A Medical Device Daily

A strategic alliance has been reported that is aimed at delivering advanced technology and centralized cardiac safety testing services to the medical device and biopharmaceutical industries in Japan.

The parties to the alliance are Medifacts International (Rockville, Maryland) and Suzuken Co. Ltd. (Nagoya, Japan), one of Japan's largest cardiac safety services providers.

They said that companies in Japan now will have access to leading cardiac safety monitoring technology and services for the management of their clinical trials. That country is regarded as the world's third-largest market for pharmaceutical development,

Operating from centers in Nagoya, Sapporo and Tokyo as well as two sites in Shanghai, China, the alliance will provide what the companies termed "the most comprehensive and localized logistics, site support and data management in Asia for central electrocardiogram and ambulatory blood pressure monitoring collection services."

The alliance will provide more than 200 personnel – including a field support force of 130 equipment experts – from five shared facilities, supporting cardiac safety studies across Asia.

Medifacts President/CEO Michael Woehler said, "We are delighted to be working with an organization of the quality, expertise and reputation of Suzuken. Our strategic alliance sets a new standard in the service delivery of Japanese as well as global studies; and we are now able to provide our global clients with full service cardiac safety support operating from hubs in Japan, China, Europe and the Americas."

Boaz Mendzelevski, MD, Medifacts' director of cardiology and consultant to the pharmaceutical industry, said, "With the impending adoption of ICH E14 guidelines in Japan, Japanese and global biopharmaceutical companies are going to be confronted with an immediate need to address complex new regulations across the entire range of development activities."

China approves Zoll defibrillators

Zoll Medical (Chelmsford, Massachusetts) reported receipt of clearance from China's State Food and Drug Administration to sell the Zoll R Series Code-Ready defibrillators to hospitals in that country.

The company said the original R Series ALS, along with its new R Series BLS and R Series Plus models, "are designed to extend simple, smart and ready defibrillation to every hospital department with advanced, cost-effective solutions for resuscitation. They also offer smart tools to help clinicians improve CPR performance, which is important since more than half of in-hospital codes involve non-shockable rhythms and, in such cases, the only treatment is high-quality CPR with minimal interruptions."

President Jonathan Rennert said, "Since defibrillators are widely distributed throughout hospitals, and their use is both infrequent and extremely critical, code readiness helps clinicians save more lives. We're extremely pleased that the SFDA of China recognizes the value the R Series platform has in helping to ensure readiness any time a code occurs."

Zoll said the R Series BLS is "a simple, easy-to-use AED [automated external defibrillator] that becomes a full-featured, advanced life support device for critical care at the touch of a button."

The R Series Plus, which has both AED and ALS capabilities, also has networking capabilities and See-Thru CPR, which allows a professional rescuer to view a patient's underlying cardiac rhythm during resuscitation efforts without the need to stop compressions to see if defibrillation was successful.

Cervical cancer screening set in India

Qiagen (Venlo, the Netherlands) and Chittaranjan National Cancer Institute (CNCI; Kolkata, India) have reported a collaboration to establish the first large-scale cervical cancer screening program for women in Kolkata.

Qiagen will provide its diagnostic tests for the human papillomavirus virus (HPV), the primary cause of cervical cancer. CNCI will conduct the screening and provide appropriate treatment as needed.

Financial terms were not disclosed.

The QiagenCares Kolkata Project will use Qiagen's hybrid capture 2 (hc2) HPV DNA testing technology, also known as the digene HPV Test, to screen women for cancer-causing types of HPV to identify those with or at risk for developing cervical cancer.

Participating women also will be screened using VIA (visual inspection with acetic acid), as per the Indian National Guidelines for Cervical Screening. Screening will take place at community-based mobile field clinics in the villages neighboring Kolkata. Women found to have cervical cancer or pre-cancer will be immediately treated at the field clinic or referred to the CNCI for follow up.

The project also includes educational campaigns to raise awareness about HPV, cervical cancer, and other women's health issues. The initiative will be conducted over five years and is expected to reach 50,000 women.

Qiagen CEO Peer Schatz said, "Kolkata, India, is a particularly fitting location to launch this project as India has the world's highest incidence rate of cervical cancer. We believe that launching this project can play a role in helping to change those statistics."

Japanese distributor for BioSphere

BioSphere Medical (Rockland, Massachusetts) said it has signed an exclusive agreement with Nippon Kayaku Co. Ltd. for the planned distribution of HepaSphere and Embosphere microspheres in Japan.

Under the agreement, Nippon Kayaku will be responsible for regulatory strategy and seeking to obtain requisite product registrations, including performing any clinical studies that may be required as a condition to product registration, and will bear the related cost for those activities.

Once either or both of the products receive market clearance and the government reimbursement rate is set, BioSphere will provide the approved product to Nippon Kayaku for distribution and sale based on a predetermined formula indexed to the final Japanese government reimbursement rate.

The agreement calls for BioSphere to receive a $1 million milestone payment in 2009, and Nippon Kayaku has agreed to pay up to $3 million in additional milestone payments in subsequent periods based on achievement of product registration goals and revenue targets.

"Japan is one of the major world markets for the treatment of liver cancer, with approximately 75,000 transcatheter arterial embolizations performed in 2008," said BioSphere CEO Richard Faleschini. "We believe that Nippon Kayaku is well positioned to gain regulatory approval for our embolic products and drive market adoption with interventional oncologists in this significant market."

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