Medical Device Daily and Staff Reports

Guerbet (Villepinte, France), A provider of contrast agents for medical imaging, said it is entering the expanding market for nuclear medicine securing European distribution rights for products from Draxis Specialty Pharmaceuticals (Kirkland, Quebec).

"This constitutes a first step for Guerbet," said Philippe Decazes, chairman of the executive committee for the company, adding that the partnership provide a promising driver for growth.

Four Draximage products — MDP, Sestamibi, DTPA, MAA and I-131 — will become available immediately through Guerbet's European distribution network and Decazes said Guerbet holds a preferential right to distribute any new Draximage products.

Guerbet generated 80% of its annual sales of 1321 million ($415 million) in Europe in 2008 and estimates that it holds a 25% share of the market.

Sales grew 5% from 2007, with Germany reporting particularly robust growth.

Nuclear medicine explores the function and processes of organs with the injection of radioactive agents and is increasingly used for the diagnosis of cancers and cardiovascular disorders.

The growing trend in radiology for studying complex disease processes are combinations of nuclear agents with scans for magnetic resonance imaging (MRI) and computed tomography. (CT).

While expanding into the developing market for nuclear agents, Guerbet also announced developments reinforcing it product line for contract agents used in traditional MRI, X-ray and CT imaging.

Sales of Guerbet's flagship MRI product, Dotarem, grew 29% in volume and 24% in value to become the leading European product in this market.

The company opened four new production facilities in 2008, and is a leading partner in the Franco-German research program, Iseult, that is focused on new contrast products for molecular imaging using high field magnetic resonance neuroimaging technologies for early diagnosis and therapeutic monitoring of Alzheimer's disease, cerebrovascular accidents and brain tumors.

With a budget of €137 million, participants in the consortium of manufacturing groups and public research laboratories include Siemens (Erlangen, Germany); Bruker Biospin (Rheinstetten, Germany), a subsidiary of Brucker (Billerica, Massachusetts); CEA (Commissariat l' nergie Atomique, Grenoble, France) and the University of Freiburg (Germany).

Guerbet received €34 million as part of a grant for the Iseult program from the French innovation agency, OSEO, that the company says will fund provides eight years of funding for developing MRI contrast agents.

ThyroChek now available in EU

Screening Devices Canada (Saint John, New Brunswick) reported the availability of ThyroChek, its rapid test for elevated TSH, the first clinical indicator of hypothyroidism to countries in the European Union.

Until now, the test has only been offered in the U.S. as an FDA-regulated, CLIA-waived test for adults to some 200,000 physician office labs.

With receipt of the CE mark, both adult and neonatal ThyroChek tests now are available for sale worldwide, the company said.

The move to overseas markets will build the thyroid health market, according to Sharon Cunningham, president of Screening Devices Canada. "Europeans know their thyroid gland. Food, such as bread in Russia, is marked indicating that the nutrients contained in the loaf support thyroid health."

She added that ThyroChek may also be available as a home test in Europe, so that consumers can assess their own thyroid health. "This is important," Cunningham said, "especially to women planning pregnancies, to seniors concerned about vagaries of aging and to residents that have environmental concerns such as nuclear waste storage that may reflect in thyroid health."

ThyroChek NeoNatal has never been available in the U.S., since testing newborns for TSH elevation, an indication of congenital hypothyroidism, is performed routinely in every hospital.

Screening Devices Canada said this is not the case in some countries of the EU, adding that most countries of South America, Africa and Asia also do not have a testing program. Cunningham said the CE-mark approval "will enhance neonatal testing opportunities for this disease in iodine-deprived areas of the world."

Partnership aims at cancer reduction

The U.S. Agency for International Development (USAID; Washington) is launching a partnership to reduce illnesses and deaths caused by cervical and breast cancers in the country of Georgia.

The program, called Survive, involves numerous USAID partners, including the U.S. Embassy in Georgia, the JSI Research and Training Institute, the Susan G. Komen Foundation, the Georgian Pharmaceutical Co., International Women's Association, the Georgian insurance company IRAO, HSBC Bank, and BP Georgia.

Ken Yamashita, acting administrator for the Europe and Eurasia Bureau of USAID, said, "This partnership values women as productive contributors to society and the economy and targets some of their primary health problems."

The incidence of cervical and breast cancers, a major cause of illness and death among adult Georgian women, has risen dramatically in that country over the last decade. While cervical cancer has one of the greatest potentials for early detection and cure, USAID said that in Georgia, there is a two-fold increase in untreated cases detected in late stages of the disease. Similar statistics exist for breast cancer.

The agency noted that although there are almost twice as many detected cases in North America as in Georgia, only one-fifth of those cases are fatal compared to nearly half in Georgia. It said the disproportionate mortality risk for Georgian women is attributable, in large part, to delayed detection of the disease.

As a result of the Survive partnership, primary health care providers in that country will take on a key role in educating clients and the public about cervical and breast cancers.

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