Cytogen Corporation and Berlex Laboratories, a U.S. affiliate of Schering AG, Germany announced an agreement whereby marketing rights held by Berlex to market Quadramet (Samarium Sm 153 Lexidronam), a skeletal targeting therapeutic radiopharmaceutical for the relief of bone pain in prostate and other types of cancer, in North and South America are to be returned to Cytogen in exchange for an upfront payment and royalties based on future sales. The transaction, which is targeted for completion within 90 days, is subject to Cytogen obtaining any necessary financing for the reacquisition.

"The reacquisition of the marketing rights to Quadraamet in the U.S. provides an excellent opportunity to accelerate Cytogen's product-driven, oncology-focused business model," said Michael D. Becker, President and Chief Executive Officer of Cytogen Corporation. "When Quadramet marketing rights were licensed to Berlex, Cytogen had not yet established an internal sales and marketing infrastructure. However, with this capability now in place, the addition of Quadramet to our marketed product portfolio has great significance for Cytogen's future growth."

Under a 1998 agreement, Berlex had marketing rights to Quadramet in North and South America. Under this agreement, Cytogen received royalties on product sales through Berlex. In 2002, Berlex recorded Quadramet sales of approximately $8 million. Schering AG will continue to market the product in Europe through CIS Bio International, which it acquired in 2000.

Cytogen obtained a license to manufacture, use and sell Quadramet under an agreement with the Dow Chemical Company. Quadramet is a skeletal targeting radiotherapeutic consisting of a short half-life therapeutic radionuclide (Samarium-153) bound to a small-molecule, bone-seeking phosphonate (EDTMP) that targets and accumulates in osteoblastic sites (areas of new bone formation), thereby delivering radioactivity in areas that have been invaded by metastatic tumor. In 1997, Cytogen received clearance from the United States Food and Drug Administration (FDA) to market Quadramet to treat pain associated with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. Osteoblastic bone lesions are most commonly associated with advanced prostate, breast and other cancers that metastasize to bone, which can cause pain that may be severe and difficult to treat.

"In addition to providing pain relief, recently reported and ongoing clinical studies suggest that the unique properties of Quadramet may allow it to be used in combination with other drugs, such a chemotherapeutics and bisphosphonates, to treat a variety of cancers and we will continue to aggressively pursue these investigational applications," said William Goeckeler, Vice President of Operations of Cytogen Corporation, who was involved in the discovery and initial development of Quadramet. "Cytogen is very pleased to be able to offer Quadramet to its customers and in doing so build value for its shareholders through a product the company was responsible for bringing to the market."