A Diagnostics & Imaging Week
Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said it has signed a term sheet with Cardinal Health (Dublin, Ohio) for the distribution of Lymphoseek on an exclusive basis in the U.S. through Cardinal's more than 150 nuclear pharmacies and wholesale distribution operations to in-hospital nuclear pharmacies.
Lymphoseek (Technetium Tc99m DTPA-mannosyl-dextran) is a radioactive lymphatic mapping agent developed by Neoprobe for use with handheld gamma detection devices, such as Neoprobe's neo2000 system, in a surgical procedure known as Sentinel Lymph Node Biopsy. Neoprobe reported positive preliminary data from a Phase II multicenter clinical trial for Lymphoseek and is preparing to submit a proposed Phase III protocol to FDA.
Details of the term sheet will remain confidential until a definitive marketing and distribution arrangement has been negotiated and signed, Neoprobe said.
David Bupp, Neoprobe's president/CEO, said that the agreement "coupled with our recent announcement of preliminary results for the Phase II clinical evaluation of Lymphoseek, will be an important milestone event for the company."
Neoprobe markets the neo2000 line of gamma detection systems and the Quantix line of blood flow measurement products developed by its subsidiary, Cardiosonix. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek and RIGScan CR.
In other agreement activity:
• Affymetrix Clinical Services Laboratory (ACSL; Santa Clara, California) reported a co-marketing agreement with Docro (Seymour, Connecticut), a contact research organization specializing in the commercialization of in vitro diagnostic biomarker technologies.
The two companies will collaborate to help customers gain FDA approval of IVD products and bring them to market more rapidly. Researchers have not had effective or efficient means to translate discoveries in the field into validated clinical diagnostic tests, the companies said.
ACSL is a CLIA-registered clinical testing laboratory that specializes in send-out and clinical trial testing services for gene expression monitoring, genotyping and chromosomal copy number analysis, as well as other molecular diagnostic tests. Docro's services include strategic consulting, product development, specimen acquisition and regulatory consulting.
• Third Wave Technologies (Madison, Wisconsin) reported that it has signed a pharmacogentics collaboration with Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) to develop a companion diagnostic to help physicians personalize treatment for heart failure patients.
The test is being developed with Third wave's Invader chemistry in conjunction with the prescription of bucindolol, a next-generation beta blocker being developed by ARCA Discovery (Denver, Colorado).
The companies said there is extensive Phase III efficacy and safety data of bucindolol in heart failure patients, including genetic data that ARCA will use to seek FDA approval in 2008 to target those patients most likely to respond. ARCA has exclusive, worldwide rights to bucindolol. LabCorp in February reported that it had acquired exclusive rights to develop and commercialize a companion diagnostic for bucindolol.
Third Wave will collaborate with LabCorp on the development of the diagnostic in parallel with the drug's approval process. The test identifies common genetic variations of the alpha-2c and the beta-1 adrenergic receptors that regulate the human heart.
Third Wave develops molecular diagnostic reagents for DNA and RNA analysis applications.