Overview

Human Genome Sciences Inc., founded in 1992, is a leader in moving genomics-based drugs into clinical trials; it has six drugs in the clinic, including the first of its genomics drugs. Its goal is to discover, develop, manufacture and sell its own genomics-based drugs.

HGS has methods of making small quantities of undiscovered proteins, it has isolated a collection of human genes in messenger RNA form and it has developed systems to analyze the effects of the gene products on human cells and tissues.

It has called itself “an antibody company with a difference.” It has its own set of proprietary antibody targets arising from its collection of human secretory proteins. HGS’s Department for Antibody Discovery and Development was created to take advantage of its antibody collection.

Through its albumin fusion technology, HGS can create an altered version of a protein by fusing the gene for human albumin to the gene that encodes the active protein drug.

Through its drug discovery technologies gene and protein functional identification, informatics, antibody discovery and albumin fusion technology HGS said it is building on and expanding its development and manufacturing of protein drugs to fight disease.

In December 2001, HGS said results of two Phase IIa trials demonstrated safety of systemically administered repifermin, a treatment for cancer therapy-induced mucositis. The primary endpoint for both studies was safety.

November saw the FDA approve HGS’s investigational new drug application for trials of LymphoStat-B as a potential treatment for autoimmune diseases. Human Genome Sciences said it would proceed with a Phase I trial in patients with systemic lupus erythematosus.

Partners

HGS and Medarex Inc. announced in July 2001 they entered an agreement to use Medarex’s technology to create fully human antibodies for commercialization by HGS. Through the deal, HGS has an option to exclusively license therapeutic and diagnostic antibody products resulting from the collaboration. Medarex is entitled to receive license fees, milestone payments and royalties on products.

Other partners are in the Human Gene Consortium (Merck KgaA , Schering-Plough Corp., SmithKline Beecham plc, Synthelabo and Takeda Chemicals Industries Inc.); in gene therapy alliances (Schering-Plough Corp., Transgene SA, Vascular Genetics Inc. and Vical Inc.); in antimicrobial collaborations (Affymetrix Inc., MedImmune Inc., Praecis Pharmaceuticals Inc.; F. Hoffmann La Roche Inc., Pasteur Merieux Connaught/Oravax Inc. and Pharmacia & Upjohn Inc.); and in antibody alliances (Abgenix Inc., Cambridge Antibody Technology Ltd. and Dyax Corp.)