A Medical Device Daily

The Ohio State University (OSU; Columbus), Cardinal Health (Dublin, Ohio) and the Ohio Third Frontier (Columbus) reported a collaboration to invest more than $10 million in the medical diagnostic industry, combining the research capabilities of OSU's Wright Center of Innovation in Biomedical Imaging (WCIBI) and Cardinal's expertise in the manufacturing and commercialization of molecular imaging products.

The partnership will expand the WCIBI to include a new Molecular Imaging Technology Center which will house OSU researchers and Cardinal's radiopharmaceutical manufacturing facility and nuclear pharmacy operations. Also, a faculty position in radiopharmaceutical chemistry will be added to OSU's department of radiology.

The WCIBI will provide OSU researchers with manufacturing capabilities and expertise for developing new molecular imaging agents for Positron Emission Tomography (PET). Cardinal will support manufacturing and dispensing of the agents for clinical trials across its network of radiopharmaceutical facilities.

John Rademacher, president of Cardinal's Nuclear Pharmacy business, said, "Researchers and industry alike will be attracted to the Molecular Imaging Technology Center as a one-stop shop for research, development, clinical investigational trials and full commercialization of new molecular imaging agents."

In other dealmaking activity:

• Gen-Probe (San Diego) and DiagnoCure (Quebec City) reported signing an amendment to their 2003 agreement, establishing new FDA submission milestones and distribution arrangements to leverage the potential of the PCA3-based test for prostate cancer in the U.S., Europe and other countries.

Gen-Probe will acquire 4.9 million shares of newly issued DiagnoCure convertible preferred stock for $5 million (C$6.1 million), a premium of 19.8% over the average market price of the common shares of DiagnoCure during the 20 trading days from Wednesday, subject to DiagnoCure securing approvals from the Toronto Stock Exchange. DiagnoCure will be able to redeem the shares or to require their conversion into common shares in certain circumstances.

Gen-Probe will receive a liquidation preference in certain cases and a security interest in some intellectual property. This subscription will take place on or around May 7.

The new milestones for an FDA submission of a PCA3 test can be fulfilled by Gen-Probe with its current end-point TMA assay or its investigational, real-time TMA assay, and Gen-Probe will make annual payments of $500,000 to DiagnoCure until specific milestones are met. Half the amounts paid will be applied against future royalties payable to DiagnoCure.

Also, DiagnoCure and Gen-Probe have agreed to develop distributor relationships in countries such as in Japan, Asia, Israel, South Africa and others.

In a separate release, Gen-Probe said that it intends to initiate in 3Q09 a pivotal clinical study of its investigational PCA3 assay that could lead to regulatory approval by the (FDA).

• Bio-Matrix Scientific Group (San Diego) and Entest BioMedical, BMSN's wholly-owned subsidiary, reported a contract with Dr. Brian Koos, a professor of obstetrics and gynecology at the David Geffen School of Medicine at the University of California, Los Angeles for the development and validation of a screening test for gestational diabetes, a glucose intolerance in pregnant women.

Koos is the developer of the test which is licensed to Entest by UCLA. The test is intended to mitigate the lengthy process of diagnosing gestational diabetes. Entest is the exclusive licensee for Koos' gestational diabetes screening test. The companies said their goal is to develop a large scale sampling for validation of the screening test with FDA and then be marketed to hospitals and medical clinics.

No Comments