Dec 4 2009
Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced the execution of a collaborative agreement with Idis, a UK-based global company, to manage the named patient program for FOLOTYN™ (pralatrexate injection) outside of the United States. The U.S. Food and Drug Administration (FDA) has granted accelerated approval for FOLOTYN for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (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. Allos retains exclusive worldwide rights to develop and commercialize FOLOTYN in all indications. FOLOTYN has been available to patients in the U.S. since October 2009, and is expected to be available under the named patient program outside the U.S. beginning in January 2010.
“We are pleased to partner with Idis, a recognized leader in named patient programs, to provide access to FOLOTYN for patients with relapsed or refractory peripheral T-cell lymphoma outside the U.S.,” explained Paul L. Berns, president and chief executive officer at Allos Therapeutics, Inc. “Importantly, this program will allow a greater number of patients with relapsed or refractory PTCL to potentially benefit from the use of FOLOTYN.”
A named patient program is a mechanism through which physicians can legally and ethically prescribe investigational or approved drugs for patients prior to their commercial launch. Under the terms of the agreement, Idis will be the exclusive supplier of FOLOTYN to health care providers outside of the U.S. on a named patient basis.
Source Allos Therapeutics