Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the United States Patent and Trademark Office (USPTO) has extended by five years the U.S. Patent No. 6,028,071, which covers FOLOTYN
(pralatrexate injection). The extension was granted through the Hatch-Waxman Act and postpones the original July 16, 2017 expiration date to July 16, 2022.
“The extension of the FOLOTYN patent provides Spectrum with an additional five years of exclusive commercial rights to the product. We believe the drug is an important treatment option in relapsed or refractory PTCL and look forward to reaching a greater physician and patient base in the upcoming year,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “In addition, the patent extension confirms substantial expected revenue growth for the Company in the near- and long-term.”
FOLOTYN, a folate analogue metabolic inhibitor, was discovered by Memorial Sloan-Kettering Cancer Center, SRI International and Southern Research Institute and developed by Allos Therapeutics. In September 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. FOLOTYN has been available to patients in the U.S. since October 2009. An updated analysis of data from PROPEL, the pivotal study of FOLOTYN in patients with relapsed or refractory PTCL, was published in the March 20, 2011 issue of the Journal of Clinical Oncology. FOLOTYN has patent protection through July 2022. Please see full Prescribing Information for FOLOTYN at
Warnings and Precautions
FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.