A CDU

German news media reported last month that the center-left government headed by Chancellor Gerhard Schroeder and the conservative Christian Democrat opposition had reached agreement on a wide-ranging plan to cut healthcare costs in the country that currently are said to be among the highest in the world. The agreement apparently paves the way for the legislative approvals needed to start implementing the reforms as of Jan. 1 of next year.

The agreed-upon reforms are aimed at cutting just under EUR 10 billion in costs next year, with annual savings rising to more than EUR 23 billion by 2007. State-paid healthcare contributions are currently around EUR 142 billion a year, but costs exceeded that by about EUR 2.5 billion last year. Because of persistent high unemployment, the German government has been forced to increase mandatory contributions from workers to subsidize the healthcare system.

Health Minister Ulla Schmidt said the proposed reforms "aim at spending every euro efficiently." She added: "We will get rid of many outdated structures." The planned reforms also focus on what many have cited as antiquated rules that are protective of the traditional high margins for pharmaceutical companies. Among the changes are anticipated expansion of the retail pharmacy market, with pharmacies being allowed to have up to three subsidiaries rather than current rules that allow ownership of only a single drug store. It also would enforce price controls on certain patented drugs and would permit German residents to order medicines by phone or Internet, giving them access to lower prices in other European Union countries. Mail-order drug purchases are prohibited at present.

The cost burden on patients also will increase under the reform plan, to EUR 10 for quarterly doctor visits, and EUR 10 per day for hospital stays for a maximum 28 days per year. Under the reform plan, patients will have to pay the full amount of private insurance for dental prostheses beginning in 2005, and beginning in 2007 will have to cover their own sick pay insurance.

Cutting catheter-based infection

Bioenvision (London) reported results of a four-year observational study of its Oligon anti-infective technology for the reduction of catheter-related infection. The study was conducted at Frimley Park Hospital NHS Trust in the UK. The company said the study revealed that the introduction of the Oligon material was associated with a significant reduction in bloodstream infections. In the 2,482-patient study, those receiving Oligon-coated central venous catheters showed only a 0.16% infection rate, compared to a 4% when using traditional chlorhexidine-coated catheters.

Christopher Wood, MD, chairman and chief executive officer of Bioenvision, said, "The results of this study clearly indicate the effectiveness of Oligon in preventing catheter-related infections. Using the Oligon material, infection rates decreased by over 95% compared to traditional catheters." The Oligon technology involves the impregnation of a polymer material with silver, platinum and carbon particles. Bioenvision said that upon contact with an ionic solution such as saline, medications or body fluids, an electrochemical reaction between the silver and platinum particles is activated, and silver ions are released to the surface of the polymer and then into its immediate environment.

"The silver ions destroy bacteria, fungi and even antibiotic-resistant microbes on the entire device surface, both inside and outside, and in the immediately surrounding environment over extended periods of time," the company reported. It said that physicians involved in the study have indicated that they are now confident to leave Oligon catheters in for up to 31 days, thus reducing patient discomfort associated with repeated line changes and will reduce costs as well.

Bioenvision said Oligon has been approved by the FDA in the U.S. for inclusion in two commercialized catheters, for which the company is receiving royalties based on sales. It said that approval has been received to use Oligon in a third commercial product and added that it is currently considering other devices as well.

Study shows DVT treatment is effective

A new therapeutic product under development by AstraZeneca (London) called ximelagatran (to be trade-named Exanta) can treat deep vein thrombosis (DVT) and prevent life-threatening consequences, according to results of a 2,500-patient study presented during last month's meeting of the International Society on Thrombosis and Hemostasis in Birmingham, UK.

In the THRIVE Treatment study, a fixed dose of ximelagatran was shown to be as effective as the current treatment, which involves a combination of injected heparin (enoxaparin) plus warfarin tablets, in order to prevent further DVTs or pulmonary embolisms. Overall, the study resulted in a trend toward fewer incidences of major bleeding for patients on ximelagatran vs. those on the treatment combination during the six-month study.

"This study raises the possibility of an effective new treatment that is simple to administer and does not require close anticoagulation monitoring," said Dr. Gerry Dolan, consultant hematologist at the Queen's Medical Center (Nottingham, UK). "The current treatment regimes are effective, but are very complex to deliver. Ximelagatran is a tablet, rather than an injection. It appears to require no anticoagulation monitoring, no initial titration of treatment and seems to have no significant interactions with food or other medicines, factors that are a particular problem with injected heparins and warfarin."

Various studies have indicated that between 30,000 and 100,000 people in the UK each year develop a venous thromboembolism, including both DVT and pulmonary embolism. A recent pilot study showed that symptomless DVTs may occur in up to 10% of long-distance airline travelers. Ximelagatran is not yet available but is expected to be launched over the coming year. It is being developed for the treatment and prevention of a range of conditions caused by blood clots, including treatment of DVT and stroke prevention in non-valvular atrial fibrillation. It is the first in a new class of anti-thrombotic drugs known as oral DTIs (direct thrombin inhibitors).

Eurand eyes sales in Japan

Eurand (Milan, Italy), a speciality pharmaceutical company, has signed an agreement that will result in the company's first direct product sales in Japan. The agreement with Eisai Co. Ltd. involves Nitorol-R capsules, a long-acting version of isosorbide dinitrate that is used for the prevention of angina.

Gearoid Faherty, chief executive officer of Eurand, said, "One of our primary goals as a company is to ensure that we are a significant competitor in all major pharmaceutical markets. Eurand has secure and strong market footholds in both Europe and North America [and] the company is building momentum in Japan by continuing to sign development and supply agreements with leading Japanese companies." Faherty said Japan is the second-largest pharmaceutical market in the world, and offers "significant growth opportunities for our company."

Sales of sustained-release Nitorol R capsules in Japan are expected to begin in 3Q04.