Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued an opinion recommending against conditional approval of FOLOTYN
(pralatrexate injection) for the treatment of patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy. The Company plans to submit a request for re-examination of the CHMP opinion within two weeks.
“We are committed to making FOLOTYN available in the EU for patients with relapsed or refractory peripheral T-cell lymphoma -- an aggressive and progressive disease where there remains a high unmet need for new therapies,” said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics.
“We continue to believe that the available data for FOLOTYN meet the criteria for conditional approval, and we intend to work closely with our partner Mundipharma and the CHMP during the re-examination process.
PTCL is an indication for which there are currently no approved therapies in Europe and no accepted standard of care.”
In May 2011, Allos entered into a strategic collaboration agreement with Mundipharma International Corporation Limited (Mundipharma) to co-develop FOLOTYN globally. Under the agreement, Allos retains full commercialization rights for FOLOTYN in the United States and Canada, with Mundipharma having exclusive rights to commercialize FOLOTYN in all other countries. To date, Mundipharma has submitted applications seeking regulatory approval of FOLOTYN in Australia, S. Korea and Switzerland.
Pralatrexate has orphan medicinal product designation in Europe for the treatment of PTCL (nodal, other extranodal, and leukaemic/disseminated). In the E.U., orphan medicinal product designation is conferred upon investigational products for diseases that affect fewer than five in 10,000 patients. Products with orphan designation that are the first to be approved for a specific indication, and continue to meet the requirements for orphan designation, receive up to ten years of market exclusivity in the E.U.