A Medical Device Daily

Genzyme (Cambridge, Massachusetts) said it has filed with the European authority to expand the CE mark for Synvisc (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder.

Approval of a new label will provide opportunity to broaden the use of Synvisc beyond its current European-approved use in the knee and hip to the two additional joints.

“Our filing in Europe for approval of Synvisc in the ankle and shoulder reaffirms our commitment to the field of osteoarthritis and to pursuing new medical indications to help patients manage pain from OA,” said Ann Merrifield, president of Genzyme Biosurgery , the business unit of Genzyme Corp. that manufactures Synvisc. “With approval in the ankle and shoulder, Synvisc will be one of the few viscosupplements available in Europe for treating OA pain in four major joints that is supported by strong clinical data.”

The filing for label expansion of Synvisc contains data from two clinical trials in the ankle and shoulder. The prospective, multi-center studies that took place in several countries throughout Europe found treatment with Synvisc to be well-tolerated, and data show that Synvisc significantly decreases pain due to OA in the ankle and shoulder and that the decreased pain effect is maintained for up to six months.

Data from the ankle study have been accepted for presentation at the American College of Rheumatology meeting this fall in Washington. Genzyme expects the European regulatory review of the Synvisc label expansion request to be complete by year-end.

Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people.

European agency reflects on nanotechnology

The potential for nanotechnology-based medicines is under review by the European Medicines Agency , which has just released a paper that reflects the current thinking and initiatives it has taken “in view of recent developments in relation to nanotechnology-based medicinal products.”

Nanotechnology “will contribute in developing a more proactive paradigm for the diagnosis and therapy of diseases,” the paper predicted. Medicines containing nanoparticles already have been authorized both in the European Union and the U.S. under the existing regulatory frameworks, it pointed out, and “although nanosizing does not necessarily imply novelty, it is expected that nanotechnology will yield innovative products.”

The likelihood, predicted the agency, is that these products could span the regulatory boundaries between medicines and medical devices, challenging the current criteria for classification and evaluation. They might exhibit a complex mechanism of action combining mechanical, chemical, pharmacological and immunological properties and combining diagnostic and therapeutic functions. In addition, appropriate expertise will have to be mobilized for evaluating the quality, safety, efficacy and risk management of nanomedicinal products.

The majority of current commercial applications of nanotechnology to medicine are geared toward drug delivery to enable new modes of action, as well as better targeting and bioavailability of existing medicinal substances.

Pending the emergence of more understanding of the potential and of appropriate guidance, the agency has created an innovation task force to coordinate scientific and regulatory competence in the field of the emerging therapies and technologies, and to provide a forum for early dialogue with applicants on regulatory, scientific or other issues that may arise from the development.

Meridian, Merck in accord on assays

Meridian Bioscience (Cincinnati) said it has entered into a partnership agreement with the Performance & Life Science Chemicals Division of Merck KgaA (Darmstadt, Germany) and its American subsidiary, EMD.

This strategic partnership is focused on the development of new assays for the clinical market, which Meridian will sell through its sales force and distribution partners.

The first product of this partnership is scheduled to launch in the U.S. market during the first half of Meridian's FY07. The long-term partnership is expected to enhance Meridian's new product pipeline for the microbiology laboratory and will contribute sales growth over the next several years, the company said.

John Kraeutler, president and chief operating officer, said, “This partnership demonstrates [our] dedication to organic growth through innovation that maximizes internal and external R&D efforts. Meridian will continue to focus its R&D resources to develop new, differentiated products.”