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Cytochroma and Mitsubishi Tanabe form partnership for chronic kidney disease therapies in U.S. and Asia

MARKHAM, ON, and OSAKA, Japan, July 30 /PRNewswire/ - Cytochroma and Mitsubishi Tanabe Pharma Corporation ("MTPC") today announced that the companies have signed a license agreement under which Cytochroma granted MTPC an exclusive license in the U.S. and Asia, including Japan, to develop and commercialize CTA018, Cytochroma's novel vitamin D analog. CTA018 is entering Phase II 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 U.S. 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 U.S. 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."

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 U.S. and Asia, but also enables us to access Cytochroma's valuable expertise for the development of our own commercialization platform in the U.S."

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 I 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.

Cytochroma's management team has extensive experience in successfully developing and commercializing new vitamin D therapies for the CKD market, including Zemplar(R) and Hectorol(R), currently the two leading vitamin D hormone therapies used to treat SHPT in the U.S. Cytochroma's therapies are designed to treat disorders related to abnormal or insufficient vitamin D metabolism in CKD patients, including SHPT. These new products will address target markets that are expected to grow significantly, reaching more than $1.4 billion annually by 2013 in North America. The Company has three lead product candidates in development for CKD patients: CTA018 and CTAP201 are being developed for the treatment of SHPT, while CTAP101 is being developed for the treatment of vitamin D insufficiency.

About CTA018

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 signaling pathway as well as a potent inhibitor of CYP24, the intracellular enzyme responsible for catabolism of vitamin D hormones. Based on its mechanism of action, CTA018 is expected to be more effective in treating SHPT and safer than currently available therapies. This compound was specifically designed by Professor Gary H. Posner, Ph.D. and is protected under patents and patent applications exclusively licensed to Cytochroma Inc. from the Johns Hopkins University.

About Chronic Kidney Disease

According to the National Kidney Foundation, more than eight million patients in the U.S. suffer from moderate CKD (Stages 3 and 4) to severe CKD (Stage 5). Stages 3 and 4 CKD are characterized by progressively decreasing kidney function as measured by glomerular filtration rate. In Stage 5 CKD, kidney function is altogether absent and patients require regular dialysis or kidney transplant for survival. An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases. Mounting evidence continues to link vitamin D insufficiency with progression of CKD and death. CKD is caused most frequently by diabetes or hypertension, both of which are consequences of a growing obesity epidemic in countries worldwide.

About Secondary Hyperparathyroidism

Secondary hyperparathyroidism ("SHPT") is a condition commonly associated with chronic kidney disease ("CKD") patients in which the parathyroid glands secrete excessive amounts of parathyroid hormone ("PTH"). This excess PTH secretion arises as a result of impaired kidneys that are neither able to produce sufficient quantities of active vitamin D hormone, nor maintain a state of balance (homeostasis) between calcium and phosphate in the body. The low levels of active vitamin D hormone and lack of homeostasis between calcium and phosphate is detected by the parathyroid gland, which, in turn, continues to secrete PTH, resulting in excessive levels of PTH in the body. Excessive levels of PTH cause calcium to be released from bone and into the blood, leading to softening of the bones (osteomalacia), and calcification of vascular tissues. SHPT affects approximately 90% of severe, and 40-60% of moderate CKD patients.

About Cytochroma

Cytochroma is a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary products to treat and prevent the clinical consequences of vitamin D insufficiency and SHPT associated with CKD. The Company's vitamin D-based therapeutics are designed to safely and effectively treat patients with Stage 3, 4 or 5 CKD. In addition, Cytochroma is developing novel therapies to treat hyperphosphatemia in these same patients.

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About Mitsubishi Tanabe Pharma Corporation ("MTPC")

Mitsubishi Tanabe Pharma Corporation is a research-driven global pharmaceutical company based in Japan. It specializes in the fields of cardiovascular and metabolic diseases, brain and nerve diseases, and renal and urinary system diseases. The company was established through the merger of Tanabe Seiyaku Co., Ltd. and Mitsubishi Pharma Corporation in October 2007. MTPC commits to bring its innovation to the patients around the world, and plans to build a commercialization presence in U.S. MTPC is currently developing two Phase III clinical candidates in the U.S. and EU; MP-146 for CKD and MCI-196 for hyperphosphatemia.

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SOURCE Cytochroma
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