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BTG extends orphan drug distribution partnership with Clinigen

Deal covers treatment for overexposure to chemotherapy

UK-based Clinigen Group is to manage a named patient programme for an investigational orphan drug to treat overexposure to chemotherapyon behalf of BTG International.

The distribution deal will see Clinigen's global access operations, Clinigen Global Access Program (Clinigen GAP), work on behalf of BTG's Protherics Medicines Development business to make uridine triacetate available.

The drug is being developed as a treatment for 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, and its US and European licence applications are being handled by Wellstat Therapeutics.

Wellstat Therapeutics granted named patient supply rights, which allow controlled, pre-approved access to unapproved medicines when requested by doctors on behalf of specific, 'named' patients, to BTG in the 37 European Countries in 2012.

Uridine triacetate is the third product that BTG has placed under Clinigen GAP's management and the latest programme will cover 37 European countries.

“We are pleased to be extending our current agreement with BTG to add a third programme to the portfolio already handled by Clinigen,” said senior vice president, Clinigen GAP, Mark Corbett.

“We are committed to ensuring that our bespoke access programme delivers uridine triacetate to healthcare 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.”

1st August 2013

From: Research



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