how will management play down this news, page-8

This patent application (and approval) are all part of their ongoing R&D - its part of the reason we are holders, I guess. It bubbles away in the background. I guess it is nice to know when/that a patent application is approved, but yes, it really is embryonic stuff in the scheme of things - more likely to possibly hear about this in an investor update, or in a science paper and when the program commences early phase trials.

From the Biota website, see below - note - this is not new info and is under R & D.

"Biota has active research programs in two drug classes which are expected to form cornerstones of DAA combination treatments for HCV. These comprise nucleoside (or nucleotide) and non-nucleoside inhibitors which block the NS5b polymerase protein, the protein responsible for viral RNA synthesis and genome replication."

The above is an excerpt from the following:

http://www.biota.com.au/?page=1021001&subpage=1021016

Hepatitis C virus

The World Health Organisation (WHO) estimates that about 3% of the world's population has been infected with hepatitis C virus (HCV). Based on the known association of HCV infection with significant liver damage and cancer this translates into more than 170 million chronic carriers who are at risk at risk of developing serious life threatening disease. The Centre of Disease Control (CDC) estimates that in the United States alone 4.1 million (1.6%) have been infected with HCV. Of these people, 3.2 million are chronically infected. 70% of chronically infected patients progress to chronic liver disease. 1-5% of infected patients die as a result of HCV infection.

Since May 2011, the current standard of care for treating HCV patients involves combination of an oral form of ribavirin with various forms of interferon together with one of the first generation direct acting antivirals (DAA); boceprevir and telaprevir. Although these first generation DAA protease inhibitors raise the efficacy of the treatment regime from being effective in about half of treated patients to around two thirds, the combination remains imperfect. They are genotype 1 selective, require comparatively frequent dosing and must be administered with interferon and ribavirin. The side effect profile of the combination is also far from ideal and the need to monitor patients for response can place a significant burden on patients and health care givers. Many patients cannot be treated because of underlying health/lifestyle concerns, intolerance to interferon and/or ribavirin or the potential for interference with other medicines they may be taking.

There remains a significant unmet need for a convenient, effective, well tolerated treatment for all HCV genotypes without the complexities of response guided therapy, drug and medical condition contraindications, etc. All oral combinations of new DAA drugs without interferon that address all genotypes, minimize resistance emergence and are well-tolerated with a simple regimen remain the preferred target. These DAA combinations, should they be successfully discovered and developed, are widely expected to herald a new wave of diagnosis and therapy.

Biota's solution

There is a compelling need for an effective direct acting antiviral (DAA) treatment for HCV without the side effect profile and inconvenience of current drugs. Treatment of HCV is anticipated to evolve towards oral multidrug therapy, in which combinations of different DAA drugs with complementary mechanisms of action serve to increase viral suppression and delay or prevent the emergence of resistance. This ideally would avert the need for interferon and ribavirin use.

Biota has active research programs in two drug classes which are expected to form cornerstones of DAA combination treatments for HCV. These comprise nucleoside (or nucleotide) and non-nucleoside inhibitors which block the NS5b polymerase protein, the protein responsible for viral RNA synthesis and genome replication. The nucleoside/tides and the non-nucleosides together form an important complementary part of Biota's HCV portfolio at the Lead Optimisation stage of the Biota pipeline.

Nucleoside/tides

Based on evidence to date, a representative of the nucleoside or nucleotide class of antivirals is expected to form a lynch pin in effective DAA combination therapy. Nucleoside/tide drugs are a successful class of drugs and numerous examples are on the market (eg HIV/AIDS and herpes drugs) and have been, or are, in development for HCV. This class of compounds typically have a highly desirable HCV pan-genotypic profile and a high barrier to the development of resistance.

Biota has developed extensive 'know how' and expertise in the chemistry and biology of antiviral nucleoside/tides. The research program has led to the discovery of several novel classes of such compounds which inhibit HCV replication. Selected HCV nucleosides and nucleotides from the Biota series have demonstrated potent pan-genotype HCV inhibition in enzyme and cellular assays and excellent pharmacokinetic profiles in multiple species including high concentrations and long half-lives of the active triphosphate species in the liver cells.

Non-nucleosides

Biota has discovered a new class of potent and selective pan-genotypic non-nucleoside (NN) polymerase inhibitors. Unlike the majority of non-nucleoside compounds in clinical development which generally only inhibit genotype 1, the Biota compounds target a site on the NS5b polymerase which confers HCV activity across the major genotypes (1-4). Our antiviral compounds have a favourable pharmacokinetic profile with the potential for once-daily dosing in a combination therapy, demonstrate activity against clinically relevant resistant mutants and possess strong synergistic effects when tested in conjunction with other DAAs used to treat HCV. Our HCV-NN inhibitor program is on track to nominate a preclinical candidate in 2012.