Saturday, November 3, 2012

Azaya ramps up effort to produce generic cancer drug

Azaya ramps up effort to produce generic cancer drug

Nov 2012

Azaya Therapeutics is conducting a study of a generic version of a popular drug used to treat ovarian cancer. The company hopes that drug will fill a gap in the market next year.
Azaya’s drug is currently known as ATI-0918, but it is essentially a generic copy of the drug Doxil. The company that was producing Doxil recently shut down its manufacturing operation and this has led to a worldwide shortage of the drug for ovarian and breast cancer patients.
In response, San Antonio-based Azaya has accelerated efforts to produce a generic version in hopes of having the product on the market by 2014. The U.S. Food and Drug Administration has approved the new study and Azaya expects to file for full approval to market the drug later next year.
“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,” says 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.”
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