Clinigen to Manage Third Access program for BTG

Clinigen Group to Manage Third Access Program for BTG

Supplying Potentially Life-Saving Oncology Antidote in 37 European Countries

Burton-on-Trent, UK - 31 July 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that Clinigen Global Access Programs ('Clinigen GAP') has extended its existing distribution agreement with Protherics Medicines Development Ltd, a BTG International group company ('BTG'), to exclusively manage a named patient program in 37 European Countries for uridine triacetate for use as an antidote to overexposure to the chemotherapy drug 5-fluorouracil ('5-FU'). Wellstat Therapeutics Corporation ('Wellstat') is seeking approval in the US and Europe for its investigational drug, uridine triacetate, and granted named patient supply rights to BTG in the 37 European Countries in 2012. Uridine triacetate is the third product that BTG has placed under Clinigen GAP's management.

Under the named patient program, uridine triacetate will be available for healthcare professionals to treat patients who are overexposed to the widely-used cancer chemotherapy 5-FU due to dosing errors, an inability to breakdown 5-FU normally, and other forms of impaired clearance. According to data from the European Medicines Agency ('EMEA') the number of patients in the European Union affected by a 5-FU overdose each year is over 10,0001. Uridine triacetate has orphan drug designation from the EMEA and the US Food and Drug Administration ('FDA').

Although uridine triacetate is not yet approved in Europe, this program operates within regulatory compliant mechanisms to allow healthcare professionals to prescribe uridine triacetate to individual named patients. Clinigen will provide access to uridine triacetate 24 hours a day, 7 days a week.

Mark Corbett, Senior Vice President, Clinigen GAP said, "We are pleased to be extending our current agreement with BTG to add a third program to the portfolio already handled by Clinigen. We are committed to ensuring that our bespoke access program delivers uridine triacetate to health care professionals for their patients within a critical time period. 5-FU overexposure is an important unmet medical need and making available the supply of uridine triacetate on a named patient basis will provide healthcare professionals access to this investigational antidote to treat patients."

1European Medicines Agency (2009). Public summary of positive opinion for orphan designation of 2', 3', 5'-tri-O-acetyluridine for the treatment of 5-fluorouracil overdose. EMEA/COMP/231352/2009

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About 5-FUIn use as a cancer drug for decades, 5-FU is a mainstay of various treatment regimens for solid tumors including those of the colon, stomach, esophagus, breast, and head and neck. The drug is most commonly administered by infusion pump at or near what is considered the maximum tolerated dose. Expected side effects of 5-FU include myelosuppression (a reduction in white-blood-cell counts and thus increased risk of infection), diarrhea, nausea, vomiting, and mucositis (a painful inflammation of the mucous membranes lining the digestive tract). Overexposure to 5-FU can lead to severe myelosuppression, gastrointestinal hemorrhage, septic shock, multiple organ failure, and death.The incidence of 5-FU overexposure is low though difficult to quantify. Overexposure may result because patients vary in their capacity to break down 5-FU and eliminate it from the body and because infusions pumps can malfunction or be misprogrammed.

About uridine triacetate

Uridine triacetate is Wellstat's investigational drug currently under development for use as a treatment for overexposure to 5-FU due to dosing errors or impaired clearance of 5-FU from the body. It is an orally active prodrug of uridine, meaning that uridine triacetate is converted to uridine in the body. Once uridine triacetate is converted to uridine it reduces the incorporation of 5-FU metabolites particularly into non-cancerous cells. Because of the poor bioavailability of oral uridine, however, and because of complications associated with intravenously administered uridine, uridine itself is not a clinically viable treatment for 5-FU overexposure. Wellstat studies have demonstrated that uridine triacetate delivers four- toeight-fold more uridine into the bloodstream than does oral administration of uridineitself.

About named patient programsNamed patient programs provide controlled, pre-approved access to unapproved medicines in response to requests from physicians on behalf of specific or 'named' patients before those medicines are licensed in the patients' home country.

About Clinigen

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen GAP develops and implements global access programs for biotechnology and pharmaceutical companies and has provided access to unlicensed, licensed and end-of-lifecycle products to thousands of patients. Clinigen has experience in the implementation of more than 30 access programs worldwide.

Clinigen SP is focused on acquiring its own intellectual property in licensed, niche, hospital-only critical care medicines, increasing the value of these medicines by developing new formulations and indications, then registering and marketing them in defined global markets. Clinigen SP extended its oncology support portfolio with the acquisition of Cardioxane® from Novartis in March 2013. Cardioxane, is a cardioprotective agent used to prevent the cardiotoxicity of anthracycline chemotherapy for patients with advanced and/or metastatic breast cancer.

www.clinigengroup.com 

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