Seattle Genetics, Inc. is a biotechnology company developing monoclonal antibody-based therapies for treating cancer and autoimmune disease. The company is working to develop next generation monoclonal therapies called antibody-drug conjugates (ADCs). The technology links potent synthetic drugs with monoclonal antibodies. The company has collaborations with major industry players all over the world such as: Millennium Pharmaceuticals, Bayer AG (BAYRY), Celldex Therapeutic (BER:TCE1), GlaxoSmithKline (GSK), Genentech (DNA), and quite a few others. Leveraging these collaborations the company is working to navigate the high development costs and regulations that are indicative of the drug industry.
Seattle Genetics does not have any commercial products yet, but had revenue of $107.5 million for 2010. This was an increase of 107% from 2009. The company derived its revenue from payments that included technology access and maintenance fees, milestone and reimbursement payments from its collaborations. Its large jump from 2009 was primarily due to payments received from its collaborations with Genentech, Millennium, and other ADC collaborations.
For more detailed information on the FDA approval process, see also Clinical trials.
Developing a new drug is a time-consuming and costly endeavor. Hundreds of thousands of candidate compounds must be screened to identify a handful of potential drugs, and even fewer of these candidate drugs are found to be effective at treating a disease. The drug must then pass strict safety standards in several series of clinical trials. The entire process of developing a new drug and bringing it to the market takes up to 10 to 15 years and on average costs $1.3 billion.
Beginning in 2009, the FDA implemented a series of reforms that include stricter monitoring of drug adverse events, more funding for the agency, stronger ability to force product recalls, more scientific expertise within the agency, more transparency. Even before 2009 the result has been a much more conservative FDA, demanding more product information.
The various aspects of patent protection and the extremely high costs of researching and developing drugs marks the pharmaceutical industry with high risk and high competitiveness. It is important to keep in mind when considering a comparison of industry players that competition does not arise between each company as a whole, but rather between specific drug areas and their relative advantages in therapeutic treatment. Due to this fact many of Seattle Genetic's collaborators are competitors since they are developing therapies in similar disease areas. They include: