Medical Device Daily

Subsidiaries of Baxter International (Deerfield, Illinois) and Cerus (Concord, California) yesterday said they have restructured their collaboration related to the Intercept Blood System, initially developed by Cerus, and that they have settled a loan dispute between them and agreed to dismiss their related legal actions.

With the restructuring, the companies emphasized a reaffirmation of their commitment to development and marketing of the Intercept Blood System for platelets and plasma in Europe through 2006 and “potentially beyond.“

Intercept is a system for inactivating pathogens in blood and the separate constituents of blood. The system inactivates pathogens by targeting nucleic acid with a light-activated compound and an illumination device.

The agreement revisions include new development, manufacturing and marketing responsibilities for the two firms related to the Intercept Blood System for plasma and red blood cells.

Additionally, the companies resolved a loan dispute between them and dismissed their related legal fight.

In a Thursday morning conference call, Claes Glassell, president and CEO of Cerus, said that when he assumed the reins of the company last year (Medical Device Daily, May 6, 2004), one of his top priorities was “improving our relationship with Baxter . . . I'm pleased that we have achieved this goal.“

He added: “We value our relationship with Baxter and BioOne [Tokyo]“, another partner in the Intercept development deal. Cerus, Glassell said, “will continue to seek additional collaborations with new and capable partners to bring Intercept into new market segments.“

Under a separate agreement, Cerus said it would pay $34.5 million to Baxter Capital and provide a promissory note for $4.5 million, payable with interest in December 2006.

Cerus in 2002 received a loan commitment of $50 million from Baxter, based on the sales potential for the Intercept system (MDD, Nov. 1, 2002).

Last summer Cerus slashed one-third of its work force, in a de-emphasis of its blood safety program, and said it was putting more focus on its R&D effort in vaccine development (MDD, July 2, 2004).

In a statement outlining the revised pact with Baxter, Kevin McCulloch, general manager for that company's Transfusion Therapies business, said, “Baxter remains committed to advancing innovations that support a safe and sufficient blood supply for patients worldwide. This new agreement allows both Baxter and Cerus to focus attention on our respective strategic business goals and still pursue the commercialization of these important products.“

Under the terms of the restructured Intercept agreement:

  • Baxter will continue to invest in Intercept Platelet and Plasma commercialization activities in Europe in 2005 and 2006 and work with Cerus to prepare a CE mark application for plasma. Baxter has an option beyond 2006 to continue as the exclusive European marketing partner for Intercept Platelets and Plasma (MDD, June 2, 2002).
  • The companies will continue to seek market approval for the pathogen inactivation system for platelets in the U.S. and continue collaboration on commercialization for Intercept Platelets and Plasma outside the U.S. and Canada, not covered by existing third-party agreements.
  • Cerus acquires worldwide rights for Intercept Red Cells and also U.S. and Canadian rights for Intercept Plasma, previously held by Baxter. Thus, Cerus will have responsibility for developing and commercializing Intercept Red Cells worldwide and Intercept Plasma in the U.S. and Canada.
  • Baxter continues certain manufacturing responsibilities supporting Cerus' development and commercialization activities.

Revisions of the agreement do not change the relationship with BioOne, the companies' Asian partner, they said. The companies last year unveiled an agreement for BioOne — and expanded in January — to distribute the Intercept Blood System for platelets in Japan, China, Taiwan, South Korea, Thailand, Vietnam and Singapore, following regulatory approval in those countries (MDD, July 30, 2004/Jan. 13, 2005).

Baxter and Cerus also recently reported am agreement with BioOne for commercialization of Intercept for plasma in parts of Asia.

Intercept is designed to reduce transfusion-transmitted diseases by inactivating certain pathogens in donated blood, such as bacteria, HIV and hepatitis B and C viruses. The technology also has been shown to inactivate emerging and migrating pathogens, such as the West Nile virus and severe acute respiratory syndrome (SARS).

The Intercept Blood System is approved for use in Europe for platelets, and blood centers in several European countries are applying the Intercept technology to provide an additional layer of safety to their platelet supply. The Intercept Blood System under development for plasma has completed three Phase III trials in the U.S.

Phase III trials of the Intercept System for red cells were halted in 2003 after antibody formation was observed in two patients (MDD, Sept. 5, 2003). Cerus is currently evaluating product and process enhancements that might allow re-initiation of red blood cell clinical trials.

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