Caladrius Subsidiary PCT Licenses Cell Therapy Rights in Parts of Asia to Hitachi Chemical

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Caladrius Biosciences said today its subsidiary PCT has licensed rights to its cell therapy manufacturing technology for Japan and parts of Asia to Hitachi Chemical for $5.6 million plus royalties.

The licensing deal is part of a collaboration between the companies that includes Hitachi Chemical buying a 19.9% stake in PCT for $19.4 million. Caladrius said it will retain the remaining 80.1% ownership, while using the proceeds toward continued expansion and improvements designed to support readiness to launch commercial products, as well as unspecified general corporate purposes.

PCT and Hitachi Chemical also agreed to explore the establishment of a joint venture in Europe.

Caladrius CEO David J. Mazzo, Ph.D., said in a statement that the deal valued PCT at approximately $100 million, while providing the parent company with nondilutive capital that will strengthen its financial position.

“Together, Caladrius, PCT and Hitachi Chemical are focused on building a global leadership position in cell therapy development and manufacturing with this transformative collaboration,” Dr. Mazzo said.

The collaboration reflects both Hitachi Chemical’s desire to expand its franchise in the life sciences—especially regenerative medicine—as well as Caladrius’ commitment to shift greater focus and resources to its growing cell therapy process development, optimization, and manufacturing services business at PCT.

Caladrius has said it expects PCT’s revenues to grow 30% this year, following a 43% year-over-year jump in Q3 2015 revenues, to $5.9 million; the company is set to announce fourth-quarter and full-year 2015 results tomorrow.

Caladrius expressed that commitment in January while disclosing a restructuring that included laying off approximately 40 employees and ending development of its Phase III lead candidate CLBS20 for metastatic melanoma.

The company—which changed its name last year from NeoStem—added that it was refocusing its clinical development efforts on CLBS03, a Phase II T regulatory cell therapy candidate for type 1 diabetes.

Since January, Caladrius has also licensed some of its technologies to partners for undisclosed sums. These include the company’s CD34 ischemic repair technology (CD34 cell therapy) for acute myocardial infarction (AMI) and chronic heart failure (CHF), licensed to SPS Cardio in selected Asia-Pacific and Latin American countries, including India, and its cell-derived dermatological technology for topical skin applications, for which exclusive global rights were licensed last month to AiVita Biomedical.

Life sciences is one of four key business fields for Hitachi Chemical; the other three are telecommunications and displays; environment and energy; and automobiles and transportation infrastructure.

Hitachi Chemical President and CEO Kazuyuki Tanaka added that his company will receive technological assistance from the parent 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.

“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,” Tanaka said.








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