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Clinigen Signs EU-wide Clinical Trial Distribution Agreement for Accord Healthcare's Injectable Oncology Drugs Portfolio

6/20/2012 12:49:38 PM

Burton-on-Trent, UK and Harrow, UK – 20 June 2012 -- Clinigen Clinical Trials Supply (Clinigen CTS), a Clinigen Group company, and Accord Healthcare, the wholly-owned marketing subsidiary of India’s Intas Pharmaceuticals Ltd, today signed an exclusive clinical trial distribution agreement covering the administration and distribution of Accord’s injectable cancer drugs across the EU.

Under the terms of the agreement, Clinigen CTS will act as the sole point of enquiry, order receipt and distribution of Accord products to manufacturers, contract research organizations (CROs), clinical trial contract packagers and other specialist service providers looking to source pharmaceutical products for use in clinical trials in the EU.

“We consider timely fulfilment of requests as being of utmost importance and as demand for our products has grown, we decided that outsourcing distribution activities to a specialist in the clinical trial supply space made sense both for Accord and for our customers,” said James Burt, vice-president Hospitals at Accord Healthcare. “A critical consideration for us in choosing a partner was the fact that Clinigen CTS only sources products for clinical trials and tracks them all the way from source to the point of use. This reassured us that no Accord products will be diverted through other channels for alternative purposes.”

As part of Intas Pharmaceuticals, Accord can leverage the manufacturing infrastructure of its parent organization, which comprises eight formulation manufacturing facilities in India and one each in the UK and Mexico. Accord markets more than 15 generic injectable cancer drugs in the EU including carboplatin, docetaxel, irinotecan and oxaliplatin and has over 50 injectable molecules in development or registration.

“Accord’s rapid expansion to having a presence in many global territories underlines its impressive growth. As an innovative, forward-thinking company, their culture very much mirrors that of Clinigen,” said Shaun Chilton, Chief Operating Officer of Clinigen’s Services division, which includes Clinigen CTS. “Even before our new agreement with Accord, we have been receiving frequent requests for injectable cancer products. We are now able to connect the manufacturing capacity of Intas with our own European distribution network which gives us confidence that this will be an excellent working relationship on both sides.”

About the clinical trial supply market

The European Clinical Trials Directive 2001/20/EC (EUCTD) was introduced to establish standardization of research activity in clinical trials throughout the European Community. Sponsors conducting clinical trials on new investigational medicines have seen a rise in the importance of comparator studies as comparisons to existing treatments become more important. Sponsors increasingly work in partnership with specialist clinical trial supply companies, such as Clinigen CTS, to source the drugs required for use in clinical trials. These include comparator drugs, which are used as benchmarks to assess the comparative-effectiveness of investigational products; concomitant drugs, which together with other medicines are used to treat disease and/or treatment side-effects; adjuvant drugs, which improve the effectiveness of the trial medicine; and rescue therapies for patients who have experienced an exacerbation of symptoms or insufficient therapeutic effect during the trial.

About Clinigen CTS

Clinigen Clinical Trials Supply (Clinigen CTS), formerly Keats Healthcare, became part of Clinigen Group in 2010. Working in partnership with suppliers, pharmaceutical/biotech companies and contract research and manufacturing organizations, Clinigen CTS sources commercial medicinal products for use exclusively in customers’ clinical studies, including comparator trials. Clinigen Group is headquartered in Burton-on-Trent, UK, with offices in Philadelphia, US, and Tokyo, Japan.

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About Accord Healthcare

Accord Healthcare is a wholly-owned marketing subsidiary of Intas Pharmaceuticals Ltd. Accord is a global company with a presence in Australia, Brazil, Canada, Kenya, Mexico, New Zealand, Peru, South Africa, Spain, the UK, the US and Vietnam. Accord is committed to maximizing customer satisfaction by introducing innovative, quality products to the market.

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