BioWorld International Correspondent

BRUSSELS, Belgium - A humanized monoclonal antibody is the first product to benefit from the European Union's new accelerated assessment procedure.

At its late-April meeting, the European Medicines Agency's scientific committee recommended the grant of a marketing authorization for Soliris (eculizumab), from Alexion Europe SAS. The new procedure provides for assessment in a maximum of 150 days, instead of the normal 210-day timetable for the agency's centralized procedure.

Accelerated assessment was introduced by the revised EU pharmaceutical legislation in November 2005, to help speed patients' access to new medicines of major public health interest. Companies can request accelerated assessment provided they are able to demonstrate that their product responds to unmet medical needs or constitutes a significant improvement over the available methods of prevention, diagnosis or treatment of a condition. In 2006, the CHMP received 13 requests for accelerated assessment, four of which were accepted.

Soliris is intended to reduce hemolysis in patients with the rare blood disorder of paroxysmal nocturnal hemoglobinuria. It blocks complement-mediated cell lysis and activation, and can significantly reduce intravascular hemolysis and the need for red-cell transfusions. Evidence of clinical benefit of Soliris is limited to patients with a history of transfusions, but the agency said that it considers, on the basis of quality, safety and efficacy data, there is a favorable benefit to risk balance.

Soliris already won orphan drug status from the agency, and assessment of the marketing application, which began Oct. 25, was completed in 147 days. The positive opinion is also a first for a product submitted by a company benefiting from specific incentives for small and medium-sized companies.

Report: Germany Must Preserve Potential

Biotechnology must be applied more intensively in a wider range of uses, in order to keep up and to strengthen the competitiveness of German industry in the international arena, according to a new study from the German Institute for Economic Research.

Germany must use the potential of this new technology in a more decisive manner and improve the framework conditions, so that the German industry is not left behind in international developments, said Edeltraut Glänzer, board member of the German chemical industry association, which commissioned the study.

It said that between 258,000 and 443,000 jobs are influenced directly by biotechnology, and that a further 100,000 jobs could be added over the next 10 years. By 2020, biotechnology can secure or create between 369,000 and 596,000 jobs, said Bernward Garthoff, chairman of the German biotech industry association DIB. "By 2020, the number of people in a workplace connected with biotechnology will be higher than the number of persons currently employed in the entire German chemical industry, where the present staff total is around 440,000."

At present the food industry ranks first in employment levels, followed by agriculture. But the study predicts that the greatest growth leaps for biotechnology will take place in the chemical industry, with novel products and improved processes tripling current employment levels and sales, and in the pharma industry, where sales are forecast to double.

Biotech Industry Addresses Patient Needs

The European biotech industry announced Monday new priorities to ensure patient-centered health care.

EuropaBio's Healthcare Manifesto 2007 laid out how the industry plans to handle health care innovations in order to meet Europe's unmet medical needs over the next few years. It focused on economic evaluation of biotechnology medicines, biosimilar medicinal products, orphan medicines, advanced therapies, bioethics, pharmacogenomics and genetics and the creation of an innovation-friendly environment for smaller firms in the biotech industry. The manifesto is twinned with an industry "patient charter" setting out a framework to ensure the integrity and independence of patient groups and industry partnerships.

The manifesto contains a long list of biotechnology's contributions to health care - treatments for more than 325 million patients, treatments for rare diseases with a genetic origin affecting as many as 30 million Europeans and their families and targeted research.

The chairman of EuropaBio's Healthcare Council, Andrea Rappagliosi of Merck-Serono, said, "EuropaBio's manifesto sets out the challenges to be met by policy makers and the industry to deliver a patient-centered approach to modern health care. We need to reverse the budget-driven, cost-containment paradigm of the current healthcare systems in Europe and put at the center of modern policy-making the ultimate consumer of health care: the patient."