Seattle Genetics submits sBLA to FDA for ADCETRIS Seattle Genetics has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration supporting the use of ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL. The sBLA is based on results from a phase II clinical trial with two treatment arms. One arm evaluated retreatment with ADCETRIS in patients who previously responded to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse. The other arm allowed treatment extension and evaluated prolonged treatment with ADCETRIS beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this phase II trial. Preliminary data from this trial were previously reported at the 2011 American Society of Hematology Annual Meeting and at the 2012 American Society of Clinical Oncology Annual meeting.
On The Fly: Analyst Initiation Summary Today's noteworthy initiations include: AT&T (T) initiated with a Buy at DA Davidson... Abaxis (ABAX) initiated with an Underperform at Credit Suisse... Aratana Therapeutics (PETX) initiated with an Outperform at Credit Suisse... Care.com (CRCM) initiated with an Equal Weight at Morgan Stanley... GCP Applied Technologies (GCP) initiated with a Buy at Jefferies... Heritage-Crystal Clean (HCCI) initiated with a Buy at Roth Capital... IDEXX (IDXX) initiated with an Outperform at Credit Suisse... Nexvet Biopharma (NVET) initiated with an Outperform at Credit Suisse... PetMed Express (PETS) initiated with an Underperform at Credit Suisse... Phibro Animal Health (PAHC) initiated with an Outperform at Credit Suisse... Pure Storage (PSTG) initiated with a Perform at Oppenheimer... SeaWorld (SEAS) initiated with a Neutral at Janney Capital... Seattle Genetics (SGEN) initiated with an Overweight at Barclays... VCA Inc. (WOOF) initiated with an Outperform at Credit Suisse... Verizon (VZ) initiated with a Neutral at DA Davidson... Zoetis (ZTS) initiated with an Outperform at Credit Suisse.
Seattle Genetics to receive $20M milestone payment under ADCETRIS collaboration Seattle Genetics (SGEN) announced that it will receive a one-time $20M milestone payment under its ADCETRIS collaboration with Takeda Pharmaceutical Company Limited (TKPYY). The milestone was triggered by Takeda surpassing annual ADCETRIS net sales of $200M in its territory during 2015. The milestone will be recognized as royalty revenue in the first quarter of 2016. In addition, the company announced that the European Commission recently approved a Type II variation that includes data on the retreatment of adult patients with relapsed or refractory Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma who previously responded to ADCETRIS and who later relapse. The label update follows a positive opinion from the Committee for Medicinal Products for Human Use in October 2015.