BIO 2010: Australian biotech, state of the nation

This feature appeared in the March/April 2010 issue of Australian Life Scientist. To subscribe to the magazine, go here.

It’s not just the Big Three – CSL, ResMed and Cochlear – with high hopes for 2010. Many other Australian biotechnology companies are either in the final stages of trials and are close to gaining regulatory approval, or they are in the initial stages of commercialising their products, with several forming strategic partnerships to expand into new and lucrative overseas markets.

One of the leaders, and a good news story of 2009, is Sydney-based Pharmaxis. Not only did Pharmaxis weather the global financial crisis without breaking a sweat, it also completed construction of its factory in the outer suburbs of Sydney in leafy Frenchs Forest (see Australian Life Scientist, September/October 2009, p42).

Its lead product, Aridol – a diagnostic test for asthma – already has regulatory approval in Australia, Europe and South Korea, with US approval not far off. Its second product, Bronchitol, for the treatment of cystic fibrosis , is also close to achieving marketing approval in Europe following a successful phase III trial demonstrating clear benefit for patients with cystic fibrosis, with a second phase III trial underway.

Pharmaxis is also not resting on its laurels but is pursuing a research programme to find new marketable compounds. One contender is PXS25, which is currently undergoing phase IA trials for the treatment of pulmonary fibrosis. Early this year the company also acquired Canadian biopharmaceutical company, Topigen, which is also investigating a number of drug candidates in the respiratory field.

Victoria’s Biota Holdings also enjoyed a strong performance in 2009, particularly off the back of royalties from the anti-viral, Relenza, marketed by GlaxoSmithKline. Biota managed to rake in over $55 million in royalties in the second half of 2009, buoyed by several countries stockpiling the drug in response to the H1N1 pandemic, putting the company well in the black.

It’s also hard at work on another anti-viral, laninamivir, in cooperation with partners, Daiichi-Sankyo, in Japan. The drug has already undergone Phase III trials with positive results, with more trials on the way as well as an New Drug Application (NDA) filed with the US Food and Drug Administration (FDA).

Biota is also aiming at other viruses, including human rhinovirus – the fiendish family of viruses which are the greatest contributor to the common cold – as well as respiratory syncytial virus, hepatitis C and human cytomegalovirus, which is a member of the herpes family. The company also further boosted its anti-viral and antibiotic credentials with the acquisition of pharmaceutical company, Prolysis, and antibacterial drug discovery company, MaxThera, late last year.

While Biota’s share price has dipped then plateaued since its peak in October 2009, it’s still up over 300 per cent over the past 12 months. Its outlook for 2010 is strong, with continued demand for Relenza, and laninamivir showing positive signs, as well as a growing pipeline of other promising pharmaceuticals.

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Friends in high places Starpharma had a relatively cracking 2009, adding 230 per cent to its stock price throughout the year. It’s a company with diverse interests, springing from its underlying dendrimer nanotechnology, which allows complex molecules to be assembled one layer at a time.

It’s lead product is VivaGel, a vaginal microbicide to prevent transmission of genital herpes and HIV. In 2008 it partnered with SSL International – which produces the popular Durex brand of condoms – to develop a VivaGel-coated condom. The deal is expected to bring in more than $100 million over the lifetime of the agreement. The VivaGel itself also has a large potential market around the world as a stand-alone product, with the US National Institutes of Health putting US$20.3 million towards its development, specifically to combat HIV. It has Fast Track status with the FDA and is undergoing clinical trials at the moment.

Starpharma is also capitalising on its dendrimer nanotechnology for other purposes, including drug delivery and industrial applications. It has signed an agreement with Elanco, Eli Lilly’s animal health company, to license the technology and will receive royalties as a part of that agreement.

Speaking of Eli Lilly, another Victorian company, Acrux, has also signed up with the pharmaceutical giant to commercialise its testosterone replacement therapy, Axiron, for men with hypogonadism, which is a deficiency of testosterone. Lilly is interested in the technology because it dovetails with its other high profile product, Cialis, for erectile dysfunction. The partnership gives Acrux a potent global partner for the marketing and distribution of Axiron, which is currently undergoing late stage trials. The deal could be worth up to US$335 million to the Victorian company, which could make it the biggest licensing agreement made by an Australian biotech.

Acrux also has a slew of other products in the pipeline, including Estradiol, for the treatment of menopause symptoms, which is sold in the US as Evamist, and is also marketed in Europe by HRA Pharma. It’s also working towards regulatory approval in Australia, although it suffered a delay late last year when the Therapeutic Goods Administration wanted it compared with a competing product before giving it the tick of approval. Acrux has also signed up with Lilly to develop and market a range of animal health products.

Partnering with big foreign firms is a popular move for technology-focused Australian biotechs, with Western Australian NemGenix following in the trend by collaborating with Dow AgroSciences, to develop nematode-resistant crops.

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On the move HealthLinx had a particularly enviable day in February, when its share price more than doubled after news its OvPlex diagnostic for ovarian cancer was to be marketed in the United Kingdom by Intus Healthcare. The UK market for ovarian cancer tests is in excess of 750,000 per year, with HealthLinx receiving around $70 in royalties for each unit. HealthLinx is also developing other diagnostic tests as well as a platform, called Cryptomics, used for the discovery of beneficial proteins and peptides from foods.

Another company to watch is Melbourne-based regenerative medicine company, Mesoblast, which is actively developing a range of therapies based on mesenchymal precursor cells. They are being targeted at things like spinal fusion, intervertebral disc repair and regeneration, long bone fracture repair, knee osteoarthritis, age-related macular degeneration, diabetes as well as a range of cardiovascular disorders through its US partner company, Angioblast. It also has developed an effective manufacturing process to output stem cells to be used for therapy.

Phase I and II clinical trials are currently underway here and in the United States, with positive results found in several trials so far. One of the more promising areas is disc repair, which taps in to the massive chronic back pain market, and another is in bone and cartilage repair. 2010 should see the company push towards phase III trials in a number of areas and we could even see a strategic partnership or two.

Bumps and troughs ChemGenex recently suffered a setback in its quest to bring its targeted leukaemia therapy, Omapro (omacetaxine mepesuccinate), to market. The drug is a second line therapy for individuals with chronic myeloid leukemia (CML) who have the T315I mutation, making them unresponsive to the first line treatment, imatinib, which is known as Glivec in Australia and Gleevec in the US. Omapro is an impressive drug for these individuals, effectively halting leukaemia in its tracks.

The FDA Oncologic Drugs Advisory Committee acknowledges all this, but in March it ruled that before Omapro can get the go-ahead, there needs to be a diagnostic for the T315I mutation approved by the FDA. There are already a number of such diagnostics about, but none have regulatory approval from the FDA. ChemGenex is now furiously working to help get one approved so it can get on with marketing Omapro. The company’s stocks took a dive following the announcement, but assuming a diagnostic is approved in reasonable time, and Omapro not far behind, the potential for ChemGenex is terrific.

Even CBio, which kicked off an IPO in February to less than spectacular results – opening at $1.00 and quickly dropping to around 37c – had some good news in March with a $1 million milestone payment from Novo Nordisk, which will stack with its float money to help push through more phase II trials this year.

This feature appeared in the March/April 2010 issue of Australian Life Scientist. To subscribe to the magazine, go here.