Founded in 2007 by pharmaceutical industry veteran Andy Leaver, Clinigen Group was originally set up to supply unlicensed medicines to patients in Britain in cases when a prescribing doctor thinks an unlicensed drug is the best option. Today it supplies unlicensed and licensed medicines to hospitals, pharmacies and individual patients worldwide. It also sells and distributes drugs for clinical trials across the globe. Leaver has been involved in several pharmaceutical start-ups as investor and chairman. The idea for Clinigen was, however, first conceived by Peter George, who in a previous pharmaceutical role saw the potential in acquiring specific drugs and establishing a global distribution network for them. After discussions with Leaver, Clinigen was set up, although George joined the company only early last year. The business has seen impressive growth in the past year, predominantly due to its acquisition of one of Leaver’s former investments, Keats Healthcare. Keats supplies comparator drugs against which trial medicines can be judged, a regulatory requirement in most countries because new drugs have to be at least as clinically successful and cost-effective as the market leader. Keats sources the drugs and supplies them to pharmaceutical companies for clinical trials. It says it works with 15 of the top 20 pharmaceutical companies on about 100 projects a year. The acquisition added £17m to Clinigen’s revenues – accounting for half its sales in 2011 – and allowed it to generate sufficient cashflow to acquire and market new products. Last year it acquired the rights from Astra Zeneca to manufacture and distribute globally an anti-viral medicine for HIV and bone-marrow-transplant patients. At the time of the acquisition, the drug, Foscavir, had been discontinued in America and its licence there had lapsed. Clinigen started supplying the drug to named patients in America, initiated the process of reviving its US licence, and agreed a distribution contract. It also started the process of enhancing its Japanese licence. Today its work with Foscavir accounts for revenues of almost £10m, up from £1.5m in 2010, and about a quarter of the company’s total sales. Foscavir is the first big example of Clinigen’s strategy for growth: to buy end-of-life-cycle drugs from their manufacturers, revitalise them and market them globally. The drugs the company looks to acquire are usually hospital-only medicines, administered at the end of a life or to save a life, usually for patients with leukaemia, cancer or infectious diseases. Supplying medicines for clinical trials and acquiring drugs for global marketing and distribution represent two arms of Clinigen. The third focuses on managing the global distribution and supply of drugs still in development and not yet fully licensed on behalf of pharmaceutical firms. By exploiting its international network, Clinigen says it is able to roll out solutions globally for manufacturers to meet demand for early access to these drugs and address unmet clinical need. Conversely, it is also able to support the withdrawal or discontinuation of drugs that have reached the end of their life cycle, but which still have active users, in a controlled way. Over the past three years the Burton on Trent group’s sales have soared by 242% a year, from an annualised £875,000 in 2008 to £35m in 2011, with some of the highest profit margins on the league table. In the past year it has reviewed 4,000 drugs to identify its next targets, and it is now in talks with a manufacturer to buy another drug with a revival profile similar to that of Foscavir. It also has plans to expand its clinical drug supply in America, where it has recently established a sales team. Leaver acts as chairman, with George as chief executive. The management plans to use its experience and contacts to market Clinigen’s drugs globally.
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