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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________
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: November 5, 1998
Commission File Number 0-11094
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RIBI IMMUNOCHEM RESEARCH, INC.
(Exact name of registrant as specified in its charter)
Delaware 81-0394349
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(State of Incorporation) (I.R.S. Employer Identification No.)
553 Old Corvallis Road, Hamilton, MT 59840
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(Address of principal executive offices and zip code)
Registrant's telephone number, including area code (406) 363-6214
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RIBI IMMUNOCHEM RESEARCH, INC.
Item 5. Other Materially Important Events
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(a) On November 2, 1998 Ribi ImmunoChem Research, Inc. announced that
following discussions with the European Agency for the Evaluation of
Medicinal Products (EMEA), it had decided to withdraw the Marketing
Authorization Application (MAA) for the use of MELACINE melanoma
theraccine for the treatment of Stage IV melanoma in Europe. Ribi made
the decision after the EMEA requested Ribi conduct additional Phase 3
studies in Stage IV disease before it would continue review of the
MAA.
A copy of the press release issued on November 2, 1998 is attached
hereto as Exhibit 99.1
Item 7. Financial Statements and Exhibits
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(a) Financial Statements - None
(b) Performa Financial Information - None
(c) Exhibits
99.1 Press Release dated November 2, 1998
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereto duly authorized.
RIBI IMMUNOCHEM RESEARCH, INC.
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(Registrant)
November 5, 1998 By /s/ Ronald H. Kullick
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Ronald H. Kullick
Vice President - Legal Counsel
and Secretary
2
Exhibit 99.1
[LOGO]
Ribi ImmunoChem Research, Inc.
NASDAQ Symbol: RIBI
New Release
Founded in 1981 to pursue immunostimulants as therapeutic opportunities.
VOLUME 18 NOVEMBER 2, 1998 NUMBER 14
FOR IMMEDIATE RELEASE:
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Contact: Robert E. Ivy, Chief Executive Officer, President and Chairman
Kris Dyszynski, Director, Licensing Activities (406) 363-6214
RIBI WITHDRAWS MELACINE APPLICATION IN EUROPE
Will focus on U.S. and Canadian Applications
HAMILTON, MONTANA, NOVEMBER 2, 1998 - Ribi ImmunoChem Research, Inc.
(NASDAQ:RIBI) announced today that following discussions with the European
Agency for the Evaluation of Medicinal Products (EMEA), it has decided to
withdraw the Marketing Authorization Application (MAA) for the use of MELACINE
melanoma theraccine for the treatment of Stage IV melanoma in Europe.
Ribi made this decision after the EMEA requested that Ribi conduct additional
Phase 3 studies in Stage IV disease before it would continue review of the MAA.
Ribi submitted the MAA on the basis that median survival was equal to that of
four-drug chemotherapy, that clinical responders to MELACINE therapy lived
significantly longer than nonresponders, 18.2 months versus 9.4 months, and that
the quality of life associated with MELACINE was superior to that of four-drug
chemotherapy.
Ribi will continue to develop the Food and Drug Administration (FDA) filing for
approval of MELACINE for marketing in the United States. After reviewing the
data presented at a Biologic Licensing Application (BLA) meeting in July 1998,
the FDA directed Ribi to file data that supports a claim for the durability of
tumor response in Stage IV melanoma patients receiving MELACINE. "We are
encouraged the FDA will consider durability of tumor response in their review of
MELACINE. Durability is quite different from the clinical application or claims
requested from the EMEA in the European MAA. Durability of response claims are,
we believe, supported by the data generated in our completed Stage IV study,"
stated Robert E. Ivy, CEO, President and Chairman of Ribi. "Ribi's belief that
marketing approval can be achieved in the U.S. has not changed, and with the
European review now suspended, Ribi can focus its attention on our filing with
the FDA."
The filing of the New Drug Submission (NDS) for MELACINE with Canada's Health
Protection Branch (HPB) was completed over a year ago. Since that time Ribi has
responded to all questions asked in a timely manner, and the HPB conducted a
site inspection of Ribi's manufacturing facility in July 1998. By the end of
December 1998 Ribi will have responded to issues raised during the inspection
and completed submission of several serial production runs of MELACINE required
by the HPB. Ribi will continue to work cooperatively with the HPB to ensure the
most expeditious review of the NDS.
(MORE)
RIBI WITHDRAWS MELACINE APPLICATION IN EUROPE
PAGE 2 - Volume 18, Number 14
November 2, 1998
MELACINE is presently being studied in two additional Phase 3 trials. The
Southwest Oncology Group is conducting a trial of MELACINE in patients with
Stage II melanoma as adjuvant therapy after surgical removal of primary disease.
This study will determine if MELACINE therapy reduces the recurrence rate of
melanoma in Stage II disease. Using current therapies, the recurrence of disease
in these patients approximates 30%. Accrual to this study was completed in
November 1996. In cooperation with Schering-Plough Corporation, Ribi is
conducting a trial using combination therapy of MELACINE and INTRON A in Stage
IV melanoma. This study will include 300 patients randomly assigned to either
MELACINE plus INTRON A or INTRON A alone. Results from these two trials are
expected in 1999.
Worldwide, the incidence of melanoma is increasing at a rate greater than any
other cancer with the exception of lung cancer in women. Stage IV melanoma is
the most advanced and deadly form of melanoma, with associated metastasis to the
brain, lungs, liver or other visceral organs the most common cause of death. If
approved, MELACINE could be the first tumor-specific vaccine to reach
commercialization.
Corporate collaborations developing vaccines with Ribi adjuvants are continuing.
Recently announced were the favorable Phase 2 results in breast cancer patients
of a vaccine being developed by Chiron Corporation and Biomira, Inc. containing
Ribi adjuvant, as well as the FDA's agreement that this vaccine may now move
forward into pivotal Phase 3 studies. In a new partnership, Ribi recently
announced an agreement with Allergy Therapeutics, Ltd. which provides for Ribi's
adjuvant, MPL immunomodulator, to be used in vaccines to desensitize patients
which suffer from certain allergies.
Since 1991 SmithKline Beecham and since 1992 American Home Products have been
developing vaccines for infectious diseases containing Ribi's MPL. Two vaccines,
one for hepatitis B and one for genital herpes, are nearing the end of extensive
Phase 3 studies. The data from these studies should be announced soon.
Ribi ImmunoChem Research, Inc., a biopharmaceutical company founded in 1981, is
engaged in the development of immunomodulators for use in preventing and
treating human disease.
Forward Looking Information Statements in this news release are based on current
expectations. Actual results may differ materially based upon various risk
factors. Additional information regarding risk factors is contained in the
Company's Form 10-K for the year ended 1997, and Form 10-Q for the first and
second quarters of 1998, as filed with the U.S. Securities and Exchange
Commission.
# # #
Ribi ImmunoChem Research Inc. press releases are available through Company News
On-Call by fax, 800-758-5804, ext. 752250, or at
http://www.prnewswire.com/cnoc.html and the Corporate web site at
http://www.ribi.com.