Medical Device Daily Correspondent, and Staff Reports

BRUSSELS, Belgium – The European biotech and pharma sectors received a promise of support last week from the man who recently became the top European Union (EU) official responsible for medicines legislation.

G nther Verheugen, European Commission vice president, during a presentation at the European Medicines Agency (London), said that European biotech "needs a clear regulatory framework for new technologies so that it can design its studies and develop products for the benefit of patients."

That was Verheugen's first major pronouncement on his vision for the biotech/pharma sector since he became the EU's industry chief at the end of 2004. Speaking at the 10th anniversary celebrations of the medicines agency, he particularly welcomed the European industry's capacities for tissue engineering, cell therapies and gene therapy, and he acknowledged that unclear rules "increase uncertainty and risks for industry and reduce innovation."

He promised to make a priority of providing a clearer operating environment "for these advanced therapies" so as to help stimulate industry innovation. "It is no secret that the historical dominance of the European pharmaceutical industry has been eroded, particularly by the growth of the industry in the United States," he said.

"We look forward to evolution" in the EU's rules, responded one of the European pharmaceutical industry's leading figures, Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations. He insisted on the need not only for a high-quality regulatory system, but also for a Europe-wide marketplace "which rewards innovation."

SIRS-Labs, OGT in biochip accord

The biotech company SIRS-Lab (Jena, Germany) and the Oxford Gene Technology (OGT; Oxford, UK) yesterday reported an agreement concerning the licensing of OGT's technology for nucleotide-based biochips. The contract enables SIRS-Lab to produce biochips using the patented technology and to distribute these products, and related services, Europe-wide.

Dr. Stefan Russwurm, CEO and founder of SIRS-Lab, said, "In addition to our high-grade quality assurance, the use of nucleotide chips combines several advantages which we would like to provide to our customers. Compared to cDNA probes, nucleotides can be systematically optimized and synthesized. Thus, product development can be adapted to customer needs in a more flexible fashion."

Russwurm added that the license enables SIRS "to offer its quality products using the latest state of the art" and strengthens the company's Lab-Arraytor product line.

SIRS-Lab, first operational in 2001, makes biochip diagnostic systems for early diagnosis and therapy control of generalized inflammatory reactions and sepsis. It also offers services in genomics and proteomics as well as an application and training center for microarray analysis.

Oxford Gene Technology was founded in 1995 by Professor Edwin Southern – considered one of the inventors of DNA microarrays – to exploit patented technology developed in his research laboratories at Oxford University. OGT also holds patents in a number of other areas, all relating to "molecular tools" to boost the power of biological research.

Researcher: stop-smoking laser works

M. Breteler, MD, of the Behavioral Science Institute of Radboud University (Nijmegen, the Netherlands) reported that he has researched, as a method to stop smoking, the laser therapy system developed by Prostop (Grave, the Netherlands) and has found it to be successful.

"Of the 300 people in the group who started this therapy to quit smoking in January 2004, 32.1% did not start smoking again," Breteler said, calling this "an extraordinary success rate."

This success rate is higher than the numbers that have been reported by Stivoro, an organization providing education concerning the health risks of smoking. Stivoro's research among people who quit smoking in January 2004 showed a success rate of 24% after 11 months, according to Prostop.

Prostop describes its laser treatment system as a "refinement" in acupuncture, using a "soft" laser beam to penetrate the skin deeply enough to stimulate the selected points without damage to the skin.

Prostop describes the laser's mechanism of action as using "light amplification by stimulated emission of radiation" to release endorphins "which temporarily saturate the nicotine receptors" to produce "a feeling of relaxation and stability." Then: "Since the need for nicotine is replaced with an increased endorphin level, the former smoker can make it through the difficult time after he or she quits smoking without suffering too much discomfort." It says the system is painless and has no side-effects.

Prostop reports its laser therapy performed throughout the Netherlands since 1996. It is developing franchises in both the Netherlands and in Germany.

Boston Sci's Letterkenny facility okayed

Boston Scientific (Natick, Massachusetts) reported that its Letterkenny, Ireland, facility has received FDA approval to manufacture two versions of its Cutting Balloon product line for distribution in the U.S. The approval follows quality systems inspections at Letterkenny, in which the company, it said, "received no adverse observations from the FDA."

The company also received FDA approval of its sterilization facility in Quincy, Illinois. "These FDA approvals will enable us to deliver the Cutting Balloon technology to more clinicians more efficiently," said Paul LaViolette, chief operating officer for Boston Scientific. "In-house sterilization of the Cutting Balloon product line in Quincy, combined with expanded manufacturing in Letterkenny, will allow us to increase production, improve operational efficiency and decrease the time it takes to get our products from the manufacturing floor to the customer and ultimately, the patient."

The Letterkenny facility received FDA approval to manufacture the Cutting Balloon Ultra2 device and the 2 cm Peripheral Cutting Balloon device. The facility has previously manufactured both products for distribution outside the U.S.

The Cutting Balloon Ultra2 device represents the current generation of the company's Cutting Balloon product for the treatment of coronary artery disease. It is described as having "a novel mechanism that safely dilates coronary lesions at lower pressures."

The Cutting Balloon Ultra2 features tiny, longitudinally mounted atherotomes (microsurgical blades) that relieve stress in the artery as the balloon inflates, reducing resistance of a lesion to expansion. The blades create incisions that relieve stress in the artery as the balloon inflates, reducing the force necessary to expand the vessel. The device's proprietary fold mechanism shields the blades and protects the vessel wall as the catheter is passed to and from the treatment site.

The Peripheral Cutting Balloon device uses the same mechanism of action as the Cutting Balloon Ultra2 but in a larger size (2 cm length and diameters up to 8 mm). The Peripheral Cutting Balloon will be used to treat the synthetic grafts of patients who are undergoing hemodialysis for end stage renal disease.