Add Ranier Technology (Cambridge, UK) to the list of firms seeking to commercialize artificial disc products and compete with DePuy Spine (Raynham, Massachusetts), the only company so far to win FDA approval in what is expected to be a fast-growing and important sector once the technology is fully mature
Ranier Technology reported in mid-June receiving $7.3 million (GBP 4 million) in a second institutional funding round. The funding was provided by FNI Venture Capital, an investor in Ranier's first financing round in 2002. FNI Venture Capital is the UK venture capital arm of German-based Renate Nixdorf Verwaltungsgesellschaft
Ranier said that the new funding would be used to push forward the development, through clinical trials, of its spinal disc implant, CAdisc. Dr. Geoffrey Andrews, CEO of Ranier, said that the financing would provide enough money "to ensure CAdisc progresses to become a leading contender for the next-generation artificial lumbar disc."
CAdisc is a polyurethane disc based on the company's proprietary Precision Polyurethane Manufacture (PPM) biomaterials technology. It is designed to mimic and restore the physiological properties and biomechanics of the natural spinal disc. Ranier said that it offers "improved device durability, motion restoration and minimal stress on adjacent spinal segments, which will result in significant benefits for patients."
Peter Wolfers, of FNI Venture Capital, said about the CAdisc: "It is a very promising device, backed by strong intellectual property and technology. We are confident that the CAdisc development program will lead to a new standard of treatment for total disc replacement."
Ranier puts the worldwide spinal implant market at more than $3.7 billion a year and growing at more than 12% annually. It estimates the total disc replacement market at growing to $1.4 billion by 2010.
Quintiles to expand China lab services
Quintiles Transnational (Research Triangle Park, North Carolina) said its Quintiles Laboratories Asia (Singapore) unit has amended its existing agreement with Peking Union Medical College Hospital (PUMCH; Beijing) to enhance central laboratory services in China. Under the agreement, Quintiles central laboratory (QLAB) facilities in China will have dedicated rooms for specimen management and analytical testing using Quintiles' instruments and processes that follow QLAB global operating procedures and quality standards.
Quintiles said it already operates "the largest and most comprehensive" central lab testing facility in Asia at its Singapore base and has been providing central lab services in China under the initial agreement with PUMCH since October 2003.
Anand Tharmaratnam, MD, CEO of Quintiles Southeast Asia and QLAB Asia, said, "The new agreement represents true growth and quality standardization of our Asia central lab service. It . . . very nicely complements our clinical business, which is the largest pharmaceutical development group in Asia."
Alan Ong, vice president and general manager, QLAB Asia, said of the enhanced services: "QLAB Asia performed nearly a million tests in 2004, of which 400,000 tests were for China trials. Our new enhanced services will now allow our customers to participate in the growth of clinical trials in Asia, freed from the problems and difficulties of exporting blood samples out of China."
Quintiles said that QLAB in China would apply for accreditation from the College of American Pathologists (CAP; Northfield, Illinois) by early 2006. QLAB facilities in Singapore; Atlanta; Edinburgh, Scotland; and Pretoria, South Africa, all are CAP-certified.
Quintiles Asia has clinical development offices across seven countries in Southeast Asia, among Quintiles Transnational's offices in 50 countries. Since 1995, the Quintiles clinical team in Southeast Asia reports completing more than 150 Phase II and III studies from 1,000 sites and recruited more than 35,000 patients into international clinical trials. Its central lab operations in Singapore have serviced more than 200 studies, with samples shipped in from 15 Asia Pacific countries.
Dutch court backs Boston Sci
Boston Scientific (Natick, Massachusetts) reported in early June that a Dutch court had ruled that Cordis Europa NV, a subsidiary of Johnson & Johnson (J&J; New Brunswick, New Jersey), infringes a Boston Scientific balloon catheter patent. In its own news release on the decision, J&J's Cordis (Miami Lakes, Florida) unit said that it intends to file an appeal with the Dutch Appeals Court.
The catheter products found to infringe include the Cypher Raptor, the Cypher Select, the Bx Velocity Raptor, the Bx Sonic, the U-Pass and the Aqua T3. The catheter shaft at issue in the case is used in the delivery system for the Cypher and Cypher Select sirolimus-eluting coronary stents, as well as several other catheter-based products.
Boston Scientific said the court's decision gives it the right to damages and to an injunction against Cordis manufacturing, using or selling the infringing catheters in the Netherlands.
Paul LaViolette, Boston Sci's chief operating officer, said the decision "confirms our belief that [we have] fundamental intellectual property in the treatment of coronary artery disease." He added: "We are hopeful that it will provide an opportunity for a fair and reasonable settlement of the numerous disputes between our two companies."
Boston Scientific said the court ruling requires that Cordis cease production of the balloon catheters made at its facility in Roden, the Netherlands, which supplies Cypher and Cypher Select products for markets outside the U.S., and to cease sales of those products in the Netherlands.
In promising an appeal to the ruling, Cordis also said that the decision does not prevent sales of the products outside of the Netherlands and will not impact the supply of the Cypher drug-eluting stent in the U.S. Given its current inventory and expanding manufacturing capabilities elsewhere, the company said it does not expect "a significant impact" on its ability to supply the outside-U.S. marketplace for the products.
pSivida cites findings from Phase IIa trial
Global nanotechnology company pSivida (Perth, Australia) and Singapore General Hospital reported key findings last month from the final report on Phase IIa clinical trials with the company's BrachySil product as a potential new brachytherapy treatment for inoperable primary liver cancer.
BrachySil is a micron-sized, nanostructured silicon particle in which radioactive 32-phosphorus (32-P) is immobilized. It is administered as a liquid suspension through a fine-gauge needle directly into tumors. The procedure takes place under local anesthesia and without the need for shielded rooms or robotic injectors, the company said, adding that patients can be discharged the next day.
The trial was conducted at the Singapore hospital on eight patients with advanced liver cancer who were evaluated at three and six months following treatment.
The report confirmed that the primary endpoint of the trial was achieved in its key indication that BrachySil (32-P BioSilicon) was found to be both safe and well tolerated.
Another key finding was that BrachySil also significantly reduced the size of tumors treated as determined by computed tomography (CT) scanning. No product-related adverse events were reported.
The company said the results pave the way for a multi-center Phase IIb dose-profiling study for BrachySil for the inoperable primary liver cancer indication. That trial, which is scheduled to begin later this year, is intended to provide data to support the registration of BrachySil as an approved treatment for liver cancer.