Cytori Restarting Texas Facility it Inherited From Azaya Therapeutics Buyout Deal

May 4, 2017
By Alex Keown, BioSpace.com Breaking News Staff

SAN ANTONIO, Texas – Nearly five months after acquiring Azaya Therapeutics and its nanoparticle-based oncology pipeline, Cytori Therapeutics is looking to restart production at a Texas facility and is seeking a European partner for one of the new drugs.

In an interview with Xconomy, John Harris, a Cytori vice president in charge of commercial and partnership operations, said the company is looking for a European partner that has an existing pipeline that would be complemented by ATI-0918, a generic formulation of the chemotherapy drug iposomal doxorubicin. Harris said an ideal European partner will be looking for “ate-term and existing assets to put into their funnel.”

As part of Cytori’s plans to push for European partnerships, the company will relaunch a Texas manufacturing site that Azaya abandoned in 2015 after the company failed to strike a deal with Hospira. While little was reported about Cytori’s plans for the San Antonio facility, Xconomy said the company is looking to have about 20 employees at the operation. Also, Cytori may add additional capabilities to that facility, such as a chemical lab. The Texas site will focus on the development of the Azaya compounds, but the facility could eventually begin to manufacture some of Cytori’s own products, Xconomy reported.

In clinical trials, ATI-0918 demonstrated bioequivalence to the reference drug for doxorubicin in Europe, which is marketed by Johnson & Johnson as Doxil and Caelyx. Cytori has plans to seek European approval for its compound in 2018. Cytori is also planning to seek regulatory approval for ATI-0918 in the United States, but that will require additional studies. If the company is successful in securing U.S. authorization, ATI-0918 would have the bioequivalence of Lipodox, which is manufactured by Sun Pharma .

At the time, Cytori acquired Azaya, the company said independent research showed the doxorubicin market is expected to grow to approximately $1.4 billion worldwide by 2024. Additionally, Cytori said the market has been “underserved” in recent years due to supply disruptions, which is part of the reason Cytori will ramp up production in San Antonio.

Also in the acquisition, Cytori nabbed ATI-1123, a patented, nanoparticle-stabilized liposomal formulation of docetaxel. A Phase I study of that compound showed positive safety results for ATI-1123 in its Phase 1 study of 29 patients with solid tumor cancers who failed other therapies.

As those products move forward, Harris told Xconomy that Cytori could license ATI-0918 on a regional basis and ATI-1123 globally.

In April, Cytori received approval from the U.S. Food and Drug Administration for an Investigational Device Exemption for a pilot clinical trial to evaluate Cytori Cell Therapy in patients with thermal burn injuries. The trial will be a continuation of the company’s research under its contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.