Healthcare Industry News: CV Therapeutics
News Release - November 5, 2009
NeurogesX Expands Commercial Operations Leadership TeamAdds Key Sales, Marketing and Commercial Executives in Preparation for Possible U.S. Product Launch
SAN MATEO, Calif., Nov. 5 (Healthcare Sales & Marketing Network) -- NeurogesX, Inc. (Nasdaq: NGSX ), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced the expansion of its U.S. commercial operations team to include a Vice President of Sales, Senior Director of Marketing and Director of Commercial Operations.
- Timothy Arendt has been named Vice President Sales. He will implement and manage the U.S. specialty sales force for Qutenza(TM).
Mr. Arendt has 20 years of pharmaceutical marketing and sales experience. Prior to his arrival at NeurogesX, Mr. Arendt was Vice President, Sales at Xanodyne Pharmaceuticals. In this position he managed the sales organization, sales operations, managed care and training departments. From 2003 to 2007 Mr. Arendt was at Valeant Pharmaceuticals, where he was Senior Vice President and General Manager, US Pharmaceuticals. Mr. Arendt began his career at GlaxoSmithKline, where he worked in sales positions of increasing responsibility from 1989 to 2003, most recently as Regional Sales Vice President, CNS Division. He earned a Bachelor of Science degree in business administration from the University of Arizona.
Ms. Cavers has more than 20 years experience building global and U.S. marketing initiatives at leading biopharmaceutical companies. She has been involved in numerous approvals that resulted in several important drug launches, including four first in-class drugs. Her previous positions included Senior Director, Oncology Marketing and US Commercial Lead at Bristol-Myers Squibb; Senior Director, Global Strategic Marketing at Millennium Pharmaceuticals Inc; and Vice President of Marketing at Celgene. In her role at Celgene, she was involved with the launch of Thalomid® and related risk management program S.T.E.P.S®. From 1988 to 1997 Ms. Cavers worked at Allergan in sales and marketing roles of increasing responsibility, including the initial launches of Botox® in the US and Canada. She received a Bachelor of Science degree in Animal Health Science from the University of Arizona.
Ms. Schock has over 20 years of industry experience which spans distribution, pricing, Managed Care and Government contracting, reimbursement and patient assistance programs. Ms. Schock worked at CV Therapeutics from 2005 until its acquisition by Gilead Sciences in 2009, most recently as Director, Pricing, Contracts and Reimbursement in Commercial Operations. From 2001 to 2005 Ms. Schock was Associate Director, Distribution and Reimbursement in Commercial Sales Operations at Actelion Pharmaceuticals. Ms Schock began her career at Genentech, Inc, where she worked in commercial operations positions of increasing responsibility from 1987 to 2001, most recently as Manager, Government Contract Operations (Managed Markets / Sales Operations). Ms. Schock received a Bachelor of Science degree in accounting and business administration from the San Jose State University in California.
Dr. Panarites has over 15 years of experience in reimbursement, health economics and pricing at a number of pharmaceutical and biotechnology companies. Prior to joining NeurogesX in 2008, Dr. Panarites held senior positions at Nuvelo (now ARCA Biopharma, Inc.), Scios (acquired by Johnson & Johnson), sanofi-aventis, and the American Red Cross (Biomedical Services). In addition, he was a vice president at Covance Market Access Services and a senior consultant at William M. Mercer, Inc. Dr. Panarites is an expert at Medicare coverage policies and payment mechanisms for drugs and related services across a variety of settings, including hospital inpatient, hospital outpatient, physician office and retail pharmacy. He led new product launch teams and managed field-based reimbursement managers calling on payer decision makers, including pharmacy directors and medical directors. Dr. Panarites has co-authored several peer reviewed book chapters, articles and posters. Dr. Panarites received a B.S. in Latin American Studies from Georgetown University and a Ph.D. in Health Services Research from UCLA.
About NeurogesX, Inc.
NeurogesX (Nasdaq: NGSX ) is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX' late-stage product portfolio is led by its product candidate Qutenza(TM), a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions. Qutenza is currently approved in the European Union for the treatment of neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. Qutenza will be marketed in the European Union, Switzerland, Norway, Iceland, Liechtenstein and certain countries in Eastern Europe, the Middle East and Africa, by Astellas Pharma Europe, Ltd. In the United States, NeurogesX submitted a new drug application (NDA) for PHN to the U.S. Food and Drug Administration (FDA) which was accepted for filing by the FDA in December 2008 and has been given an extended Prescription Drug User Fee Act (PDUFA) date of November 16, 2009.
NeurogesX' second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 has completed three Phase 1 studies and NeurogesX is currently planning the design and timing of this program.
NeurogesX' early stage product pipeline includes pre-clinical compounds, which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is seeking development partners for these programs.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that may be obtained with respect to the NDA for Qutenza with the FDA, including the PDUFA date for the NDA; plans, timing and size of potential product launch and commercialization activities for Qutenza, including the hiring and integration of additional personnel and establishment of distribution channels; and development activities for NGX-1998 and other product candidates, including regulatory submissions and any outcomes of such submissions. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: positive results in clinical trials may not be sufficient to obtain FDA approval; the FDA may request additional clinical trials or other information prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to certain indications; NeurogesX' product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy or tolerability; physician or patient reluctance to use Qutenza or NGX-1998, if approved; and other difficulties or delays in, clinical development of, and obtaining regulatory approval for NeurogesX' product candidates. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
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