Seattle Genetics won FDA approval for its first cancer drug last August in the U.S., and now its partner appears close to getting that same clearance in Europe.
The Bothell, WA-based biotech company (NASDAQ: SGEN) said today that its partner, Cambridge, MA-based Millenium: The Takeda Oncology Company, got a positive recommendation for brentuximab vedotin (Adcetris) from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The European Commission has the authority to decide whether new drugs can be cleared for sale in the 27-member European Union—and that body hasn’t made its decision yet—but it usually follows the committee’s recommendations within about three months.
Millennium and Seattle Genetics formed their partnership in December 2009, and structured it so that Millennium would get exclusive commercial rights to the product in all countries other than the U.S. and Canada, where Seattle Genetics retained the rights. If the new lymphoma drug is approved in Europe, Seattle Genetics will get a $25 million milestone payment from Millennium, and will be eligible to get a tiered double-digit percentage royalty on sales. Although the product is currently FDA approved for a small population of relapsed and treatment-resistant patients with Hodgkin’s disease and anaplastic large cell lymphoma, it has exceeded early sales forecasts.
The U.S. sales performance has helped encourage the companies to push hard on plans to make this drug the cornerstone of therapy for patients with earlier forms of disease, for those getting repeat dosing, for people with other cancers that express the CD30 biomarker that Adcetris hits, and for patients around the world. Seattle Genetics CEO Clay Siegall predicted this spring that the drug could eclipse $1 billion in annual sales at its peak.
Seattle Genetics shares climbed 20 cents to $26.99 at 11:44 am Eastern time, after the news.