Seattle Genetics/Takeda Adectris' Label Expanded In The EU

Seattle Genetics, Inc. (NASDAQ:SGEN) announced that its partner Takeda Pharmaceutical Company Limited (OTC:TKPYY) has received marketing authorization for the label expansion of its lymphoma drug, Adcetris.

The European Commission (EC) has approved the drug for a third indication – for the treatment of adult patients with CD30+ Hodgkin lymphoma, who are at increased risk of relapse or progression following autologous stem cell transplant (ASCT).

We note that the EC had granted conditional marketing authorization to Adcetris in 2012 for two indications in adult patients – relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Last month, the EC extended the current conditional approval of the drug. The drug is now approved for the treatment of adult patients with CD30+ Hodgkin lymphoma, who are at increased risk of relapse or progression following ASCT.

This January, the EC approved a type II variation to include data on the retreatment of adult patients with Hodgkin lymphoma or sALCL, who had responded to Adcetris but which relapsed later.

We remind investors that the drug is already approved in the U.S. for three indications related to lymphoma.

Meanwhile, Adcetris is being evaluated in more than 70 ongoing clinical trials which include ALCANZA trial (phase III), ECHELON-1(front-line classical HL), ECHELON-2 (front-line mature T-cell lymphomas), along with additional types of CD30-expressing lymphomas, including B-cell lymphomas.

Both Seattle Genetics and Takeda are developing Adcetris under a collaboration agreement, under which Seattle Genetics owns the commercialization rights of the drug in the U.S. and Canada, while Takeda enjoys the same in the rest of the world. The companies are jointly funding the development costs equally, except in Japan where Takeda is solely responsible for development costs.

We note that Adcetris is the growth engine for Seattle Genetics. Apart from Adcetris, the company is evaluating another antibody-drug conjugate (ADC) candidate, vadastuximab talirine (SGN-CD33A; 33A), in a phase III trial for acute myeloid leukemia.

Seattle Genetics carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the healthcare sector include Pfizer Inc. (NYSE:PFE) and Johnson & Johnson (NYSE:JNJ) . Both the stocks carry the same rank as Seattle Genetics.