Key Developments For Seattle Genetics
Seattle Genetics (SGEN.O) (Consolidated Issue listed on NASDAQ Global Market)
Seattle Genetics and Astellas Pharma Inc. Affiliate Expand Antibody-Drug Conjugate Collaboration
Seattle Genetics and Agensys, Inc., an Astellas Pharma Inc. affiliate, announced an expansion of the companies' antibody-drug conjugate (ADC) collaboration. Under the amended agreement, Agensys will pay a $12 million fee for exclusive rights to ADC licenses against additional antigen targets. Seattle Genetics also receives an option to co-develop another ADC at the time of investigational new drug (IND) submission. Under the expanded collaboration, Agensys receives the right to obtain exclusive ADC licenses for multiple additional targets in exchange for payment of the upfront fee. Seattle Genetics also receives an option for 50:50 cost and profit-sharing of a third ADC program at IND filing. The remaining ADC programs will be developed and commercialized exclusively by Agensys. Seattle Genetics is entitled to progress-dependent fees, payments and mid-single digit royalties on worldwide net sales of ADC products developed and commercialized solely by Agensys. Under the terms of the amendment, Seattle Genetics is eligible to receive up to $250 million in development milestones and $100 million in sales milestones if all of the additional ADC programs are successful. Agensys utilizes its portfolio of cancer targets to generate high affinity fully human, antibodies, and combines selected antibodies with the ADC technology to produce new cancer therapies. ADCs utilize the targeting ability of monoclonal antibodies to deliver potent, cell-killing payloads to specific cells.
Seattle Genetics Initiates Phase I Clinical Trial Of Antibody-Drug Conjugate SGN-75
Seattle Genetics announced that it has initiated a phase I clinical trial of SGN-75 for metastatic renal cell carcinoma and relapsed and refractory non-Hodgkin lymphoma. SGN-75 is an antibody-drug conjugate (ADC) targeting CD70 that utilizes the Company's technology. The single-agent phase I study is designed to enroll up to 80 patients at multiple centers in the United States. The trial will evaluate the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75 in order to identify a dose and schedule for future clinical trials. SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent, synthetic drug payload, monomethyl auristatin F (MMAF), using the Company's technology. The ADC is designed to be stable in the bloodstream, but to release its payload upon internalization into CD70-expressing tumor cells, resulting in targeted cell-killing.
Seattle Genetics Announces Discontinuation of Dacetuzumab Phase IIb Diffuse Large B-Cell Lymphoma Clinical Trial
Seattle Genetics announced that it has discontinued the SeaGen MARINER clinical trial based on a determination that the trial would be unlikely to meet its primary endpoint of superior complete response rate in the dacetuzumab combination arm as compared to the placebo combination arm. The SeaGen MARINER trial was a randomized, double-blind phase IIb clinical trial of dacetuzumab or placebo in combination with Rituxan® (rituximab) plus ifosfamide, carboplatin and etoposide (R-ICE) chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The trial was closed based upon a recommendation by the Independent Data Monitoring Committee (IDMC) following a pre-specified interim analysis conducted on Friday, October 2, 2009. As a result of the closure, dacetuzumab will no longer be provided to patients enrolled on the trial.
Seattle Genetics Reaffirms FY 2009 Revenue Guidance-Conference Call
Seattle Genetics announced that for fiscal 2009, it is tracking well to projected revenue guidance to be between $35 million and $40 million. According to Reuters Estimates, analysts are expecting the Company to report revenue of $38 million for the same period.
Seattle Genetics Achieves Milestone Under Antibody-Drug Conjugate Collaboration With Bayer Schering Pharma AG
Seattle Genetics announced that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Bayer Schering Pharma AG, Germany. The milestone was triggered by Bayer's submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for MN-IC, an ADC for solid tumors. Under the terms of the ADC collaboration agreement, Bayer has rights to use Seattle Genetics' ADC technology with antibodies against MN. Bayer is responsible for research, product development, manufacturing and commercialization of all products under the collaboration. Seattle Genetics receives material supply and annual maintenance fees as well as research support payments for any assistance provided to Bayer in developing ADC products. The antibody component of the ADC targeted to MN is derived from HuCAL technology that Bayer licensed from MorphoSys AG.
