Market Overview

Azaya Therapeutics Initiates Bioequivalency Study for Regulatory Approval of ATI-0918, a Liposomal Formulation of Doxorubicin Hydrochloride


Azaya Therapeutics, Inc. today announced the initiation of a bioequivalence study of ATI-0918 in patients with ovarian cancer. The test product is ATI-0918 (generic doxorubicin hydrochloride liposome injection). The reference product is doxorubicin hydrochloride (HCl) liposome injection, which is marketed in the United States, Israel and Japan as DOXIL® and in the rest of the world as CAELYX®. The U.S. Food and Drug Administration has approved this study.

“We have been working on this development program of ATI-0918 since 2009 and it is gratifying to finally get the product into the clinic for final testing,” said Mike Dwyer, President and CEO of Azaya. “We expect to have the results of this study by mid-year 2013 and file all of the required information and the clinical data for regulatory approval shortly thereafter.”

“Since the shortage of DOXIL/CAELYX arose in 2011, we have redoubled our efforts to complete the development program for ATI-0918,” continued Dwyer. “Azaya's goal with ATI-0918 is to have it approved as a generic equivalent to DOXIL/CAELYX and offer physicians and patients another reliable source for this important product.”

Trial Design

This study is a single-blind, randomized, two-way, crossover bioequivalence study of intravenously administered ATI-0918 in patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy. The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. This study will be conducted at research centers both in the United States and in Europe.

About Azaya Therapeutics:

Azaya Therapeutics ( 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. Azaya has leveraged its 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 and Azaya has completed Phase I clinical trials with this product. Docetaxel is available as a generic product and is also the active ingredient in Taxotere®. Docetaxel is one of the largest selling chemotherapy drugs in the world.

Azaya is also developing a generic version of DOXIL/CAELYX, the first liposomal encapsulated chemotherapy drug approved by the FDA and the EMA.

Azaya Therapeutics, Inc.
Michael T. Dwyer, CEO, 210-341-6600 ext. 204

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