Orexigen is seeking marketing authorization for Mysimba. In December 2014, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion with 31 member states voting in favor and 2 opposed recommending that Mysimba be granted marketing authorization throughout the European Union. The European Commission’s Standing Committee for Medicinal Products will review the draft European Commission (EC) decision to grant marketing authorization for Mysimba during a meeting being held in March.
Financial results for the three months ended December 31, 2014
For the three months ended December 31, 2014, Orexigen reported a net profit of $0.6 million, or $0.00 per share, as compared to a net loss of $21.5 million, or $0.21 per share, for the fourth quarter of 2013.
Total operating expenses for the fourth quarter of 2014 were $20.6 million compared to $21.8 million for the fourth quarter of 2013.
Financial results for the year ended December 31, 2014
For the year ended December 31, 2014, Orexigen reported a net loss of $37.5 million, or $0.32 per share, as compared to a net loss of $77.7 million, or $0.80 per share, for 2013. Total operating expenses for 2014 were $86.1 million compared to $80.6 million for 2013. This overall increase in operating expenses primarily reflects an increase in raw materials, inventory, and manufacturing-related expenses and in stock based compensation expense. The overall increase was partially offset by a decrease in research and development expenses associated with the conduct of the Light Study, the Contrave cardiovascular outcomes trial. While Orexigen is responsible for manufacturing Contrave, Takeda will reimburse Orexigen for manufacturing related costs, including finished goods.
As of December 31, 2014, Orexigen had $104.2 million in cash and cash equivalents and an additional $101.3 million in marketable securities, for a total of $205.5 million.
Conference Call Today at 7:30 a.m. Eastern Time (4:30 a.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the fourth quarter and full year 2014 financial results and recent business highlights. The live call may be accessed by phone by calling (800) 708-4540 (domestic) or (847) 619-6397 (international), participant code 39030980. The webcast can be accessed live on the Investors section of the Orexigen web site at http://www.orexigen.com, and will be archived for 14 days following the call.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Contrave® (naltrexone HCl and bupropion HCl extended release), which is approved in the United States and is being commercialized there by the company’s North American partner, Takeda Pharmaceuticals. In Europe the drug is being reviewed for marketing authorization under the brand name MysimbaTM (naltrexone HCl/ bupropion HCl prolonged release). Orexigen’s strategy for Contrave is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization. Further information about the Company can be found at http://www.orexigen.com/.
Important Safety Information for Contrave (naltrexone HCl and bupropion HCl)
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 patients with uncontrolled hypertension, seizure disorder, or current or prior diagnosis of anorexia nervosa or bulimia; in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; with use of other bupropion-containing products; for use with chronic opioids or opiate agonists (eg, methadone) or partial agonists (eg, buprenorphine) or acute opiate withdrawal; during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); in patients with known allergy to any other component of CONTRAVEanaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; in 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. Consider changing the therapeutic regimen or discontinuing in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, or mania, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Alert families and caregivers of patients being treated with antidepressants about the need to monitor patients for the emergence of above mentioned symptoms, as well as the emergence of suicidality, daily and to report such symptoms immediately. 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, including 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. Use caution and consider the risk when prescribing CONTRAVE to patients with predisposing factors, clinical situations, and concomitant medications that may lower seizure threshold. Risk of seizure may be minimized by adhering to the recommended dosing schedule and avoiding co-administration with a high-fat meal.
Patients Receiving Opioid Analgesics: CONTRAVE should not be administered to patients receiving chronic opioids. Patients may be vulnerable to opioid overdose and/or precipitated opioid withdrawal.
Increase in Blood Pressure (BP) and Heart Rate (HR): CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. Monitor BP and HR especially in patients with cardiac or cerebrovascular disease and/or with controlled hypertension.
Allergic Reactions: Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported in clinical trials with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock.
Hepatotoxicity: Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Use of CONTRAVE should be discontinued in the event of symptoms/signs of acute hepatitis.
Activation of Mania: Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression).
Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, a component of CONTRAVE, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Use of Antidiabetic Medications:
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