Seattle Genetics, Millennium Cancer Drug Cleared in EU
Seattle Genetics cashed a $60 million check three years ago from Millennium: The Takeda Oncology Company, as Millennium wanted a piece of a potent new cancer drug it could sell outside the U.S. Now regulators have given Millennium the go-ahead to start recouping that investment by selling the drug in the 27-member European Union, world’s second-biggest pharmaceutical market.
Cambridge, MA-based Millennium, a unit of Japan-based Takeda, said today it has gotten conditional approval from the European Commission to start selling brentuximab vedotin (Adcetris) as a new treatment for relapsed Hodgkin’s lymphoma and anaplastic large cell lymphoma. As part of the licensing deal struck in December 2009, Millennium will now pay Seattle Genetics (NASDAQ: SGEN) another $25 million in milestone payments and a tiered double-digit percentage royalty on European sales.
The nod from European regulators is another important milestone for this product, the only marketed drug that combines the targeting ability of an antibody with a toxin to give it extra tumor-killing oomph. Seattle Genetics retained the U.S. commercial rights for itself, and it won the initial regulatory approval from the FDA in August 2011. Since then, the cancer drug has gotten off to a fast start, as Seattle Genetics has forecast about $140 million to $150 million in U.S. sales in its first full year on the U.S. market.
There has been little doubt about the drug’s chances of winning regulatory approval in either the U.S. or Europe. The drug has shown an ability to shrink tumors and provide remissions for patients who have otherwise run out of treatment options, and Seattle Genetics and Millennium are running trials now to see if it might improve upon the standard of care in broader groups of newly diagnosed patients.
The price for Adcetris was originally set at $13,500 per dose in the U.S., which Seattle Genetics has said projects to about $108,000 per patient on the dosing schedule used in clinical trials. Millennium didn’t say in today’s statement what the drug’s price will be in the EU.