Allos Therapeutics, a biopharmaceutical company, has reported that the European Medicines Agency, with a positive opinion of the Committee for Orphan Medicinal Products, has granted orphan medicinal product designation to the company’s novel antifolate, pralatrexate, for the treatment of non-papillary transitional cell carcinoma of the urinary bladder, a form of bladder cancer.
The company is currently investigating pralatrexate in a Phase II study in patients with advanced or metastatic relapsed transitional cell carcinoma of the urinary bladder. In April 2007, the European Medicines Agency (EMEA) granted orphan drug designation to pralatrexate for the treatment of patients with peripheral T-cell lymphoma.
Under EMEA guidelines, orphan medicinal product designation provides 10 years of potential market exclusivity once the product candidate is approved for marketing for the designated indication in the EU. Orphan medicinal product designation also provides potential protocol assistance, advice on the conduct of clinical trials, a reduced marketing authorization application filing fee for the drug’s sponsor and the potential for grant funding.
Paul Berns, president and CEO of Allos Therapeutics, said: We value the positive recognition from the EMEA of the unmet medical need for effective new therapies for the treatment of patients with bladder cancer. In addition, the orphan medicinal product designation further strengthens our program for pralatrexate by offering important clinical development and commercialization benefits.