BioWorld International Correspondent
BRUSSELS, Belgium - Bigger and better funding for new European biotechnology medicines could result from the European Parliament's Dec. 14 endorsement on the European Union's plan for research support.
The parliament voted through the proposed Innovative Medicines Initiative, adding special provisions to increase aid to small firms. The plan aims at implementing a coordinated approach to overcoming bottlenecks in the drug development process, bringing together industry, regulators, patient organizations, academia and clinical centers.
In its vote, the parliament inserted a clause favoring investment in smaller firms' research, "enhancing their capacity for innovation and their ability to exploit the results of research." It also tightened the rules so that research-based pharmaceutical companies that are full members of the European Federation of Pharmaceutical Industries and Associations "shall not be eligible to receive direct or indirect support" from the scheme.
Meanwhile, the EU has just published its plan of priorities for the implementation of the new advanced therapies regulation it adopted earlier this year, and which goes into effect formally in 2008.
The first task the authorities face is to outline how the description of the physical characteristics, performance and product design methods should be included in a marketing authorization application under the new procedure. The committee for advanced therapies created by the regulation - expected to include representatives of patients associations and clinicians - also has to be named.
It will be necessary to update and adapt the EU's guidelines on good clinical practice, with specific reference to advanced therapies, and to create new procedures for post-authorization follow-up of efficacy and adverse reactions.
Despite all those efforts to promote innovation, Guerbet, of France, has withdrawn its MAA for Sinerem, superparamagnetic iron oxide nanoparticles stabilized with dextran and sodium citrate, the European medicines agency announced after the December meeting of its scientific committee. Sinerem was expected to be used for the characterization of lymph nodes visualized with magnetic resonance imaging in the evaluation of primary tumor spread in pelvic cancers.
The MAA was submitted in October 2006 and was under review by the agency's Committee for Medicinal Products for Human Use. In its official letter, the company stated that the withdrawal was based on the committee's opinion that the main study used to evaluate the benefit-risk profile of Sinerem failed to statistically demonstrate efficacy.