Chairman's Address
It gives me much pleasure to open this Annual General Meeting of Biota
Holdings and to present to you the Annual Report and Financial
Statements for the 1996/97 year.
It has been a very busy and exciting year for Biota with our influenza
drug GG167 going into Phase III Clinical Trials and the first field
trials of our influenza diagnostic test kit. We have also brought new
projects into our portfolio in the area of cancer, as well as advancing
our existing projects in diabetes and cancer to the next stages of their
development. We are undertaking research into RSV, a virus causing a
very common flu-like illness in young children, and into rhinovirus, the
cause of the common cold. For these projects we are using the same
discovery techniques as were employed in the influenza project. All of
these targets are in keeping with Biota's goal of addressing important
diseases with no suitable or effective current treatment.
GG167 - The Influenza Therapeutic
Biota is pleased to advise that the Southern Hemisphere Phase III
clinical trials of GG167, conducted by our partner Glaxo Wellcome
Australia, are now complete. A total of 455 patients with a clinical
diagnosis of influenza were enrolled, well in excess of the target
number of 350. Analysis of the data from the study is now under way.
This Southern Hemisphere trial is part of a comprehensive world-wide
Phase III programme which includes two separate pivotal proof of
efficacy studies which commence in the Northern Hemisphere this month.
This continued progress, and the positive results of earlier Phase II
trials give us encouragement that the goal of filing for market approval
towards the end of next year should be met.
Point of Care Influenza Diagnostic
Over 100 patients with a clinical diagnosis of influenza have been
enrolled into a pilot study of the influenza diagnostic test kit. This
study was carried out in Adelaide, in conjunction with our development
partner BioStar, Inc of Boulder, Colorado and compared the rapid, on the
spot test to existing laboratory methods which require several days to
generate a diagnosis. The study was conducted through 5 clinics in the
Adelaide area with two scientists from BioStar working at the Institute
of Medical and Veterinary Science (IMVS) Infectious Diseases
Laboratories. Final analysis of samples is still in progress. Further
trials will now be undertaken in the United States this forthcoming
winter (1997/98), in preparation for FDA submission in 1998.
Strategic Alliance
Biota further strengthened its relationship with Dr. Peter Colman and
the Biomolecular Research Institute in the area of structure-based drug
design by signing a strategic alliance agreement earlier this year. Work
is being undertaken on both the RSV project and on a colon cancer
project in collaboration with the BRI.
Progress in Cancer Program
In April 1997, Biota signed an agreement with LaTrobe University for
exclusive rights to a series of novel anti-cancer compounds. These could
have applications for colon and rectal cancer and possibly others, such
as stomach and lung cancers. Work is ongoing to select a lead candidate
drug for further animal testing and clinical development.
The company is also evaluating anticancer compounds available under an
option agreement with two Japanese Companies. We have taken up a second
option period for evaluation and are currently conducting animal tests
so that we may further analyse the data.
Work on a third cancer project, to develop an inhibitor of colorectal
cancer, which works on a different principle, is being conducted under a
recently signed agreement with the Biomolecular Research Institute, as
part of Biota's broad alliance with that institute, already mentioned.
Diabetes Project
As advised earlier this year, we are continuing support for our diabetes
project at the CSIRO to develop an oral form of insulin. The project
continues to meet expectations and funding has been extended to July
next year. |
