A Medical Device Daily

MDS Nordion (Ottawa), a global provider of medical isotopes and radiopharmaceuticals used in molecular medicine, has reported the opening of a facility in Fleurus, Belgium, for the production of Glucotrace (fluorodeoxyglucose), a radiopharmaceutical used in positron emission tomography imaging.

PET imaging produces a 3-D image of functional processes in the body, such as brain activity, and is "a highly accurate and effective method of diagnosing disease and managing patient therapy," according to MDS Nordion.

The company said its new facility will provide timely supply of Glucotrace to hospitals throughout Belgium, France, the Netherlands, Luxembourg and Germany.

Company President Steve West said, "Our investment in this facility further demonstrates our commitment to address the growing demand for PET diagnostic imaging in targeted European regions, and provides the medical community greater service for their future patient care."

MDS Nordion said the PET imaging market "is the most rapidly growing area of nuclear medicine and procedures."

It said statistics from a recent Medical Options survey indicate PET examinations are on a rapid rise in Europe, and are expected to grow at a compound annual rate of about 20% through 2012.

"To help meet increasing demand, this Good Manufacturing Practices production facility will have three daily production runs and a customer service team available 24 hours a day, seven days a week," the company said.

"PET imaging is effective because it allows early detection of tumors, as well as assessment of therapeutic strategies," said Professor Roland Hustinx of the nuclear medicine department at CHU-Universite de Liege. "MDS Nordion's new facility will provide another source of supply of Glucotrace to existing and new medical facilities, thereby increasing the ability of healthcare practitioners to conduct this critical type of imaging."

Licensing agreement on pain treatment

Z-Cube (Milan, Italy), the corporate venture arm of Zambon Company SpA, and Yissum Research Development, the technology transfer company of the Hebrew University of Jerusalem, reported entering into a license agreement for Z-Cube to develop and commercialize an innovative nanotechnology drug-delivery system for the treatment of pain.

The technology was invented by Professor Elka Touitou from the Department of Pharmaceutics, Faculty of Medicine, at the Hebrew University of Jerusalem.

Under the terms of the agreement, Z-Cube has received the worldwide exclusive right to develop and commercialize the technology for pain applications and will sponsor a research program to be conducted by Prof. Touitou and her group. Z-Cube has also received the right to grant sublicenses. Yissum will receive license fees, milestones and royalty payments.

"We are pleased to partner with Z-Cube, a world leader in the commercialization of drug-delivery technologies," said Yaacov Michlin, CEO of Yissum. "Our novel drug-delivery system has the potential to enable relief of both mild and severe pain quickly and efficiently."

"This innovative drug-delivery system is a powerful tool enabling the development of improved medicines for the treatment of pain," said Lorenzo Pradella, PhD, business and operational development director of Z-Cube. "Patients suffering from pain will benefit from this new approach that promises to generate upgraded and easier to use therapeutics."

Collaboration on cytology imaging

mtm laboratories (Heidelberg, Germany), a privately held diagnostics company developing in vitro diagnostics for cervical cancer early detection and diagnosis, and MetaSystems (also Heidelber), a maker of microscopic imaging systems worldwide, reported the signing of an agreement to co-develop a customized automated imaging system for use in conjunction with mtm's CINtec Cytology products.

The CINtec Cytology kit is a qualitative, immunocytochemical assay for the evaluation of p16, a biomarker indicative of the onset of cervical disease, and is available globally for the early detection and management of cervical cancer. CINtec Cytology visually stains cervical cells that are over-expressing the biomarker p16, which clinically correlates with the screened women who harbor underlying high-grade cervical disease.

The automated imaging solution that the two companies are now developing is targeted to achieve equal or better sensitivity and specificity compared to manual observation and evaluation of the cytology slides, but with a greater degree of efficiency. This will be done by adapting Metafer, a system developed by MetaSystems that offers a unique high performance slide scanning and imaging platform, to the specific needs for analyzing CINtec Cytology stained slides.

The agreement initially covers the co-development of the imaging system and will lead upon success to a co-promotion effort from both companies based on any successfully developed end product. The combined system that the two companies aim to develop should be a cost effective and highly efficient tool to assess large numbers of cytology slides to pinpoint those specimens showing over-expression of p16 in the context of cervical cancer early detection and diagnosis.

Bob Silverman, CEO of mtm laboratories, said, "MetaSystems offers very valuable tools for leveraging the well-established clinical utility of mtm's CINtec Cytology products in the early detection of cervical cancer. As a result we will together meet the market demand for automated solutions that have the potential to improve on current approaches to the early detection of cervical cancer"

European distribution deals signed

Accumetrics (San Diego) reported signing new exclusive distribution agreements for its VerifyNow System in several European countries.

Distribution of VerifyNow products will be handled by AAZ in France; BITmedical GmbH in both Austria and Switzerland; and Kordia in the Netherlands, Belgium and Luxembourg.

The VerifyNow System assesses response to antiplatelet therapies, such as aspirin, Plavix and GP IIb/IIIa inhibitors. As response to these drugs varies, the tests help physicians ensure their patients on antiplatelet medications are receiving the optimal benefit.

"We're ... excited to continue with the global expansion of our distribution strategy for the VerifyNow System," said President/CEO Timothy Still. "Accumetrics has chosen each of these partners based on their demonstrated expertise and knowledge of our markets in their respective territories."