Cytori Therapeutics is set to gain cancer drugs and a liposomal nanoparticle technology platform through the acquisition of Azaya Therapeutics. The lead drug is a formulation of doxorubicin, the active ingredient in Johnson & Johnson’s off-patent ovarian cancer drug Doxil.
San Diego, CA-based Cytori thinks the lead program, ATI-0918, could come to market in Europe in 2019. That timeline assumes Cytori starts manufacturing preparations upon closing the takeover and goes on to file for approval early next year on the strength of a bioequivalence trial comparing ATI-0918 to Doxil. Cytori is weighing up whether to run a new study comparing ATI-0918 to the U.S. reference drug, Sun Pharma’s Lipodox.
The plan is to partner ATI-0918 to gain a quick return on the Azaya buyout without having to build out a commercial operation in Europe. Cytori is paying little upfront for this opportunity and other assets, but the value of the deal swell to upward of $160 million if assorted milestones and royalty payments are triggered.
Exactly how much Cytori ends up paying will depend on the progress of the assets it is buying from Azaya. The other cancer drug, ATI-1123, is a nanoparticle-stabilized liposomal formulation of docetaxel Azaya tested in a 29-person phase 1 solid tumor trial. On the strength of data from that trial, Cytori plans to work with partners on phase 2 studies of the candidate in multiple indications.
The two cancer drugs give Cytori near-term opportunities but sit outside of its core focus, namely regenerative medicines. Cytori expects this side of the business, the centerpiece of which is the experimental cell therapy Habeo, to benefit from Azaya’s liposomal nanoparticle technology platform.
“Azaya’s technology and intellectual property present an exciting opportunity to marry Cytori’s cell therapy technology, which is currently in late-stage clinical trials, to a clinically proven and patented off-the-shelf pharmaceutical delivery system directly applicable to regenerative medicine,” Cytori CEO Marc Hedrick said in a statement.
Cytori hopes to use the platform to deliver regenerative medicines to sites affected by acute or chronic injuries.