(SHAMAN-PHARMACEUTICALS)(SHMN) Shaman Initiates Open-Label Study of SP-303/Provir: Provides Access to Diarrhea Treatment for People With AIDS Business Wire
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(SHAMAN-PHARMACEUTICALS)(SHMN) Shaman Initiates Open-Label Study of SP-303/Provir: Provides Access to Diarrhea Treatment for People With AIDS

Business Wire - Tuesday, January 12, 1999


SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Jan. 12, 1999-- Shaman Pharmaceuticals, Inc. (Nasdaq:SHMN) announced that it enrolled as planned at the end of December the first patients in an open-label study of SP-303/Provir(TM) for the treatment of diarrhea in people with AIDS to provide access to the drug for some patients from previous trials of SP-303 who are most in need.

The intent of the open-label study is to provide a sub-group of patients with access to the drug on an on-going basis pending registration and commercial availability. Individuals who are eligible for the study will be identified by selected physicians who served as study investigators, and the drug is expected to go to those who are in the greatest medical need.

"We have worked for some time with both the FDA and the Community on the design of this trial," commented Jim Pennington, Senior Vice President of Clinical Research and Chief Medical Officer. "Because of the success of our Phase III trial, we are now even more committed to this study which serves two purposes: to provide access to the drug for patients most in need, and to allow for the collection of even longer term safety data to support SP-303."

The news follows on the heels of positive results announced at the end of December from the pivotal phase III study of SP-303 for the treatment of diarrhea in people with AIDS. That study further reinforced the efficacy and safety profile of SP-303, which has now been administered for periods of up to one month, and has been well-tolerated, even in a medically complex patient population of people living with AIDS.

Lisa Conte, President and Chief Executive Officer, commented, "We are quite pleased with the strength of our Phase III results in such a heterogeneous population, who experience diarrhea of multiple, and for the most part, unknown etiologies. We are particularly heartened by the fact that Provir seemed to have an even more pronounced effect in the patients who entered the trial with the most severe diarrhea. One can only imagine the dramatic impact of treatment on the lifestyle of such patients."

The Company will be meeting with the FDA in January for a pre-NDA meeting, and remains on track to submit an NDA filing in early 1999. SP-303 has already received "fast-track" designation from the FDA for the AIDS indication.

J.D. Haldeman, Vice President of Commercial Development added, "We are committed to working with the FDA and the AIDS/HIV Community to make this product commercially available as soon as possible. We are acutely aware that the problem of diarrhea in people living with AIDS remains a significant unmet medical need. We hope to be part of the solution."

Shaman Pharmaceuticals discovers and develops novel pharmaceutical products for major human diseases by isolating active compounds from tropical plants with a history of medicinal use. The Company has three compounds in clinical development: SP-303/Provir(TM), an oral product for the treatment of diarrhea in people with AIDS, and other watery diarrhea indications; nikkomycin Z, an oral antifungal for the treatment of systemic fungal infections; and SP-134101, an oral product for the treatment of Type II diabetes. Shaman maintains an active Type II diabetes research program which serves as the basis for its collaboration with Lipha s.a., a wholly-owned subsidiary of Merck KGaA, Darmstadt, Germany.

Note: Provir(TM) is a trademark of Shaman Pharmaceuticals, Inc. Shaman Pharmaceuticals(R) is a registered U.S. trademark of the company.

This press release contains, among other things, certain statements of a forward-looking nature relating to Shaman's ability to advance its clinical development and research programs. Such statements involve a number of risks and uncertainties including the timing and results of preclinical and clinical studies and determinations by the U.S. Food and Drug Administration with regard to the approvability of, and label indications for, the Company's products, as well as the Risk Factors listed in the Company's SEC filings including, but not limited to, those contained in Shaman Pharmaceuticals, Inc.'s Annual Report on Form 10-K/A for the year ended December 31, 1997. These filings are available upon request at 650/952-7070. Also, visit Shaman at http://www.shaman.com.

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CONTACT: Shaman Pharmaceuticals, Inc. J.D. Haldeman, 650/952-7070 ext. 485
990112
BW990103


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