Millennium Pharmaceuticals, Inc., announced that the European Medicines Evaluation Agency's (EMEA) Committee on Proprietary Medicinal Products (CPMP) has issued a positive opinion to recommend approval under exceptional circumstances for Velcade (bortezomib) for the treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on their last therapy. The Marketing Authorization Application for Velcade (bortezomib) was submitted to the EMEA in January 2003 and accepted for review in February 2003.

The CPMP's opinion was issued today in London, UK, and will be forwarded to the European Commission. The company anticipates that the commission will ratify the opinion and will issue a Marketing Authorization in the second quarter of this year. Under a Marketing Authorization, a single license would be granted to Millennium to market Velcade in the 15 member states of the European Union, the 10 accession member countries, plus Norway and Iceland.

"The committee's positive recommendation to approve this application represents another significant step toward the company's global mission of developing breakthrough products that make an important difference in patients' lives," said David Schenkein, MD, vice president, oncology clinical development at Millennium. "With its new and unique mechanism of action of inhibiting the proteasome, Velcade is different from traditional chemotherapies and represents a completely new approach to treating cancer."

Under the terms of the co-development and commercialization agreement for Velcade, Ortho Biotech and its affiliate, Janssen-Cilag, will commercialize Velcade outside of the US, including Europe. Millennium will receive royalties from Ortho Biotech and its affiliate Janssen-Cilag on sales outside the US.

"We are pleased to have worked in partnership with Millennium to secure a positive CPMP opinion for Velcade in Europe," said Martine George, MD, vice president, global clinical research and development for Johnson & Johnson Pharmaceutical Research and Development, LLC. "We are committed to bringing this important medication forward to multiple myeloma patients in Europe as quickly as possible."

In the US, the drug was approved in May 2003 for patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Millennium continues to investigate the full potential of Velcade (bortezomib) in both hematologic and solid tumours and currently has over 80 ongoing or planned clinical trials.