BioWorld International Correspondent

BRUSSELS, Belgium - Europe and the U.S. are joining forces to boost treatments for rare diseases - a move that is expected on both sides of the Atlantic to encourage innovative biotech companies.

The European Union and the FDA agreed Nov 26 on a common application for orphan designation for medicines. Creating a single entry point for sponsors seeking orphan designation of medicines in the EU and the U.S. is intended to simplify the process in both jurisdictions.

Justifying the move, a joint statement from FDA and the European Medicines Agency pointed out that some 30 million people living in the EU and 25 million Americans suffer from more than 6,000 rare diseases, which are defined as those affecting fewer than five in 10,000 people in the EU and fewer than 200,000 people in the U.S.

Until now, developers of treatments for rare diseases have had to make separate applications under different formats for orphan designation from the EMEA and the FDA if they wanted to be eligible for regulatory and financial incentives, including protocol assistance and marketing exclusivity.

Promotion Of European Innovation

European biotech industry leaders gave a ringing endorsement to the focus that the current Portuguese presidency of the EU brought to innovation's benefits for patients at a high-level meeting in Viseu, Portugal. Andrea Rappagliosi of EuropaBio - the European association for bioindustries - welcomed "the opportunity to discuss ways to better integrate scientific knowledge into the development of therapies and into facilitating patient access to innovative therapies."

"Our companies need predictability and urgency in the product approval process," said EuropaBio's secretary general Johan Vanhemelrijck. "I was happy to see recognition of the struggle for our companies, including smaller firms, to bring a treatment to market."

The Portuguese presidency underlined that new technologies "have brought new borders to R&D. Biotechnology, nanotechnology, pharmacogenomics and gene therapy created new possibilities for the development of personalized therapies, more efficient and safer."

Pharmaceuticals Highly Competitive

Pharmaceuticals is the most competitive manufacturing sector in Europe, according to a new European Union report. Based on export figures, medicine comes in ahead of machinery and equipment, aircraft and spacecraft, non-metallic mineral products, printing and publishing, and scientific instruments. Those six leading sectors account for 34 percent of the EU's total manufacturing exports.

European Ministers Back Nanotechnology

European industry ministers gave their backing to nanotechnology at a meeting of the European Union Council in Brussels. "The role of nanosciences and nanotechnologies is crucial for the improvement of Europe's competitiveness and the quality of life of its citizens," they said, urging wide cooperation between industry and all other stakeholders. "Progress can only be achieved with the full involvement of the private sector," they concluded. They also called for greater EU funding for research in the field.

Ministers stressed that currently-rising world investments in nanosciences and nanotechnologies - "particularly by the union's major competitors, the US and Asia" - needed increased investment and political attention in Europe, including training.