Cytogen reacquires marketing rights to Quadramet pain therapy product
Cytogen Corporation has completed the reacquisition of marketing rights held by Berlex Laboratories, a U.S. affiliate of Schering AG, Germany, to Quadramet (Samarium Sm 153 Lexidronam) in North and Latin America in exchange for an upfront payment of $8 million and royalties based on future sales. Quadramet is a skeletal targeting therapeutic radiopharmaceutical for the relief of pain due to bone metastases arising from prostate, breast, multiple myeloma and other types of cancer.
"Cytogen is very pleased to be able to offer Quadramet to customers through its in-house specialty sales force that already calls upon urologists and radiation oncologists," said Michael D. Becker, President and Chief Executive Officer of Cytogen Corporation. "Our reacquisition of marketing rights to Quadramet in the U.S. provides an excellent opportunity to accelerate Cytogen's product-driven, oncology-focused business model, and we believe that the addition of Quadramet to our marketed product portfolio has great significance for Cytogen's future growth. In addition to providing pain relief, recently reported and ongoing clinical studies suggest that certain unique properties of Quadramet may allow it to be used in combination with other drugs, such as chemotherapeutics and bisphosphonates, to treat a variety of cancers. We intend to continue to aggressively pursue these investigational applications."
Under a 1998 agreement, Berlex had marketing rights to Quadramet in North and Latin America. Under this agreement, Cytogen received and reported royalties on product sales made by Berlex. In 2002, Berlex recorded Quadramet sales of approximately $7.36 million, for which Cytogen recorded $ 1.84 million in royalty revenue. Effective immediately, Cytogen will begin receiving and recording all revenue from the sales of Quadramet, less a continuing obligation to make royalty payments to Berlex. Schering AG, which acquired CIS Bio International in 2000, will continue to market Quadramet in Europe as a direct licensee of Dow.
In 1993, Cytogen obtained a license to manufacture, use and sell Quadramet under an agreement with the Dow Chemical Company. Quadramet is a skeletal targeting therapeutic radiopharmaceutical 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 can be associated with advanced prostate, breast, multiple myeloma and other cancers that have metastasized to bone, which can cause pain that may be severe and difficult to treat.