Biosite (San Diego, California) and Beckman Coulter (Fullerton, California) signed an agreement for Beckman Coulter to manufacture and Biosite to commercialize a b-type natriuretic peptide (BNP) test for use on Beckman Coulter's immunoassay systems. Expected to be available in 1Q04, the BNP test will be sold worldwide through a combination of Biosite's direct and distributor sales forces. Through clinical evaluation data, a large publications base and a proven clinical performance history, BNP has been identified as the marker of choice for diagnosing and assessing the severity of heart failure and for risk stratification of acute coronary syndromes patients. Designed to correlate to the existing rapid Triage BNP Test run on Biosite's Triage MeterPlus testing platform, the BNP test will be available for use on Beckman Coulter systems including the Access and Access 2 immunoassay systems, Synchron LXi 725 combination chemistry and immunoassay workstation, and the new high-throughput UniCel DxI 800 Access immunoassay system. Beckman Coulter will manufacture BNP test reagents for use on its immunoassay systems. Under terms of the collaborative agreement, Biosite will retain sole control of promotion, pricing, sales and support for the new test, while Beckman Coulter will retain responsibility for placing and supporting its immunoassay systems. Beckman Coulter is a maker of instrument systems, chemistries and supplies that simplify and automate laboratory processes. Biosite is focused on the discovery and development of protein-based diagnostics.
Epix Medical (Cambridge, Massachusetts) has formed an alliance with Schering AG (Berlin) for the discovery, development and commercialization of novel molecularly targeted contrast agents for magnetic resonance imaging. The first area of collaboration is an exclusive development and commercialization partnership for EP-2104R, Epix's product candidate for the detection of thrombus. The second area is an exclusive research partnership to discover novel compounds for MRI. Epix said that Schering AG has an option to the late-stage development and worldwide marketing rights for EP-2104R, and for all development candidates emerging from the MRI research collaboration. For EP-2104R, Epix will conduct early development activities, which Schering will support with up to $9 million. For the exclusive research partnership, Schering committed R&D funding of Epix's early development activities of about $4 million over the next two years and a loan facility of up to $15 million, with principal repayment beginning in 2007. Under terms of the agreement, Epix has the right to increase its royalty rate through financial participation in clinical development, in addition to research, milestone and base royalty payments from Schering. This would allow Epix to earn royalties on sales consistent with being a late-stage, co-development partner of EP-2104R as well as all new products resulting from the joint research program.
MedicalCV (Minneapolis, Minnesota), a heart valve manufacturer, signed a three-year agreement with Premier Purchasing Partners, the group purchasing division of Premier (San Diego, California), for MedicalCV's Omnicarbon mechanical heart valves, effective immediately. The Omnicarbon valve will be available to Premier's nearly 1,500 member and affiliated hospitals at competitive terms and conditions. The Omnicarbon mechanical heart valve is manufactured and marketed by MedicalCV. The company said that results from at least 10 clinical studies, including more than 10,000 patient years of use, have consistently demonstrated one-third to one-half fewer complications with the Omnicarbon valve, such as blood clots and stroke, compared to other mechanical heart valves. MedicalCV said the Omnicarbon heart valve is unique in that it is the only monoleaflet valve that is, a valve with a single hingeless pivoting disc to employ pyrolytic carbon in both its housing and disc for improved blood compatibility. Another advantage of the Omnicarbon valve's design is that it does not have the "problematic" fixed pivot recesses that are characteristic of bileaflet designs and which are demonstrated to be the primary location for blood clot formation, according to the company.
Vision-Sciences (Natick, Massachusetts) signed a development, supply and distribution agreement with privately held Estech (Danville, California) for products designed to provide access and visualization for minimally invasive cardiac surgery for the treatment and ablation of atrial fibrillation (AF). The Vision Sciences CT-F100 and CTSS-F21 Cardiothoracic Endoscope and Slide-On EndoSheath System is designed to provide minimally invasive access to the pericardium in order to enhance visualization during epicardial AF ablation procedures. Under the agreement, Estech will distribute the CT-F100 and CTSS-F21 with its suite of products for AF ablation. The agreement gives Estech exclusive rights for the distribution of the Vision-Sciences CT-F100 and CTSS-F21 products within the field of minimally invasive atrial fibrillation ablation surgery, contingent upon meeting certain terms and conditions. Vision-Sciences makes flexible endoscopic products using sterile, disposable sheaths. Estech offers a system of least-invasive cardiac surgery products for both beating-heart and stopped-heart surgical approaches.