Ribi ImmunoChem's Melacine Marketing Application Granted Expedited
Review By European Regulatory Agency
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HAMILTON, Mont., March 30 /PRNewswire/ -- Ribi ImmunoChem Research, Inc. (Nasdaq: RIBI - news) 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 [NYSE:SGP - news] 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.
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SOURCE: Ribi ImmunoChem Research, Inc. |
