Major Milestones for Biota's Influenza Drug
Melbourne, Australia, 30 March 1998
Biota Holdings Limited has announced that an application to market its influenza drug, RelenzaTM (zanamivir) will be filed today with the regulatory authorities in Australia.
The filing marks the culmination of comprehensive scientific efforts that began in the 1980s, as well as the completion of a demanding clinical program in Australia.
Biota also announced that it had reached an agreement with its development partner Glaxo Wellcome, whereby it will receive an increased royalty arising from net sales in Australia, New Zealand, Indonesia and South Africa, in return for its co-marketing rights.
RelenzaTM Filed for Marketing Approval
Following a successful Phase III trial in Australia last winter, Glaxo Wellcome Australia will today file with the Therapeutic Goods Administration (TGA) of the Commonwealth Department of Health and Community Services for approval to market the drug.
Biota's Chief Executive Officer, Dr. Hugh Niall, said: "We are delighted that RelenzaTM has passed its most demanding clinical trial and that filing is going ahead."
"As well as being an important day in the history of Biota and its development of the influenza drug, it is significant from the perspective of Australian science."
"There is now a distinct likelihood of this Australian discovery reaching the Australian market ahead of the rest of the world."
Dr. Niall said the filing and co-marketing agreement gave strong indication of the commitment of Glaxo Wellcome Australia to taking RelenzaTM through to the market place.
Following completion of current Phase III trials in the United States and Europe, filings should take place in the rest of the world later this year.
Trial Confirms Efficacy and Safety
Dr. Niall complimented the Glaxo Wellcome Australia team for its impressive efforts in completing the challenging Phase III trial.
The data confirmed and extended the results from earlier Phase II trials, particularly the efficacy and safety of RelenzaTM.
The Phase III trial showed RelenzaTM (formerly known as zanamivir or GG167) significantly reduced the duration and severity of symptoms when taken soon after a person was infected with influenza. The results also showed a reduction of complications in high risk patients, including the elderly and those with respiratory and cardiovascular disease.
Increased Royalty Under Co-Marketing Agreement
Under the agreement signed today, Biota will receive a royalty rate of 10% of net sales in Australia, New Zealand, Indonesia, and South Africa in exchange for marketing rights in those countries.
The royalty for sales in the rest of the world will remain at 7% of net sales.
In addition, in Australia and New Zealand, Biota's name and logo will be displayed on all promotional material in recognition of its role in the discovery and development of the drug.
"This provides Biota with the opportunity of further establishing in its home market its position as a leading edge biotechnology firm," Dr. Niall said. |
