Tissue Therapies, beset by setbacks, changes tack on developing VitroGro as drug
July 28, 2015 9:18pm
Liam WalshThe Courier-Mail
The biotechnology sector is high-risk, high reward.
BIOTECHNOLOGY outfit Tissue Therapies has gone back to the strategic drawing board, pushing out ambitions of getting a wound-healing product to market to beyond 2018.
The reasoning behind Brisbane-based Tissue developing a new strategy, of getting US and European clearance for a drug, is this path will be more profitable.
The change comes after setbacks beset Tissue. It had initially hoped to sell in Europe by 2012 its VitroGro technology, which heals ulcers.
It marks another example of the long and potholed times it can take to develop products in the speculative biotechnology sector. Tissue has accumulated losses of $46.5 million and first listed in 2004.
In a stockmarket announcement on Tuesday, Tissue announced plans to develop its product as a drug worldwide instead of a medical device in Europe.
This strategy “offers a far greater value” although it will take longer, Tissue said.
That reverses strategy of previous management about busting first into Europe’s market with VitroGro as a device. The strategy got shipwrecked on various European regulatory questions.
Tissue will now try conducting more trials for ulcers, potentially getting a wider market, and is seeking partners to help funding.
Assuming things went smoothly, Tissue hoped to file for a new drug application with the US Food and Drug Administration in calendar 2018’s second half. If again things went smoothly, that could suggest a launch in 2019 as the FDA’s latest annual report indicates most reviews are completed within 10 months.
Meanwhile, Anatara, which is working on a drug to stop pig diarhorrea, said it had raised another $2 million from existing investors via a share purchase plan. People would get about 60 per cent of the stock applied for.
