Last June, the Food and Drug Administration (FDA) granted Velcade fast-track status, which hastens the review process and is granted to drugs that may serve unmet needs in treating lethal diseases. This status has allowed Millennium to file Velcade for initial approval based on only phase II data, rather than data from all three phases of human trials. The drug continues phase III trials, nonetheless.
Velcade has also been granted Orphan Product Designation, a big deal. Upon approval, Orphan drugs are given seven-year marketing exclusivity rights in the United States. Orphan status may be granted to significant new drugs that serve life-threatening diseases affecting no more than 200,000 people in the U.S.
Multiple myeloma afflicts about 30,000 people annually in the U.S. and 74,000 worldwide. Given its fast-track status, the drug could be approved within about six months. If the drug is approved, Velcade's sales could reach a few hundred million dollars per year. More importantly, with approval, the odds of later drug approvals for other cancers, including solid tumor cancers, would rise. The drug could get to near-blockbuster status a handful of years from now with approvals to treat other cancers.
Sticking to the here and now, Millennium recently outlined its objectives for 2003. The company expects revenue of $450 million to $475 million (up from about $300 million last year), and a net operating loss of up to $320 million. It expects to hold about $1.3 billion in cash at year-end. Millennium has 12 products in clinical trials and currently models a break-even financial performance in 2006.