SYDNEY - After good results from Phase III trials in the Southern Hemisphere, Glaxo Wellcome Australia has kicked off worldwide registration of the flu cure drug Relenza (formerly Zanamivir) by applying for registration in Australia.
The news - reported to the stock exchange by Relenza developer Biota Holdings Ltd., of Sydney, last week, along with disclosure of joint Biota-Glaxo marketing arrangements for the drug in Australia, New Zealand, Indonesia and South Africa - pushed the share price of Biota up by A$0.33 to A$4.20. Glaxo Wellcome Australia is a subsidiary of London-based Glaxo Wellcome plc.
By the end of the week Biota's share price had reached A$4.70 (each Biota American depositary share traded in the U.S. is worth three Australian shares).
Biota Managing Director Hugh Niall said that as far as he understands, Relenza (also formerly referred to as GG 167) is one of the few drugs, if not the only one, where application for registration for retail sales was made in Australia before any other market, notably the much larger U.S market.
He said that despite the novelty, he does not expect any difficulties with Glaxo's application to Australia's Therapeutic Goods Administration (TGA), and he expects the drug to be on the market there before the Southern Hemisphere's next winter.
Following the completion of Phase III trials in the U.S. and Europe, filings should take place in the rest of the world later this year, he said.
As previously reported, Relenza, a neurominidase inhibitor licensed to Glaxo by Biota, is undergoing Phase III trials in the Northern Hemisphere, but the Southern Hemisphere trials have been completed.
Niall said he could not give details of the Southern Hemisphere results (involving 350 people) until they officially are released, but added they are “at least as good“ as the Phase II results, which showed reductions of between one and three days in sickness time for those with influenza.
Patients with more virus in them - the sicker patients - gained considerably more benefit from the drug than those with only a mild dose of the flu.
The Phase III results also showed Relenza reduced complications in high-risk patients, including the elderly and those with respiratory and cardiovascular disease, Niall said.
Despite rarely going first in processing drug applications, Australia's TGA does not simply accept registration with America's FDA as proof of the safety or efficacy of a drug. The TGA does its own checking of the data supplied and has standards similar to that of the FDA.
Biota To Receive Double-Digit Royalties
Once the drug is approved, and as part of its original agreement with Glaxo, Biota will receive royalties of 10 percent of net sales in Australia, New Zealand, Indonesia and South Africa. In all other countries, Biota will receive royalties of 7 percent of net sales.
Niall said that in the original agreement with Glaxo, Biota retained marketing rights in those four countries, but agreed to swap those rights for an increase in royalties and the display of its corporate name on the drug package.
Biota is a drug developer and not a marketing company, he said. The company has put together a portfolio of drug development projects, focusing mainly on treatments for viral respiratory diseases and cancer.
The latest in that growing list of projects is a potential treatment for Alzheimer's disease, discovered at the Howard Florey Institute of Experimental Physiology and Medicine, in Melbourne.
In addition to those projects, Biota also has licensed its technology to Biostar Inc., of Boulder, Colo, which is merging with Denver-based Cortech Inc., to develop a flu cure kit. *