Melbourne, Australia -- September 4, 2000 -- Biota Holdings Limited (ASX:BTA) today announced that it has signed a Heads of Agreement granting Glaxo Wellcome rights to develop and market worldwide a new influenza drug based on inhibition of the viral neuraminidase.
Biota has discovered and will, subject to final agreement being reached, work with Glaxo Wellcome to develop drug candidates with properties that will result in increased convenience in dosing regimen for both patient and doctor.
Biota also said that Glaxo Wellcome had recently completed a clinical study of Relenza, Biota's first generation flu drug, in over 500 high-risk influenza patients, including those with asthma and chronic lung disease. The study, which will be published shortly, demonstrated significant clinical benefit to the patients with no drug-related side effects. This result provides further support for the efficacy and safety of the direct delivery approach used with Relenza.
Chief Executive Officer of Biota, Dr Hugh Niall said, "Biota has developed a considerable level of expertise in the area and has already spent a number of years on this particular project. The work with Glaxo Wellcome is already underway. I don't want to underestimate the challenges ahead, but we can look forward to the development of a new drug that is expected to dominate the anti-viral market for influenza and importantly, deliver a royalty stream out to 2020."
The new generation neuraminidase inhibitors, are, like Relenza, delivered directly to the site of infection in the lungs. They will therefore still have the key advantages to patients of Relenza. These are: low effective dose, almost instant onset of action, minimal systemic absorption resulting in negligible systemic side effects, high anti-viral activity, comprehensive strain coverage and minimal propensity to resistance.
This new research and development collaboration between Biota and Glaxo Wellcome will build on the successful partnership established with Relenza. It aims to exploit Biota's expertise and leadership in the area of anti-virals for respiratory infections, and Glaxo Wellcome's expertise and leadership in developing and marketing drugs for delivery directly to the lungs.
The agreement will provide for the two companies to work closely together and to fund their own research and development costs to the point of selecting a lead compound for clinical development. Beyond that point Glaxo Wellcome will fund the program through to the market. Biota will receive development milestones at various stages of the project and royalties to be paid over the life of the relevant patents.
Biota is an Australian listed company (BTA), based in Melbourne and engaged in the research and development of new human pharmaceuticals for the treatment of viral respiratory diseases. The Company's ADRs (BTAHY) trade in the United States on the pink sheets at a ratio of three shares to each ADR.
Relenza® is a registered trademark of the Glaxo Wellcome group of companies.
Add'l Contacts:
Dr. Hugh Niall
Chief Executive Officer, Biota Holdings Limited
011- 61 3 9529 2311
Will Hetherton
Turnbull Porter Novelli
011-61 3 9289 9555