DHEA (Leland Stanford Junior University)

Genelabs is developing oral dehydroepiandrosterone (DHEA), for the potential treatment of systemic lupus erythematosus (SLE) in women. Results of a second phase III study, due for completion in March 1999, will determine whether Genelabs files an NDA in the US. Because of the public domain nature of DHEA, Genelabs is not certain that it will 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 DHEA in lupus patients to reduce their dosage of concomitant corticosteroids. The US FDA has also granted Subpart E designation to DHEA, which permits expedited development. 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.