Oxford BioMedica secures EU boost for cancer drug

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The Independent Online

Oxford BioMedica, a biotechnology firm specialising in gene therapy, is set to gain orphan drug status in the European Union, securing it exclusive 10-year marketing rights for its key cancer drug.

Its shares rose 13 per cent on the news yesterday, valuing the company at around £187m.

BioMedica said it had received a "positive opinion" from the Committee for Orphan Medicinal Products (COMP) for TroVax, a drug it is developing against renal cancer.

TroVax went into final stage trials last month - the first of the firm's current family of drugs to do so. About 700 patients will be recruited from about 120 centres in the USA, EU and Eastern Europe.

BioMedica said it was in talks with several major drug firms over a potential licensing deal for the development and commercialisation of the drug.

The group's chief medical officer, Dr Mike McDonald, said the positive recommendation for orphan drug designation adds further momentum to the development of TroVax. "It underscores the need for effective treatments for renal cancer, where treatment options are limited and the prognosis is poor," he said.

Orphan status is a category for drugs designed to treat rare conditions, for example affecting not more than 5 in 10,000 people in the EU. It affords exclusive marketing rights for a certain period. The agreement will give the firm and its prospective partner the benefit of accelerated approval procedure for the drug under the European Medicines Agency.

Renal cancer represents any malignant tumour with its origin in the tissues of the kidneys. About 150,000 cases of renal cancer are diagnosed every year. Some 33,000 patients die from the disease each year in the US and Europe.

If renal cancer has spread to other organs at the time of diagnosis, the five-year survival rate is less than 5 per cent.

Data from IMS suggests that more than 5,000 patients in the UK received treatment for metastatic renal cancer in 2005.

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