Home' Australasian BioTechnology : Vol 27 No 3 Contents Australasian BioTechnology | Volume 27 | Number 3
at AusBiotech’s 2017 national conference
When it comes to early-stage clinical
development, Australia has long been able
to hold a distinguished position of being
simultaneously efficient, affordable and
Additionally, clinical dossiers generated through
Australian clinical trials are routinely accepted by major
regulatory agencies around the globe, resulting in an
advantageous and user-friendly jurisdiction. Over the
years, the Australian Government has worked to cultivate
and maintain this position through such efforts as the
continued implementation of the country’s Clinical
Trials Notification (CTN) scheme, and its research and
development (R&D) Tax Incentive.
In addition to local Australian companies, firms from the
United States – and, to a lesser extent, Europe – have
been the major benefactors of Australia’s early-stage
clinical development advantages. Japanese companies,
hailing from the world’s second-largest single-country
pharmaceutical market after the United States, have
lagged behind their United States and European Union
counterparts. This status quo, however, is being altered
with an increasing number of cost- and quality-conscious
Japanese biotechnology companies (referred to more
commonly as ‘bioventures’ in Japan) taking advantage
of the benefits available Down Under. OncoTherapy
Science, ID Pharma, and AnGes are three influential and
recent adopters of the Australian early-stage clinical path.
Founded in 2001 as a university-launched bioventure,
OncoTherapy Science (OTS) conducts research and
development of oncological drugs and therapies. Their
technology is based on Dr Yusuke Nakamura’s cancer-
genomics research targeting oncogenes and proteins.
The company announced in early January 2016 that they
had received a green light from an Australian Human
Research Ethics Committee (HREC) to commence a Phase
I bioavailability study on their OTS167 (a MELK Inhibitor)
investigational product (IP). Just over two months later in
mid March 2016, the company announced completion,
with ‘favourable results’, of the same study.
Another company taking advantage of the opportunities
in Australia is ID Pharma. Established in 2003 as DNAVEC
Corp., the successor company of a Japanese governmental
research project that started in 1995, ID Pharma develops
gene therapies and gene vaccines based on the firm’s
patented and proprietary Sendai virus vector technology.
The company announced the commencement of a Phase
I/IIa Australian trial in early May 2016 for its DVC1-0101
product for the treatment of critical limb ischemia. The
company was acquired in 2013 by I’rom Group, the same
firm to subsequently acquire Adelaide’s CMAX Clinical
Research from IDT Australia earlier this year.
Finally, we would be remiss not to mention AnGes.
AnGes, established in 1999 by researchers from Osaka
University, has been one of the most influential and
trendsetting bioventures in Japan. So much so that its
lead product, AMG0001, is on course to become Japan’s
first (and the world’s sixth) approved gene therapy in
the coming months. The company announced in late
July 2017 that it is working towards a Phase I/II clinical
trial in Australia for its AGMG0201 IP, a DNA vaccine for
hypertension. Furthermore, this trial will take place at
CMAX Clinical Research facilities, further intertwining the
interests of Japan and Australia.
Traditionally, Japanese bioventures have faced the same
problems that any non–United States biotechnology
company is bound to face at some point: specifically, a
lack of available capital. While some countries, including
Australia, have opened their stock-exchange gates to the
biotech community/industry, the listing requirements in
Japan remain prohibitive for bioventures. Despite being
the second-largest pharmaceutical market in the world,
even a liberal count of listed bioventures in Japan comes
to 25 companies; the contrast to the number of biotechs
listed on the ASX is stark.
As Japanese firms are increasingly keen to tap into
pharmaceutical markets outside of their home market,
the speed/efficiency and cost benefits of the Australian
CTN scheme make for a convincing strategic avenue for
clinical development. We believe that more Japanese
bioventures will make their way to Australia for early-
stage clinical trials, with larger pharmaceutical companies
to follow suit.
JAPANESE INNOVATION AWAKES
TO AUSTRALIAN CLINICAL TRIALS
BY COLIN LEE NOVICK AND ANDREW FLEURY, CJ PARTNERS INC.
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