Pipeline and Collaborations Could Propel Seattle Genetics

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If there is such a thing as a business trifecta, Seattle Genetics is nearly there. The Washington state biotechnology company is focused on the development and commercialization of monoclonal antibody— based therapies for the treatment of cancer and autoimmune disease. And with a potent pipeline of potential products and numerous technology and marketing collaborations in place, the opportunities for growth are in the air.

“It’s a very exciting, interesting, and challenging time at Seattle Genetics right now,” said president and CEO Clay Siegall, PhD, emphasizing the “challenging” aspect. “We’re considering how we need to strategically grow our business, and at the same time, since we’re not profitable as a company at this point in our history, make sure we’re doing it in a way that we utilize our dollars wisely.”

Part of that strategy began last April, when the company entered into the first of two collaborations with Millennium Pharmaceuticals that involved the licensing of Seattle Genetics’ antibody-drug conjugate (ADC) technology. Then, in December 2009, a separate and much larger collaboration was entered into with Millennium to globally develop and commercialize brentuximab vedotin (SGN-35). Under the collaboration, Seattle Genetics received an upfront payment of $60 million while retaining full commercialization rights for the drug in the United States and Canada. Millennium receives exclusive rights to commercialize the product in all other countries.

“Our market cap right now is approximately $1 billion,” said Siegall, explaining the reasoning behind the second Millennium collaboration. “Our charges to go forward are not only to make great products to treat unmet medical needs for patients with diseases like cancer, but also to grow the company for our shareholders who are believing in us and investing in us.” According to Siegall, strategic alignment with Millennium, which is owned by Takeda Pharmaceutical Company, one of the largest pharmaceutical companies in the world and the largest in Japan, made sense. “It’s a very positive transaction for us and for them. It’s a win-win.”

Siegall explained that the data thus far on brentuximab vedotin, which is currently the focus of three phase III and phase II clinical trials, has been strong. As such, the company has informed Wall Street that it plans to release top-line data from its first pivotal trial during the second half of 2010. Additional data from other trials will follow as the indications for the product are broadened beyond the first indication of Hodgkin lymphoma. “Provided the data are sufficiently strong, and we have no reason to believe otherwise, we will try to turn around a New Drug Application filing in the first half of 2011 for our first product,” Siegall said.

Seattle Genetics and Millennium recently announced the initiation of a phase I clinical trial investigating a combination of brentuximab vedotin with chemotherapy as a front-line therapy for Hodgkin lymphoma. The trial is taking place at the Mayo Clinic in Rochester, Minnesota, and investigators plan to enroll 40 patients (ClinicalTrials.gov ID: r: NCT01060904).

And there is more in the pipeline. Lintuzumab (SGN-33) is currently in a late stage phase II clinical trial for the treatment of acute myeloid leukemia, and the company plans to “unblind the data” during the second quarter of 2010. A product the company calls SGN-75, its second ADC that has been developed internally (brentuximab being the first), is currently in phase I clinical trials for treating patients with renal cell cancer and non- Hodgkin lymphoma.

Siegall, of course, recognizes that not every product in the pipeline is going to become a huge commercial success. “There is substantial attrition in the biotech field as you develop products because these are tough diseases to treat,” he said. “But we feel that we have enough of a strong pipeline that even with the attrition that’s normally seen, we believe that Seattle Genetics, from a strategic standpoint, could be a multi-product company and become one of the key biotech companies that is making products that make a difference in patients’ lives.”