UroGenesys Inc.

The business mission of UroGenesys Inc. is the development of improved diagnostic and therapeutic products for prostate cancer.

Tackling the genetics of prostate cancer

• 1791 Colorado Ave.

• Santa Monica, CA 90404

• Phone: [phone]

• Fax: [phone]

• E-mail: [email protected]

• Contact: Donald B. Rice, PhD, President, CEO & Director

• Business: Gene discovery program to improve treatments and diagnosis of prostate cancer

• Founded: Late 1996

• Founders: Arie Belldegrun, MD; Jean deKernion, MD; Robert Filgin, MD; Owen Witte, MD; and Donald Rice, PhD.

• Employees: 19

• Financing to date: $8 million

• Scientific Advisory Board: Owen Witte, MD (UCLA); Arnold Berk, MD (Molecular Biology Institute, UCLA); Peter Doherty, PhD (St. Jude Children's Research Hospital); Robert Eisenman, PhD (American Cancer Society, Fred Hutchinson Cancer Research Center); William Isaacs, PhD (Brady Urological Institute, Johns Hopkins University); Inder Verma, PhD (American Cancer Society, the Salk Institute)

UroGenesys Inc. is an early-stage development biotechnology company founded in 1996 by leading cancer researchers from the University of California, Los Angeles , which has a large prostate cancer program, and Donald Rice, PhD, former president and COO of Teledyne from 1993-1996, president of Rand Corp., and US Secretary of the Armed Forces. The company's business mission is the development of improved diagnostic and therapeutic products for prostate cancer.

While such a focus—on a disease not a target—looks limiting, UroGenesys rationalizes it based on the significant market size for prostate cancer. Almost 200,000 new cases of prostate cancer are diagnosed each year in the US and nearly 40,000 American men die of the disease annually. Prostate cancer kills more American men than any other cancer except lung cancer. There is a well-recognized need for improvement in both diagnostic and therapeutic products for the disease.

UroGenesys' initial research efforts are focused on the discovery of genes associated with prostate cancer and its progression into advanced disease. The company's founders believe that genetic changes occur as prostate cancer metastasizes from the prostate and, in the process, evolves from dependence on hormones for growth to being hormone independent. Specific genes may play roles in determining whether the disease will become more aggressive in some patients and its propensity to metastasize to the bone.

The company's strategy is to amass proprietary rights to genes and proteins which are implicated in various stages of the disease and which could be further characterized and developed into therapeutic or diagnostic products. For example, a prostate-cancer associated antigen could be the basis for a monoclonal antibody or cancer vaccine product. Both types of therapies have been increasingly popular areas for development within the biotechnology industry. The industry has witnessed several recent approvals of monoclonal antibodies for cancer treatment: Genentech Inc. 's Herceptinand Idec Pharmaceuticals Corp. /Genentech's co-developed Rituxan. Additionally, there are a number of companies researching cancer vaccines, with several reaching Phase III clinical trials.

In diagnostics, UroGenesys is studying a protein that appears to be secreted into the bloodstream of patients with prostate cancer. This protein could potentially have predictive value for the disease and be developed into a diagnostic assay. While diagnostics generally don't command the same returns as pharmaceuticals, in the case of prostate cancer and based on experience with prostate specific antigen (PSA), a diagnostic could be a very attractive goal for the company.

The company licensed its first projects from UCLA in 1997: a prostate-specific enhancer and promoter; the genes PSCA (prostate stem cell antigen) and E-25; and proprietary human prostate cancer models in immune deficient (SCID) mice [See Deal]. The model could be an important agent for gene discovery. PSCA has drawn the most attention as it is a gene located on the cell surface of prostate cancer cells and is highly expressed in the disease. The company is exploring collaborations with several partners for further development of this target.

UroGenesys employs 15 full-time scientists and also draws upon the research and clinical expertise of the seven UCLA scientists who helped start it. The company has accelerated its development by making extensive use of outsourcing, using outside providers for gene sequencing, gene cloning, SCID mouse facilities, monoclonal antibody production and administrative services.

UroGenesys' business strategy includes seeking collaborations with large companies with late-stage development capabilities to speed up the development and commercialization of some of the products emerging from its pipeline. In the future, the company will devote financial resources to build new internal capabilities and take responsibility for commercial development of its proprietary genes.

Arie Belldegrun, chairman of the board of directors, is chief of the urological oncology department of the UCLA School of Medicineand director of the Genitourinary Oncology Program at the Jonsson Comprehensive Cancer Center. Owen Witte, MD, the company's co-founder and chairman of its scientific advisory board, is a professor of microbiology and molecular genetics at UCLA and an investigator of the Howard Hughes Institute.—WD