A Diagnostics & Imaging Week

Roche (Basel, Switzerland) and GE Healthcare (Chalfont St. Giles, UK) have joined in a drug-and-imaging agent collaboration focused on developing personalized care for patients with Alzheimer's disease. Financial terms were not disclosed.

In clinical trials, patients taking a Roche anti-amyloid drug candidate for Alzheimer's disease will be monitored clinically for drug response using GE's positron emission tomography (PET) diagnostic imaging agent. The PET technology measures and tracks levels of beta-amyloid, a form of brain plaque believed to cause memory loss in Alzheimer's patients.

Previously, the presence of plaque could only be confirmed during autopsy.

GE Healthcare licensed a broad class of imaging compounds from the University of Pittsburgh in 2003. Those compounds attach to beta-amyloid plaque in the brain, allowing the plaque to be imaged with PET. By using these compounds to measure the levels of beta-amyloid during clinical trials, the company said it should be possible to measure the effectiveness of drug therapies being developed by Roche to combat Alzheimer's disease.

Both companies will independently analyze patient data gathered during the controlled trials to monitor the progression of the disease and then share information to validate the efficacy of both the therapeutic product and the diagnostic tool.

The data gathered will aid both companies in submitting comprehensive data to regulatory authorities for approvals.

Peter Hug, Roche's global head of pharma partnering, called the collaboration "an early step in experimental medicine," noting that use of GE's PET technology "allows Roche to test the efficacy of our product more accurately than was previously possible, which in the long term, will help us efficiently advance through clinical development, potentially helping patients sooner."

"This imaginative and groundbreaking agreement demonstrates how medical equipment and pharmaceutical companies are increasingly collaborating with the aim of developing innovative, more effective and safer treatments," said Bill Clarke, chief technology and medical officer at GE Healthcare.

He said the collaboration "should allow clinicians to identify effective treatments earlier for this debilitating disease."

When General Electric (Fairfield, Connecticut) announced its plans to acquire Amersham (Little Chalfont, UK) in the fall of 2003, a $9.5 billion deal that was completed in April 2004, it said its mission was to transform healthcare from a late-disease treatment orientation to an "early health" diagnostics orientation.

Clarke said the Roche-GE Healthcare deal, which will increase "clinical value at the intersection of diagnostics and therapeutics, is one way that GE is carrying out its mission."

The World Health Organization (Geneva, Switzerland) estimates that there are about 18 million people worldwide suffering with Alzheimer's disease, a figure projected to nearly double by 2025 to 34 million.

More African distributors for Calypte

Calypte Biomedical (Pleasanton, California) said it has executed agreements with two distributors for the marketing and sale of its Aware rapid HIV antibody tests in eight countries in sub-Saharan Africa.

Lily-Max (Kampala, Uganda) will have exclusive distribution rights in Uganda, Rwanda, Burundi and Democratic Republic of Congo, while Bioweb will have similar rights in Kenya, Tanzania, Cameroon and Chad.

Calypte previously reported that it had received a positive recommendation that the Uganda National Drug Authority grant approval for the importation of the Aware rapid HIV 1/2 Antibody Tests. Subsequent to that recommendation, Calypte received its first purchase order from Lily-Max and will complete shipment of that order out of its Thailand manufacturing facility.

Dr. J. Richard George, president and CEO of Calypte, said, "We're making great progress in moving our strategy forward in the African continent by building what we believe to be a solid foundation that leverages the strengths and resources of these distributors. We have expanded our representation from two sub-Saharan countries to 10 in total, and we will be aggressively pursuing sales as the regulatory process is completed in the appropriate territories."

He said the company expects to complete regulatory trials in at least four countries during the second half of this year.

Additionally, regulatory trials have been initiated in Zimbabwe for Aware BSP, a rapid test for HIV antibodies using whole blood, serum and plasma samples. Calypte also has signed agreements to begin trials for all three Aware rapid tests in Kenya and Cameroon. Those trials are scheduled to begin this month.

Calypte has developed three rapid tests for the detection of antibodies to HIV-1 and HIV-2 viruses. Each is designed for use on a different sample type — Aware BSP uses whole blood, serum or plasma samples Aware OMT uses oral fluid samples and Aware U uses urine samples.

600,000 HIV test kits ordered

Medical Services International (Edmonton, Alberta) said it has agreed to supply a group of 17 hospitals in China with 600,000 VScan HIV test kits by Sept. 15, with the first shipment to be delivered by this week.

The company said the order has an approximate value of $1.4 million and does not includes sales from other contracts for the VScan HIV test kit or any other VScan test kits. It said its Shanghai facility would begin production of the kits immediately.