Patent in Japan big advance

David Darling
David Darling
Dunedin-based Pacific Edge has made a breakthrough into Japan with a patent for colorectal cancer prognostic technology having been approved in the world's largest biomedical market.

Chief executive David Darling told the Otago Daily Times yesterday the patent acceptance came after extensive and exhaustive examination in Japan.

The two hurdles before the patent was granted were meeting the grounds of being novel and inventive.

''The examiners really work you over. You have to show your product is different than any others on the market - novel - and the product is interesting, rated for its inventiveness.''

That test would also apply to any further patents presented for approval by Pacific Edge, he said.

As the company filed second- and third-generation patents, it had to prove each one fit the categories of novel and inventive.

However, now the first patent had been accepted, Pacific Edge could take the ''very high ground'' in the future by shutting other companies out of the market. Others would struggle to prove inventiveness.

Pacific Edge was better known for its Cxbladder product which enables the non-invasive detection of bladder and other urinary tract cancers from a small volume of urine.

Cxbladder was commercialised in New Zealand and Australia in 2012 and the United States last year.

''This is great - we are really rocking along,'' he said.

Craigs Investment Partners broker Chris Timms said the effect of the approval of the patent in Japan should not be underestimated.

It was an extremely hard market to break into.

''This is a fantastic result. It is a huge opportunity to get into Japan, an extremely cautious market. It gives Pacific Edge opportunities to much wider markets and shows it is not tied to only one product. It can only add to their credibility and help them into profit.''

Dr Darling said the work on colorectal cancer started in 2003-04.

Colorectal cancer was the most prevalent cancer in Japan, due to the change in lifestyle and adopting Western eating habits.

The product enabled the detection of aggressive cancer in patients already diagnosed with colorectal cancer.

''This prognostic test in development is expected to provide clinicians with a significantly improved capability to determine the aggressiveness of stage two and stage three colorectal cancer.''

The test results would enable

progression to be predicted and provide patients with a more specific treatment following surgery, he said.

The cancer prognostic gene signature was in late stage development and, on completion, would become another commercial product for the company, joining the Cx family as Cxcolorectal.

Now, patients with stage two disease were generally not treated with adjuvant chemotherapy as it was not possible to identify the subset of patients who would have aggressive disease, Dr Darling said.

In the five major European countries, the US and Japan, about 430,000 individuals were diagnosed with colorectal cancer each year.

Of those cases, about 280,000 patients were diagnosed with stage two and stage three progressions of the cancer.

About 30% of the patients with stage two and half of those with stage three experienced disease progression, including distant metastasis of the liver and lung or local recurrence within three to five years after the surgery.

''If the cancer spreads to distant organs, the five-year survival rate for these patients is approximately 8%, making the early detection of those patients with an aggressive disease a significant medical opportunity for clinicians and patients.''

For now, Pacific Edge was focusing on accelerating the roll-out of Cxbladder Detect in the United States, Dr Darling said.

The company was gaining commercial traction in the US and the opportunity to launch the Cxbladder system into other markets along with other intellectual property, such as the colorectal cancer technology, was becoming attractive.

dene.mackenzie@odt.co.nz

Add a Comment