A Medical Device Daily

BioSphere Medical (Rockland, Massachusetts), a developer of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations, said its embolic delivery system products, the EmboCath Infusion Catheter and Segway Guidewire, have been approved by the Medical Device Department of the State Food and Drug Administration in China for use in embolization procedures.

In China, the company plans to sell both its delivery system products and its Embosphere Microspheres for embolization procedures. The use of Embosphere Microspheres for embolization is under review by the Chinese regulatory authorities based on a clinical trial using the microspheres in a treatment protocol for patients with primary liver cancer (hepatocellular carcinoma, or HCC).

BioSphere Medical said its expects market clearance for the use of Embosphere Microspheres during the first half of this year.

Richard Faleschini, president and CEO, said, “The approval of BioSphere delivery system products in China is part of our commitment to the growth of embolic therapies and is also an important step in our efforts to address the clinical needs of an estimated 350,000 patients in China with primary liver cancer.“

Liver cancer patients in China comprise roughly half of the total worldwide patient population. The incidence of primary liver cancer in Asia is attributed to a higher incidence of hepatitis B and C in the region.

Many primary liver cancer patients are diagnosed at a level of tumor development where they are no longer good candidates for surgical intervention, and BioSphere Medical said many physicians believe that minimally invasive embolic therapy may be used to slow the advance of cancer in conjunction with other therapies.

Interventional radiologists deliver embolics to the site of service through the blood vessels with catheters threaded via guidewires under live imaging. EmboCath and Segway are approved for use in the U.S., Canada, the European Union and other countries.

Asian distribution accord for Ciphergen

Ciphergen Biosystems (Fremont, California) said it has signed an agreement for distribution of its products in China and other Asian markets.

The agreement with Techcomp (Holdings) Ltd. (Singapore) covers distribution of Ciphergen's ProteinChip family of products in China, Hong Kong, Singapore, Malaysia, Vietnam and Indonesia.

The two companies also have entered into a product development and manufacturing agreement for sample preparation technology and an associated device. The resulting product or products would be manufactured by Techcomp and sold by Ciphergen on a worldwide basis.

“We are delighted to be working with Techcomp to cover a market that clearly has significant potential for [us],“ said Gail Page, Ciphergen's president and CEO. “Techcomp has a proven capability in these territories in distributing and servicing analytical instruments, life science instrumentation and laboratory equipment for other companies. In addition, they are a proven original design manufacturer for international companies and under their own brand for the Chinese market.“

Richard Lo, president of Techcomp, said, “We believe that there is a significant market opportunity in China for the ProteinChip technology and with our wide coverage of the Chinese customer base we are confident we can contribute to the success of Ciphergen.“

Ciphergen is focused on the discovery of protein biomarkers and panels of biomarkers and their development into protein molecular diagnostic tests, as well as on providing collaborative R&D services through its Biomarker Discovery Center laboratories for biomarker discovery and pharmacoproteomic services for improved drug toxicology, efficacy and theranostic assays.

Its ProteinChip systems enable protein discovery, validation, identification and assay development to provide researchers with predictive, multi-marker assay capabilities and a better understanding of biological function at the protein level.

Joint venture eyes drug candidates

CombinatoRx (Boston) and Bio*One Capital (Singapore) have established CombinatoRx Singapore Pte Ltd., which will apply CombinatoRx's combination high-throughput screening (cHTS) technology to discover and potentially develop novel product candidates to treat infectious diseases, with an initial focus on hepatitis B and C.

“The formation of CombinatoRx Singapore is designed to address a significant global health need by advancing the development of novel therapeutics for infectious disease while also acting as a gateway for CombinatoRx to the Asian scientific and business communities,“ said CombinatorRx president and CEO Alexis Borisy. “We chose Singapore because of the availability of world class scientific and clinical talents in infectious diseases, developed intellectual property and regulatory infrastructure and most importantly, the Singapore government's commitment to the biomedical sciences industry.“

He said the support of Bio*One Capital “allows Com-binatoRx to apply its discovery technology and expand its pipeline of new potential medicines in one of the largest global disease markets.“

As a drug development company, CombinatoRx Singapore has plans to employ about 20 researchers and is expected to commit $20 million to the development of drug candidates for infectious diseases.

Quintiles' China lab earns certifications

Quintiles Transnational (Research Triangle Park, North Carolina) said its central laboratory operation in China has earned two important certifications, one from the College of American Pathologists (CAP) and the other from the National Glycohemoglobin Standardization Program.

Quintiles provides central lab services in China through an agreement with the Peking Union Medical College Hospital (PUMCH). The accreditations apply to the services provided by the Quintiles facility at PUMCH.

“These certifications are important for our customers, who are seeking high-quality laboratory services to support their efforts in China,“ said Tom Wollman, vice president, Quintiles Global Central Laboratories. “Customers need local laboratory services that will stand up to regulatory requirements worldwide. Now, Quintiles is one of only two central laboratory service providers in China to receive CAP accreditation.“

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