Biota- Is about to leave the starting blocks- stand by for the ride!!!!!
Biota will receive $150million on the handover of it's new drug
Zanamivir.It will get further royalty payments of 6 % throughout the
patent life of the product.This new and novel compound represents a
major step forward in the treatment of influenza.Biota is set to become
a major Biotech company with the imminent release of Zanamivir.
Biota Annnounces Zanamivir Will Enter Phase III Clinical Trials in May
1997
24 February 1997
Melbourne, Australia, - Biota Holdings Limited (Australian Stock
Exchange: BTA) today announced that Glaxo Wellcome plc, the Company's
development partner, has informed management that Phase III clinical
trials of Zanamivir, or GG167, for the treatment of influenza, planned
to start in 1997, will begin in Australia in May. This Southern
Hemisphere trial will be a part of a comprehensive world-wide Phase III
programme which will also include two separate pivotal proof of efficacy
studies to be initiated in the Northern Hemisphere from October of this
year.
Results from the Phase IIB studies from the Northern Hemisphere,
together with those from earlier studies confirm that zanamivir is a
potentially valuable therapy for influenza. These data allow
optimisation of the design of the Phase III programme.
Zanamivir will be administered twice daily for 5 days in these trials
using Glaxo Wellcome's proven DiskhalerT technology for inhaled dosing
directly into the lungs. Human studies conducted during the last few
months have confirmed that the DiskhalerT delivers zanamivir
consistently and effectively throughout the respiratory tract. Lung
delivery ensures that the drug is given directly to the site of the flu
infection. The DiskhalerT, based on the well established device used by
millions of asthma patients, has been well accepted by patients in all
clinical trials of zanamivir conducted to date.
Concurrent with the Phase III programme, Biota in collaboration with
Biostar, will continue to develop and commercialise a rapid and
easy-to-use diagnostic aid for influenza.
World-wide filing for zanamivir is planned to take place in the second
half of 1998. |
