Clear kidney connection

Cytochroma, Mitsubishi Tanabe ink deal for chronic kidney disease therapeutics

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MARKHAM, Ontario—Seeking to advance its portfolio of novel vitamin D-based therapeutics for the treatment of chronic kidney disease (CKD), Canadian firm Cytochroma in late July inked a deal worth up to CDN $103 million with Mitsubishi Tanabe Pharma Corp. (MTPC) that will move its product candidates, including CTA018, a novel vitamin D analog for the treatment of secondary hyperparathyroidism (SHPT) in CKD patients, into mid- and late-stage clinical trials.

Cytochroma President and CEO Dr. Charles Bishop says talks with MTPC began nearly a year ago, when Cytochroma learned that MTPC had set a goal of building an American sales force targeting endocrinologists for the purpose of marketing new therapies for CKD patients. This fit well with Cytochroma's focus on developing Vitamin D-based therapies for patients with stage 3, 4 or 5 CKD, which affects more than 8 million patients in the United States, Bishop says.

"We believe their commitment to building a sales force in the United States makes them an ideal partner for Cytochroma because we intend to build our own sales force in North America for the purpose of selling our three products when they are approved," Bishop says. "We thought that the two companies selling CTA018 together would give us a lot more legs and lungs in the marketplace."

According to the agreement, Cytochroma closed a CDN $45 million Series C financing round led by MTPC and granted MTPC an exclusive license to develop, manufacture and commercialize CTA018. The companies will jointly develop and commercialize CTA018 in the United States. In Asia, MTPC has full rights and responsibilities for product development and commercialization of CTA018 and will pay Cytochroma a royalty on sales. Cytochroma stands to gain up to CDN $105 million, which includes an upfront payment, milestone payments and an equity investment.

In addition to CTA018, the financing will be used to advance other therapeutics in Cytochroma's portfolio, including CTAP201 for the treatment of SHPT and CTAP101 for the treatment of vitamin D insufficiency, markets which are expected to grow to more than $1.4 billion annually by 2013 in North America.

MTPC, which has two CKD drugs of its own in Phase III development, was attracted to Cytochroma's track record in developing and commercializing CKD products in North America, says Dr. Seiichi Kiso, general manager of MTPC's business development and licensing department and a newly appointed member of Cytochroma's board of directors.

"They are developing two candidates for chronic kidney disease patients in the U.S. and consequently have relevant skills and a current understanding of this area," Kiso says.

Designed to be a strong activator of the vitamin D signaling pathway, CTA018 is expected to be safer and more effective and in treating SHPT and may have applications beyond CKD, Bishop says.

"Current thinking in vitamin D circles is that the level considered to be adequate today is much lower than will be considered adequate in a few years," Bishop says. "I think you will find that a much greater percentage of North Americans are Vitamin D insufficient when the field catches up to where researchers are." DDN

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