With the possibility of three product filings in 1997 and potentialapprovals in 1998, US firm Ribi ImmunoChem says it is ready to meet commercial demands with a facility capable of manufacturing 60 million adjuvant doses annually.
Speaking at the 15th annual Hambrecht & Quist health care conference in the USA, Robert Ivy, chief executive of the firm, told delegates that his company plans to submit requests for regulatory approval of its Melacine melanoma theraccine (therapeutic vaccine) in Canada, Europe and the USA in 1997. Melacine, which could become the first off-the-shelf, tumor-specific therapeutic cancer vaccine ever approved, provides a survival benefit to late-stage melanoma patients equal to or better than other currently available therapies with superior quality of life benefits over current state-of-the-art chemotherapy, he said.
Ribi ImmunoChem is awaiting a mid-1997 analysis of definitive data of a herpes vaccine being developed by SmithKline Beecham and incorporating a Ribi adjuvant (Marketletters passim). If the data is favorable, Ribi is hopeful that SB could file for approval towards the end of the current year. If approved, the product would be the first commercialized infectious disease vaccine incorporating a Ribi adjuvant and the first incorporating a new adjuvant since the 1930s.
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