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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): OCTOBER 30, 1997
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SHAMAN PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in charter)
DELAWARE 0-21022 94-3095806
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
213 EAST GRAND AVENUE, SOUTH SAN FRANCISCO, CALIFORNIA 94080
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (415) 952-7070
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(Former Name or Former Address, if Changed Since Last Report.)
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ITEM 5. OTHER EVENTS
In a press release disseminated on October 30, 1997, Shaman
Pharmaceuticals, Inc. (the "Company") publicly announced results of development
of Provir for the treatment of AIDS diarrhea as well as the status of Provir
acute watery diarrhea studies.
A copy of the Press Release is attached hereto as Exhibit 99.1 and
incorporated herein by reference.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(a) Financial Statements.
The registrant has determined that no financial statements are required
to be filed pursuant to this item.
(b) Pro Forma Financial Information.
The registrant has determined that no pro forma financial information
is required to be filed pursuant to this item.
(c) Exhibits.
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Exhibit No. Description
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99.1 Press Release dated October 30, 1997.
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2.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: November 18, 1997 SHAMAN PHARMACEUTICALS, INC.
(Registrant)
By: /s/ LISA A. CONTE
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Name: Lisa A. Conte
Title: President and Chief Executive
Officer
3.
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Shaman Pharmaceuticals, Inc.
Exhibit Index
to Form 8-K
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Sequentially
Numbered
Exhibit No. Description Page
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<S> <C> <C>
99.1 Press Release dated October 30, 1997.
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EXHIBIT 99.1
Contact: Lisa A. Conte FOR IMMEDIATE RELEASE
Shaman Pharmaceuticals, Inc.
(650) 952-7070, x465
SHAMAN ANNOUNCES POSITIVE RESULTS AND CONTINUATION OF
DEVELOPMENT OF PROVIR FOR TREATMENT OF AIDS DIARRHEA AND
STATUS OF PROVIR ACUTE WATERY DIARRHEA STUDIES
South San Francisco, California -- October 30, 1997 -- Shaman
Pharmaceuticals, Inc. (Nasdaq: SHMN) announced today the results of a Phase II
double-blind, randomized, placebo-controlled pilot study that examined Provir's
ability to treat diarrhea in patients with AIDS. The study was a five-day,
in-hospital trial that required a 24-hour baseline observation period and four
days of treatment with either Provir or a placebo.
The trial was conducted at San Francisco General Hospital and at the
Veterans Administration Hospital of Palo Alto which is closely affiliated with
the Stanford University School of Medicine. The data from the study will be
submitted for presentation at the Twelfth World AIDS Conference in June 1998.
Dr. James Pennington, Shaman's senior vice president and chief medical
officer, who recently joined the Company from Bayer Corporation, stated, "The
data from this study show a statistically significant treatment effect over the
four days of the study period and suggest that there may be additional benefit
to be gained by a longer treatment period. We intend to work with the FDA in an
expedited program to design and conduct trials that test Provir for longer
treatment periods with larger patient populations." Specific data from this
trial are attached.
Dr. Pennington also commented, "Diarrhea remains a major problem in
patients suffering from AIDS. We are convinced that Provir can have a
substantial impact on decreasing this devastating syndrome for which no
satisfactory treatment currently exists."
Shaman also announced today conclusions derived from an interim analysis
from one of its ongoing Phase II dose-optimization studies of Provir in acute
watery diarrhea, which includes mild non-specific diarrhea, moderate to severe
traveler's diarrhea, and moderate to severe non-specific diarrhea. This interim
analysis involved 166 Mexican national patients in a double-blind,
placebo-controlled, mild diarrhea study of non-specific causes in Mexico.
Although the analysis provides additional evidence that Provir is safe,
well-tolerated, and not systemically absorbed, it did not support further
studies in this particular mild diarrhea indication. The Company instead will
continue its efforts involving the use of Provir in moderate to severe diarrhea,
such as traveler's diarrhea.
Lisa Conte, Shaman's president and CEO stated, "The data from this
interim analysis, together with our very positive results in diarrhea in
patients with AIDS, provide supporting information for the ongoing and upcoming
studies of Provir in traveler's diarrhea and other more serious diarrheas,
including an in-hospital study that we have recently initiated in Venezuela."
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Shaman Pharmaceuticals discovers and develops novel pharmaceutical
products for major human diseases by isolating active compounds from tropical
plants. The Company has three compounds in clinical development: Provir, an oral
product for the treatment of watery diarrhea; Virend, a topical antiviral for
the treatment of herpes; and nikkomycin Z, an oral antifungal for the treatment
of endemic mycoses. Shaman also has an active Type II diabetes program which
served as the basis for its collaborations for the development of its diabetes
drugs with Lipha s.a., a wholly owned subsidiary of Merck KGaA, Darmstadt,
Germany and with Ono Pharmaceutical Co., Ltd. of Japan.
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Note: Virend(R) and Provir(TM) are trademarks of Shaman Pharmaceuticals, Inc.
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, 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, 1996 and Quarterly Report on Form 10-Q
for the quarter ended June 30, 1997. These filings are available upon request at
650/952-7070.
2.
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DATA FROM SHAMAN'S PHASE II DOUBLE-BLIND, PLACEBO-CONTROLLED
AIDS DIARRHEA STUDY
Data from 51 evaluable patients indicate that Provir showed improvement
in treating AIDS-related diarrhea in the primary variables of reduction in stool
weight and abnormal stool frequency. A multivariate analysis of the treatment
effect over four days based on evaluation of daily measurements indicated that
patients treated with Provir experienced a statistically significant reduction
in stool weight (p=0.018), and a reduction in abnormal stool frequency (p=0.047)
when compared with a placebo.
The Provir treated group (26/51 evaluable patients) experienced a mean
reduction from baseline stool weight of 451.3 grams by day four of treatment
versus a mean reduction from baseline stool weight of 150.7 grams for the same
measurement period (p=0.14) in patients receiving placebo (25/51 evaluable
patients). Provir-treated patients also experienced a reduction in abnormal
stool frequency from a mean of 5.2 abnormal stools in 24 hours to a mean of 2.2
abnormal stools at day four compared with a reduction in abnormal stool
frequency from 5.2 abnormal stools in 24 hours to 3.1 abnormal stools at day
four in placebo treated patients (p=0.26).
The study did not achieve statistical significance for Provir in
subjective patient assessments of gastrointestinal symptoms associated with
diarrhea. However, the study did achieve statistically significant results
(p=0.035) for a measurement of relief, defined as the maximum time between
abnormal stools.
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