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News

MCA approves pivotal Phase III trials for Varisolve in the UK

BTG : 15 October, 2006  (Company News)
BTG plc announced that its wholly owned subsidiary, Provensis Ltd, has received a letter of approval from the Medicines Controls Agency for its Clinical Trials Exemption confirming that the Phase III study for its Varisolve procedure can go ahead in the UK.
Following presentation of pre-clinical and toxicology data, and the DDX (physician-led) studies which are nearing completion, the MCA concluded that the safety, dosing and toxicity standards, traditionally tested through conventional Phase I and II clinical trials, were sufficient to permit approval of the start of Phase III studies under a CTX.

The outcome of discussions with the FDA concerning the need for Phase II studies in the US will be reported shortly. As previously indicated, any requirement to carry out Phase II trials will not impact the target launch date in the US.

Varisolve is a virtually painless out-patient treatment for varicose veins and is expected to provide an alternative to surgery. Over 150 million people in the US and Europe suffer from varicose veins and could benefit from surgery. Proprietary research has indicated that although a significant segment of this population would not opt for surgery, they are likely to pursue an alternative out-patient treatment with the benefits expected from the Varisolve procedure. Approximately 4 million new cases arise each year.

Ian Harvey, Chief Executive Officer of BTG, said: 'This news represents an important development milestone and keeps us well on track for the launch of Varisolve in Europe.'

BTG announced its collaborative venture with Croda Chemicals for the manufacture of polidocanol, the active in the Varisolve procedure. Construction work on the new dedicated manufacturing facility in East Yorkshire will commence this month. This will be the first production centre in the world to manufacture pharmaceutical grade polidocanol to cGMP/FDA standards.
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