Adrian: Here's a news release that says 3TC and Epivir are the same drug I think.
TSE, ME SYMBOL: BCH
NASDAQ SYMBOL: BCHXF
JULY 23, 1996
BioChem Pharma Inc. - Epivir(TM) (3TC(R)) Clinical Endpoint Study
Stopped Early Results Show Significant Reduction in HIV Disease
Progression or Death
LAVAL, QUEBEC - BioChem Pharma Inc. today announced that a study to
determine the effect of the anti-HIV therapy 3TC(R) (Epivir(TM)) on
survival or delay in disease progression has been stopped after an interim
analysis of data showed a 54 percent reduction in the rate of progression to
AIDS or death for HIV patients who had 3TC in their treatment regimen,
compared to placebo. The trial, begun in March 1995, was originally
scheduled to end in March 1997.
The study was designed to investigate the clinical efficacy of adding 3TC to
patients' existing anti-HIV therapy, or adding 3TC to AZT for patients who
were not receiving therapy at study entry. The most common existing therapy
among patients recruited
into the study was AZT alone.
Discontinuation of the study nearly eight months early was
recommended by an independent Data Safety and Monitoring Board
(DSMB) following a scheduled interim analysis of data from the
trial. The recommendation was made on the basis of data which
exceeded the pre-specified requirements for possible
discontinuation due to the superior efficacy of one treatment
arm. The trial's coordinating committee endorsed the DSMB
recommendation.
"Members of the DSMB have reviewed the results of this study and
unanimously recommend the discontinuation of the trial to allow
all participants access to the 3TC/AZT combination," said
Professor Ragnar Norrby, Chairman of the DSMB and a clinician at
the University of Lund, Sweden.
The clinical endpoint study, known as CAESAR, an acronym of the
countries involved in the study, (Canada, Australia, Europe,
South Africa), was initiated in March 1995. Patients recruited
into the study had CD4 counts of between 25 to 250 cells/mm3 and
were currently receiving one of three "background" treatments -
AZT alone, AZT + ddI or AZT + ddC. Patients were then randomized
to one of three regimens: their current HIV therapy plus 3TC;
current HIV therapy plus 3TC and loviride (investigational
non-nucleoside reverse transcriptase inhibitor; Janssen
Pharmaceutica); or, current therapy plus placebo.
Results from the scheduled interim analysis of the data were
reviewed by the DSMB on July 15, 1996. These results showed that
amongst the 1,892 HIV positive patients recruited, progression to
the combined endpoint of AIDS or death was reduced by 54 percent
for those treated with 3TC compared to placebo. The addition of
3TC also resulted in a significant survival benefit when assessed
alone. The addition of loviride was not shown to provide
additional clinical benefit to that seen with 3TC in the overall
trial. Additional analyses are underway to determine the effect
of loviride within specific groups of the study population.
The addition of 3TC or loviride to the existing treatment
regimens resulted in no additional clinical or laboratory side
effects over the control arm. All three arms were generally well
tolerated with 5 percent of patients receiving current therapy
plus placebo, 3 percent of patients receiving current therapy
plus 3TC and loviride and only 2 percent of patients receiving
current therapy plus 3TC withdrawing from the study due to
adverse events.
Today's news comes on the heels of several major presentations of
data two weeks ago in Vancouver, BC, at the XI International
Conference on AIDS in which the addition of a third drug to the
cornerstone combination of 3TC/AZT resulted in unmeasurable
plasma HIV RNA levels in many patients. The results reported
today also support the findings of a meta-analysis presented in
Vancouver which suggested that the combination of 3TC/AZT may
have been associated with a delay in disease progression in the
four pivotal clinical trials on which the drug's accelerated
approval was based.
Epivir is now approved in the US and Brazil and, under the trade
name 3TC, in Canada, New Zealand, Uruguay, Australia, South
Africa and Switzerland. The European Union's Committee for
Proprietary Medicinal Products (CPMP) voted in April 1996 in
favor of recommending the approval of Epivir for marketing in
Europe and the final decision on marketing approval by the
European Commission is awaited.
Under the terms of a license agreement between BioChem Pharma and
Glaxo Wellcome, BioChem receives royalties based on sales of
3TC(R) (Epivir(TM)). Under the terms of the agreement, Glaxo
Wellcome has the right to develop, manufacture and sell 3TC(R)
(Epivir(TM)) worldwide, subject to special arrangements in
Canada, where a Glaxo Wellcome BioChem partnership is
commercializing 3TC(R).
BioChem Pharma is an international biopharmaceutical company
dedicated to the research, development and commercialization of
innovative products for the prevention, detection, and treatment
of human diseases. The Company's shares are traded on the
Montreal and Toronto Stock exchanges (BCH) and on NASDAQ (BCHXF).
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FOR FURTHER INFORMATION PLEASE CONTACT:
BioChem Pharma Inc.
Christine Lennon
Vice President, Corporate Communications
(514) 978-7938
John |
