BB&Ts

Royal Philips Electronics (Eindhoven, the Netherlands) will lead a European consortium to develop local drug delivery using nanoparticles activated by ultrasound.

Funded with €11 million ($14 million) from the European Union's Framework 7 program to stimulate innovation, the SonoDrugs project will gather 15 industrial partners, university medical centers and academic institutions located across the continent.

The partners will contribute a third of the financing for the four-year program, totaling €5 million ($6.5 million) as well as expertise and in-kind services for research and prototype development.

The program will focus on drug delivery for cancer and cardiovascular disease, exploring the use of existing nanocapsules filled with existing therapeutics as well as the development of new capsule materials combined with new medications, a Philips spokesman, Steve Klink, told Biomedical & Business Technology.

Although powerful drugs are available to treat cancers and cardiovascular disease they are typically administered systemically as intravenous or oral doses, with very limited control over the distribution of drugs in the body.

The random interaction of these molecules with different tissues and organs is responsible for the heavy side effects often associated with these therapies.

The SonoDrugs project aims to address this challenge by developing drug delivery vehicles that can be tracked by ultrasound or MRI and triggered by ultrasound to release the drugs at a highly targeted site in the desired location. It is hoped that such control of the drug delivery process will increase therapeutic efficiency and minimize side effects, while also providing a means of tailoring the therapy to individual patients.

"New therapeutic options such as externally triggered local drug release at the specific site of disease hold the promise to significantly improve patient care," says Henk van Houten, senior VP of Philips Research and head of Philips' healthcare research program.

He added that targeted drug delivery also holds the potential to tailor therapies for specific patients at different stages of treatment.

One of the program partners, Nanobiotix (Paris), received a European patent covering novel activable particles for use in medical applications in 4Q08.

The core of the company's current nanoXray product is a non-drug agent with at its core an inert and inactive substance called Nbtxr3 coated with a material taken up by cancerous cells, thereby attracting a concentration of particles on the diseased cells while leaving healthy cells untouched.

Introducing a blast of gamma rays from an everyday X-ray unit activates Nbtxr3 locally, setting off tumor necrosis by inducing a chain reaction where a reactive oxygen intermediate blocks the formation of free radicals and arrests the cytotoxic response of tumor cells.

"For Nanobiotix, collaboration with SonoDrugs valorizes the company's know-how in MRI contrast agents and activated therapies as well as nanoparticle design and manufacturing," said President/CEO Laurent Lévy, PhD, who also is co-president of the French Technology Platform on Nanotechnology. He called the SonoDrugs program a "groundbreaking" effort.

Meanwhile Philips said it has two other programs for local drug delivery using ultrasound activation currently in late-stage development.

Philips is working with the University of Virginia (Charlottesville) on a 4-micron microbubble loaded with an anti-cancer therapeutic that is in pre-clinical development and it has announced a collaboration with Celsion (Columbia, Maryland) encapsulating the approved drug Docetaxel s in that company's ThermoDox shell which is activated by MRI-guided high-intensity focused ultrasound system.

Use of proven chemotherapeutics is believed to lower development risk and accelerate speed-to-market for drug-device combination through clinical programs that are less complex.

Yet Klink cautions against this rush to market, saying the development timeline remains fixed closer to a pharmaceutical development than a medical device approval cycle.

"Microbubbles and the drugs they contained are approved for specific indications so that new combinations and new materials means approvals are not as straightforward as a device maker would expect," Klink told BB&T, adding that a 10-year horizon is more likely for any product emerging from the SonoDrugs program.

Other partners on the program include Lipoid (Germany), the university medical centers Erasmus Medical Center (the Netherlands) and Universit ts Klinikum Münster (Germany), and the academic institutions University of Cyprus (Cyprus), University of Gent (Belgium), University of Helsinki (Finland), University of London (UK), University of Tours (France), University Victor Segalen Bordeaux (France), University of Technology Eindhoven (the Netherlands) and the University of Udine (Italy).

Taxus Liberté approved in Japan

Boston Scientific (Natick, Massachusetts) said last month it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its Taxus Liberté paclitaxel-eluting coronary stent system in that country. It said the Liberté is the only second-generation drug-eluting stent approved for use in Japan.

The company said it plans to launch the product as soon as reimbursement approval is granted, which is expected in the coming weeks.

Boston Sci said design improvements over the first-generation Taxus Express2 stent include thinner struts to allow better stent deliverability and conformability, as well as a more uniform stent geometry for consistent lesion coverage and drug distribution.

Donald Baim, MD, chief medical and scientific officer of Boston Scientific, said, "The Taxus Liberté Stent is the latest advance in drug-eluting stent technology for Japan," said "Its safety and efficacy have been well demonstrated in multiple clinical studies and years of clinical use."

President/CEO Jim Tobin said, "We are very pleased with this approval, which provides access to proven technology to Japanese physicians and their patients."

The Taxus Liberté stent uses proven paclitaxel-eluting technology, which has been evaluated by what Boston Sci characterized as "the industry's most extensive randomized, controlled clinical trial program," and studied in 35,000 real-world patients enrolled in post-approval registries. More than 4.6 million Taxus stent systems have been implanted globally.

The Taxus Liberté will replace the Taxus Express2 stent, which was launched in Japan in May 2007. It has been approved for sale in the U.S., Europe and other international markets.

Boston Sci to close Ireland facility

Boston Scientific, which has roughly 4,500 employees in Ireland, last month reported plans to close its facility in Letterkenny, County Donegal, next year. About 120 people are employed at the site, which has been operating since 1992.

The company said that most of the manufacturing currently carried out at the Letterkenny plant would switch to its Galway facility. The decision to close the facility was made after a review of the U.S. firm's operations in Ireland.

Last August, Boston Scientific announced the closure of its Tullamore plant, with the loss of 240 jobs.

The company said opportunities would be made available for workers at Letterkenny to move to the Galway facility.

Boston Scientific, which recently acquired Labcoat, a small medical device development firm based in Galway, said it remained committed to its operations in Ireland.

NHS evaluating nine devices for HCAIs

Nine medical devices have advanced to a hospital-based evaluation by England's National Health Service (NHS) for effectiveness in screening and preventing healthcare-associated infections (HCAIs).

NHS research concluded up to 8% of incoming patients at hospitals are carriers of one superbug, methicillin-resistant Staphylococcus aureus (MRSA), compared to just over 1% who are infected while they are in hospital.

Several NHS hospital trusts have mandated screening of all incoming patients to combat the spread of this superbug as well as five other pathogens responsible for in-hospital infections.

In a system wide effort, the NHS Purchasing and Supply Agency set up the Smart Solutions program to identify innovative technologies from different industry sectors with the potential to fight hospital bugs.

Almost 250 applications were submitted and the nine selected devices will be evaluated in a hospital setting starting soon at more than 30 NHS hospitals that offered to serve as an evaluation site for the Smart Solutions program.

An international HCAI Technology Innovation Summit is set for Feb. 26 as a kickoff for the evaluation program and to highlight innovations and technological developments in the field.

The finalists in the competition represent diverse approaches to controlling infection and the evaluations will not result in a single winner but recommendations with all nine companies potentially earning the prize of supplying the entire NHS network if they prove to be effective.

Among the selected technologies are products developed by Baxter Healthcare (Deerfield, Illinois), Chemspec (Baltimore), GE Healthcare (Chalfont St. Giles, UK) with Medixair (Brierley Hill, UK), UV Light Technology (Oldbury, UK), Inov8 Science (Buckingham, UK), Quest International UK (Ashford, UK), TwistDx (Cambridge, UK), Ergomedica (Bucks, UK), and Nanopool (Hülzweiler-Schwalbach, Germany).

Baxter is proposing the V-link luer-activated device with VitalShield protective coating, an antimicrobial needle-free IV connector using the controlled release of silver particles effective in killing the six most common pathogens causing catheter-related bloodstream infections as a result of IV therapy.

Medixair proposes use of a high-intensity ultraviolet germicidal irradiation through wall-mounted and portable units with UV tubes from GE for eradication of airborne bacteria, viruses, yeasts and mold.

Ergomedica's MedMat is a self-contained changing mat developed by a surgeon from the Royal London and Barts Hospital Trust that protects both patient and caregivers from cross contamination during procedures that requires a sterile field.

Nanopool proposes a liquid glass layering technology for enhancing working surfaces with new anti-microbial properties by applying ultra thin nano layers of silicon dioxide, the primary element in common glass, modified by aluminium oxide, potassium oxide, calcium oxide and other components. The nano coatings are transparent and super-durable glass, with characteristic having what the company calls "massive implications for healthcare environments."

TwistDx has developed a novel point-of-care test technology using recombinase polymerase amplification, an evolution of the widely used diagnostic technique polymerase chain reaction that the company says is faster, taking from 10 to 15 minutes.

Medical Fair Thailand set for September

With the new name Medical Fair Thailand, the International Exhibition on Hospital, Diagnostic, Pharmaceutical, Medical & Rehabilitation Equipment & Supplies, will take place from Sept. 16–18 at the Queen Sirikit National Convention Center in Bangkok.

Formerly named Hospimedica Thailand, the event will again be organized by Messe Düsseldorf Asia, a subsidiary of Messe Düsseldorf in Germany, the organizer of MEDICA, the world's largest medical trade fair.

Medical Fair Thailand 2009 will bring global healthcare equipment manufacturers and suppliers together with Southeast Asia's medical and healthcare industry.

An expected 250 exhibitors from 24 countries will showcase the latest equipment for the medical industry, including diagnostics, electromedical and medical technology, dental equipment, laboratory technology, rehabilitation and orthopedic equipment as well as pharmaceutical supplies, emergency equipment, building technology and furniture.

More than 3,800 visitors are expected to attend.

Messe Düsseldorf Asia said the healthcare industry in Asia is growing steadily and is expected to gross $7 billion annually by 2012. It said Southeast Asia's governments have focused on revamping their healthcare systems. As a result, the medical equipment and supplies market is estimated to increase by 30% to a value of about $43 billion by 2010.

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