“Recently we have seen a strong uptick in interest across Asia in general, and a number of major projects we are currently in the process of initiating include sites in HK and the Philippines,” Novotech CEO Alek Safarian told Outsourcing-Pharma.com. Due to the volume of work, “it makes sense for us to set up a legal entity with locally based staff rather than servicing from neighbouring countries… our intention had always been to establish a presence in both these markets, however the timing has been brought forward by about a year as a result of increasing demand in the region.”
The local staff hires will be clinical operations personnel “engaged in management of Phase II-III clinical studies awarded to Novotech,” Safarian said.
Novotech, Australia’s largest clinical CRO, now is situated in 10 Asian countries and Safarian said he believes his company is well-positioned for future increases in Phase II and III studies in the region.
“We expect this current trend of greater Asian participation in global clinical trials to continue and gather pace,” Safarian said. “The interest level from US based biotechs in particular has noticeably increased since the start of the year, and that is the sector in which we have many long established relationships. The projects already awarded in HK and Philippines are mainly from this sector.”
In a recent EMA report on clinical trials, the Philippines ranked tenth among countries outside the EU with at least 0.5% of patients in the pivotal trials included in the MAA (marketing authorization application) submitted to the agency between 2005 and 2011. Both Hong Kong and the Philippines also ranked in the top 20 of countries outside the EU and US in terms of the number of pivotal clinical trials in MAAs submitted to the agency.
In addition, Hong Kong is officially recognized by the China Food and Drug Administration for conducting clinical trials for drug registration purposes in mainland China in certain therapeutic areas.
Private Equity Stake
The expansion of Novotech’s services further into Asia comes about a month after the company announced that Australian private equity firm Mercury Capital acquired a 30% stake in Novotech. Mercury also has the option to increase this to a 50% stake at a later date.
“The investment from Mercury Capital provides both funding needs, as well as strategic input into managed growth in the region,” Safarian said.
Mercury Capital was founded by former Goldman Sachs managing director Clark Perkins, and typically invests in firms with a value of between $30M and $120M.