BIO 2011 report: Australian biotechnology trials and tribulations

Read part I, BIO 2011 report: Australian biotechnology spotlight.

Sydney-based Pharmaxis has had a somewhat bumpy ride over the last 12 months, but signs are picking up. Mid-2010 it received results from a trial of its flagship cystic fibrosis treatment, Bronchitol, that were less impressive than hoped.

The company is currently in discussion with the European regulators about how to move forward with the application. However, the results have proven enough to convince the Therapeutic Goods Administration (TGA) to give the drug the go ahead here in Australia, which it did so in February.

It’s still not quite smooth sailing, however, with the TGA delaying the decision to add Bronchitol to the Pharmaceutical Benefits Scheme (PBS), which would see it subsidised by the Australian government, due to “uncertainties in where Bronchitol will fit in clinical practice and consequent difficulties in identifying the right comparator in one clinical setting that leads to uncertain cost-effectiveness.”

The company has prepared a resubmission, with CEO Alan Robertson noting that “cystic fibrosis is a disease where there have been no new treatments approved for more than 18 years and Bronchitol will have an effect on the way other products are used. We are working with the CF community to more accurately predict these likely changes and remove any ambiguities.”

The company did receive the go ahead from the FDA for its asthma diagnostic, Aridol, in October of last year, which will help bring in some revenues until Bronchitol hits the shelves.

The company continues to forge ahead with Bronchitol, and is still pushing for marketing approval in Europe and the United States, either or both of which could happen later this year. Should that eventuate, and the signs are positive, Pharmaxis might once again regain its status as a high achiever in Australian biotech.

Meanwhile, South Australian biopharma, Bionomics, is pushing on with trials of its lead compounds, BNC105 for renal cell carcinoma and BNC210 for anxiety. The latter saw some positive results emerge earlier this year from a phase Ib trial, suggesting the drug is safe and well tolerated, and that it significantly reduced the symptoms of a panic attack faster than placebo. It also continues to beaver away on an MS drug in partnership with Merck Serono.

Bionomics’ share price has been steadily increasing since the beginning of 2011, and more positive results like this and the company could also become an attractive proposition for an acquisition or big partnership deal.

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Rolling along

In addition to the big acquisitions and partnerships many other biotechs are just chugging along nicely, either working towards regulatory approval or steadily bringing in revenues for existing products.

However, the strong Australian dollar is putting the squeeze on export-intensive firms, such as the Big Three, CSL, Cochlear and ResMed, although each are still on track to post profits, albeit slightly deflated ones in 2011.

Another company bringing in a steady income is Sydney-based Sirtex, which sells its SIR-Spheres for the treatment of liver cancer. The company recently announced its 27th consecutive quarter of dose sales growth, with them gaining traction particularly in Europe.

This helped Sirtex post a net profit of $3.6 million for the first half of FY2011, down slightly on the first half of the previous financial year due to the stronger dollar and hampered by price hikes from ANSTO’s radiopharmaceuticals division.

Other companies continue to work on developing their technology, bringing the next wave of products closer to the market. Tasmania’s Mariova is still hard at work developing its seaweed-based cosmetics and pharmaceuticals in the areas of pain relief and anti-inflammation for osteoarthritis, and the release of adult stem cells.

Quensland’s BioProspect has been making strides with its Regen range of natural compounds, including plant extracts and emu oil. In February it announced an exclusive distribution deal with Doward International for the range. It also signed a deal with Western Australian private biotech, Bio-Gene Technology, handing over exclusive worldwide rights to natural insecticide, Qcide.

The deal involves four $200,000 fees paid annually to BioProspect and the University of Western Sydney as well as royalties of 4 per cent for the first $1 million in commercialisation income and 2 per cent on additional income over $1 million.

However, one of its other flagship products, the anti-termite Termilone, developed from eremophilone oil, extracted from the native Australian tree, Eremophila mitchellii, has been put on hiatus after field trials and economic analysis. The company has stated that it might revisit the product in a new formulation down the track.

These are but a selection of the movers and shakers over the past several momentous months in Australian biotechnology. 2011 is sure to continue to be a big year for biotech, with more acquisitions and big deals possible.

One thing is clear, Australian biotech has turned a corner, demonstrating that innovative approaches to technologies new and old is starting to be recognised internationally, and the rewards are finally forthcoming.