Clinigen Extends Accord Agreement to Capecitabine

Clinigen Group Extends Exclusive Agreement with Accord Healthcare to Supply Anti-Cancer Drug Capecitabine into Clinical Trials in Europe

Burton-on-Trent, UK - 14 January 2014 - Clinigen Group plc (AIM: CLIN) today announced that its Clinical Trials Supply business (Clinigen CTS) has extended its exclusive European Union (EU) clinical trial distribution agreement with Accord Healthcare ('Accord'), a wholly-owned marketing subsidiary of Intas Pharmaceuticals, to include capecitabine, an orally administered chemotherapeutic tablet.

Accord's capecitabine tablet adds to the company's EU portfolio of more than 15 injectable oncology drugs, including cisplatin, cytarabine, docetaxel, doxorubicin and fluorouracil currently distributed by Clinigen CTS to manufacturers, CROs, clinical re-packagers, and other specialist providers for use as comparator, co-therapy, rescue and adjunctive drugs in clinical trials. In June 2013 Clinigen CTS renewed its agreement with Accord to supply these products for a further two years and is the sole point of contact for all clinical trial supply enquiries and orders.

The Capecitabine Accord tablet, which is a hybrid generic version of Xeloda®, is available in a new strength of 300mg in addition to existing strengths of 150mg and 500mg. It was launched in Europe, a market worth almost US$400 million, in December 2013. The chemotherapeutic is indicated for the treatment of a range of cancers including breast, colon, rectum and stomach and can be used in combination with other oncology products from the Accord portfolio supplied by Clinigen CTS.

"Capecitabine is a key product for Accord," said Daniel Green, Hospital Director UK & Ireland at Accord. "We see clinical trials as an important area into which we can supply the drug and extending our exclusive agreement with Clinigen will allow us to maximize the impact and potential of the product in this area. The partnership is working well and we believe that the addition of capecitabine will serve to develop it further."

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "The extension of our exclusive agreement with Accord to include capecitabine is confirmation of the strength of our clinical trials supply business and the partnership we have built with Accord. We pride ourselves on the quality of our service and delivery capabilities and are pleased that Accord has chosen us to manage the distribution of another important product."

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About Capecitabine

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. It is a prodrug that is enzymatically converted to 5-fluorouracil (5-FU) in the tumor where it inhibits DNA synthesis and slows growth of tumor tissue. Accord's capecitabine tablet was registered in the entire European Union countries through a centralized registration procedure and launched in December 2013. Capecitabine is available in 150mg, 300mg and 500mg in packs of 30, 60 and 120 tablets. Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Capecitabine is a first-line treatment of advanced gastric cancer in combination with a platinum-based regime i.e. cisplatin and carboplatin.

About Clinigen Group

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group, dedicated to delivering 'the right drug, to the right patient at the right time', has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen CTS sources commercial medical products for use in clinical studies only. These include comparator drugs, where existing medical treatments are used as benchmarks to assess the effectiveness of investigative products, adjuvant drugs, which improve the effectiveness of the product being trialed, and rescue therapies, which help patients who have experienced a worsening of symptoms or insufficient therapeutic benefit during a trial.

For more information, please visit www.clinigengroup.com

About Accord Healthcare Ltd

Accord Europe started commercial marketing activities in August 2008. Pan-European coverage has been rapidly attained. As of 2013 Accord products have been sold in over 30 European markets. Since beginning of its commercial activities the company has shipped over 150 million packs of pharmaceuticals (equating to over five billion doses) within Europe bringing benefit to millions of patients. To date Accord has gained nearly 5,000 product approvals across the European Economic Area and the company is actively working on extending this number, so more patients can benefit from our products in future.

For more information visit www.accord-healthcare.eu

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