GL-701 Genelabs.

Abstract

Genelabs is developing GL-701 (prasterone), oral dehydroepiandrosterone (DHEA), for the potential treatment of systemic lupus erythematosus (SLE) [154020]. In September 2000, the company completed submission of its rolling NDA, begun in May 2000 [340361], [355642], [361381], [380239], [383545]. In October 2000, the FDA granted the company's NDA Priority Review designation [387020]. Genelabs began its NDA submission for GL-701 in May 2000, by submitting the complete clinical, statistical and human pharmacokinetic sections to the FDA. This includes all the human efficacy and safety data for the NDA [368932]. In March 1999, Genelabs received Fast Track designation for GL-701 from the US FDA, allowing the development and review of an NDA to be expedited [319963]. Genelabs met with the US FDA in November 1999 to present the data from the two phase III trials in women and was advised by the FDA that its NDA proposal appeared adequatefor submission [348192], [361381]. Because of the public domain nature of DHEA, Genelabs was not certain that it would obtain patent protection. In the US it received Orphan Drug designation, providing seven years of exclusive marketing rights, and in October 1996, Genelabs received US-05567696, covering the use of GL-701 in lupus patients to reduce their dosage of concomitant corticosteroids [222741], [329646]. The US FDA has also granted Subpart E designation to GL-701, which permits expedited development [169754], [222741]. Genelabs licensed the product exclusively worldwide from Stanford University, which performed the early-stage clinical studies. The Asian marketing rights have been licensed to Genelabs Biotechnology Ltd (GBL), a joint investment with the government of Taiwan [229812]. In January 2001, analysts at UBS Warburg predicted that GL-701 would be launched in 2001, and reach sales of US $ 90 million by 2004 [398731].