Allos Therapeutics, Inc. (ALTH) revealed the execution of a collaborative agreement with Idis to manage the named patient program for FOLOTYN outside of the United States.
According to 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.
The company noted that the U.S. Food and Drug Administration has granted accelerated approval for FOLOTYN for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. This indication is based on overall response rate. However, clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.
Moreover, 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.
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