Xcellerex and Itero collaborate in production of an undisclosed therapeutic protein

Xcellerex and Itero collaborate in production of an undisclosed therapeutic protein

Xcellerex, Inc. and Itero Biopharmaceuticals, Inc. announced today that they have signed a Letter of Intent to enter into a strategic collaboration for the production of Itero's lead product, an undisclosed commercially differentiated therapeutic protein. Itero will initiate technology transfer for the product to Xcellerex immediately. Xcellerex will provide development expertise and product manufacturing for global clinical and commercialization supplies under the terms of a Master Services Agreement to be executed as soon as is reasonably practicable. The parties anticipate that this will be a multi-product collaboration, and for the first product, Xcellerex will manufacture Itero's Phase 3 clinical materials in 2010/2011.

"Xcellerex is enabling Itero's rapid drug development through Phase 3 utilizing its state-of-the-art PDMax® process development platform and its FlexFactory® technology, which should provide Itero and its future partners with a cost-effective and flexible manufacturing alternative at full commercial scale," stated Joseph Zakrzewski, Xcellerex's President and Chief Executive Officer, "We believe we will provide a significant advantage to Itero in terms of cost, flexibility and control of its manufacturing destiny. Given that we will become an equity holder in Itero under this collaboration, we will be particularly interested in ensuring their success, as we grow our portfolio of biomolecules using such creative deal structures."

The parties will utilize Xcellerex's PDMax process development technology to scale-up the manufacturing process in Xcellerex's FlexFactory and rapidly produce material to initiate clinical trials. Financial terms of the partnership were not disclosed, but include contract manufacturing fees, as well as Itero equity being granted to Xcellerex as part of the payment structure. The collaboration also anticipates Itero's future purchase of a portable FlexFactory.

"We believe Xcellerex is the right choice for Itero given their innovative, portable technology and their extensive manufacturing experience, which includes nearly 20 products for clinical trial development," said Bryan Lawlis, PhD, Itero's President and CEO. "With the equity component of our collaboration, we are confident in their commitment to fully support our manufacturing needs as we make significant strides in building our product portfolio."

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