BTA 0.00% 57.0¢ biota holdings limited

relenza is a remarkably good drug

  1. 220 Posts.

    http://www.abc.net.au/insidebusiness/content/2004/s1113946.htm


    SIR GUSTAV NOSSAL, IMMUNOLOGIST: Relenza is a remarkably good drug.

    That's the first and important thing to say.

    It's an Australian discovery, it is based on high scientific principles, and as a prophylactic for influenza, if taken before the virus hits, it's really quite brilliant.

    GEOFF HUTCHISON: This is a story of discovery, achievement and then, profound disappointment.

    At its core, brilliant Australian science and inventiveness and a pioneering, headline-grabbing antiviral drug called, Relenza.

    SIMON TUCKER, RESEARCH DIRECTOR, BIOTA: What makes this product unique is that it is delivered direct to the lung where the virus grows via an inhaler.

    Here we have the drug.

    It comes in these little foil capsules, like this.

    And the inhaler is very simply loaded, it just takes it like this, it drops the capsule in, puts it back together, and it's now ready to inhale.

    GEOFF HUTCHISON: Relenza was the culmination of a generation of research into finding a chink in the armour of the flu virus.

    This new designer drug was able to trap it within infected cells and prevent it from escaping and replicating itself.

    Exhaustive trials confirmed Relenza safe and very, very effective.

    PETER MOLLOY, MANAGING DIRECTOR, BIOTA: The drug goes through development, over a period of nine years.

    It's launched in 70 countries or is registered in 70 countries around the world, and then unfortunately, after the launch, at least from our perspective, the plug is pulled on the life-support system and the drug sales and market share go down hill.

    GEOFF HUTCHISON: This is also a story of promise unfulfilled.

    Not it seems because of the failure of science, but a change in priorities at the multinational, which was meant to be driving Relenza to market.

    And it's disappearing off pharmacy shelves, not because people are buying it.

    But because it's not being stocked.

    SIR GUSTAV NOSSAL: I think that the marketing of Relenza by GlaxoSmithKline has been quite disgraceful.

    PETER MOLLOY: The promotion was stopped in virtually every market.

    The clinical trials that were designed to support the acceptance and expand the use of the drug were curtailed.

    And registrations and product launches were either stopped or put on hold or just didn't happen.

    GEOFF HUTCHISON: In 1990, Biota signed a licensing agreement with Glaxo to develop and commercialise the new drug.

    It's virtually impossible for biotech companies to go it alone.

    By 1999, Relenza was approved for use in the United States, and with big marketing dollars behind it, it quickly snared more than 40 per cent of the market.

    Biota's share price climbed beyond $9 and its market capitalisation soared beyond $500 million.

    But that was then.

    Less than a year on, Glaxo's welcomed merge with SmithKline Beecham and the relationship with Biota began to fall apart.

    When the new company CEO was quoted in the media calling Relenza a failed experiment, Biota's share price all but collapsed.

    PETER MOLLOY: Today, our share price is under 70 cents a share and our market capitalisation has dropped from $500 million to $50 to $60 million.

    So it has had a dramatic impact.

    We believe that a lot of that decline is due to the shattered promise that was in Relenza.

    We think that shattered promise didn't come from inherent deficiencies in the drug, it came from a lack of support.

    The drug's lifeline was effectively pulled.

    GEOFF HUTCHISON: A couple of weeks ago Peter Molloy made a huge announcement - Biota is taking GlaxoSmithKline to court for failing to fulfil its licensing agreement to develop and commercialise Relenza.

    No official figure has been quoted but the company is chasing more than $100 million in lost royalties.

    PETER MOLLOY: We've filed this case in the commercial list in the Victorian Supreme Court, which is a fast-track list designed to move commercial litigation to trial in 12 to 18 months.

    So, if that occurs, we could have this wrapped up in a reasonable time frame one way or another.

    And that's our goal.

    We don't want to be distracted by this for many years and we don't want to spend many millions of dollars.

    And I don't think we will.

    GEOFF HUTCHISON: Investment dollars have dried up for Relenza and many are doubting the wisdom of tackling a global giant in the courts.

    But biotech analyst David Blake says it's a positive sign of a maturing sector.

    Biota is trying to free a valuable but trapped asset.

    DAVID BLAKE, BIOSHARES: In the US, litigation is par for the course, you know, it's what people do all the time.

    It's an accepted form of business conduct to test the entitlements that you may have against somebody else's view on those entitlements.

    So it will be a very positive step forward for Biota and a very positive step forward for the Australian biotech community - when or if it does get an outcome that is in its favour.

    GEOFF HUTCHISON: The imminent scientist Sir Gustav Nossal agrees.

    SIR GUSTAV NOSSAL: But, my own belief is that a case of this sort is quite likely to be settled out of court and my hope would be that having gone down this path - I'm not saying I agree or disagree - but my hope will be having gone down this path that there will be some money in it for the Biota shareholders.

    GEOFF HUTCHISON: GlaxoSmithKline has never explained the collapse of the relationship, a company spokesman issuing only the briefest of statements: "GSK believes it has always adhered to its obligations under the agreement with Biota."

    PETER MOLLOY: We need to remember that there's another 10 years approximately of patent life here at stake and we believe that if Relenza had been handled properly up until now and up until the next 10 years - as a partner was obliged to under the agreement - that it would be in a very different business, a very different state of affairs, and we would be a handsomely profitable company.

    GEOFF HUTCHISON: But Biota clearly needs a little help from its friends and it is not certain that is forthcoming.

    Last week, the Federal Government announced it will allocate $114 million to stockpile anti-flu drugs.

    It shows not Relenza but its rival Tamiflu.

    PETER MOLLOY: I have had a number of calls from people who are interested in Relenza and some who even participated in its discovery, and have an interest in Biota.

    And they have used words like "it's a disgrace".

    SIR GUSTAV NOSSAL: I think definitely that the Australian Government at the very least, should have been even-handed and given the Australian invention at least one half of the stockpile.

    GEOFF HUTCHISON: Back in the labs, Biota's scientists are now working on a new anti-flu drug, which could get to market within five years.

    Having sucked on a bitter pill of lost opportunity, they'll be hoping the only side-effects next time round will be dizzy success.

 
watchlist Created with Sketch. Add BTA (ASX) to my watchlist

Currently unlisted public company.

arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.