Cytogen Corporation has licensed the exclusive North American rights to Caphosol from InPharma AS. Caphosol, a topical oral agent, is a prescription medical device indicated in the US as an adjunct to standard oral care in treating oral mucositis caused by radiation or high dose chemotherapy, a condition estimated to affect more than 400,000 cancer patients each year.
Caphosol is also indicated for dryness of the mouth (hyposalivation) or dryness of the throat (xerostomia) regardless of the cause or whether the conditions are temporary or permanent, a Cytogen release stated.
Caphosol, a topical oral agent, is a US patented, prescription medical device that lubricates the mucosa and helps maintain the integrity of the oral cavity through its mineralizing potential. The distinguishing feature of Caphosol is its high concentrations of calcium and phosphate ions, which are hypothesized to exert their beneficial effects by diffusing into intracellular spaces in the epithelium and permeating the mucosal lesion in mucositis. Calcium ions play a crucial role in several aspects of the inflammatory process, the blood clotting cascade, and tissue repair and phosphate ions may be a valuable supplemental source of phosphates for damaged mucosal surfaces.
"With the addition of Caphosol, Cytogen will have four marketed oncology products. Our focused experience in sales and marketing in oncology leaves us well positioned to maximize the commercial potential of CAPHOSOL while creating even stronger marketing synergies within our oncology portfolio," said Michael Becker, president and chief executive officer.
Under the terms of the agreement, InPharma will receive upfront fees of $5 million upon the closing of the transaction and an additional $1 million payment after six months. In addition, InPharma will receive royalties and sales-based milestone payments. The transaction also provides Cytogen with the option to acquire the rights to Caphosol for the European and Asian markets.
Oral mucositis is an inflammation of mucous membranes in the mouth with symptoms ranging from redness to severe ulcerations. Approximately 40 per cent of patients who receive chemotherapy develop some form of oral mucositis during the course of their treatment. In addition, more than 70 per cent of patients undergoing conditioning therapy for bone marrow transplantation and virtually all patients receiving radiation therapy to the head and neck areas develop oral mucositis. Both chemotherapy and radiation can also cause dryness of the mouth (hyposalivation) or throat (xerostomia), with an estimated 40 per cent of patients undergoing chemotherapy reporting this side effect.
"Minimizing the common and painful oral complications associated with cancer treatment is a critical goal in patient care that represents a significant commercial opportunity. With our experience in the medical and radiation oncology markets, we believe Cytogen will be able to maximize the value potential of this device while bringing this treatment option to even more patients affected by oral mucositis," Becker added.
Cytogen expects to introduce CAPHOSOL in the U S market in early 2007.