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Research by the School of Pharmacy played a key role in the 2008 regulatory approval of Janssen Pharmaceutica's HIV drug Intelence®. As a poorly soluble drug, Intelence® required specialist formulation and was the first formulation of its type to be approved by the FDA and EMA. Intelence® offers significantly improved clinical outcomes due to its efficacy in patients with HIV resistance. Global Intelence® sales in 2012 were $349M, with additional not-for-profit supplies to resource-limited countries. As a result of this landmark regulatory approval formulation development strategies at Janssen were adapted enabling a further poorly soluble drug to reach the market. Telaprevir, a second-generation Hepatitis C treatment (marketed as Incivek®, Incivo® & Telavic®), gained global regulatory approval in 2011. 2012 sales exceeded $1bn in the US alone.
Labelled compounds form an essential part of drug discovery and development within the pharmaceutical industry. Novel iridium catalysts, developed by Kerr at WestCHEM since 2008, have introduced a step-change in the ability to label pharmaceutical candidate compounds with radioactive (tritium) or non-radioactive (deuterium) isotopes.
The catalysts are applicable to specific types of compounds that comprise approximately one-third of all drug candidates. Advantages of the catalysts include greater efficacy (less catalyst needed and higher yield of labelled product, giving cost savings), greater speed (efficiency savings), and a significant decrease in radioactive waste compared with previous methods (environmental and safety benefits).
Even since 2008, their adoption within the pharmaceutical industry has been extremely rapid; e.g., the multinational pharmaceutical company AstraZeneca now applies the Kerr methodology to 90% of their relevant candidate compounds. Additional impact has been achieved by Strem Chemicals who have been manufacturing and marketing the catalysts worldwide since October 2012. Even in that very short period, multiple sales have been made on three continents providing economic benefit to the company.
The Abraham solvation parameter approach developed at UCL has become integral to the work carried out by drug discovery teams at [text removed for publication] and other major pharmaceutical companies, as well as research and development groups at international chemical companies including Syngenta and [text removed for publication]. It enables chemists to predict physicochemical and biochemical properties of chemicals, including drugs and agrochemicals, rapidly and efficiently, without the need to conduct time-consuming experiments. The method helps drug discovery teams to identify and optimise the most promising compounds, and often results in fewer compounds being made before a candidate is selected, saving time and resources. The approach has been integrated into software used for drug discovery [text removed for publication].
Innovative formulation science to create and develop the commercially successful PowderHale® technology was undertaken within the Department of Pharmacy & Pharmacology at the University of Bath, and subsequently by Vectura. This has directly provided the basis for novel, potentially life-saving treatments for chronic obstructive pulmonary disease (COPD). Seebri® Breezhaler® and Ultibro® Breezhaler® are once-daily, maintenance bronchodilators for the relief of various symptoms due to airways obstruction caused by COPD. Seebri® Breezhaler® was approved in the EU and Japan at the end of 2012 and has now been launched by Novartis. Ultibro® Breezhaler® a first-in-class combination bronchodilator was approved in Japan and the EU in September 2013. Under the terms of the licence agreement with Novartis concerning these products, Vectura has already received $52.5M with an additional >$100M anticipated upon achievement of regulatory and commercialisation targets. These medicines are major advances to treat and manage a disease that, according to the WHO, affects an estimated 210 million people worldwide and was the third leading cause of death in the developed world in 2012.
Novel vapour sorption experimental methods for the characterisation of complex particulate materials have been developed in the Department of Chemical Engineering. This research and expertise resulted in the creation of Surface Measurement Systems Limited (SMS), whose Dynamic Vapour Sorption (DVS) and Inverse Gas Chromatography (IGC) instruments are now found in >500 laboratories around the world. They are recognised standard research and development tools in the global pharmaceutical industry (DIN 66138). SMS has contributed >270 man-years of employment and generated £27M of turnover, whilst SMS instruments have generated over £300M of economic value, over the REF period.
i2c Pharmaceutical Services is the trading name for a Cardiff University spin-out company based on Cardiff University research excellence and specialising in pharmaceutical inhaler product research and development. i2c's research in formulation technologies and clinical testing has enabled development of new inhalational medicinal products for the healthcare markets in both developed and emerging countries. Impacts arising from research are at local, national and international levels and evidenced by marketed products, the improved business performance of commercial concerns and the creation of highly skilled jobs.
Research by Professor Jones, Department of Chemistry, University of Cambridge, resulted in the development of a new method for preparing composite solids, involving the grinding of two or more crystalline solids in the presence of small volumes of liquid. This so called "liquid assisted grinding" (LAG) which produces novel solids with bespoke physical and chemical properties, is now routinely used by the major pharmaceutical companies to screen for new drug forms as part of their drug product development process.
Research by Professor Abdul Basit's group at the UCL School of Pharmacy is leading to improved treatments for ulcerative colitis and other conditions through increased knowledge of the complex physiology of the gastrointestinal tract. Improved understanding of in vivo drug release and uptake has allowed development of three patent-protected technologies for improved drug delivery: PHLORALTM, for release of drugs in the colon, and DuoCoatTM and ProReleaseTM formulations designed to allow intact transit through the stomach followed by immediate release upon gastric emptying. These technologies are the subject of licences and ongoing development programmes, with PHLORALTM currently in phase III clinical trials. The impact is therefore the introduction of enabling technologies that have positively influenced the drug development programmes of pharmaceutical companies.
Graham Buckton's work at the UCL School of Pharmacy has involved the development of new techniques, which are now industry standards, for assessing the amorphous content of materials in inhalation products. This work has had a significant influence on both manufacturing quality control and regulatory requirement, including informing FDA policy, to the effect that this type of assessment is now a requirement for licensing of powder inhalation medicines in the US and Europe. Benefits to drug companies include cost savings and more reliable production. Furthermore, the associated School of Pharmacy spin-out company, Pharmaterials, offers these assessments as a core part of its commercial activity, with a large client base of industrial partners who require such assessments for their inhalation and other products. The overall result of this work has been changes and improvements in the design, control and manufacture of inhalation products.
The transition, at the end of the 20th century, from ozone-depleting chlorofluorocarbons (CFCs) to hydrofluoralkane (HFA) propellants in metered dose inhalers (MDIs), for drug delivery to the upper airways in the lungs, taxed the ingenuity of formulation scientists and device design engineers. The regulatory requirement for clinical equivalence between the CFC and HFA products demanded an unchanged drug dosing regimen and identical lung deposition profiles.
Research funded by Chiesi Farmaceutici (Parma, Italy) in the Centre of Drug Formulation Studies (CDFS) at the University of Bath led to development of the Modulite® technology which met the challenges posed and mimicked the performance of CFC MDI using HFA propellants. The proprietary technology enabled Chiesi to re-formulate and commercialise a number of products, which now represent mainstay therapies in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The Modulite® technology has provided the greatest contribution to both the turnover and the global development of the Chiesi group, via several successful in-house developmements and collaboration agreements with leading pharmaceutical companies. Global sales of Chiesi's Atimos Modulite®, Fostair/Foster (25% of sales) and Clenil Modulite® (14.4% of sales) MDI products produced revenue of in excess of $450 Million in 2012.