Commercializing The INTERCEPT System
Commercializing the INTERCEPT System for Platelets and Plasma
Cerus holds worldwide commercialization rights for INTERCEPT. Under the restructured agreement with Baxter announced in February 2005 and February 2006, we are directly responsible for the worldwide development and commercialization of the INTERCEPT Blood System, excluding commercialization rights in certain Asian countries licensed to BioOne. In March 2007, Baxter spun-off the division with which Cerus had worked to a private equity group, which renamed the division Fenwal, Inc. Fenwal is responsible for certain manufacturing activities through 2009 for the INTERCEPT platelet and plasma systems. We have established a subsidiary in Europe to market and sell the INTERCEPT platelet and plasma systems. Commercializing the INTERCEPT platelet and plasma systems in Europe remains our top priority. In the United States we are working with the FDA to determine an acceptable regulatory pathway that might lead to U.S. approval of the INTERCEPT platelet system, including the scope and dimensions of an additional data from European commercial use that, together with already submitted Phase III trial data, which we understand will be required prior to seeking product approval.
BioOne for platelets and plasma in Asia
In June 2004, we announced an agreement under which BioOne would market and distribute the platelet system in Japan, China, Taiwan, South Korea, Thailand, Vietnam and Singapore. In June 2005, we entered into a similar agreement for the commercialization of the INTERCEPT plasma system. In exchange for the licensed rights, Cerus has received $19.5 million in cash to date, plus an equity interest of less than 20% in BioOne. We may additional cash milestone payments and royalties if BioOne successfully commercializes the platelet and plasma systems in its licensed territories.
Distribution Partners
Cerus currently has established distributor agreements in Spain, Portugal, Greece, Turkey, Kuwait, Russia and other CIS countries. These distribution agreements are consistent with our overall strategy to support the rollout of the INTERCEPT system without investing in customer service and sales groups in territories where it would be too costly to build our own presence.
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