Controlled Therapeutics (Scotland) Limited, East Kilbride, Scotland, has today secured a half million pound (GB £500,000 / US $835,000) award from the UK Government via the Scottish Executive Spur plus programme to assist in the development of its next generation, polymer drug delivery system.

The one and half million pound (GB £1.5m / US $2.5m) project to develop a new biodegradable dosing system for both classical and the new biopharmaceutical drugs (peptides and proteins), such as interferon and EPO, is now underway at Controlled Therapeutics' R&D and manufacturing headquarters in Scotland.

Dr Magnus Nicolson, Controlled Therapeutics' Managing Director, said: "Unlike Pegylation, our new technology does not result in the chemical modification of the drug". Pegylation is the leading drug delivery technology, used with such biopharmaceuticals as interferon for the treatment of hepatitis C.

He added, "In our new linear polymers the drug is trapped in the pores within the hydrogel matrix until it escapes, either by erosion of the matrix or by diffusing out of the delivery system into the systemic circulation. Importantly, both processes can be timed to enable sustained release of the drug."

Dr Janet Halliday, Research and Development Director added: "Hydrogel matrices are friendly environments for proteins and we believe our formulations will greatly increase the stability of these drugs, giving our preparations significantly greater storage stability and longer shelf life."

She added, "One of the main advantages offered by this delivery system will be predictable drug release, avoiding the spiking often seen with this type of product. As a consequence, our formulations should produce fewer side effects for patients. It is hoped that the reduced frequency of dosing required using the new linear polymers will increase patient compliance, thus lowering the cost of therapy."

This latest development for Controlled Therapeutics follows on from the success of their first product, the Cervidil®/Propess® vaginal insert, which currently enjoys 85% market share in the US for cervical ripening in women during childbirth.

		Controlled Therapeutics is a drug delivery company founded in 1986 employing 54 staff at its purpose built facility in Peel Park Campus, East Kilbride, Scotland. It is a wholly owned subsidiary of Cytokine PharmaSciences, Inc., a private global biopharmaceutical company based in Pennsylvania, USA.
		The company's lead product, called Cervidil® in the US and Propess® elsewhere, was launched in 1995 and is used for cervical ripening in women during childbirth. This product is currently manufactured and exported from the East Kilbride facility to over 30 countries worldwide. In addition, more than 20 other countries have gained regulatory approval for Cervidil®/Propess® and a phased program of product launches will take place over the coming years. By 2002 over 2 million children had been safely delivered thanks to Cervidil®/Propess®.
		The linear biodegradable polymer system will be used to deliver bio-molecules which are of increasing commercial importance in the US $390 billion (2001) global pharmaceutical industry.
		Controlled Therapeutics' new polymer drug delivery system is designed to dovetail with the first raft of biopharmaceuticals now coming off patent (and subject to generic competition) and the new bio-pharmaceuticals now gaining approval. The pharmaceutical industry, both generic companies and market leaders, are looking for better delivery systems for their drugs. Controlled Therapeutics believe their bio-absorbable hydrogel matrices will be of interest to a large number of companies seeking a better way to deliver their drugs.
		Controlled Therapeutics would be pleased to hear from pharmaceutical and biotechnology companies to form co-development partnerships.

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