SALT LAKE CITY--(BW HealthWire)--Aug. 11, 1999--
IOMED, Inc. (AMEX: IOX) today announced the start of Phase III clinical studies with the iontophoretic administration of IontoDex(TM) (dexamethasone sodium phosphate) for the treatment of acute local inflammatory conditions. Utilizing the Company's proprietary iontophoretic drug delivery system, these randomized, double-blind, placebo-controlled studies will involve approximately 400 patients at 12-18 sites across the U.S. The Company believes that with New Drug Application (NDA) approval, IontoDex will effectively compete as a first-line therapy in a major segment of the NSAID (non-steroidal anti-inflammatory drug) and COX-II inhibitor markets.
Dexamethasone is a potent, highly effective corticosteroid used to treat local inflammatory conditions such as tendonitis, including golfer's and tennis elbow, and bursitis. Presently, dexamethasone is administered orally or by injection but is relegated to second- or third-line therapy due to its side effects. Because the Company's delivery systems are non-invasive and can be site specific, IOMED believes that it can offer patients the benefit of the most potent anti-inflammatory drug available with the added benefits of enhanced safety and a benign side effect profile.
"While our iontophoretic drug delivery technology is currently used to deliver dexamethasone sodium phosphate, we believe that validation of efficacy via clinical studies and an approved NDA will dramatically expand the market potential for this product," said Steven Hamilton, Vice President, Business Development. "IOMED is currently in discussions with several global pharmaceutical development and marketing partners, and we hope to finalize a collaborative agreement by the end of 1999. The $540 million U.S. market potential for the product is attracting a significant level of attention from partners potentially interested in worldwide marketing rights."
IOMED is conducting these studies with the assistance of a specialty clinical research organization. IOMED plans to complete the studies in approximately nine months, and plans to file its NDA in the third quarter of calendar year 2000. The Company expects Food and Drug Administration (FDA) review time of about one year.
Medical advisors for the studies include Robert Nirschl, M.D., a leading expert in the treatment of sports and tendon injuries, and Jeffrey C. Page, D.P.M., the Executive Dean of the California College of Podiatric Medicine.
IOMED's drug delivery systems, cleared via the FDA's 510(k) process, have been used to treat more than 11 million patients in orthopedic, sports medicine and physical therapy settings for local inflammatory conditions such as tennis elbow, joint sprains and strains. Iontophoresis is also used to induce rapid, local dermal anesthesia using IOMED's Iontocaine(R) (lidocaine HCI 2% with epinephrine 1:100,000 Topical Solution), the first drug approved for iontophoretic administration.
Iontophoresis is a method of delivering water-soluble, ionized (electrically charged) drugs through the skin by applying a low level, external electric current. The amount of drug delivered can be controlled by programming the system's electric current levels to achieve the desired drug dose, delivery rate or pattern of delivery. Depending on a drug's chemical properties and mechanism of action, drug therapy can be administered for local or systemic effects.
IOMED's iontophoretic drug delivery systems are comprised of a small reusable dose controller and single-use, disposable electrode kits. The Company believes that iontophoretic drug delivery systems may offer several advantages over other drug delivery methods, including broad applicability, increased convenience and patient compliance, and programmable control of drug delivery. Among other benefits, programmable control of drug delivery provides for rapid onset or cessation of delivery, variable dose control, patient controlled dosing and the ability to dose to effect.
IOMED plans to issue financial results for the fiscal year ended June 30, 1999, on Friday, August 13, 1999 prior to the start of trading. The Company has scheduled a conference call regarding both today's announcement and the release of its year-end financials for Friday, August 13 at 11:00 a.m. Eastern Time. To participate in the call, a few minutes prior to the start time please dial (800) 530-9010. Those unable to participate are invited to listen to a recording of the call and Q&A through 5:00 p.m. Eastern Time Monday, August 16 by dialing (800) 633-8284, access code 12930707.
Investors will have the opportunity to listen to the conference call over the Internet through Investor Broadcast Network at www.vcall.com. To listen to the live call, please go to the Web site a few minutes prior to the start of the call to register, download, and install the necessary audio software. For those who cannot listen to the live broadcast, a replay will begin shortly after the call has ended and will be available for 90 days.
IOMED, Inc. is a leader in the research, development and manufacture of iontophoretic drug delivery systems, which are marketed to healthcare providers worldwide. Iontophoretic drug delivery involves the transport of water-soluble ionic drugs into and through the skin using a mild electrical current. IOMED also conducts advanced research for local and systemic delivery of ionic pharmaceutical compounds to treat various medical conditions.
The statements contained in this news release that are not purely historical are forward-looking statements, as defined in section 21E of the Securities and Exchange Act of 1934, and include IOMED's beliefs, expectations or intentions regarding its future operations and financial condition. All forward-looking statements included in this news release are made as of the date hereof and are based upon information available to IOMED as of such date. IOMED assumes no obligation to update any forward-looking statement. It is important to note that actual outcomes could differ materially from those in such forward-looking statements. Readers should also refer to the risk factors and other disclosures set forth in IOMED's filings with the Securities and Exchange Commission on Forms S-1 and 10-K.
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