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Microsoft word - documentBIOTA RUNS A FEVER
Author: By Beth Quinlivan
Section: News and Features
As the world stockpiles drugs to treat avian flu, shares in the Australian company are soaring -and so are its court prospects. Shares in Biota Holdings have doubled in price since August, on news of big sales of its anti-influenza drug Relenza in Germany and Holland, where the national governments decided to add it to their stockpile of anti-flu drugs for use in case of an epidemic. At the urging of the World Health Organisation and with increasing international concern about the dangers posed by viruses such as the deadly avian influenza, many countries, including Australia, have been building up stocks of the market-leader in influenza drugs, Roche's Tamiflu. But Roche is struggling to meet demand and governments prefer to have more than one supplier of critical medical needs. The result is that Relenza, the only alternative, is achieving good sales for the first time. The stockpiles are potentially a huge market for Relenza. Over the next two years, sales to supply international stockpiles are estimated at $US3 billion. Even if there is no flu epidemic, the drugs still need to be regularly replaced, and further sales of $US3 billion are expected by 2012. Biota receives a royalty of 7% on Relenza sales. But a bigger issue, according to Biota and some biotechnology specialists, is the strong impetus the recent sales of Relenza will give to Biota's damages action against GlaxoSmithKline (GSK), claiming up to $430 million. Mark Saunders, a former Wall Street lawyer and now president of the New York investment bank Global Markets Capital Group, specialises in the biotechnology sector. He says: "At the very least, the sales will be damaging to GSK's defence. We have always known the drug works. That the German and Dutch Governments are buying Relenza demonstrates it is in great demand and indicates there is merit to Biota's case. With every one of these sales, it potentially increases the amount of damages Biota could claim." Until the September boost in sales, Relenza was one of the great disappointments of Australia's emerging biotechnology sector. Developed by Biota, the drug was licensed to GSK in 1990 for development and commercialisation and approved for use in the United States and Europe in 1999. It is still the only Australian-developed prescription drug on the pharmacy shelf. Although sales in its first year were reasonable, Relenza lost the marketing war. In the past three years, revenue has been minimal and the drug is no longer available in several countries where it was initially registered. Tamiflu, released a couple months after Relenza, has achieved sales exceeding $1.7 billion so far. Tamiflu and Relenza are similar, the main difference being that Tamiflu is a tablet and Relenza a powder. Relenza is inhaled, which is more difficult to administer but means the drug goes directly to the lungs. A study comparing the two drugs was published this year in the medical journal The Lancet. It concluded that Relenza is at least as effective as Tamiflu, has fewer side-effects, such as nausea and headaches and, unlike Tamiflu, there is no evidence that people build up resistance to Relenza. The drugs work by inhibiting the action of an enzyme on the surface of the flu virus. This enzyme, neuraminidase, allows the virus to escape the infected cell and attack other cells. Biota's management believes the reason Tamiflu has 97% of the market compared with its 3% is GSK's failure to market Relenza properly. In May last year, Biota issued a writ against GSK in the Supreme Court of Victoria, alleging breaches of contract and fiduciary duties. Essentially, it is claimed that GSK did not live up to the terms and conditions of a still-current licensing agreement that requires it to use its best endeavours to develop and commercialise Relenza. In a detailed statement of claim, filed in court in December, Biota says GSK did not run clinical studies that would have expanded the market for the drug. It also claims GSK did not provide promotional support for the drug, or develop other ways of administering it apart from an inhalation device called a Diskhaler, which consumers and the medical profession found hard to use. GSK's defence, filed in May, gives several reasons why it decided in 2001 to cease promoting Relenza. Even while Relenza was in development, the company did not expect it to be a big seller, nor did it appear to anticipate the huge growth in the market for anti-flu drugs. At one stage, in response to Biota's claim that GSK persisted with the Diskhaler rather than a more user-friendly way of administering the drug, GSK said: "As a result of poor efficacy results obtained for Relenza in its phase-two trials, there was only a modest sales outlook (if it succeeded in obtaining regulatory approval), which had the consequence that there would be a disproportionately high unit cost of manufacture of the FFPS (free-flow powder system) device." Elsewhere, the company says: "The Glaxo Group had been unable to identify any promotional or marketing strategies which could overcome the shortcomings of Relenza." Another factor was: "Future demand for Relenza would, in any event, be unpredictable because the incidence of influenza is, by its nature, seasonal and unpredictable." In 2001, GSK discounted Relenza's potential as a drug to stockpile. "In the event of an epidemic or pandemic, Tamiflu, which is taken orally in pill form, would be easier to administer to large groups of people suffering from influenza than would Relenza, which required patients to be instructed in the use of the inhalation device." To that point, the market response to Biota's legal action has been minimal. When the lawsuit was announced, investors thought Biota had a slim chance of winning and that management was throwing good money after bad. The share price fell nearly 15%. Sentiment is changing. Biota, under chairman John Grant, has always maintained it has a strong case. When he took the job in 2001, Biota was at a low ebb. Relenza sales had dropped sharply and GSK had just handed back the development rights of a second-generation version of the drug. "The more information we gathered, the more confidence we gained," he says. "When it became apparent that we had a strong case, taking legal action looked like a good commercial decision to make." Grant is no stranger to commercialising technology, nor to the requirements of licensing agreements. He has a background in investment banking and in 1984 co-founded the venture-capital investment fund Hambro-Grantham (now Colonial First State Private Equity), which was sold to Commonwealth Bank in 2000. Over the years, the fund has managed dozens of commercialisation deals, including several licensing deals with global companies. "The case has far wider ramifications than Biota," Grant says. "Partnerships with major pharmaceutical companies are an important way of commercialising Australian research. Making sure the commercial contractual arrangements are met is an important part of the process, regardless of the size of the other party." The principal of the law firm Goldman Partners, Bruce Goldman, is advising Biota. He says the case is being watched internationally. "There has been a very large amount of interest from small companies around the world - it is not just Australian companies involved in these licence arrangements." So far, the case appears to be low on GSK's list of legal matters. Biota does not appear on a list of pending or current litigation on GSK's web site and GSK has not commented on the case. The next step is mediation in November. If a settlement cannot be achieved, the case is expected to go to court in 2006. * Biota licensed Relenza to Glaxo in 1990, and is entitled to 7% royalty on sales. * Relenza approved for use in 1999, just months before its main competitor, Tamiflu. * In 1999-2000, Relenza won 40% of the US anti-flu (neuraminidase inhibitor) market; Biota received royalties of $6.2 million. Biota received royalties of $2.4 million. * In September 2001, GlaxoSmithKline halted promotion of Relenza; Biota's royalties were $1.1 million for year. * In 2003, the anti-flu drug market was worth $500 million and Tamiflu was clear leader; Relenza had 3%. * In 2004, Biota filed damages claim against GlaxoSmithKline and clarified its estimate of loss in July 2005, at between $308 million and $430 million. The amount is calculated on the royalties Biota believes it would have received, had it gained about 40% of the anti-flu drugs market, up to the end of patent protection in 2011. Biota estimates the stockpiling market will be worth $US3 billion between 2005 and 2007, and a further $US3 billion as drugs are replaced between 2010 and 2012. The growth of the anti-flu market to the end of 2011 is estimated to be between 53% and 135%.
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