Lotronex Withdrawal Emphasizes Lack of Pharmaceutical Treatment Options for Estimated 50 Million IBS Sufferers.

Business Editors, Health/Medical Writers

SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Dec. 6, 2000

Shaman Pharmaceuticals, Inc. (OTCBB:SHPH.OB), as part of its ongoing effort to address unmet health needs, today stated that Glaxo Wellcome's recent voluntary removal of Lotronex from the market further highlights the lack of options for treating Irritable Bowel Syndrome (IBS) or its individual manifestations such as recurrent diarrhea. Shaman believes it may have at least one product that can safely and effectively address individual symptoms in this largely unmet health care area.

Health professionals estimate that one in five adults will be affected by IBS at sometime in their lives and that currently up to 20% of the U.S. population, or over 50 million individuals, report symptoms consistent with IBS. IBS is the most common functional bowel disorder. This syndrome is also the most common GI diagnosis among gastroenterology practices in the U.S. and one of the top 10 reasons for physician visits. It affects predominately women with almost 75% of IBS sufferers being female. Furthermore, an estimated 75% of all IBS sufferers experience recurrent or chronic diarrhea.

IBS is also noted as one of the leading causes of absenteeism. U.S. data indicates that IBS is the second most common reason for reporting sick after the common cold. The financial impact on the direct cost of U.S. health care services is estimated at $8 billion a year, not including indirect costs from loss of productivity.

Historically, treatment for IBS has only tackled the symptoms of the disorder. Traditional management of IBS has centered around education, support groups, stress management, dietary modification, fiber intake, behavioral or psychological modifications, setting realistic goals, and treatment of symptoms.

Promising research for a holistic treatment option has focused on the fundamental problem, centered around the role serotonin (5-HT) plays in the gut. Serotonin is a neurotransmitter prevalent in the intestinal track. One of the first new pharmaceutical medications to emerge from this research has been Glaxo Wellcome's Lotronex, recently introduced in the U.S. Effectiveness of Lotronex against key IBS symptoms has not been firmly established however, and the company voluntarily withdrew the drug at the request of the FDA recently due to safety concerns. This leaves patients, once again, without an alternative treatment option for the core problem of IBS.

Safe and effective treatment options for the individual symptoms associated with IBS are also limited. For the recurrent diarrhea that is estimated to effect as many as 75% of IBS suffers, patients use one or more anti-motility medications such as over the counter Imodium or prescription medications such as Lomotil. Alternatives are absorbent water-binding medications, over the counter Kaopectate, or anti-secretory medications such as Pepto-Bismol. Each of these medicines can be used only intermittently. For example, anti-motility agents are labeled and recommended for use for no more than for two consecutive days and may lead to exaggerated rebound diarrhea or trigger constipation. Anti-motility agents may also be associated with abdominal discomfort based on the nature of their mechanism of action.

Importantly, based on market usage data, Shaman's NSF and NSF-IB, which contain the patented principal ingredient SP-303, may provide relief from diarrhea caused by a broader variety of stimuli than those tested in the Company's Phase II and Phase III clinical studies, such as IBS related diarrhea. This data indicates that the majority of individuals purchasing the anti-diarrheals purchase them for relief from IBS related diarrhea or undiagnosed diarrheas consistent with IBS associated diarrhea. Shaman believes NSF and NSF-IB may consequently represent a meaningful advance in treating this significant symptom.

The principal ingredient in NSF and NSF-IB works based on a unique anti-secretory mechanism of action that relieves diarrhea without causing constipation or affecting the motility of the gut. Unlike the recently introduced products for GI distress which act at the 5HT serotonin R site, or leading anti-diarrheals that provide efficacy through an anti-motility mechanism that warn customers not to use them for more than two consecutive days, SP-303 provides a safe and comfortable solution for patients. Multiple surveys of Shaman customers purchasing the SP-303 extract product indicate that 40%-60% bought it to treat IBS related diarrhea even though it was not marketed as an IBS solution originally.

Rigorous clinical studies have confirmed the safety and efficacy of NSF for extended use for controlling diarrhea. Consumers have reported using NSF safely for more than 12 consecutive months with no untoward effects. A year long study performed at the University of California, San Francisco Medical Center assessed the long-term safety and efficacy of the NSF extract.

Shaman Pharmaceuticals, Inc. is a leader in medicinal plant research and commercialization of proprietary dietary supplements. Shaman works collaboratively with indigenous communities to discover, harvest and reforest medicinal plants. The Company also provides cultural educational programs in conjunction with rainforest communities. Shaman has retained Roth Capital Inc., an investment bank that focuses on emerging growth and middle market companies, to provide a broad range of corporate finance, research, syndicate sales and trading services to assist Shaman in exploring strategic business opportunities to drive shareholder value.