Caladrius Biosciences Subsidiary Enters Into Global Collaboration & License Agreement

Caladrius Biosciences, Inc. recently announced that, through its subsidiary, PCT, has entered into a global collaboration with Hitachi Chemical Co., Ltd. that includes licensing, development, and equity components. Hitachi Chemical is a global conglomerate with a growing franchise in life sciences, including regenerative medicine.

As part of the collaboration, Hitachi Chemical has purchased a 19.9% equity interest in PCT for $19.4 million. Caladrius will retain the remaining 80.1% ownership of PCT. Caladrius intends to use the acquired capital for continued expansion and improvements at PCT in support of commercial product launch readiness as well as for general corporate purposes.

In addition, PCT has licensed its cell therapy technology and know-how to Hitachi Chemical for cell therapy manufacturing in certain Asian territories, including Japan, where the Pharmaceuticals and Medical Devices Agency (PMDA) has introduced more favorable legislation to stimulate the growth of regenerative medicine development. Under the license agreement, Hitachi Chemical is to make upfront and near term milestone payments of $5.6 million. In addition, Hitachi Chemical will pay service fees and royalties on contract revenue in those territories. Under the license arrangement, Hitachi Chemical is responsible for all capital and operational expenses associated with the establishment and operation of the Asian business on which PCT is entitled to royalty payments.
PCT and Hitachi Chemical have also agreed to explore the establishment of a joint venture in Europe.

“We are delighted about this collaboration with a company of the stature and global reach of Hitachi Chemical as it represents a clear validation of the PCT business model, technology, and know-how. Importantly, it now values our PCT business at approximately $100 million and provides non-dilutive capital that strengthens our financial position,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “Together, Caladrius, PCT and Hitachi Chemical are focused on building a global leadership position in cell therapy development and manufacturing with this transformative collaboration.”

“This partnership with Hitachi Chemical underscores the value of PCT’s expertise in cell therapy manufacturing and process development and will allow for the acceleration of our vision to create a global commercial enterprise with deep engineering expertise. Moreover, Hitachi Chemical’s investment in PCT shows its confidence in the growth of the cell therapy field as the field continues to shift towards Phase II and Phase III trials and into commercial distribution as regulatory approvals are obtained,” said Robert A. Preti, PhD, President of PCT. “By leveraging this expanded footprint, our clients will gain global access to the cell and cell-based gene therapy markets of tomorrow, where we expect engineering solutions to process optimization and automation will play a seminal role.”

“Our aim is to establish global leadership in regenerative medicine, and we believe this deep collaboration with PCT, through its veteran cell therapy manufacturing experts and global brand, can power that into a reality,” added Kazuyuki Tanaka, President and CEO of Hitachi Chemical Co., Ltd. “By leveraging PCT’s expertise and cell therapy technology, complementing PCT’s capabilities with our own and launching joint initiatives in new geographies, we will advance together towards that goal. In addition to using PCT’s support, Hitachi Chemical will receive technological assistance from Hitachi Group to develop a production control system, including automated facilities, to manufacture low-cost yet high-quality regenerative medicine cells, while also promoting consumable materials such as containers and reagents.”

Hitachi Chemical Co., Ltd., headquartered in Tokyo, Japan, delivers a wide range of innovative products, such as electronic materials, automobile parts, energy storage devices, and systems for healthcare and life science in global markets. The company’s consolidated revenues for fiscal 2014 (ended March 31, 2015) totaled 534 billion yen ($4.9 billion). For more information, visit www.hitachi-chem.co.jp/english/.

Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services, including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. For more information, visit www.caladrius.com.