Cytochroma and Mitsubishi Tanabe Pharma Corporation (MTPC) announced that the companies have signed a license agreement, under which Cytochroma granted MTPC an exclusive license in the US and Asia, including Japan, to develop and commercialize CTA018, Cytochroma's novel vitamin D analog.
CTA018 is entering phase-2 development in Canada for the treatment of secondary hyperparathyroidism (SHPT) in patients with Chronic Kidney Disease (CKD). The agreement also grants MTPC access to certain follow-on compounds to CTA018 for the same territories, with Cytochroma retaining all rights to CTA018 and these follow-on compounds in all regions outside the US and Asia.
Cytochroma's President and CEO, Charles W. Bishop, PhD, stated, "Mitsubishi Tanabe is a world-class company, which will provide Cytochroma with significant resources and pharmaceutical know-how, thereby facilitating the development and commercialization of CTA018 in the US and Asia. The formation of this partnership is a landmark event for Cytochroma and represents an important validation of our novel approach to treating secondary hyperparathyroidism in CKD patients."
CTA018 is the first compound in a new class of active vitamin D analogs having a novel dual mechanism of action. CTA018 is designed to be a strong activator of the vitamin D signalling pathway as well as a potent inhibitor of CYP24, the intracellular enzyme responsible for catabolism of vitamin D hormones.
MTPC's president and representative director, Natsuki Hayama, stated, "I am excited with this synergistic partnership that combines the unique strengths of Cytochroma, a North American-based specialty pharmaceutical company, with Mitsubishi Tanabe, a Japan-based global pharmaceutical company. Cytochroma's management team has an extensive and successful track record in developing and commercializing products for CKD patients in North America. A partnership with Cytochroma not only enhances Mitsubishi Tanabe's product pipeline in the US and Asia, but also enables us to access Cytochroma's valuable expertise for the development of our own commercialization platform in the US."
Under the terms of the agreement, Cytochroma has granted MTPC an exclusive license to develop, manufacture and commercialize CTA018 in the United States and Asia. Cytochroma may receive up to a total of CDN $105 million, which includes an upfront payment, milestone payments, and an equity investment. In exchange for the equity investment, MTPC will receive a certain number of Cytochroma's Class C shares. MTPC and Cytochroma will jointly develop and commercialize CTA018 in the United States. In Asia, including Japan, MTPC has full rights and responsibilities for product development, approval, and commercialization of CTA018, and will pay Cytochroma a royalty on sales.
CTA018 Injection was well tolerated in phase-1 clinical evaluations, where it produced clinically meaningful reductions in blood levels of intact parathyroid hormone (iPTH) after less than two weeks of administration. Excessive levels of iPTH cause calcium to be released from bone and into the blood, increasing the risk of bone disease (renal osteodystrophy) and calcification of vascular and other soft tissues.