AusBiotech 2012: The real ‘valley of death’ is dealing with regulators: Alan Robertson

There are many trials on the path from discovery to the commercialisation of a new medical innovation.

One oft-cited challenge is bridging the so-called ‘valley of death’ between publicly funded research and attracting private investment to take a new therapeutic to market.

The National Health and Medical Research Council (NHMRC) funds medical research to the tune of over $780 million a year, yet there is little funding to translate those discoveries into products that reach patients.

However, this is not the real ‘valley of death’ facing biotechnology companies, said Dr Alan Robertson, Chief Executive Officer of Pharmaxis (ASX:PXS), speaking at the AusBiotech 2012 conference in Melbourne.

Giving the Millis Oration – named in honour of Emeritus Professor Nancy Millis AC, who passed away last month – Robertson stated that the challenge of securing funding has been overstated. “Good innovative ideas will get funded one way or the other,” he said.

However, as Pharmaxis discovered on its rocky road to marketing and reimbursement approval in Europe and Australia, it is the many long months negotiating with regulators that is the real challenge for biotechs.

Pharmaxis had its marketing approval in Europe knocked back in 2011, causing its share price to plummet overnight from $2.92 to 92c, and has struggled to regain ground ever since, despite receiving marketing approval in April of this year and a recommendation from UK regulator to receive reimbursement from the National Health Service.

The company was also knocked back by the Pharmaceutical Benefits Scheme twice before being listed in March of this year.

According to Robertson, these delays have proven not only costly to the company, but have rattled investor confidence, underscoring the notion that the characteristic uncertainty of traversing the regulatory process is a major challenge for biotechnology companies.

Robertson stressed that the future is not all bleak, and that Australian biotechnology companies can find the funding to either partner or to drive product development themselves.

The AusBiotech 2012 conference is taking place in Melbourne and concludes on Friday.