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Tissue Therapies claims turf war between UK and European regulators partly to blame for lengthy delays of biotech sales

• Liam Walsh
• The Courier-Mail
• October 07, 2014 9:00PM

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Steven Mercer of Tissue Therapies.
TISSUE Therapies has complained of becoming “collateral damage” in a bureaucratic turf war, linking it to long delays for their wound healing product getting sold in Europe.
“In health regulatory affairs, perverse outcomes come along,” Tissue chief executive Steven Mercer told the Brisbane-based company’s shareholders on Tuesday.
Regulatory clearance globally is among the range of hurdles facing biotechnology companies, but Tissue’s comments were a rare public snipe at authorities.
Tissue has developed VitroGro, which is squirted on wounds such as ulcers as a way of speeding up the healing process. The company has repeatedly missed guidance since 2012 for getting first sales of its product via the European market — another delay struck last week.

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Tissue has explained a key problem lay with setbacks in getting regulatory approval to sell their product there. The company argued on Tuesday at an annual general meeting, attended by about 50 people, that regulatory hiccups were not specific to Tissue.
Tissue was only able to point to a couple of similar European occurrences publicly, although news items from Europe have flagged regulatory turmoil in recent years.
Still, some Tissue investors were restless. One complained: “I’ve been waiting four years.”
Dr Mercer cited problems such as Tissue getting written advice in June 2012 that clearance was to be received — only to have other UK and EU agencies get involved and later disagree.
He said the progress of their device “became apparently a turf war” between two agencies.
“So we ended up as collateral damage”, he said.
Tissue is hoping to have its device cleared for Europe by early 2015. Investors asked what would happen if the company’s wound healing technology was ultimately rejected, with Dr Mercer replying an appeals process was available.
Its shares closed up 0.5c at 31.5c.
Tissue posted a $6.8 million loss last year and had $7 million in cash. Bioshares analysts put a speculative buy recommendation on the company.
Requests for comment from two of the regulators, the UK’s Medicines and Health Products Regulatory Agency and the European Medicines Agency, were not answered.