Tuesday, February 5, 2013

Competition for Sun's Lipodox on the anvil

In November 2012, AZAYA Therapeutics an emerging technology company that is based in San Antonio, Texas  initiated a Bioequivalence study comparing its generic Liposomal doxorubicin
(ATI-0918) to JNJ's Doxil. The study is expected to complete in May 2013 and if the studies are successful, we expect the USFDA to approve a copy in smaller time frame than it usually takes for approving other ANDA's. 
As such under the new GDUFA regime, USFDA is expected to act on new ANDA applications within 10 months of filing.

AZAYA is using a novel, proprietary and widely applicable targeted nanotechnology platform aimed at developing safer and more effective cancer treatments for patients around the world. Azaya has received a patent for its Protein Stabilized Liposome (PSL) nanotechnology in February, 2007. This platform solves the significant problem associated with the formulation and delivery of water-insoluble active pharmaceutical ingredients, and has the potential to be applied to numerous therapeutic agents.

AZAYA is open to partnership opportunities with other organizations to utilize the proprietary PSL technology to extend the marketing life of existing cancer treatments, and to develop new agents that will markedly change the course of cancer.

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