Healthcare Industry News: Merck
News Release - December 17, 2013
Zogenix Appoints Chief Medical Officer and Expands Medical Leadership TeamAdditional Clinical and Medical Affairs Leaders Join Zogenix to Support Zohydro(TM) ER Launch
SAN DIEGO, Dec. 17, 2013 -- (Healthcare Sales & Marketing Network) -- Zogenix, Inc. (ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, announced today the expansion of its senior leadership team in support of the planned launch of Zohydro(TM) ER (hydrocodone bitartrate) extended-release capsules in March 2014. This includes the appointment of a Chief Medical Officer, Vice President of Medical and Scientific Affairs, and Executive Director of Medical Affairs, effective immediately.
The new senior appointments are all distinguished leaders in the fields of pain management and analgesic drug development and will play key roles in the launch and post marketing support of Zohydro ER, as well as building the company's product pipeline targeting CNS disorders and pain management. The new hires include the following:
Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer -- Prior to joining Zogenix, Dr. Galer served as President of the Pain Group at Nuvo Research, a specialty pharmaceutical company with three commercialized topically delivered pain products. In this position, he oversaw the strategy and operations of the Pain Group, including its commercialization, drug development activities, business development and licensing opportunities and liaising with partners. Prior to joining Nuvo, Dr. Galer was employed at Endo Pharmaceuticals as Senior Medical Officer and Group Vice President, Scientific Affairs, where he was responsible for the departments of Clinical and Biostatistics, Medical Affairs, Pharmacovigilance, Medical Liaison and Medical Information. He and his team provided clinical and scientific leadership for the development and marketing of analgesic and migraine products, including Lidoderm, Percocet, Opana, Opana ER and Frova. Dr. Galer has also held numerous other industry positions, along with academic and clinical appointments. He has published over 200 articles on pain management in peer review journals and textbooks. Dr. Galer received his medical doctorate and a neurology residency from Albert Einstein in New York and two Pain Fellowships, at Memorial Sloane-Kettering in New York and University of California San Francisco, as well as headache training at Montefiore Headache Clinic in New York and University of California San Francisco.
Arnold R. Gammaitoni, Pharm.D., Vice President, Medical and Scientific Affairs -- Prior to joining Zogenix, Dr. Gammaitoni served as Vice President of Scientific Affairs of the Pain Group at Nuvo Research. Prior to joining Nuvo, Dr. Gammaitoni was Global Director of Scientific Affairs for Analgesia, Immunology, and Anesthesia at Merck & Co. Previous to Merck, he served as Senior Director of Medical Affairs at Endo Pharmaceuticals. Dr Gammaitoni has also been a clinical practitioner with a focus on pain management and has authored or co-authored over 50 articles. He received his doctoral degree in pharmacy from the Philadelphia College of Pharmacy.
Marsha R. Stanton, Ph.D., RN, Executive Director, Medical Affairs -- Dr. Stanton is nationally known for her work in pain management including clinical practice, public policy and patient education. Prior to joining Zogenix, Dr. Stanton served as Executive Director of Program Development, External Affairs, Medical Affairs at Horizon Pharma, a specialty pharmaceutical company with three commercialized products focused on arthritis, pain and inflammatory diseases. She held similar positions representing pain products and organizations at Pfizer, King Pharmaceuticals, Alpharma Pharmaceuticals and Purdue. Prior to joining the pharmaceutical industry, Dr. Stanton practiced as a nurse responsible for the provision of acute and chronic pain services in a variety of hospital and outpatient settings. In addition to being a registered nurse, she holds a Ph.D. in health education from Glendale University, NM.
"We are very pleased to welcome Drs. Galer, Gammaitoni and Stanton to the Zogenix team," said Stephen Farr, Ph.D., President of Zogenix. "They all have a proven track record of successful accomplishments in the development and commercialization of opioid analgesics and other drug products. Under Brad's leadership we are building a strong clinical and medical affairs organization that will be immediately focused on our programs to assure the appropriate use of Zohydro ER, be active participants in the design and execution of the class-wide post marketing requirements for ER opioid analgesics, and advance our development pipeline that includes an abuse deterrent formulation of Zohydro ER."
Dr. Galer commented, "I am very excited to be joining Zogenix, with an outstanding team passionate about helping patients suffering from chronic pain and migraine. Zogenix has made significant strides in building a company focused on improving treatment options for central nervous system disorders and pain. I believe Zohydro ER will fulfill a significant need for severe chronic pain patients by providing the first extended-release hydrocodone product and the first hydrocodone product without acetaminophen. In addition, Zogenix's pipeline products could provide needed new treatments for many patients."
Zogenix, Inc. (ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with central nervous system disorders and pain-related conditions who need innovative treatment alternatives to help them return to normal daily functioning. Zogenix recently received FDA approval for Zohydro ER (hydrocodone bitartrate) extended-release capsules, the first extended-release oral formulation of hydrocodone without acetaminophen. Zogenix developed and commercialized the first needle-free subcutaneous injection, SUMAVEL(R) DosePro(R) (sumatriptan injection) for migraine and cluster headache. The development pipeline for Zogenix includes a once-monthly subcutaneous injection for schizophrenia.
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. Investors are cautioned that forward-looking statements, including without limitation statements regarding the timing of the planned launch of Zohydro ER and the potential of the Company's management team constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with competition from other pharmaceutical or biotechnology companies; the ability to retain key personnel; the scope and validity of patent protection for Zohydro ER and Zogenix's ability to commercialize Zohydro ER without infringing the patent rights of others; unexpected adverse side effects or inadequate therapeutic efficacy of Zohydro ER that could limit commercialization, or that could result in recalls or product liability claims; and other risks detailed in Zogenix's prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
SUMAVEL(R), DosePro(R), ReldayTM and ZohydroTM ER are trademarks of Zogenix, Inc.
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