A Medical Device Daily

Dr. Margaret Chan of China has been named the next director-general of the World Health Organization (WHO; Geneva).

Chan told the World Health Assembly she wanted to be judged by the impact of WHO’s work on the people of Africa and on women across the globe.

In her acceptance speech, Chan said: “what matters most to me is people, and two specific groups of people in particular. I want us to be judged by the impact we have on the health of the people of Africa and the health of women.” She said that these will be two “key indicators of the performance of WHO.”

She added: “All regions, all countries, all people are equally important. This is a health organization for the whole world. But we must focus our attention on the people in greatest need.”

Chan was nominated as director-general last week by the WHO executive board and her appointment was confirmed by the World Health Assembly. The director-general is WHO’s chief technical and administrative officer. She was previously WHO’s assistant director-general for communicable diseases and representative of the director-general for pandemic influenza.

Chan obtained her medical degree from the University of Western Ontario in Canada and she has a degree in public health from the National University of Singapore .

The procedures for the current nomination and election process were decided following the sudden death May 22 of WHO Director-General Dr. Lee Jong-wook, and the WHO executive board then decided on an “accelerated process” for electing a new director-general.

Chan said six key WHO issues will be health development, security, capacity, information and knowledge, partnership, and performance. She emphasized the importance of global health security in her vision of the organization’s role: “Health security brings benefits at both the global and community levels. New diseases are global threats to health that also bring shocks to economies and societies. Defense against these threats enhances our collective security,” she said.

pSivida in drive to add investment

pSivida (Perth, Australia/Boston) reported that it is negotiating with an investment fund specializing in the biotech sector for an A$5.2 million ($4 million) investment and an A$28.5 million ($22.0 million) investment over time in a special purpose vehicle (SPV) to fund pSivida’s portion of the costs to develop its lead ophthalmic development product, Medidur,for the treatment of diabetic macular edema (DME).

At closing, the company expects to receive a total of A$6.5m ($5.0m), consisting of the A $5.2m ($4 million) equity investment and a payment by the SPV to pSivida of A $1.3 million ($1 million).

pSivida and Alimera Sciences (Alpharetta, Georgia) are co-funding the development and will co-share in the profits of Medidur, currently in Phase III multi-national clinical trials.

After closing, pSivida will seek shareholder approval, it said, to give the investor a full exchange right on the A $28.5 million ($22 million) SPV interest into pSivida ADSs at current market. If approved, the Investor will have the option to either share SPV revenues or convert all or part of their SPV investment into ADSs, forfeiting that portion of their share of the SPV revenues.

pSivida’s lead FDA-approved ophthalmic product is Retisert for the treatment of uveitis, a leading cause of blindness in the U.S. Medidur differs from Retisert in that it is injected behind the eye in a simple office procedure, whereas Retisert is surgically inserted in a hospital procedure.

Medidur and Retisert deliver the same steroid (fluocinolone acetonide), at a similar rate to the back of the eye, and shown to reduce edema in patients with DME, reduce the progression of diabetic retinopathy and provide a significant increase in many patients’ vision.

These results were generated in a 198 patient clinical trial conducted in the U.S. by Bausch & Lomb (B&L; Rochester, New York), licensee of Retisert.

“We believe these negotiations demonstrate strong commercial interest in Medidur for DME ... and that the proposed transaction, when closed, would eliminate most of the financial risk for the company associated with this project,” said Dr. Roger Brimblecombe, CEO and chairman of pSivida. “The closing of this transaction would also allow Medidurfor DME Phase III studies to continue while freeing up funds to permit us to progress our other clinical development studies and exploit our various drug delivery technologies.

Epix reports Canada approval of Vasovist

EPIX Pharmaceuticals (Lexington, Massachusetts) reported that Health Canada’s Health Products and Food Branch has approved its blood pool imaging agent Vasovist (gadofosveset trisodium injection) for marketing.

Vasovist is indicated for contrast-enhanced magnetic resonance angiography (MRA) to visual abdominal or limb vessels in patients with suspected or known vascular disease.

Vasovist is an injectable intravascular contrast agent designed to provide imaging of the vascular system through MRA which has been developed in collaboration with and will be marketed by Schering (Berlin). Target indication for Vasovist is MRA imaging of non-coronary vascular disease. In October 2005, the European Medicines Agency granted approval of Vasovist to Schering for all 25-member states of the European Union. It also has been approved in Norway, Iceland, Switzerland, Australia and Canada.

Andrew Uprichard, MD, president of Epix, said the approval represents the 30th country for Vasovist marketing. “We remain in dialogue with the [FDA] regarding the path to approval for Vasovist in the U.S.”

Uprichard added, “In addition to this milestone for Vasovist, data from our Phase IIa clinical trial of EP-2104R, our novel thrombus imaging agent, will be the subject of an oral presentation at the Radiological Society of North America (Oak Brook, Illinois) later this month.”

Chinese agreement for acoustic devices

China Medical Technologies (Beijing), a manufacturer of high-intensity focused ultrasound (HIFU) products and in vitro diagnostic systems, said it has entered into a 10-year collaboration agreement with the Chinese Academy of Sciences Institute of Acoustics (Beijing) to establish a laboratory for developing acoustic medical devices.

China Medical will be responsible for all of the development costs and will retain the related intellectual property. The company said it expects to fund the laboratory on a project basis over the 10-year period.

China Medical develops HIFU technology to treat solid cancers and benign tumors and advanced in vitro diagnostics products using enhanced chemiluminescence technology.

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