Genelabs Submits Clinical Sections of New Drug Application to FDAFor Lupus Treatment
- GL701 Has Potential to Be First New Lupus Therapy in 40 Years -
<<<REDWOOD CITY, Calif., May 31 /PRNewswire/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB) announced today it began submission of a New Drug Application (NDA) for marketing approval of GL701 by submitting the complete clinical, statistical and human pharmacokinetic sections to the U.S. Food and Drug Administration (FDA). GL701 is an investigational drug for treatment of the chronic autoimmune disease systemic lupus erythematosus (SLE or lupus). This first submission includes all of the human efficacy and safety data for the NDA. The company plans to complete submission of the NDA by the end of 2000. In accordance with an agreement reached with the FDA, the company is utilizing a rolling process for submitting the NDA, a benefit of Fast Track designation, which was previously granted to GL701 for SLE.
(Photo: newscom.com )
"We are very pleased that the clinical sections were submitted as planned, before the end of June. We are on schedule to submit the remaining sections in the second half of this year. If approved, GL701 will be the first new treatment for lupus patients in 40 years," said James A.D. Smith, President and Chief Executive Officer of Genelabs.
Genelabs expects that, when completed, the NDA will be granted priority review by the FDA and the company hopes to receive a decision regarding approval status by mid-2001. Genelabs is seeking approval of GL701 as a first line therapy for women with active SLE to stabilize or improve their disease signs and symptoms, and also for SLE patients who are corticosteroid dependent, to reduce their corticosteroid dose. The NDA for GL701 is supported by data from 572 patients in two placebo-controlled, multicenter Phase III clinical trials in the United States. The GL701 NDA also includes data from an additional recently completed clinical trial conducted in Taiwan by a licensee of Genelabs. This placebo-controlled clinical trial enrolled 120 women with SLE (in Taiwan) and was conducted in accordance with U.S. FDA standards (good clinical practices). Genelabs believes the results of that trial are supportive of results previously reported for Genelabs' second Phase III trial. Genelabs expects its licensee will present these data at a major medical conference.
"Genelabs studied the effectiveness and safety of GL701 among women with SLE in the two largest controlled studies for lupus ever completed," said Marc Gurwith, M.D., Vice President, Drug Development and Chief Medical Officer. "The Genelabs studies demonstrated a consistent pattern of efficacy across a number of primary and secondary variables. We are excited about GL701, a potential first line treatment for people who suffer from lupus."
SLE primarily affects women, many of whom experience the initial onset of disease in their late teens and early twenties. Approximately 200,000 people in the United States and more than one million worldwide have lupus, according to U.S. government and private sector statistics. Lupus causes the immune system to attack the body's own tissue, which can lead to inflammation, arthritis pain, tissue injury and major organ damage. Common signs and symptoms of the disease that lupus sufferers experience -- extreme fatigue, arthritis, fever, seizures, headache, muscle weakness, memory loss, hair loss, facial rash, photosensitivity and depression -- can lead to poor quality of life. More serious, life-threatening symptoms include inflammation of the lungs, heart and brain tissue and organ damage, most often involving the kidneys.
Except for historical information, the statements in this news release are forward-looking and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, the adequacy of the company's GL701 clinical trial processes and whether the results of those clinical trials and other supporting information will be sufficient to support regulatory submissions and/or approvals; delays regarding the regulatory approval process including the timing and scope of approval received, if any; uncertainties and risks regarding market acceptance of GL701 as a treatment for SLE; the company's limited manufacturing and marketing experience; the validity, scope and enforceability of patents related to GL701; the company's capital requirements and history of operating losses; and uncertainties and risks regarding the company's ability to raise needed additional capital or consummate strategic or corporate partner transactions on favorable terms or at all. The company has not submitted applications for regulatory review outside the US and its application in the US is not complete. In addition, neither US nor foreign regulatory authorities have made a determination as to the safety or efficacy of GL701 for SLE. Please see the information appearing in the company's filings with the Securities and Exchange Commission for more discussion regarding these uncertainties and risks and those associated with the company's research programs, early stage of development and other risks which may affect the company. The company does not undertake any obligation to update these forward-looking statements to reflect events or circumstances after the date of this release.>>>
Genelabs' press releases are available by fax 24 hours a day at no charge by calling PR Newswire's Company News On-Call at 800-758-5804, extension 115-419. They are also posted on the Internet at genelabs.com and prnewswire.com
CONTACT: Richard A. Waldron - Vice President, Chief Financial Officer, or James A.D. Smith - President and Chief Executive Officer, both of Genelabs Technologies, Inc., 650-562-1424.
SOURCE Genelabs Technologies, Inc.
CO: Genelabs Technologies, Inc.; U.S. Food and Drug Administration
ST: California
IN: BIO MTC
SU:
05/31/2000 08:00 EDT prnewswire.com |
