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Lead Products: SPORIDIN-GTM for AIDS Diarrhea The Disease SPORIMN-G, produced from bovine colostrum with high titers of anti-Cryptosporidium parvum antibodies, is designed to mitigate the symptoms due to infections by the parasite Cryptosporidium parvum. Cryptosporidium parvum is an intestinal parasite, infecting both humans and animals. Healthy individuals recover after a week of discomfort and diarrhea; AIDS patients develop a lingering, debilitating diarrhea. Cryptosporidium parvum has been in the headlines a number of times recently, both due to its causing of diarrhea in AIDS patients and also for the epidemic it caused when it infected Milwaukee's water supply in March 1993 producing diarrheal illness in over 400,000 individuals and tragically death in at least 50 AIDS patients. The Market Opportunity It is estimated that 10 percent of AIDS patients in the U.S. have cryptosporidiosis, with higher percentages reported in developing countries. In addition, diarrhea is associated with malnutrition, wasting, decreased quality of life and early death. It is expensive, adding more than$10,000 in annual medical costs. Most cases respond poorly to existing therapies and no drug is currently approved for this indication. GalaGen believes that the medical need and market opportunity for SPORIDIN-G is substantial. Development Status Patients have received SPORIMN-G under a compassionate-use protocol. Many have had serious disease j that was unresponsive to other available, but unapproved therapies. About half of the 28 patients treated with SPORIDIN-G received clinical benefit in the form of parasite eradication,diarrheal symptom reduction, or more general clinical improvement, including weight gain and improved appetite. A Phase I/II clinical trial in adult AIDS patients was initiated in December 1994 at San Francisco General Hospital. The study is exploring the efficacy of SPORIDIN-G in several different populations. Preliminary results in the group with C.parvum as their sole infection appear to confirm the clinical benefits seen in the compassionate use program. A pivotal clinical trial planned to begin in October 1995 may be the final trial required to submit for regulatory approval in the U.S. This pivotal Phase II/III trial has been discussed with the FDA and a study design incorporating their suggestions will be submitted in August 1995. SPORIDIN-G received approval for orphan drug status in March 1994. New Adjuvant Technology In March 1995 GalaGen licensed proprietary adjuvant technology from Chiron Corporation for the immunization regimen that produces SPORIDIN-G. The adjuvant, MF59-0, increases specific anti- Cryptosporidium parvum antibody levels four-fold. SPORID[N-G produced with MF59-0 has shown superior efficacy versus non-MF59-0 product in both in vitro and animal models. GalaGen has worldwide, exclusive rights to the use of MF59-0 for producing bovine antibody products intended for Cryptosporidium parvum and will use the adjuvant for product used in pivotal clinical trials. I i