CHARLOTTE, N.C., July 18, 2006 (PRIMEZONE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has appointed Keith W. Schmidt Vice President of Marketing and Sales. Mr. Schmidt's initial focus will be to initiate pre-launch marketing and product positioning to ensure a swift and successful launch of Droxidopa, for which the company is currently preparing an orphan drug application and planning pivotal Phase III trials in the United States and Europe.
Mr. Schmidt brings to Chelsea over 25 years of experience and an outstanding reputation and proven track record in domestic and international pharmaceutical sales, and strategic marketing for launching industry leading drugs including Pegasys(tm), Naprosyn(tm), Anaprox(tm), Cialis(tm), Cymbalta(tm), and Strattera(tm). Over the course of his career, Mr. Schmidt has worked for such companies as Hoffmann-La Roche, Syntex Laboratories, and served as Vice President assigned to Eli Lilly marketing for Thomson Advanced Therapeutics Communications, a division of Thomson Healthcare, focused on developing and implementing global promotional medical education programs for newly approved drugs. During his distinguished tenure at Hoffmann-La Roche, Mr. Schmidt served as International Business Leader responsible for global pre-launch marketing preparation, launch market plans, and life cycle planning for Pegasys(tm) in Hepatitis C, Hepatitis B and Oncology. Prior to joining Roche, Mr. Schmidt served in a number of progressively senior positions at Syntex Laboratories, variously directing New Product Development, Sales Force Strategies, OBYN Sales, and Sales Training.
"Keith was an integral part of the Pegasys team -- driving the rapid acceptance and ultimate market dominance of this billion dollar drug. I am delighted to once again partner with Keith as we look to initiate the comprehensive commercialization efforts for Droxidopa," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "In anticipation of potential orphan drug status, an expedited clinical development program, and the rapid commercialization path, we are looking to implement a highly targeted launch campaign to maximize the market exclusivity afforded by orphan drug designation upon approval. We believe that Keith's proven capabilities and specific industry knowledge for commercializing new technologies will not only serve this immediate need for Droxidopa, but will also further enhance the long-term development of our entire therapeutic pipeline."
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is pursing an Orphan Drug strategy for the development of Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, generating annual revenue of approximately $50 million in Japan.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.