BioWorld International Correspondent

Symphogen A/S and Biovitrum AB deepened an existing relationship, adding co-development and commercialization aspects to a pre-existing manufacturing agreement.

The deal concerns Copenhagen, Denmark-based Symphogen's lead product, Sym001, a recombinant polyclonal antibody preparation in development for idiopathic thrombocytic purpura (ITP) and preventing hemolytic disease of newborns (HDN).

Financial terms were not disclosed, but Biovitrum is paying Symphogen a technology access fee, as well as milestones based on the progress of the development program. In return, Stockholm, Sweden-based Biovitrum receives marketing rights for Europe, Russia and the Middle East. Symphogen has retained marketing rights for the Americas, and the companies plan to seek partners for other territories. They will share the costs of the program.

Symphogen has not yet decided whether it will license its U.S. rights to a third party or commercialize the product itself.

"It's a little early. We are still in preclinical development. Over the next few years, a lot of things could happen," Chief Financial Officer Thomas Feldthus told BioWorld International. The ITP patient population is small and can be reached through specialist treatment centers. "You should be able to serve this market with a small sales force, which can be handled by a company like Symphogen," Feldthus said. The HDN market, which comprises up to 700,000 rhesus D-negative women in the U.S., is more dispersed and would require alternative channels to market, he said.

Sym001 is positioned as a replacement product for existing immunoglobulin preparations. It consists of a polyclonal preparation of 25 different antibodies, which are manufactured in a single batch using a process proprietary to Symphogen. Individual monoclonal antibodies directed at the rhesus D antigen do not appear to provide the same, consistent level of efficacy.

"There have been several attempts to do that - so far unsuccessful," Feldthus said.

Symphogen has been engaged in pre-investigational new drug application discussions with regulatory authorities, including the FDA, since last year. It plans to file an IND by late spring although it has not yet finalized the location of its Phase I trial.

"The final decision hasn't been taken yet, but we assume it will be in the U.S.," Feldthus said.

Symphogen and Biovitrum have achieved GMP production of Sym001. Ensuring batch-to-batch consistency has been an important milestone in the development program. "This is a product that is new for regulatory agencies," Feldthus said. "We had to develop a lot of new assays and characterization methods to satisfy the regulatory agencies."

Biovitrum has in-house expertise in manufacturing and marketing blood products. It manufactures ReFacto, a recombinant version of Factor VIII, on behalf of Madison, N.J.-based Wyeth, and it markets the same product in the Nordic region. Earlier this year, it entered a shared-cost development program with Syntonix Pharmaceuticals Inc., of Waltham, Mass., concerning the latter company's extended half-life recombinant Factor IX product, Fix:Fc, in development for hemophilia B.

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