Healthcare Industry News: TYSABRI
News Release - April 11, 2011
Avanir Pharmaceuticals Announces Appointment of William Sibold as Chief Commercial OfficerSibold Brings Accomplished Leadership Skills and Exceptional Commercial Record to Strengthen Executive Team
ALISO VIEJO, Calif., April 11, 2011 -- (Healthcare Sales & Marketing Network) -- Avanir Pharmaceuticals, Inc. (NASDAQ:AVNR ) today announced the appointment of William (Bill) Sibold to the position of senior vice president and chief commercial officer. In this newly created role, Mr. Sibold will be responsible for leading all of the company's commercial activities.
"Bill has an outstanding track record of success in biopharmaceutical sales and marketing," said Keith A. Katkin, president and CEO of Avanir. "I am delighted that we were able to attract someone of Bill's caliber to our growing organization. His proven ability to build and lead cross-functional teams, to develop and launch new products to drive growth further enhances our already strong commercial leadership team."
Mr. Sibold has over 20 years of experience in the biopharmaceutical industry and has worked on significant products including Prozac, Avonex and TYSABRI. Mr. Sibold's most recent commercial leadership role was as senior vice president, U.S. Commercial for Biogen Idec Inc., where he was responsible for all commercial activities, across Biogen Idec's neurology, oncology and rheumatology U.S. businesses. Mr. Sibold also held numerous international and domestic leadership positions at Biogen Idec prior to his role as senior vice president. Prior to Biogen Idec, Mr. Sibold held a number of strategic business development, sales and marketing management roles at Innovative Clinical Solutions. Mr. Sibold's experience also includes sales and marketing positions at Eli Lilly and Amgen Inc. Most recently, Mr. Sibold was president and CEO of Lycera Corp. a preclinical phase company with two innovative oral immunomodulators. Mr. Sibold earned his MBA from Harvard Business School and his BA in Molecular Biophysics and Biochemistry from Yale University.
"I am excited to be taking on this new role," said Bill Sibold, senior vice president and chief commercial officer of Avanir. "Joining Avanir is a tremendous opportunity and I look forward to working with the commercial team to continue to build upon NUEDEXTA's early launch success and future expansion both in the U.S. and internationally."
NUEDEXTA™ is the first and only FDA-approved treatment for pseudobulbar affect (PBA). NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias. The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.
NUEDEXTA Important Safety Information
NUEDEXTA can interact with other medications causing significant changes in blood levels of those medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known hypersensitivity to its components.
NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence.
NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.
Patients should take NUEDEXTA exactly as prescribed. Patients should not take more than 2 capsules in a 24- hour period, make sure that there is an approximate 12-hour interval between doses, and not take a double dose after they miss a dose.
These are not all the risks from use of NUEDEXTA. For additional important safety information about NUEDEXTA, please see the full Prescribing Information at www.NUEDEXTA.com.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
AVANIR™ and NUEDEXTA™ are trademarks owned by Avanir Pharmaceuticals, Inc.
©2011 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the future expansion of NUEDEXTA in U.S. and international markets, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from the results suggested by the forward-looking statements, including the ability to successfully commercialize NUEDEXTA, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
Source: Avanir Pharmaceuticals
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