A Medical Device Daily Staff Report

Durect (Cupertino, California) reported the signing of a collaboration agreement with Nycomed (Roskilde, Denmark), a privately held pharmaceutical company, whereby the companies will jointly develop Durect’s Posidur post-operative pain relief depot.

Posidur is a long-acting local anesthetic under development for the treatment of post-surgical pain. It is intended to be injected during surgery, where it continuously releases therapeutic levels of bupivacaine in a controlled fashion, providing up to 72 hours of uninterrupted local analgesia.

Durect’s Saber delivery system is an injectable, biodegradable drug-delivery technology that allows for less post-injection burst than is typical of polymer-based systems. Posidur is currently in Phase II clinical development, with Durect and Nycomed anticipating that the program will move into Phase III in 2007.

With the agreement, Nycomed will pay Durect an up-front license fee of $14 million, with additional milestone payments of up to $188 million upon achievement of defined development, regulatory and sales milestones.

Nycomed will have exclusive commercialization rights in Europe and other select countries, and Durect will retain full ownership of Posidur in the U.S., Canada, Asia and other countries.

“We believe that Posidur has the potential to play a major role in addressing post-surgical pain,” said Hakan Bjorklund, CEO of Nycomed. “The strategy of employing local post-surgical pain management to reduce the need for systemic pain relief is consistent with current trends to reduce the use of narcotics and associated side effects, as well as hospital stays and associated costs.”

James Brown, president/CEO of Durect, said, “Nycomed has an extensive hospital-based sales force and will provide a dedicated sales force to promote Posidur, which complements Nycomed’s existing portfolio of pain management and hospital products.”

He added that the collaboration push forward his company’s objective to become a specialty pharmaceutical company by the retention of commercialization rights in the U.S., as well as other significant territories. He said the deal also reduces the cost of funding Durect’s U.S. development program for Posidur by the shared funding with Nycomed of a common development program for the U.S. and Europe.”

The companies will jointly direct and equally fund a development program for Posidur intended to secure regulatory approval in the U.S. and the European Union.

Durect has licensed to Nycomed exclusive commercialization rights to Posidur in the EU and select other countries. The U.S. firm will manufacture and supply the product to Nycomed for commercial sale in the territory licensed to Nycomed.

Nycomed will pay Durect royalties of 15% to 40% depending on annual sales.

VeriChip cites Italian study results

VeriChip (Delray Beach, Florida) reported the results of a clinical study on its VeriMed System for patient radio frequency identification (RFID) conducted by the Spallanzi National Institute (Rome) and sponsored by the Italian Ministry of Health .

The two-year, 10-patient study was designed to evaluate the safety and efficacy of the VeriMed implantable RFID microchip and the functionality of the VeriMed System in the management of patients with chronic infectious diseases undergoing care at the Institute.

The study reported no complications or side effects related to the insertion procedure, flawless access of the ID number using a hand-held reader, and universal acceptance within the patient study group. Based on the results of the study, VeriChip’s distributor for Italy said it plans to petition the Italian Ministry of Health for full availability of the VeriMed system through the Italian National Health Service.

Richard Seelig, MD, VP medical applications at VeriChip, said, “We are extremely pleased with the results of the first long-term clinical study evaluating all aspects of the VeriMed System in a clinical management environment. The findings confirm that the VeriMed System provides a favorable clinical utility to treating physicians. The study also demonstrates the appeal of VeriMed to the patient population, as all participants in the study elected to retain their VeriChip implant for use beyond the conclusion of the study.”

VeriChip is a subsidiary of Applied Digital Solutions .

New UK center to feature Elekta systems

Elekta (Stockholm, Sweden), a developer of advanced radiation therapy solutions and oncology software systems, said it has been selected to supply the new cancer therapy unit in southwestern England with two linear accelerators for radiation treatment, as well as software for treatment planning and information management.

The new Somerset Oncology & Hematology Center at Taunton & Somerset NHS Trust’s Musgrove Park Hospital is due to open in the spring of 2009. The availability of local radiotherapy services and Musgrove Park-based consultant oncologists will substantially improve the service for cancer patients from Somerset.

The center will provide radiotherapy treatment for about 1,200 patients yearly.

Elekta will equip the new center with two Elekta Synergy platform digital linear accelerators, allowing clinicians to carry out intensity-modulated radiation therapy (IMRT) to enable higher-precision treatments, and prepared to be field upgraded to full 3-D image-guided radiation therapy (IGRT).

Included in the order are Elekta’s PrecisePLAN treatment planning system with comprehensive 3-D and IMRT planning software, as well as a full suite of information management software from Impac Medical Systems , an Elekta company.

“This is a true partnership and a comprehensive long-term solution for the Trust,” said David Belcher, Elekta’s European PFI director. “We have built up an excellent relationship with Taunton and Somerset NHS Trust and are looking forward to build upon this to make Musgrove Park Hospital a center of excellence.”

Elekta has previously been selected as equipment supplier in other PFI contracts, including St. James’ Hospital at the Leeds Teaching Hospitals NHS Trust.

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