BEDMINSTER, N.J., Oct. 25, 2011 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that Timothy J. Maines has joined the Company as Vice President of Quality. In this newly created position, reporting directly to Chief Operating Officer, Drs. Ben Machielse, Mr. Maines will be responsible for Quality, Validation and CMC development at Omthera.
Mr. Maines brings to the Company more than 25 years of pharmaceutical, medical device and biologic experience in both the U.S. and European Union, with additional skills in biochemistry, chemistry and virology.
Commenting on today's news, Drs. Machielse stated, "Timothy is a proven Quality Executive with an extensive range of expertise in start-up, clinical and commercial operations. As Vice President of Quality, Timothy will help build a strong infrastructure for Omthera's manufacturing and quality practices. As such, we are delighted to welcome him to the Company. His experience in bringing specialty products to market will be key as we pursue the ultimate commercialization of Epanova, as demonstrated by Tim's contributions to the approval of ATryn and OP-1 Implant."
Prior to joining Omthera, from November 2007 until recently, Mr. Maines was Vice President Corporate Quality Assurance at MedImmune, LLC, where he oversaw a 200 person QA Operations team at six GMP manufacturing facilities in the U.S., UK and Netherlands. From March 2000 to October 2007, Mr. Maines held various positions at GTC Biotherapeutics, including Vice President of Quality. While there, he was closely involved in the approval of the first product produced in transgenic dairy animals.
Mr. Maines' experience also includes Director of Quality at Stryker Corporation-Biotech Division; Director of Quality Assurance/Quality Control and Manager of Validation at Creative BioMolecules; and Manager of Quality Assurance at BioProcess Technologies, among others. Mr. Maines earned a Bachelor of Science in Biology/Microbiology from Gannon University.
About Omthera Pharmaceuticals, Inc.
Founded in 2008, Omthera Pharmaceuticals, Inc. is a privately-held, emerging specialty pharmaceuticals company focusing its efforts on the clinical development of new therapies for dyslipidemia. Led by a team of experts with exceptional experience in developing new therapies for lipid disorders, Omthera is dedicated to developing innovative therapies for the millions of patients who have elevated triglyceride levels and increased risk of cardiovascular disease. In March 2011, the Company initiated a pivotal Phase III clinical trial for its lead product candidate, Epanova, an Omega-3 fatty acid compound in development as a triglyceride-lowering adjunct therapy to diet in patients with very high triglycerides (greater than or equal to 500 mg/dL). In August, 2011, Omthera initiated a Phase III trial for Epanova in patients with high triglycerides (greater than or equal to 200 mg/dL and less than or equal to 500 mg/dL) currently on statin therapy. For more information, please visit www.omthera.com.
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