Cytori Therapeutics said today it plans to acquire the liposomal nanoparticle technology platform of Azaya Therapeutics for up to $170 mil, in a deal designed to expand and complement the buyer’ s regenerative medicine operations.
Azaya’ t Protein Stabilized Liposomes™ (PSL) platform is designed to allow for high-dose delivery of potent cytotoxics with potentially lower negative effects. Cytori says its research suggests that nanoparticle liposomal technology may be an useful method of delivering targeted regenerative remedies to sites of acute or chronic injury.
As part of the transaction, Cytori will acquire from Azaya two oncology drug candidates that the company deems guaranteeing enough to generate what it called sizeable near-term, global license, and revenue opportunities.
One is Azaya’ ersus lead oncology candidate ATI-0918, an off-patent, complex, universal nanoparticle liposomal formulation of the chemotherapeutic agent doxorubicin hydrochloride, used for treating breast cancer, ovarian cancer, multiple myeloma, plus Kaposi’ s sarcoma.
In a clinical demo, ATI-0918 showed bioequivalence to the reference drug for doxorubicin in Europe, which is marketed by Johnson & Manley as Doxil ® and Caelyx ® .
Cytori stated it expects to begin manufacturing preparation of ATI-0918 on closing the deal and plans to file for EU regulating approval of ATI-0918 in early 2018, as well as seek commercialization partners for the drug. Cytori intends to manufacture ATI-0918 in Azaya’ s protein-stabilized nanoparticle manufacturing and growth facility in San Antonio, TX, which has recently been improved in anticipation of commercial scale-up— and which the company programs to lease for 5 years.
Cytori added that it is considering a follow-on study to demonstrate the particular bioequivalence of ATI-0918 to the reference drug in the Oughout. S., which is marketed by Sun Pharma as Lipodox.
The other candidate, ATI-1123, is Azaya’ t nanoparticle-stabilized liposomal formulation of docetaxel. Azaya reported beneficial safety results for ATI-1123 in a Phase I research of 29 patients with solid tumor cancers whom failed other therapies.
Cytori said this plans to proceed through partners with Phase II medical studies of ATI-1123 in multiple indications.
Terms of the acquisition call for Cytori to issue $2 mil in common stock upfront and pay off about $2 mil of Azaya’ s trade payables. Cytori also decided to pay Azaya up to $16. 25 million in obligations tied to achieving commercial milestones and up to $100 mil in royalties based on product revenues.
Ought to any of the candidates or the ATI-1123 patent be licensed to some partner, Cytori agreed to pay Azaya up to $50 mil in license/sale or other transfer fees.
“ Azaya’ s technology and intellectual property existing an exciting opportunity to marry Cytori’ s cell therapy technologies, which is currently in late-stage clinical trials, to a medically proven and patented off-the-shelf pharmaceutical delivery system straight applicable to regenerative medicine, ” Cytori president plus CEO Marc H. Hedrick, M. D., said within a statement.
The deal is subject to customary shutting conditions, including approval from Azaya shareholders and permission from third parties, and is set to close on or even before February 28.