Nexxus Scotland

Controlled Therapeutics – Celebrating 25 years of business

Controlled Therapeutics – Celebrating 25 years of business

Controlled Therapeutics is a 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, US. The Scottish facility is the location for polymer development projects, product manufacturing and product distribution.

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 six million units in over 50 countries worldwide.

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

Controlled Therapeutics has been established in Scotland for more than 23 years and employs over 70 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, win two Queen’s Awards - most recently in 2010 - host a visit from HRH the Princess Royal, and be highly commended at the Best Factory Awards in London in 2010.

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 for the induction of labour. 

The product is licensed for marketing by Forest Laboratories in the US, its largest market, where the product name is Cervidil®. Ferring Pharmaceuticals market the product in the EU and Latin America under the brand name, Propess® and in Canada as Cervidil®. The product is sold in over 50 countries worldwide, thanks to its unique and highly effective drug delivery system. This product is the market leader in many of its territories across the world and has become the largest obstetric brand in the world in value terms.

Across the United States, Controlled Therapeutics enjoys a significant market share for induced labour using prostaglandins. When sales worldwide are added, the product has played an important role in the birth of around six million people.

The dinoprostone vaginal insert, and all Controlled Therapeutics’ products, are designed and manufactured in Scotland.

Steve Robertson, Director of Strategic Projects at Controlled Therapeutics, says “We have now launched in the emerging markets of India and China with our core product and continue to role it out to new territories on an ongoing basis.

“Controlled Therapeutics is still growing and we enjoy a highly innovative culture where our manufacturing processes are constantly being upgraded.”

Steve adds, “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 excellent Universities in Scotland, and from overseas.”

Steve Robertson stresses that although the company is well established, it is prudent in its operations and aware of the dangers of getting carried away on a wave 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.  

Controlled Therapeutics has three products in development including a next generation product for the labour induction market, which is in late stage clinical trials in the US. A higher dose product used to make gynaecological procedures such as hysteroscopy simpler to perform for the physician and less painful for the patient is in phase II trials, and an antibacterial product for the treatment of bacterial vaginosis is ready to enter Phase II trials.

Janet Halliday, Director of Research and Development says, “Our strategy for new products is to focus on women’s health, an area we understand, whilst licensing our technology to other organisations who can make use of it in other clinical applications.”
 
New polymers, and products from them, are being added to the pipeline and are likely to be the start of an exciting future for the company and its employees.

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