Cytogen has canceled plans to acquire Advanced Magnetics and instead has signed a marketing and sales agreement for the rights to two Advanced Magnetics products.Advanced Magnetics of Cambridge, MA, will give Cytogen of Princeton, NJ, the U.S. rights to
Cytogen has canceled plans to acquire Advanced Magnetics and instead has signed a marketing and sales agreement for the rights to two Advanced Magnetics products.
Advanced Magnetics of Cambridge, MA, will give Cytogen of Princeton, NJ, the U.S. rights to Combidex, an MRI agent used for detection of lymph node metastases, and to Code 7228, Advanced Magnetics next-generation imaging agent.
In exchange, Advanced Magnetics received 1.5 million shares of Cytogen stock and will receive another half-million shares in milestone payments. Cytogen will pay Advanced Magnetics a royalty based on the products sales, when they are approved by the FDA.
Cytogen shares were basically unchanged the day after the new deal was announced (Aug. 28), falling 9¢ to $8.94. But Advanced Magnetics stock lost $2.44 to close at $5.13 a share.
Advanced Magnetics is halfway to an NDA approval for its MR contrast agent, Combidex. The FDA in July sent the company a letter saying that although it found Combidex approvable for its principal indication, as a lymph node imaging agent, it could not approve the agent for its secondary indication, imaging of the liver and spleen (SCAN 7/5/00).
Jerome Goldstein, chairman and CEO of Advanced Magnetics, said that Combidex is the first lymph-node-specific MR contrast agent to be filed with the FDA.
The firm submitted its new drug application for Combidex to the FDA in December 1999. Advanced Magnetics European marketing partner, Guerbet, submitted the European equivalent of an NDA to the European Medicines Evaluations Agency at the same time.
The company has incurred financial losses while waiting for approval to market this product.
Cytogen currently markets two imaging agents: ProstaScint for prostate cancer and OncoScint CR/O for colorectal and ovarian cancers.
Study Reaffirms Low Risk for csPCa with Biopsy Omission After Negative Prostate MRI
December 19th 2024In a new study involving nearly 600 biopsy-naïve men, researchers found that only 4 percent of those with negative prostate MRI had clinically significant prostate cancer after three years of active monitoring.
Study Examines Impact of Deep Learning on Fast MRI Protocols for Knee Pain
December 17th 2024Ten-minute and five-minute knee MRI exams with compressed sequences facilitated by deep learning offered nearly equivalent sensitivity and specificity as an 18-minute conventional MRI knee exam, according to research presented recently at the RSNA conference.
Can Radiomics Bolster Low-Dose CT Prognostic Assessment for High-Risk Lung Adenocarcinoma?
December 16th 2024A CT-based radiomic model offered over 10 percent higher specificity and positive predictive value for high-risk lung adenocarcinoma in comparison to a radiographic model, according to external validation testing in a recent study.