Allos Therapeutics gets EU Orphan Medicinal Product designation for pralatrexate in Hodgkin lymphoma.
M2 PHARMA-October 15, 2010-Allos Therapeutics gets EU Orphan Medicinal Product designation for pralatrexate in Hodgkin lymphoma(C)2010 M2 COMMUNICATIONS
15 October 2010 - US Allos Therapeutics Inc (NASDAQ: ALTH) said today that the European Commission (EC) has granted Orphan Medicinal Product designation for pralatrexate for the treatment of Hodgkin lymphoma (HL).
The company said it is currently investigating pralatrexate in a number of ongoing studies, including a Phase II clinical study in patients with relapsed or refractory non-Hodgkin lymphoma or Hodgkin lymphoma.
The EC previously granted orphan designations for pralatrexate for the treatment of patients with peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and non-papillary transitional cell carcinoma (TCC) of the urinary bladder, a form of bladder cancer.
Under EC legislation, Orphan Medicinal Product designation provides ten 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 allows for protocol assistance free of charge on clinical trials, a reduced Marketing Authorisation Application (MAA) filing fee and the potential for grant funding.
This designation is based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), the company further said.
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|Date:||Oct 15, 2010|
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