18 junio 2012

Doxil . Azaya Therapeutics esta Desarrollando una Versión Genérica de Doxil ( R ) ... El ATI-0918 que se Presenta este año a la FDA .

Azaya Therapeutics ( www.AzayaTherapeutics.com ) is a San Antonio-based emerging biopharmaceutical company whose innovative technology platform allows it to make safer and more effective cancer treatments. Azaya utilizes a proprietary manufacturing process to produce liposome-encapsulated chemotherapeutics that eliminate the use of toxic carriers and incorporates a naturally occurring protein to stabilize the liposomal encapsulated drug. Its unique and patented Protein Stabilized Liposome (PSL(TM)) platform also addresses the significant problems associated with the delivery of water insoluble drugs. Azaya has leveraged this platform to develop a differentiated drug product for the global oncology market with docetaxel as its active ingredient. ATI-1123 is a patented human serum albumin-stabilized nanoparticle liposomal formulation of docetaxel. Docetaxel is available as a generic product and is also the active ingredient in Taxotere(R). Docetaxel is one of the largest selling chemotherapy drugs in the world.

ATI-0918 . The Company is also developing a generic version of Doxil(R), the first liposomal encapsulated chemotherapy drug approved by the FDA. There is currently a global shortage of Doxil due to problems at the manufacturing facility. The Company's management and advisor team is highly experienced in biotechnology and oncology and has a track record of obtaining FDA drug approvals and successfully building companies.

ATI-0918 is undergoing final laboratory studies to establish its pharmaceutical equivalency to DOXIL, and will pursue work as required by the FDA. Due to manufacturing challenges, there is a severe world-wide shortage of DOXIL, and no generic alternative is currently on the market – AZAYA is on a path to resolve this critical problem for cancer patients.

“Doxil currently has global sales over $500 million annually and we will file for FDA approval of ATI-0918 in 2012 to enter this market”.


SOURCE: Azaya Therapeutics, Inc.