$OREX down in pre, on good news. Orexigen Therapeutics

$OREX down in pre, on good news.

Orexigen Therapeutics Announces Promotions of Tom Cannell to COO and Jason Keyes to CFO
16 hours 23 minutes ago - DJNF
SAN DIEGO, June 8, 2016 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced the promotions of Thomas Cannell, D.V.M., to Executive Vice President, Chief Operating Officer, and President of Global Commercial Products and Jason Keyes to Senior Vice President, Chief Financial Officer.

The Company's senior executive and commercial leadership team is now in place to manage an effective and efficient U.S. sales and marketing organization and a growing number of alliances around the world for ex-U.S. commercialization of Contrave(R) (naltrexone HCl / bupropion HCl extended release) and Mysimba(R) , as the drug is known in Europe. In March 2016, Orexigen announced the agreement to acquire full United States rights to Contrave following a six-month transition period. Orexigen is preparing to assume U.S. commercialization of the product later this year.

Tom Cannell's promotion to COO and President of Global Commercial Products provides a single point of accountability for global revenue and key related activities, including Contrave sales in the United States and the establishment and management of Contrave / Mysimba alliances around the world. Cannell joined Orexigen as Executive Vice President, Chief Commercial Officer in 2015 after 27 years at Merck & Co. Inc. where he held senior leadership positions in global commercialization, consumer marketing, and sales operations and management. At Merck, Cannell's assignments included President of Merck Canada (2012 -- 2014) and Head of Marketing and Strategy for MSD Japan (2010-2012). Earlier he served in general manager roles for a U.S. sales division, as leader of a Merck business unit, managing a multi-billion dollar product portfolio and thousands of employees, and as General Manager, New Commercial Model, U.S., where he designed and successfully piloted an innovative, customer-centric commercial model for Merck's U.S. business. Cannell holds a Bachelor of Science degree in Veterinary Science and a Doctor of Veterinary Medicine degree from Washington State University. He has also served in the U.S. Army Reserves (currently inactive) since 1987.

Jason Keyes' promotion to CFO provides Orexigen's senior leadership team with an accomplished executive with 15 years of experience in finance and strategy. Keyes, a San Diego native, joined Orexigen in 2013 and most recently served as Vice President of Finance, leading the Company's financial planning and partnership finance functions and serving as a key financial advisor to executive management setting corporate business and financial strategy. Prior to joining Orexigen, Keyes was Senior Director of Finance at Amylin Pharmaceuticals, Inc., which was acquired by Bristol Myers Squibb in 2012. Previously he worked in finance and corporate strategy at Amgen, Inc. and at Baxter Healthcare Corporation. He is also a licensed professional engineer and has six years of experience in the environmental engineering industry. Keyes holds Bachelor of Science and Master of Science degrees in Civil Engineering from Stanford University and a Master of Business Administration degree from the Anderson School at the University of California, Los Angeles.

"We are continuing to refine our organizational structure and leadership team to fit the needs of Orexigen as the Company prepares to relaunch Contrave with its own dedicated sales force and begins to generate revenue from a growing number of global alliances. Jason Keyes has distinguished himself with his finance and leadership skills, and we are very pleased to promote him to Chief Financial Officer," said Mike Narachi, Orexigen CEO. "Under Tom Cannell's leadership, Orexigen has rapidly built a talented and experienced U.S. sales and marketing organization to execute our commercial plans for Contrave. Tom also provides instrumental strategic input and oversight of our commercial activities and alliances outside the U.S. The expansion of Tom's role and responsibilities consolidates under his leadership key activities supporting all global revenue generation."

About CONTRAVE (naltrexone HCl / bupropion HCl extended release)

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/m(2) or greater (obese), or 27 kg/m(2) or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia).

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.

Important Safety Information

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: 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 CONTRAVE is used concomitantly with MAOIs and use with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated; known allergy to any component of CONTRAVE 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 to CONTRAVE because one of its components, bupropion, is a member of an antidepressant class.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of anxiety, agitation, irritability, unusual changes in behavior, and other symptoms, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. 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

(MORE TO FOLLOW) Dow Jones Newswires

June 08, 2016 16:10 ET (20:10 GMT)

­« Back to Stocks News