Prima BioMed gets European product designation

Prima BioMed announced today that its CVac ovarian cancer therapy vaccine has been granted Orphan Medicinal Product Designation by the European Medicines Agency ( EMA ).

The company said that the designation would open the way for major tax deductions, research support, protocol assistance and exemptions from certain regulatory fees. The designation also gives Prima exclusive rights to CVac for a 10-year period from the granting of commercial approval.

Prima BioMed CEO Martin Rogers said: “The designation represents a significant step in the Company’s goal of commercialising CVac into the multibillion global pharmacy oncology market for the benefit ovarian cancer patients.”

Prima BioMed’s lead product, CVac is a maintenance therapy administered post-surgery and post-chemotherapy to delay relapse and control metastases. The company is hoping the product will address what it says is a large unmet need for new treatments for ovarian cancer, which has an especially high morbidity rate compared with other cancers.

Prima BioMed said that globally the market for ovarian cancer therapeutics was worth over $US2 billion in 2007 and is expected to reach US$3.6 billion this year.

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