Medical Device Daily Contributing Writer
And MDDs

The holding company for British Biocell International (BBI; Cardiff, UK), a developer and manufacturer of rapid result diagnostic tests, acquired the rights to the D-dimer tests of Agenix (Brisbane, Australia) and said it plans to take this chemistry for point-of-care (POC) diagnostics to a new level through a proprietary platform for next-generation rapid-test diagnostics.

In addition to the product rights, purchased for A$2.7 million ($2.11 million), BBI Holdings (Cardiff) acquired plant equipment and existing stock and inventory for another A$1.2 million ($940,000).

BBI said it would install the production line at its recently acquired facility in Dundee, Scotland. Agenix will support the manufacture of the product through this transfer process, which is expected to take up to a year. Financing came from cash resources and a loan for pounds 1.3 million ($2.5 million), BBI reported in a statement.

The agreement includes the Simplify and SimpliRED range of D-dimer diagnostic products, distributed exclusively by Inverness Medical Professional Diagnostics (Waltham, Massachusetts), as well as two diagnostics to detect fibrin degradation products, a process essential in rapid diagnosis tests of deep vein thrombosis, pulmonary embolism and disseminated intravascular coagulation.

Julian Baines, managing director of BBI, said, "The deal with Agenix will diversify our range. Not only are we moving up the value chain with a unique product, but the equipment that we will acquire will bring a higher level of automation to BBI, strengthening our manufacturing services." In addition to its own product line, BBI is a contract manufacturer for leading medical device manufacturers, including Merck (Darmstadt, Germany).

Two days after announcing the agreement, BBI reported a 50/50 joint venture with precision plastics manufacturer Carclo (West Yorkshire, UK) for acquiring Platform Diagnostics (Liverpool, UK), a developer of POC diagnostics with four patents covering its capillary agglutination technologies (CAT) used to adapt standard diagnostic testing to lower-cost, disposable, "digital" test units. Compared to sandwich immunoassays currently available that require a yes-no, or qualitative result, the digital signal generated by CAT will include quantitative results.

"We look forward to taking the D-dimer test to a new level through this collaboration with Platform," said Baines. The Agenix line will be the first development target for the patented capillary system developed by Platform, he said.

The second focus will be a new format of lateral flow currently in development and awaiting the results of feasibility studies.

Ian Williamson, chief executive for Carclo, said the CAT platform, "combined with BBI's newly acquired D-dimer chemistry, is an ideal opportunity to bring to market a new generation of low cost, rapid diagnostic tests for the point-of-care market."

Reporting a "much-improved balance sheet," Carclo said last year that it intended to move aggressively into medical diagnostics to expand upon its traditional base in automotive, electronics and aerospace.

The main division, Carclo Technical Plastics, accounted for two-thirds of 2006 sales of pounds 90 million ($173 million) and has developed an expertise in microfluidics, surface coatings and optics. The division produces lateral flow cassettes, reaction test kits and immunoassay test cartridges, as well as laboratory disposables.

The partners said they expect to complete the development of the first products using the Platform technology within the next 12 to 18 months.

Meanwhile, BBI in January upgraded its financial support as a "business angel" for Quotient Diagnostics (Surrey, UK), developer of a near-to-patient diabetes test for A1c, a fraction of the blood protein hemoglobin.

The three-minute test is performed in a small disposable cartridge that is then inserted into a reader to detect changes of fluorescence in the reagent and convert the resulting signal into a readable displayed for patient care staff.

Quotient is currently conducting clinical studies as part of a 510(k) submission in the U.S. and CE-mark submission in Europe.

Production plagues Guerbet profitability

A specialist in patient-consumable medical imaging contrast agents, Guerbet (Paris) blamed an 18% drop in 2006 profitability on "production incidents that are now resolved." The company reported a sales increase of 7.4% for total 2006 revenues of EUR 289 million ($390 million) and net income of almost EUR 19 million ($26 million).

The company's production problems, which it declined to specify, resulted in sharply increased manufacturing costs for the second half of the year. Continued production investments are expected for 2007.

Guerbet provides contrast agents for X-ray imaging and MRI, including Xenetix for whole-body imaging; Dotarem, a gadoteric acid for MRI imaging; and Imagenil for intra-arterial and intravenous indications in conventional radiology and CT scanning.

Agence Option Finance reported that Guerbet saw sales increase 5.1% for Xenetix and 8.6% for Dotarem in 2006. While European sales "kept pace with the market" at 2.3%, the company reported sales in Asia increased nearly 38% year-to-year and by 18% in Latin America.

Hovione in inhaler deal with Biota, Sankyo

Hovione (Loures, Portugal) reported signing an agreement where Sankyo (Tokyo) and Biota Holdings (Melbourne, Australia) have jointly licensed Hovione's dry powder inhaler technology for the delivery of long-acting neuraminidase inhibitors (LANI) owned by Sankyo and Biota, which are active against the influenza virus.

An improvement over other approved medicines which have to be taken repeatedly, is that this novel compound is expected to remain active for several days and require to be taken once only.

Hovione retains all inhaler rights outside the field of influenza.

Under the agreement, Hovione has developed a low-cost, disposable inhaler, Twin Caps, specifically for this indication. It also carried out inhaler compatibility studies and comprehensive formulation development to demonstrate that the lead clinical candidate CS-8958 can be delivered by inhalation.

Sankyo and Biota are responsible for the clinical development of the drug product, which is expected to start in the near future. A Phase I clinical trial of CS-8958 in a prototype inhaler has already been completed.

Peter Villax, Hovione VP, said, "This agreement is the confirmation that Hovione is recognized as a reliable partner in inhalation product development.

No Comments