- Subject: Ribi ImmunoChem's Melacine Marketing Application Granted...
- From: AOL News <AOLNews@aol.com>
- Date: Mon, 30 Mar 1998 10:08:54 EST
- Organization: AOL (http://www.aol.com)
Ribi ImmunoChem's Melacine Marketing Application Granted Expedited Review By
European Regulatory Agency
HAMILTON, Mont., March 30 /PRNewswire/ -- Ribi ImmunoChem Research, Inc.
(Nasdaq: RIBI) today announced that the Marketing Authorization Application
(MAA) for Melacine melanoma theraccine has been fully accepted and granted
expedited review by the European Agency for Evaluation of Medicinal Products
(EMEA). Melacine was also awarded Orphan Drug designation by the European
agency.
"We are extremely pleased that the EMEA found the Melacine application
complete and in full compliance," said Mr. Robert E. Ivy, Chairman, CEO and
President. "The next step in the process will be an analysis of the clinical
data by their Committee for Proprietary Medicinal Products (CPMP), followed by
detailed review of manufacturing, packaging and labeling documentation to
ensure that the needs of individual countries covered under the application
are met. With a positive outcome of this expedited review, Melacine could
receive European marketing clearance by the end of 1998."
If approved by the EMEA, Melacine will be available in fourteen European
countries and be distributed, marketed and sold by Schering-Plough Corporation
under a recently announced licensing agreement.
The European marketing application presents the results of a pivotal Phase
study that compared Melacine with four-drug chemotherapy in Stage IV melanoma
patients. Survival, quality of life, response rates, as well as toxicity and
immunologic effects were compared. In the completed study, Melacine was shown
to provide a substantial quality of life benefit over chemotherapy, while the
two modalities achieved similar median survival during the active treatment
period. However, significantly longer median survival was seen among patients
who were clinical responders to Melacine (18.2 months vs 9.4 months for
nonresponders). By comparison, median survival was not significantly longer in
responders to chemotherapy (15.2 months vs 9.5 months for nonresponders). A
clinical responder was defined as a patient showing complete or partial tumor
regression or stabilization of the disease. In a subset of patients showing
complete or partial tumor regression only, those patients given Melacine
achieved survival of 34 months compared to only 15.7 months for patients
receiving chemotherapy.
"These data indicate that patients responding to Melacine have a substantial
survival benefit," explained Mr. Ivy, "and a clinical response can be
determined after 14 weeks of therapy, allowing responding patients to continue
maintenance therapy with Melacine while giving physicians an early opportunity
to alter therapy for nonresponding patients. However, with the data indicating
no survival advantage with tumor regression for chemotherapy, if approved,
Melacine may be considered a first line of defense for these late-stage
melanoma patients."
The prevalence of melanoma in Europe is estimated at approximately 170,000
people with approximately 5,000 deaths expected in 1998. Market size for
Melacine, based on this estimate, is between $150 million to $200 million in
Europe. Similar prevalence and market size is estimated for the U.S. market.
Worldwide 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.
Localized (Stage I and II) melanoma is generally curable with surgical
excision of the lesion. However, 35% of these patients have disease recurrence
within five years and progress to terminal disease.
As previously announced, Ribi has completed submission and is awaiting
response from the Canadian Health Protection Branch for approval of Melacine
as a treatment for Stage IV melanoma in Canada. Ribi is on schedule to submit
a Biologic License Application for Melacine in Stage IV melanoma to the U.S.
Food and Drug Administration later this year.
Additionally, several other studies using Melacine as monotherapy or in
combination with biotherapy are in various stages of study. A pivotal Phase 3
study of Melacine in Stage II melanoma patients, which utilizes. Melacine
after surgical removal of their lesions to prevent recurrence of the disease,
reached full accrual in 1996. Patients will be followed to determine
prevention of recurrence through November 1998, and for overall survival until
November 2000. Final disease-free data is expected mid 1999, with overall
survival data expected mid 2001. This study is being conducted by the
Southwest Oncology Group, with support from the National Cancer Institute.
Recently, an initial analysis of the first 168 patients accrued in a study of
Stage IV melanoma patients receiving Melacine/Intron A combination biotherapy
resulted in the Data and Safety Monitoring Board unanimously recommending
continuation of the study. Full patient accrual is expected by year-end 1998
with final analysis at the end of 1999.
"Ribi is steadily progressing toward our goal of bringing Melacine to a
worldwide market; thus providing physicians a clinically proven alternative to
chemotherapy and to melanoma patients a therapeutic with a better quality of
life during treatment," stated Mr. Ivy.
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.
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.
SOURCE Ribi ImmunoChem Research, Inc.
CO: Ribi ImmunoChem Research, Inc.; Schering-Plough Corporation
ST: Montana
IN: MTC
SU:
03/30/98 09:57 EST http://www.prnewswire.com
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