Nexxus Scotland

Controlled Therapeutics

Controlled Therapeutics is an established and successful company first set up in the West of Scotland in 1986.

Since 1993, it has been a wholly owned subsidiary of Cytokine PharmaSciences Inc. based near Philadelphia, USA, but the Scottish facility still enjoys a high degree of autonomy.

Controlled Therapeutics develops proprietary products for the pharmaceutical market, based on its own, unique drug delivery systems. Current key products include Cervidil®/Propess®; a human birth induction system which has already sold more than three million units in 48 countries worldwide.

Controlled Therapeutics' site in East Kilbride in the West of Scotland has FDA site approval and the facilities are carefully designed to comply with all current quality standards for marketed products and clinical trials.

Controlled Therapeutics has been established in Scotland for twenty years and employs more than fifty people at its facility in a tree-lined Science Park in East Kilbride.

From small beginnings, and using technology first developed at the University of Strathclyde in Glasgow, the company's approach has been sufficiently commercial to attract support from a range of investors. In 1993, it also became a wholly owned subsidiary of Cytokine PharmaSciences.  

Controlled Therapeutics' key product is its unique hydrogel drug delivery system, which, when combined with dinoprostone in a vaginal dosage form, is used for ripening the cervix in cases where there is an obstetric or medical need reason for the induction of labour. 

The product is licensed for marketing by Ferring Pharmaceuticals in the EU under the brand name, Propess® and in Canada as Cervidil®. In the US, the marketing partner is Forest laboratories and the product name is Cervidil®.

Across the United States, Controlled Therapeutics enjoys 80% market share for induced labour using prostaglandins and has therefore played an important role in the birth of around two million new US citizens. The product is also sold in almost fifty countries worldwide, thanks to its unique and highly effective drug delivery system. Propess® is also the market leader in France and several other territories across the EU.

The Dinoprostone hydrogel system, and all Controlled Therapeutics' products are designed and manufactured in Scotland

Steve Robertson, Director of Strategic Projects at Controlled Therapeutics, says "The technology we use is highly specialised and much of the manufacturing process is unique to us. For instance, the hydrogel used in the induction process is a polymer which swells in the presence of water but does not dissolve."

"We have long experience of developing such targeted and efficient polymers for specific uses and have good links with Scottish University researchers to keep us at the forefront of our field. The West of Scotland offers an excellent scientific and research community as a backdrop and we enjoy an excellent network of local suppliers, which is important both to our success and our company ethos."

"The success and maturity of the company mean that we are also able to attract first class graduates, both from the network of good universities in Scotland, and from overseas."

Steve Robertson stresses however that although the company is well established, it is prudent in its operations and aware of the dangers of getting carried away on a flight of enthusiasm about each new piece of emerging technology.

It is part of the company's strategy to licence the marketing and distribution of emerging products to commercial partners. This collaboration may begin at the product concept stage, with the risks and benefits of development being shared. In other cases, Controlled Therapeutics funds the development programme as far as proof-of-concept stage, whereupon commercial partnerships will be established.  

Steve adds, "We are currently developing several other high value, niche products for pharmaceutical companies worldwide and actively targeting emerging markets in India and China with our core products."

"Controlled Therapeutics is still growing and we enjoy a highly innovative culture where our manufacturing processes are constantly being upgraded. We are also very active in exploring new markets and busily engaged in increasing our exposure in Japan at the moment."

Future projects for Controlled Therapeutics include a follow on product for the labour induction market, which is entering phase 3 clinical trials in 2006.

They are also trialling (phase two testing) a product for bacterial vaginosis, and applying their knowledge of polymer technology to the treatment of Xerostomia, or "dry mouth syndrome". This system would also have applications in cancer and Sjogrens Disease (a disease of the auto-immune system).

Steve Robertson adds, "The secret of our success is reflected in our strategy; we constantly explore new avenues but are careful never to spread our wings too widely."

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