Developing a Worldwide Standard of Care, One Microsphere at a Time

Sirtex Medical Limited

As the fifth most common type of cancer in men and the seventh in women, each year an estimated seven hundred and fifty thousand individuals are diagnosed with liver cancer. Sadly, because of its high fatality (with an overall ratio of mortality to incidence of 0.93 – 2008 estimate), liver cancer has become the third most common cause of death from cancer worldwide, taking the lives of nearly seven hundred thousand people each year.

Sirtex Medical Limited, an Australian company that supplies globally, has joined in the fight against liver cancer, bringing to market in 2001 its approved cancer treatment – a targeted radioactive liver cancer treatment called SIR-Spheres® microspheres. The product has approval from the US Food & Drug Administration (FDA), the European Union (CE Mark) and Australia’s Therapeutic Goods Administration (TGA). Since its inception, liver cancer patients in over six hundred medical centres across twenty-seven countries have been supplied with greater than thirty-five thousand doses. Sirtex currently has manufacturing capabilities in the US, Singapore and Australia.

Used to deliver targeted internal radiation therapy directly to liver tumours via the hepatic artery, SIR-Spheres® microspheres are used in primary liver cancer (hepatocellular carcinoma) and secondary liver cancer (metastatic liver cancer), where the tumour has originated from another part of the body but has spread to the liver. This therapy is called Selective Internal Radiation Therapy (SIRT) and is performed using minimally invasive surgical techniques by an interventional radiologist.

“Where SIR-Spheres® microspheres are used,” reports Dr David Cade, Chief Medical Officer, “the available clinical evidence suggests SIR-Spheres® microspheres may approximately double the rate of tumour shrinkage and tumour remission. The evidence also suggests it may be capable of improving the life expectancy of patients by between 35 per cent and 100 per cent compared to standard treatment.”

“Sirtex’s product SIR-Spheres® microspheres were invented by researchers at the University of Western Australia in the 1990s,” explains Darren Smith, Chief Financial Officer and Company Secretary.

With the support of monies raised from private investors, the company was able to prove the technology and confirm its efficacy and safety. Upon establishing this, Sirtex listed on the Australian Securities Exchange; funds raised were used to apply for US and European regulatory approval in 2000. In 2001, this approval was achieved and the company began marketing its product to radiation oncologists. In 2004, five hundred and eighty-one doses were sold; in 2013, Sirtex had sold seven thousand, two hundred and ninety-nine doses and earned revenue of $100 million.

“In August Sirtex reported a lift in net profit 6.8 per cent to $18.27 million for the year ended June 30. Revenues rose 16 per cent to $100.3 million from $86.57 million the previous year. Basic earnings per share were 32.8 cents, up from 30.7 cents last year. The company has delivered another year of growth through the disciplined and considered execution of the business’s long-term strategic growth plans. Sirtex’s financial results in 2013 financial year are once again confirmation the group’s strategic direction is on course.”

“The business continues to evolve and is investing in studies to show its product can be used as a first line of treatment for liver cancer,” continues Mr Smith. “It is also developing new applications for a range of other cancers.”

As Dr Cade explains, Sirtex believes strongly in the efficacy of SIR-Spheres® microspheres and is “focused on developing the therapy as a worldwide standard of care for patients with liver cancer. To achieve this, Sirtex is investing in five major clinical studies to clearly demonstrate efficacy in the treatment of liver cancer in a first line setting. At the same time, Sirtex is developing the necessary internal infrastructure to ensure it will meet the current organic growth demands and anticipated global demand for its product following the release of the expected positive clinical evidence that will result from the clinical studies.”

At present, SIR-Spheres® microspheres are currently used primarily in what is referred to as the “salvage” phase for liver cancer, at which point existing chemotherapy or other treatment options have already failed. The market segment is of course lucrative, delivering a five-year compound annual growth rate of twenty-three per cent, with growth over the next several years expected to continue due to the under-penetrate status of the product as well as expected increases in clinician awareness and adoption globally. However, by working at this capacity only, SIR-Spheres® microspheres dose sales currently represent less than one per cent of the total addressable market of metastatic colorectal cancer and hepatocellular carcinoma.

“In the future,” states Dr Cade, “Sirtex believes the release of positive data from its major clinical studies will lead to the expanded use of SIR-Spheres® microspheres in the clinical setting. This is expected to produce a step change in demand for this innovative product and move it from a ‘treatment of last resort’ to a ‘first-line standard of care.’”

These major clinical studies are part of what Sirtex has coined its 2020 Vision strategy, through which the company has committed $60 million over five years to work together alongside industry leading radiation oncologists and healthcare institutions from across the globe; this will “demonstrate conclusively the efficacy of SIR-Spheres® microspheres as a first-line treatment.” Data from the first of these major studies, SIRFLOX, is due to be released late 2014 and will be the world’s largest randomised controlled trial in interventional oncology – with more than five hundred patients involved.

Reveals Dr Cade, “SIRFLOX aims to show standard-of-care chemotherapy plus SIR-Spheres® microspheres is more effective in delaying cancer progression than chemotherapy alone in patients with inoperable liver metastases from primary colorectal cancer. The end point of the SIRFLOX study is to assess progression free survival. Two other studies, FOXFIRE and FOXFIREGlobal, will assess overall patient survival. Together the data will look at the results of over 1,020 patients. We believe the data will lead to a significant change in the way liver cancer is treated globally.”

The company is also heavily involved in encouraging development within the industry overall, and recently announced in August that it would be sponsoring a professorship at the Australian National University (ANU) as part of a continuing partnership to develop cancer treatments using nanotechnology. “Another key driver of growth is our collaboration with leading institutions around the world… We will invest up to $3 million over the next three years in ANU research developing Sirtex’s cancer treatment product which attacks liver cancer by delivering radiation therapy directly to the site of tumours,” explains Dr Cade. “We have similar agreements in place with the National Cancer Centre in Singapore and Singapore Health.”

Ultimately, Sirtex is positioned to continue to deliver growth over the coming decade. “We are still very much in the early stages of our global expansion and Sirtex is well positioned for sustained long-term growth,” shares Mr Smith. “Our significant investments in people, research, product development, marketing, clinical studies and other sales growth initiatives have created a foundation for a global business that will continue to create value over coming years.”

Dr Cade is similarly positive about the future development of the company as it continues to work collaboratively, both internally and as part of the global community, to develop new ways of fighting this devastating disease. “Our plans for the future,” he says, “involve creating the capability and capacity to meet demand. A key element of this strategy involves expanding our manufacturing. Sirtex is currently working to triple its manufacturing capacity with new facilities in Germany and the US to better serve our global customers.

“We enter the new financial year with confidence and momentum thanks to the hard work of our teams worldwide,” he asserts. “All of us remain focused and determined to realise the full potential of our business and to create long-term value for our shareholders and the significant opportunity to bring real hope to cancer patients.”

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January 18, 2019, 3:29 AM AEDT